FREE BONUS offer! - Colgate Professional

Transcription

FLUORIDE
YOUR PARTNER IN ORAL HEALTH
Therapy Guide
FREE BONUS offer!
PARTNER IN ORAL®HEALTH
If you buyYOUR
48 units
of PreviDent home fluorides, you can receive:
2- PreviDent® Varnish boxes (50ct each)
Offer expires 12/31/2013
543-0159
Raspberry
Eligibility: New Offices that have not purchased PreviDent® home fluorides
in latest 12 months.
or call 1-800-2COLGATE
to speak to your Oral Care
Consultant today
www.colgateprofessional.com
©2013 Colgate Oral Pharmaceuticals, a subsidiary of Colgate-Palmolive Company, New York, NY 10022, USA
03/2013
SO407171
2013
IMPROVED
PreviDent® 5000 BOOSTER PLUS
1.1% Sodium Fluoride Anti-caries Toothpaste (Rx Only)
our most advanced FORMULA FOR
UNSURPASSED
Table of Contents
REMINERALIZATION*1
Fluoride dispersion........................... 4
Take-home fluoride therapy............. 5
In-office fluoride................................ 7
Catalog & plan pricing..................... 8
Plus Over 4X better remineralization †1
Plus 86% greater enamel fluoride uptake †2
Plus FluoriGard ™‡ Technology
Plus 20 years of PreviDent® leadership in Rx fluorides
Contains
tricalcium
phosphate
Important Safety Information: PreviDent ® 5000 Booster Plus (1.1% Sodium Fluoride) is a dental caries preventative toothpaste for adults and pediatric patients 6 years of age and older.
The product is for once daily, topical use. It is not to be swallowed. Allergic reactions and idiosyncrasies have been rarely reported. See page 3 for brief summary of risk information.
* Comparison vs ClinPro™ 5000 toothpaste and MI Paste Plus™ topical creme. † Comparison vs PreviDent® 5000 Booster. ‡ Optimized fluoride delivery system.
1. Data on file; Colgate-Palmolive, 2012. In vitro pH cycling model after 10 and 20 days. 2. Data on file; Colgate-Palmolive, 2012. In vitro standard method for enamel fluoride uptake.
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To Order: 1.800.372.4346
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3
Take-home fluoride therapy
®
Fluoride dispersion
®
Not all patients are the same... Choose the right PreviDent® 5000 for your patient!
4500
PreviDent® 5000
Liquid Gel Dentifrice
ppm fluoride release
4000
+26%
3500
3000
2500
2000
1500
NEW &
IMPROVED!
Colgate® PreviDent®
5000 Booster Plus
5000 Sensitive
1.1% sodium fluoride
Prescription strength
fluoride toothpaste formula
that delivers unsurpassed
remineralization.*
1.1% sodium fluoride,
5% potassium nitrate Prescription strength
fluoride toothpaste with
sensitivity relief in a
unique liquid gel formula.
5000 Dry Mouth
Colgate®PreviDent®
5000 Enamel Protect
An SLS-free prescription
strength fluoride toothpaste
specifically formulated for
dry mouth sufferers. 1.1% sodium fluoride,
5% potassium nitrate
Prescription strength
fluoride toothpaste
formulated to help
strengthen tooth enamel
with sensitivity relief.
1000
500
5000 ppm Toothpaste
0
0
5
10
15
20
25
30
Time (Seconds)
• Clinically proven technology to significantly
remineralize root caries by 38% in less than
3 months1
• Ideal therapy for patients with high
caries risk, crown & bridge work, and
orthodontic decalcification
• Liquid gel formula enables faster fluoride
dispersion than paste-form Rx toothpaste2
• Mild cleaning system with low level abrasion
• Helps reverse white spot lesions1
• One-step fluoride treatment to help improve
patient compliance
1. Beaglehole R, Benzian H, Crail J, Mackay J. The Oral Health Atlas: Mapping a Neglected Global Health Issue. Geneva & Brighton: FDI World Dental Education Ltd & Myriad
Editions; 2009. 2. Data on file; Colgate-Palmolive, 2012. In vitro pH cycling model after 10 and 20 days.
4
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To Order: 1.800.372.4346
*Data on file; Colgate-Palmolive, 2012. In vitro pH cycling model after 10 and 20 days. Comparison vs Clinpro™ 5000 toothpaste, MI Paste Plus™ topical creme and
original PreviDent® 5000 Booster
|
5
Take-home fluoride
In-office fluoride
PreviDent® Varnish
5% sodium fluoride
PreviDent® 5000 Plus®
PreviDent® Gel
Prescription strength fluoride toothpaste
shown to significantly remineralize root
caries and strengthen teeth.
An effective second fluoride
treatment after brushing with a
fluoride toothpaste.
Patient Condition
• Dentin hypersensitivity
• Post periodontal surgery
• Medium to high caries risk*
• Post scaling / root planing
• Root exposure
Mode of Action
Deposition of significant amounts of calcium fluoride that inhibit dentin fluid flow and provide a reservoir
of fluoride ions
Dental Professional
and Patient Benefits
•
•
•
•
•
PreviDent® Rinse
Gel-Kam® Gel
0.4% stannous fluoride
An effective second fluoride treatment
after brushing with a fluoride toothpaste
to remineralize enamel & provide
sensitivity relief.
6
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To Order: 1.800.372.4346
Once weekly regimen that
provides 4 times the fluoride
of an OTC fluoride rinse.
Ready-to-use unit dose treatment
Highest fluoride concentration available (22,600 ppm F-) as compared to non-varnish fluorides
Provides high concentration of fluoride at the enamel and exposed dentin surface
Dries transparent on teeth
Contains xylitol, a natural sweetener
* Use of fluoride varnish for caries prevention has been endorsed by the ADA Council of Scientific Affairs.
Although FDA has cleared fluoride varnishes to be used as cavity varnishes/liners and for the treatment of hypersensitive teeth, caries prevention is an “off-label” use because
FDA has not cleared it for this purpose.15
|
7
DESCRIPTION: Self-topical neutral fluoride toothpaste containing 1.1% (w/w) sodium fluoride and 5%
potassium nitrate.
®
®
Catalog & plan pricing
Take-Home Fluoride
Product
INDICATIONS AND USAGE: A dental caries preventive and sensitive teeth toothpaste; for twice daily self-applied
topical use, followed by rinsing. Helps reduce the painful sensitivity of the teeth to cold, heat, acids, sweets or contact
in adult patients and children 12 years of age and older. It is well established that 1.1% sodium fluoride is safe and
PRESCRIPTION STRENGTH
TOOTHPASTE FOR SENSITIVE TEETH
extraordinarily effective as a caries preventive when applied frequently with mouthpiece applicators.1-4 PreviDent® 5000
Sensitive brand of 1.1% sodium fluoride toothpaste with 5% potassium nitrate in a squeeze bottle is easily applied
onto a toothbrush. This prescription toothpaste should be used twice daily in place of your regular toothpaste unless otherwise instructed by your dental professional. May be
used in areas where drinking water is fluoridated since topical fluoride cannot produce fluorosis. (See WARNINGS for exception.)
CONTRAINDICATIONS: Do not use in pediatric patients under age 12 years unless recommended by a dentist or physician.
Item # Unit Minimums Catalog
1 12 48
Plan 96 144 288576
Booster Plus Spearmint
543-0080-D1 Booster Plus Fruitastic™
543-0079-D1
Sensitive
Active Ingredients: Sodium fluoride 1.1% (w/w),Potassium nitrate 5%
SENSITIVE
1.1% Sodium Fluoride
5% Potassium Nitrate
543-3243-D1
Dry Mouth 543-2898-D1 $8.49
$7.99 $7.49 $6.99 $6.49 $5.99 $5.49
Enamel Protect 543-0025-D1
5000 Plus - Spearmint
543-5917-D1
5000 Plus - Fruitastic™
543-9752-D1
WARNINGS: Not for systemic treatment - DO NOT SWALLOW. Keep out of reach of infants and children. Children under 12 years of age, consult a dentist or physician.
Note: Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. See your dentist if the problem persists or worsens. Do not use this product longer
than 4 weeks unless recommended by a dentist or physician.
PRECAUTIONS:
General: Not for systemic treatment. DO NOT SWALLOW.
Carcinogenesis, Mutagenesis, Impairment of Fertility: In a study conducted in rodents, no carcinogenesis was found in male and female mice and female rats treated with
fluoride at dose levels ranging from 4.1 to 9.1 mg/kg of body weight. Equivocal evidence of carcinogenesis was reported in male rats treated with 2.5 and 4.1 mg/kg of body
weight. In a second study, no carcinogenesis was observed in rats, males or females, treated with fluoride up to 11.3 mg/kg of body weight. Epidemiological data provide no
credible evidence for an association between fluoride, either naturally occurring or added to drinking water, and risk of human cancer.
Fluoride ion is not mutagenic in standard bacterial systems. It has been shown that fluoride ion has potential to induce chromosome aberrations in cultured human and rodent
cells at doses much higher than those to which humans are exposed. In vivo data are conflicting. Some studies report chromosome damage in rodents, while other studies using
similar protocols report negative results.
Potential adverse reproductive effects of fluoride exposure in humans has not been adequately evaluated. Adverse effects on reproduction were reported for rats, mice, fox, and
cattle exposed to 100 ppm or greater concentrations of fluoride in their diet or drinking water. Other studies conducted in rats demonstrated that lower concentrations of fluoride
(5 mg/kg of body weight) did not result in impaired fertility and reproductive capabilities.
Pregnancy: Teratogenic Effects: Pregnancy Category B. It has been shown that fluoride crosses the placenta of rats, but only 0.01% of the amount administered is
incorporated in fetal tissue. Animal studies (rats, mice, rabbits) have shown that fluoride is not a teratogen. Maternal exposure to 12.2 mg fluoride/kg of body weight (rats) or
13.1 mg/kg of body weight (rabbits) did not affect the litter size or fetal weight and did not increase the frequency of skeletal or visceral malformations. There are no adequate
and well-controlled studies in pregnant women. However, epidemiological studies conducted in areas with high levels of naturally fluoridated water showed no increase in birth
defects. Heavy exposure to fluoride during in utero development may result in skeletal fluorosis which becomes evident in childhood.
Nursing Mothers: It is not known if fluoride is excreted in human milk. However, many drugs are excreted in milk, and caution should be exercised when products containing
fluoride are administered to a nursing woman. Reduced milk production was reported in farm-raised fox when the animals were fed a diet containing a high concentration of
fluoride (98-137 mg/kg of body weight). No adverse effects on parturition, lactation, or offspring were seen in rats administered fluoride up to 5 mg/kg of body weight.
Pediatric Use: Safety and effectiveness in pediatric patients below the age of 12 years have not been established. Please refer to the CONTRAINDICATIONS and
WARNINGS sections.
Geriatric Use: Of the total number of subjects in clinical studies of 1.1% (w/v) sodium fluoride, 15 percent were 65 and over, while 1 percent were 75 and over. No overall
differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in
responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. This drug is known to be substantially excreted by
the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal
function, care should be taken in dose selection, and it may be useful to monitor renal function.5
ADVERSE REACTIONS: Allergic reactions and other idiosyncrasies have been rarely reported.
Gel - Fresh Mint
Gel - Very Berry
$6.29 $6.19 $5.99 $5.66 $5.03
543-8854-D1
Rinse
543-2879-D1 $8.69 Gel-Kam Gel - Mint
543-0562-D1
$8.39 $7.89 $7.30 $6.56 $5.79 $5.59 $5.29 $4.92 $4.61
Gel-Kam® Gel - Fruit & Berry 543-6567-D1
®
543-6347-D1
OVERDOSAGE: Accidental ingestion of large amounts of fluoride may result in acute burning in the mouth and sore tongue. Nausea, vomiting, and diarrhea may occur soon
after ingestion. (within 30 minutes) and are accompanied by salivation, hematemesis, and epigastric cramping abdominal pain. These symptoms may persist for 24 hours. If less
than 5 mg fluoride/kg body weight (i.e., less than 2.3 mg fluoride/lb body weight) have been ingested, give calcium (e.g., milk) orally to relieve gastrointestinal symptoms and
observe for a few hours. If more than 5 mg fluoride/kg body weight (i.e., more than 2.3 mg fluoride/lb body weight) have been ingested, induce vomiting, give orally soluble
calcium (e.g., milk, 5% calcium gluconate or calcium lactate solution) and immediately seek medical assistance. For accidental ingestion of more than 15 mg fluoride/kg of body
weight (i.e., more than 6.9 mg fluoride/lb body weight), induce vomiting and admit immediately to a hospital facility.
A treatment dose (a thin ribbon) of PreviDent® 5000 Sensitive contains approximately 2.5 mg fluoride. A 3.4 FL OZ (100 mL) bottle contains approximately 575 mg fluoride.
DOSAGE AND ADMINISTRATION: Follow these instructions unless otherwise instructed by your dental professional:
Adults and children 12 years of age and older: Apply at least a 1 inch strip of PreviDent® 5000 Sensitive onto a soft bristle toothbrush. Brush teeth thoroughly for at least 1
minute, expectorate, and rinse mouth thoroughly. Use twice a day (morning and evening) or as recommended by a dentist or physician. Make sure to brush all sensitive areas of
the teeth. Children under 12 years of age: Consult a dentist or physician.
Rev. 11/08
DESCRIPTION: Self-topical neutral fluoride toothpaste containing 1.1% (w/w) sodium fluoride and 5% potassium nitrate.
®
®
Item # Catalog
Box Minimums 1
3
Varnish - Raspberry 50 dose 543-0159-D1
Varnish - Mint 50 dose
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|
To Order: 1.800.372.4346
Plan 5
$87.99 $76.99 $65.99 543-0006-D1
Varnish - Raspberry 150 dose543-3558-D1
Varnish - Mint 150 dose
INDICATIONS AND USAGE: A dental caries preventive and sensitive teeth toothpaste; for twice daily self-applied topical
use, followed by rinsing. Helps reduce the painful sensitivity of the teeth to cold, heat, acids, sweets or contact in adult patients
and children 12 years of age and older. It is well established that 1.1% sodium fluoride is safe and extraordinarily effective as
a caries preventive when applied frequently with mouthpiece applicators.1-4 PreviDent® 5000 Enamel Protect brand of 1.1%
PRESCRIPTION STRENGTH
sodium fluoride toothpaste with 5% potassium nitrate in a squeeze bottle is easily applied onto a toothbrush. This prescription
TOOTHPASTE FOR SENSITIVE TEETH
toothpaste should be used twice daily in place of your regular toothpaste unless otherwise instructed by your dental
professional. May be used in areas where drinking water is fluoridated since topical fluoride cannot produce fluorosis. (See WARNINGS for exception.)
ENAMEL PROTECT
In-Office Fluoride
Product
Active Ingredients: Sodium fluoride 1.1% (w/w), Potassium nitrate 5%
543-2479-D1
$199.00
25
$59.39
WARNINGS: Not for systemic treatment - DO NOT SWALLOW. Keep out of reach of infants and children. Children under 12 years of age, consult a dentist or physician.
Note: Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. See your dentist if the problem persists or worsens. Do not use this product longer than 4
weeks unless recommended by a dentist or physician.
PRECAUTIONS:
fluoride at dose levels ranging from 4.1 to 9.1 mg/kg of body weight. Equivocal evidence of carcinogenesis was reported in male rats treated with 2.5 and 4.1 mg/kg of body weight. In a
second study, no carcinogenesis was observed in rats, males or females, treated with fluoride up to 11.3 mg/kg of body weight. Epidemiological data provide no credible evidence for an
association between fluoride, either naturally occurring or added to drinking water, and risk of human cancer.
Fluoride ion is not mutagenic in standard bacterial systems. It has been shown that fluoride ion has potential to induce chromosome aberrations in cultured human and rodent cells at
doses much higher than those to which humans are exposed. In vivo data are conflicting. Some studies report chromosome damage in rodents, while other studies using similar protocols
report negative results.
Potential adverse reproductive effects of fluoride exposure in humans has not been adequately evaluated. Adverse effects on reproduction were reported for rats, mice, fox, and cattle
exposed to 100 ppm or greater concentrations of fluoride in their diet or drinking water. Other studies conducted in rats demonstrated that lower concentrations of fluoride (5 mg/kg of
body weight) did not result in impaired fertility and reproductive capabilities.
Pregnancy: Teratogenic Effects: Pregnancy Category B. It has been shown that fluoride crosses the placenta of rats, but only 0.01% of the amount administered is incorporated
in fetal tissue. Animal studies (rats, mice, rabbits) have shown that fluoride is not a teratogen. Maternal exposure to 12.2 mg fluoride/kg of body weight (rats) or 13.1 mg/kg of body
weight (rabbits) did not affect the litter size or fetal weight and did not increase the frequency of skeletal or visceral malformations. There are no adequate and well-controlled studies
in pregnant women. However, epidemiological studies conducted in areas with high levels of naturally fluoridated water showed no increase in birth defects. Heavy exposure to fluoride
during in utero development may result in skeletal fluorosis which becomes evident in childhood.
Nursing Mothers: It is not known if fluoride is excreted in human milk. However, many drugs are excreted in milk, and caution should be exercised when products containing fluoride
are administered to a nursing woman. Reduced milk production was reported in farm-raised fox when the animals were fed a diet containing a high concentration of fluoride (98-137
mg/kg of body weight). No adverse effects on parturition, lactation, or offspring were seen in rats administered fluoride up to 5 mg/kg of body weight.
Pediatric Use: Safety and effectiveness in pediatric patients below the age of 12 years have not been established. Please refer to the CONTRAINDICATIONS and WARNINGS sections.
Geriatric Use: Of the total number of subjects in clinical studies of 1.1% (w/v) sodium fluoride, 15 percent were 65 and over, while 1 percent were 75 and over. No overall differences in
safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly
and younger patients, but greater sensitivity of some older individuals cannot be ruled out. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to
this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it
may be useful to monitor renal function.5
OVERDOSAGE: Accidental ingestion of large amounts of fluoride may result in acute burning in the mouth and sore tongue. Nausea, vomiting, and diarrhea may occur soon after
ingestion (within 30 minutes) and are accompanied by salivation, hematemesis, and epigastric cramping abdominal pain. These symptoms may persist for 24 hours. If less than 5 mg
fluoride/kg body weight (i.e., less than 2.3 mg fluoride/lb body weight) have been ingested, give calcium (e.g., milk) orally to relieve gastrointestinal symptoms and observe for a few
hours. If more than 5 mg fluoride/kg body weight (i.e., more than 2.3 mg fluoride/lb body weight) have been ingested, induce vomiting, give orally soluble calcium (e.g., milk, 5% calcium
gluconate or calcium lactate solution) and immediately seek medical assistance. For accidental ingestion of more than 15 mg fluoride/kg of body weight (i.e., more than 6.9 mg fluoride/
lb body weight), induce vomiting and admit immediately to a hospital facility.
A treatment dose (a thin ribbon) of PreviDent® 5000 Enamel Protect contains approximately 2.5 mg fluoride. A 3.4 FL OZ (100 mL) bottle contains approximately 575 mg fluoride.
1. Adults and children 12 years of age and older: Apply at least a 1 inch strip of PreviDent® 5000 Enamel Protect onto a soft bristle toothbrush. Brush teeth thoroughly for at least 1
minute, expectorate, and rinse mouth thoroughly.
2. U se twice a day (morning and evening) or as recommended by a dentist or physician. Make sure to brush all sensitive areas of the teeth. Children under 12 years of age: Consult a
dentist or physician.
Rev. 12/10
DESCRIPTION: Self-topical neutral fluoride dentifrice containing 1.1% (w/w) sodium fluoride for use as a dental caries
preventive in adults and pediatric patients.
®
®
Active Ingredient: Sodium fluoride 1.1% (w/w)
INDICATIONS AND USAGE: A dental caries preventive; for once daily self-applied topical use. It is well established
that 1.1% sodium fluoride is safe and extraordinarily effective as a caries preventive when applied frequently with
mouthpiece applicators.1-4 PreviDent® 5000 BoosterPlus brand of 1.1% sodium fluoride toothpaste in a squeeze bottle
is easily applied onto a toothbrush. This prescription toothpaste should be used once daily in place of your regular
toothpaste unless otherwise instructed by your dental professional. May be used in areas where drinking water is fluoridated since topical fluoride cannot produce fluorosis. (See
WARNINGS for exception.)
PRESCRIPTION STRENGTH TOOTHPASTE
WARNINGS: Prolonged daily ingestion may result in various degrees of dental fluorosis in pediatric patients under age 6 years, especially if the water fluoridation exceeds 0.6
ppm, since younger pediatric patients frequently cannot perform the brushing process without significant swallowing. Use in pediatric patients under age 6 years requires special
supervision to prevent repeated swallowing of toothpaste which could cause dental fluorosis. Pediatric patients under age 12 should be supervised in the use of this product.
Read directions carefully before using. Keep out of reach of infants and children.
PRECAUTIONS:
fluoride at dose levels ranging from 4.1 to 9.1 mg/kg of body weight. Equivocal evidence of carcinogenesis was reported in male rats treated with 2.5 and 4.1 mg/kg of body
weight. In a second study, no carcinogenesis was observed in rats, males or females, treated with fluoride up to 11.3 mg/kg of body weight. Epidemiological data provide no
credible evidence for an association between fluoride, either naturally occurring or added to drinking water, and risk of human cancer. Fluoride ion is not mutagenic in standard
bacterial systems. It has been shown that fluoride ion has potential to induce chromosome aberrations in cultured human and rodent cells at doses much higher than those to
which humans are exposed. In vivo data are conflicting. Some studies report chromosome damage in rodents, while other studies using similar protocols report negative results.
Potential adverse reproductive effects of fluoride exposure in humans have not been adequately evaluated. Adverse effects on reproduction were reported for rats, mice, fox, and
cattle exposed to 100 ppm or greater concentrations of fluoride in their diet or drinking water. Other studies conducted in rats demonstrated that lower concentrations of fluoride
(5 mg/kg of body weight) did not result in impaired fertility and reproductive capabilities.
Pregnancy: Teratogenic Effects: Pregnancy Category B. It has been shown that fluoride crosses the placenta of rats, but only 0.01% of the amount administered is
incorporated in fetal tissue. Animal studies (rats, mice, rabbits) have shown that fluoride is not a teratogen. Maternal exposure to 12.2 mg fluoride/kg of body weight (rats) or
Pediatric Use: The use of PreviDent® 5000 BoosterPlus in pediatric age groups 6 to 16 years as a caries preventive is supported by pioneering clinical studies with 1.1% sodium
fluoride gels in mouth trays in students age 11 to 14 years conducted by Englander et al.2-4 Safety and effectiveness in pediatric patients below the age of 6 years have not been
established. Please refer to the CONTRAINDICATIONS and WARNINGS sections.
the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal
after ingestion (within 30 minutes) and are accompanied by salivation, hematemesis, and epigastric cramping abdominal pain. These symptoms may persist for 24 hours. If less
than 5 mg fluoride/kg body weight (i.e., less than 2.3 mg fluoride/lb body weight) has been ingested, give calcium (e.g., milk) orally to relieve gastrointestinal symptoms and
observe for a few hours. If more than 5 mg fluoride/kg body weight (i.e., more than 2.3 mg fluoride/lb body weight) has been ingested, induce vomiting, give orally soluble
calcium (e.g., milk, 5% calcium gluconate or calcium lactate solution) and immediately seek medical assistance. For accidental ingestion of more than 15 mg fluoride/kg of body
weight (i.e., more than 6.9 mg fluoride/lb body weight), induce vomiting and admit immediately to a hospital facility.
A treatment dose (a thin ribbon) of PreviDent® 5000 BoosterPlus contains approximately 2.5 mg fluoride. A 3.4 FL OZ (100 mL) bottle contains approximately 605 mg fluoride.
1. Adults and pediatric patients 6 years of age or older, apply a thin ribbon of PreviDent® 5000 BoosterPlus to a toothbrush. Brush teeth thoroughly once daily for two minutes,
preferably at bedtime, in place of your regular toothpaste.
2. After use, adults expectorate. For best results, do not eat, drink, or rinse for 30 minutes. Pediatric patients, age 6-16, expectorate after use and rinse mouth thoroughly.
Rev. 07/12
|
9
DESCRIPTION: Self-topical neutral fluoride toothpaste containing 1.1% (w/w) sodium fluoride for use as a dental
caries preventative in adults and pediatric patients.
®
®
Active Ingredient: Sodium fluoride1.1% (w/w)
DRY MOUTH
INDICATIONS AND USAGE: A dental caries preventive; for once daily self-applied topical use. It is well established
that 1.1% sodium fluoride is safe and extraordinarily effective as a caries preventive when applied frequently with
mouthpiece applicators.1-4 PreviDent® 5000 Dry Mouth brand of 1.1% sodium fluoride toothpaste in a squeeze
bottle is easily applied onto a toothbrush. This prescription toothpaste should be used once daily in place of your
regular toothpaste unless otherwise instructed by your dental professional. May be used in areas where drinking
water is fluoridated since topical fluoride cannot produce fluorosis. (See WARNINGS for exception.)
*Formulated for Dry Mouth Sufferers
WARNINGS: Prolonged daily ingestion may result in various degrees of dental fluorosis in pediatric patients under age 6 years, especially if the water fluoridation exceeds
0.6 ppm, since younger pediatric patients frequently cannot perform the brushing process without significant swallowing. Use in pediatric patients under age 6 years requires
special supervision to prevent repeated swallowing of toothpaste which could cause dental fluorosis. Pediatric patients under age 12 should be supervised in the use of this
product. Read directions carefully before using. Keep out of reach of infants and children.
and cattle exposed to 100 ppm or greater concentrations of fluoride in their diet or drinking water. Other studies conducted in rats demonstrated that lower
concentrations of fluoride (5 mg/kg of body weight) did not result in impaired fertility and reproductive capabilities.
Pregnancy: Teratogenic Effects: Pregnancy Category B. It has been shown that fluoride crosses the placenta of rats, but only 0.01% of the amount
administered is incorporated in fetal tissue. Animal studies (rats, mice, rabbits) have shown that fluoride is not a teratogen. Maternal exposure to 12.2 mg
fluoride/kg of body weight (rats) or 13.1 mg/kg of body weight (rabbits) did not affect the litter size or fetal weight and did not increase the frequency of
skeletal or visceral malformations. There are no adequate and well-controlled studies in pregnant women. However, epidemiological studies conducted in
areas with high levels of naturally fluoridated water showed no increase in birth defects. Heavy exposure to fluoride during in utero development may result
in skeletal fluorosis which becomes evident in childhood.
Nursing Mothers: It is not known if fluoride is excreted in human milk. However, many drugs are excreted in milk, and caution should be exercised when
products containing fluoride are administered to a nursing woman. Reduced milk production was reported in farm-raised fox when the animals were fed a
diet containing a high concentration of fluoride (98-137 mg/kg of body weight). No adverse effects on parturition, lactation, or offspring were seen in rats
administered fluoride up to 5 mg/kg of body weight.
Pediatric Use: The use of PreviDent® 5000 Plus® in pediatric age groups 6 to 16 years as a caries preventive is supported by pioneering clinical studies
with 1.1% sodium fluoride gels in mouth trays in students age 11-14 years conducted by Englander, et al.2,3,4 Safety and effectiveness in pediatric patients
below the age of 6 years have not been established. Please refer to the Contraindications and Warnings sections.
Geriatric Use: Of the total number of subjects in clinical studies of 1.1% (w/w) sodium fluoride, 15 percent were 65 and over, while 1 percent were 75
and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience
has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal
function.® Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor
renal function.5
PRECAUTIONS:
Carcinogenesis, Mutagenesis, Impairment of Fertility: In a study conducted in rodents, no carcinogenesis was found in male and female mice and female rats treated
®
with fluoride at dose levels ranging
from 4.1 to 9.1 mg/kg of body weight. Equivocal evidence of carcinogenesis ®was reported in male rats treated with 2.5 and 4.1 mg/kg of
body weight. In a second study, no carcinogenesis was observed in rats, males or females, treated with fluoride up to 11.3 mg/kg of body weight. Epidemiological data provide
no credible evidence for an association
® between fluoride, either naturally occurring or added to drinking water, and risk®of human cancer.
®
ADVERSE REACTIONS:
Allergic reactions and other idiosyncrasies have been rarely reported.
Fluoride ion is not mutagenic in standard bacterial systems. It has been shown that fluoride ion has potential to induce chromosome aberrations in cultured human and rodent
cells at doses much higher than those to which humans are exposed. In vivo data are conflicting. Some studies report chromosome damage in rodents, while other studies using
OVERDOSAGE: Accidental ingestion of large amounts of fluoride may result in acute burning in the mouth and sore tongue. Nausea, vomiting, and
similar protocols report negative results.
diarrhea may occur soon after ingestion (within 30 minutes) and are accompanied by salivation, hematemesis, and epigastric cramping abdominal pain.
Potential adverse reproductive effects of fluoride exposure in humans has not been adequately evaluated. Adverse effects on reproduction were reported for rats, mice, fox,
symptoms may persist for 24 hours. If less than 5 mg
fluoride/kg
body
weight (i.e., less than 2.3 mg fluoride/lb1.1
body
weight) have
been ingested, give
% Sodium
1.1%
Fluoride
1.1
% Sodium
Fluoride
% Sodium
Fluoride
1.1%water.
Sodium
and1.1
cattle
exposed toFluoride
100 ppm or greater concentrations of fluoride in their diet or drinking
OtherFluoride
studies conducted in rats demonstrated that lower concentrations
of SodiumThese
calcium (e.g., milk) orally to relieve gastrointestinal symptoms
and observe for a few hours. If more than 5 mg fluoride/kg
body weight (i.e., more than 2.3
fluoride
(5 mg/kg of STRENGTH
body weight)
did not result in impaired fertility and reproductive capabilities.
PRESCRIPTION
TOOTHPASTE
Non-abrasive formula is gentle
TOOTHPASTE
teeth and or
gums
mg fluoride/lb
body weight) have been ingested, induce vomiting, give orally soluble calcium (e.g., milk, 5% calciumon
gluconate
calcium lactate solution)
PRESCRIPTION
Pregnancy: Teratogenic Effects: Pregnancy Category B. It has been shown that fluoride
crosses theSTRENGTH
placenta of rats, but only 0.01% of the amount administered is PRESCRIPTION STRENGTH
FOR SENSITIVE TEETH
and immediately seek medical assistance. For accidental ingestion of more than 15 mg fluoride/kg of body weight (i.e., more than 6.9 mg fluoride/lb body
incorporated in fetal tissue. Animal studies (rats, mice, rabbits) have shown that fluorideTOOTHPASTE
is not a teratogen.
Maternal exposure to 12.2 mg fluoride/kg of body weight (rats) or
weight), induce vomiting and admit immediately to a hospital facility. A treatment dose (a thin ribbon) of PreviDent® 5000 Plus® contains 2.5 mg fluoride. A
1.8 oz. tube contains 255 mg fluoride.
1. Adults and pediatric patients 6 years of age or older, apply a thin ribbon of PreviDent® 5000 Plus® to a toothbrush. Brush thoroughly once daily for two
minutes, preferably at bedtime.
Pediatric Use: The use of PreviDent® 5000 Dry Mouth in pediatric age groups 6 to 16 years as a caries preventive is supported by pioneering clinical studies with 1.1% sodium
2.After use, adults expectorate. For best results, do not eat, drink, or rinse for 30 minutes. Pediatric patients, age 6-16, expectorate after use and rinse
fluoride gels in mouth trays in students age 11 to 14 years conducted by Englander et al.2-4 Safety and effectiveness in pediatric patients below the age of 6 years have not been
mouth thoroughly.
established. Please refer to the CONTRAINDICATIONS and WARNINGS sections.
REV 05/03
the kidney, and the risk of toxic reactions to this drug may be greater
in patients with impaired renal function. Because elderly patients are more likely to have decreased renal
DESCRIPTION: Self-topical neutral fluoride gel containing 1.1% sodium fluoride for use as a dental
®
caries preventive in pediatric patients and adults. This prescription product is not a dentifrice.
SENSITIVE
®
EETH
DRY MOUTH
® been rarely reported.
ADVERSE REACTIONS: Allergic reactions and other idiosyncrasies have
after ingestion (within 30 minutes) and are accompanied by salivation, hematemesis, and epigastric cramping abdominal pain. These symptoms may persist for 24 hours. If less
than 5 mg fluoride/kg body weight (i.e., less than 2.3 mg fluoride/lb body weight) have been ingested, give calcium (e.g., milk) orally to relieve gastrointestinal symptoms and
%fluoride/kg
Sodium body
Fluoride
1.1
% Sodium
Fluoride
observe for a few hours. If more than 1.1
5 mg
weight (i.e., more than 2.3 mg fluoride/lb body weight) have
been
ingested, induce
vomiting, give orally soluble
PRESCRIPTION
TOOTHPASTE
calcium (e.g., milk, 5% calcium gluconate or calcium lactate solution) and immediately seek medical assistance. For accidental
ingestion STRENGTH
of more than
15 mg fluoride/kg of body
weight (i.e., more than 6.9 mg fluoride/lb
body weight), induce vomiting and admit immediately to a hospital facility.
A treatment dose (a thin ribbon) of PreviDent® 5000 Dry Mouth contains approximately 2.5 mg fluoride. A 3.4 FL OZ (100 mL) bottle contains approximately 608 mg fluoride.
ACTIVE INGREDIENTS: Sodium Fluoride (NaF) 1.1% (w/v).
DRY MOUTH
1.Adults and pediatric patients 6 years of age or older, apply a thin ribbon of PreviDent® 5000 Dry Mouth to a toothbrush. Brush thoroughly once daily for two minutes,
preferably at bedtime, in place of your regular toothpaste.
2.After use, adults expectorate. For best results, do not eat, drink, or rinse for 30 minutes. Pediatric patients, ages 6-16 years of age, expectorate after use and rinse mouth
thoroughly.
Rev. 11/08
DESCRIPTION: Self-topical neutral fluoride dentifrice containing 1.1% (w/w) sodium fluoride for use as a
dental caries preventive in adults and pediatric patients.
ACTIVE INGREDIENT: Sodium Fluoride 1.1% (w/w).
INDICATIONS AND USAGE: A dental caries preventive; for once daily self-applied topical use. It is well
established that 1.1% sodium fluoride is safe and extraordinarily effective as a caries preventive when
1-4
®
0.2%
Fluoride
applied frequently
with mouthpiece
Plus®Neutral
brand of Sodium
1.1% sodium
fluoride
1.1% Sodium
Fluoride applicators. PreviDent 5000
in a squeeze-tube
is easily applied onto a toothbrush. This prescription dental cream should be used once
on teeth
and gums
daily in place
of your
regular toothpaste unless otherwise instructed by your dental professional. May be
used in areas where drinking water is fluoridated since topical fluoride cannot produce fluorosis. (See
WARNINGS for exception.)
WARNINGS: Prolonged daily ingestion may result in various degrees of dental fluorosis in pediatric patients under age 6 years, especially if the water
fluoridation exceeds 0.6 ppm, since younger pediatric patients frequently cannot perform the brushing process without significant swallowing. Use in
pediatric patients under age 6 years requires special supervision to prevent repeated swallowing of dental cream which could cause dental fluorosis. Read
directions carefully before using. Keep out of reach of infants and children.
PRECAUTIONS:
Carcinogenesis, Mutagenesis, Impairment of Fertility: In a study conducted in rodents, no carcinogenesis was found in male and female mice and
female rats treated with fluoride at dose levels ranging from 4.1 to 9.1 mg/kg of body weight. Equivocal evidence of carcinogenesis was reported in male
rats treated with 2.5 and 4.1 mg/kg of body weight. In a second study, no carcinogenesis was observed in rats, males or females, treated with fluoride up
to 11.3 mg/kg of body weight. Epidemiological data provide no credible evidence for an association between fluoride, either naturally occurring or added
to drinking water, and risk of human cancer. Fluoride ion is not mutagenic in standard bacterial systems. It has been shown that fluoride ion has potential
to induce chromosome aberrations in cultured human and rodent cells at doses much higher than those to which humans are exposed. In vivo data are
conflicting. Some studies report chromosome damage in rodents, while other studies using similar protocols report negative results. Potential adverse
reproductive effects of fluoride exposure in humans has not been adequately evaluated. Adverse effects on reproduction were reported for rats, mice, fox,
10
|
To Order: 1.800.372.4346
on teeth and gums
INDICATIONS AND USAGE: A dental caries preventive, for once daily self-applied topical use. It is well
0.63% Stannous
established that 1.1% sodium fluoride is safe and extraordinarily Fluoride
effective asConcentrate
a caries preventive when
Neutral
Sodium Fluoride
in a squeeze-tube
is easily applied onto
applied0.2%
frequently
with mouthpiece
applicators.1-4 PreviDent® GelORAL
CARE RINSE
a toothbrush as well as a mouthpiece tray. This prescription dental gel should be used once daily following
use of a regular toothpaste unless otherwise instructed by your dental professional.
CONTRAINDICATIONS: Do not use in pediatric patients under age 6 years unless recommended by a
dentist or physician.
WARNINGS: Prolonged daily ingestion may result in various degrees of dental fluorosis in pediatric patients under age 6 years, especially in the areas with
high fluoride concentration in drinking water. Use in pediatric patients under age 6 years requires special supervision to prevent repeated swallowing of gel.
Read directions carefully before using. Keep out of reach of infants and children.
PRECAUTIONS:
Carcinogenesis, Mutagenesis, Impairment of Fertility: In a study conducted in rodents, no carcinogenesis was found in male and female mice and
female rats treated with fluoride at dose levels ranging from 4.1 to 9.1 mg/kg of body weight. Equivocal evidence of carcinogenesis was reported in male
rats treated with 2.5 and 4.1 mg/kg of body weight. In a second study, no carcinogenesis was observed in rats, males or females, treated with fluoride up
to 11.3 mg/kg of body weight. Epidemiological data provide no credible evidence for an association between fluoride, either naturally occurring or added to
drinking water, and risk of human cancer.
Fluoride ion is not mutagenic in standard bacterial systems. It has been shown that fluoride ion has potential to induce chromosome aberrations in cultured
0.63%
Stannous
human and
rodent Stannous
cells
at doses much higher than those to which 0.4%
humansStable
are exposed.
In vivoFluoride
data are conflicting. Some studies report chromosome
Fluoride
Concentrate
PREVENTATIVE
TREATMENT
GEL adverse reproductive effects of fluoride exposure in
damage in rodents, while other studies using similar protocols report
negative results.
Potential
Acidulated Phosphate Fluoride Solution
ORAL CARE RINSE
humans has not been adequately evaluated. Adverse effects on reproduction were reported for rats, mice, fox, and cattle exposed to 100 ppm or greater
concentrations of fluoride in their diet or drinking water. Other studies conducted in rats demonstrated that lower concentrations of fluoride (5 mg/kg of
body weight) did not result in impaired fertility and reproductive capabilities.
fluoride/kg of body weight (rats) or 13.1 mg/kg of body weight (rabbits) did not affect the litter size or fetal weight and did not increase the frequency of
skeletal or visceral malformations. There are no adequate and well-controlled studies in pregnant women. However, epidemiological studies conducted in
areas with high levels of naturally fluoridated water showed no increase in birth defects. Heavy exposure to fluoride during in utero development may result
in skeletal fluorosis which becomes evident in childhood.
Pediatric Use: The use of PreviDent® Brush-On Gel in pediatric age groups 6 to 16 years as a caries preventive is supported by pioneering clinical studies
with 1.1% sodium fluoride gels in mouth trays in students age 11-14 years conducted by Englander, et al.2,3,4 Safety and effectiveness in pediatric patients
below the age of 6 years have not been established. Please refer to the Contraindications and Warnings sections.
Geriatric Use: Of the total number of subjects in clinical studies of 1.1% (w/v) sodium fluoride, 15 percent were 65 and over, while 1 percent were 75 and
over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience
function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor
renal function.
Overdosage: Accidental ingestion of large amounts of fluoride may result in acute burning in the mouth and sore tongue. Nausea, vomiting, and diarrhea
may occur soon after ingestion (within 30 minutes) and are accompanied by salivation, hematemesis, and epigastric cramping abdominal pain. These
symptoms may persist for 24 hours. If less than 5 mg fluoride/kg body weight (i.e., less than 2.3 mg fluoride/lb body weight) have been ingested, give
calcium (e.g., milk) orally to relieve gastrointestinal symptoms and observe for a few hours. If more than 5 mg fluoride/kg body weight (i.e., more than 2.3 mg
fluoride/lb body weight) have been ingested, induce vomiting, give orally soluble calcium (e.g., milk, 5% calcium gluconate or calcium lactate solution) and
immediately seek medical assistance. For accidental ingestion of more than 15 mg fluoride/kg of body weight (i.e., more than 6.9 mg fluoride/lb body weight),
induce vomiting and admit immediately to a hospital facility. A treatment dose (a thin ribbon) of PreviDent® Gel contains approximately 2 mg fluoride. A 0.8
oz. tube contains approximately 104 mg fluoride. A 2 oz. tube contains approximately 266 mg fluoride.
1.After brushing thoroughly with toothpaste, rinse as usual. Adults and pediatric patients 6 years of age or older, apply a thin ribbon of gel to the teeth with a
toothbrush or mouth trays once daily for at least one minute, preferably at bedtime.
2. After use, adults expectorate gel. For best results, do not eat, drink, or rinse for 30 minutes. Pediatric patients, age 6-16, expectorate gel after use and rinse
mouth thoroughly.
REV 05/03
DESCRIPTION: PreviDent® Rinse brand of 0.2% neutral sodium fluoride is a mint-flavored, neutral,
aqueous solution containing 6% alcohol.
0.2% Neutral Sodium Fluoride
Description: PreviDent 5% Sodium Fluoride Varnish contains 22,600 ppm fluoride. It has a strong
desensitizing action when applied to dental surfaces, treating hypersensitivity quickly and easily. This
product sets rapidly on contact with saliva, resulting in patient comfort and acceptance. PreviDent®
Varnish will leave a thin film on the teeth after application.
Composition: 1 mL of this suspension contains 50 mg sodium fluoride, equivalent to 22.6 mg fluoride
ion, in an alcoholic solution of natural resins.
5% Sodium Fluoride
Indications: PreviDent® Varnish is a topical fluoride for the treatment of dentinal and post
operative sensitivity.
Dosage: To be administered by the dental professional for the treatment of dentin hypersensitivity. The
fluoride content in this product is dosed in such a way that neither acute nor chronic side effects are to be expected if applied according to the instructions.
Directions for Use: Please observe when treating hypersensitive teeth
1. Wash and dry tooth surface.
2. Mix well prior to application.
3. Apply product with supplied brush in theconventional manner.
4. Thin excess varnish on the tooth’s surface untilthe varnish surface is dry.
5. Covers even moist teeth with a coating of varnishfilm for several hours which occludes the openings of the dental tubules.
6. Hardens on contact with saliva so the patient may leave immediately after application of the product.
7. It is recommended that the patient be instructed to eat only soft foods for 2 hours after treatment.
Contraindications: Ulcerative gingivitis and stomatitis
Active Ingredient: Sodium Fluoride 0.2% (w/v).
Interactions: When PreviDent® Varnish is applied, other fluoride preparations such as fluoride gels should not be administered during the same day. The
routine use of fluoride tablets should be interrupted for several days after treatment.
INDICATIONS AND USAGE: A dental caries preventive, for weekly self-applied topical use. Weekly
0.63%
Stannous
0.4%dental
Stable
Stannous
Fluoride
rinsingFluoride
with a neutral
0.2% sodium fluoride solution protects against
caries
in pediatric
patients.
Concentrate
PREVENTATIVE
TREATMENT
administration
andGEL
favorable
PreviDent® Rinse provides a ready-to-use preparation for convenient
ORAL CARE RINSE
compliance. May be used in areas where drinking water is fluoridated since topical fluoride cannot
produce fluorosis. (See WARNINGS for exception.)
Adverse Reactions: Edematous swellings have been reported only in rare instances in someVA
fluoride
products, especially after application to
R N ISvarnish
H
extensive surfaces. Dyspnea, although extremely rare, has occurred in asthmatic children. Nausea has been reported when extensive applications have been
5% Sodium Fluoride
5%
Sodium
Fluoride
made.
If
required,
varnish
film
can
be
removed
with
a
thorough
brushing.
Store
in
a
cool,
dry
place.
Acidulated Phosphate Fluoride Solution
Rev. 12/08
CONTRAINDIACTIONS: Do not use in patients with dysphagia. Do not use in pediatric patients under age 6 years unless recommended by a dentist
or physician.
WARNINGS: Keep out of reach of infants and children. Pediatric patients under age 12 should be supervised in the use of this product. Patients under age 6
require special supervision to prevent repeated swallowing of rinse since they frequently swallow significant amounts while rinsing. Prolonged daily ingestion
may result in dental fluorosis in patients under age 6, especially if the water fluoridation exceeds 0.6 ppm. Read directions carefully before using.
DO NOT USE IF PRINTED NECK BAND IS BROKEN OR MISSING
PRECAUTIONS:
Carcinogenesis, Mutagenesis, Impairment of Fertility: No carcinogenesis was found in mice or female rats treated with fluoride at doses ranging from
4.1 to 9.1 mg/kg of body weight. Equivocal evidence of carcinogenesis was reported in male rats treated with 2.5 and 4.1 mg/kg of body weight. In another
study, no carcinogenesis was observed in rats treated with fluoride up to 11.3 mg/kg of body weight. Epidemiological data provide no credible evidence for an
association between fluoride, either naturally occurring or added to drinking water, and risk of human cancer.
Fluoride ion is not mutagenic in standard bacterial systems but has been associated with chromosome aberrations in cultured human and rodent cells at
doses much higher than expected human exposures. Some in vivo report chromosome damage in rodents while other studies using similar protocols report
negative results.
Potential
adverseStannous
reproductive
effects of fluoride exposure in humans has not been adequately evaluated. Adverse effects on reproduction were reported
0.4% Stable
Fluoride
V A R N IS H
for
rats, mice,TREATMENT
fox, and cattle
diet or drinking water. Other studies conducted in rats
5% Sodium Fluoride
PREVENTATIVE
GEL exposed to 100 ppm or greater concentrations of fluoride in their 5%
Sodium Fluoride
Fluoride
demonstrated that lower concentrations of fluoride (5Acidulated
mg/kg of Phosphate
body weight)
did Solution
not result in impaired fertility and reproductive capabilities
fluoride/kg of body weight (rats) or 13.1 mg/kg of body weight (rabbits) did not affect litter size or fetal weight and did not increase frequency of skeletal
or visceral malformations. There are no adequate and well-controlled studies in pregnant women. However, epidemiological studies conducted in areas with
high levels of naturally fluoridated water showed no increase in birth defects. Heavy exposure to fluoride during in utero development may result in skeletal
fluorosis which becomes evident in childhood.
Pediatric Use: The use of PreviDent® Rinse as a weekly caries preventive in pediatric patients aged 6 to 16 years is supported by adequate and wellcontrolled clinical studies in students aged 6 to 12 years.1-3 Safety and effectiveness in pediatric patients below the age of 6 years have not been established.
Please refer to the CONTRAINDICATIONS and WARNINGS sections.
Geriatric Use: Of the total number of subjects in clinical studies of 1.1% (w/v) sodium fluoride, 15 percent were 65 and over, while 1 percent were 75
and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience
V A R N IS H
function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor
5% Sodium Fluoride
5% Sodium
renalFluoride
function.
ADVERSE REACTIONS: In patients with mucositis, gingival tissues may be hypersensitive to flavor or alcohol present in formulation. Allergic reactions and
other idiosyncrasies are rarely reported.
OVERDOSAGE: Accidental ingestion of large amounts of fluoride may result in acute burning in the mouth and sore tongue. Nausea, vomiting, and diarrhea
may occur soon after ingestion (within 30 minutes) and are accompanied by salivation, hematemesis, and epigastric cramping abdominal pain. These
symptoms may persist for 24 hours. If less than 5 mg fluoride/kg body weight (i.e., less than 2.3 mg fluoride/lb body weight) has been ingested, give calcium
(e.g., milk) orally to relieve gastrointestinal symptoms and observe for a few hours. If more than 5 mg fluoride/kg body weight (i.e., more than 2.3 mg fluoride/
lb body weight) has been ingested, induce vomiting, give orally soluble calcium (e.g., milk, 5% calcium gluconate or calcium lactate solution) and immediately
seek medical assistance. For accidental ingestion of more than 15 mg fluoride/kg of body weight (i.e., more than 6.9 mg fluoride/lb body weight), induce
vomiting and admit immediately to a hospital facility.
A treatment dose (10 mL or two teaspoonfuls) of PreviDent® Rinse contains approximately 9 mg fluoride. One 16 fl. oz. bottle contains approximately
429 mg fluoride.
DOSAGE AND ADMINISTRATION: For caries — Adults and pediatric patients over age 6 years, 2 teaspoonfuls (10 mL). Once a week, preferably at bedtime
after thoroughly brushing the teeth, rinse vigorously around and between the teeth for one minute, then expectorate. DO NOT SWALLOW. For maximum
benefit, do not eat, drink, or rinse mouth for at least 30 minutes afterwards.
Rev. 02/09
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