INSTRUCTIONS FOR USE

INSTRUCTIONS
FOR USE
NITOLIC® head lice treatment system intended for the comprehensive treatment
of head lice infestations (Pediculus humanus capitis).
How it works:
!
kills lice eggs (nits)
makes it easier to comb out lice and nits
after treatment, eliminates head lice and nits from the environment of the infected person
kills all active developmental stages of head lice
Always read the instructions before use.
• Keep these instructions for future use.
• Use only as directed and follow the directions in these instructions.
• If you have any further questions, contact your doctor, health care provider or pharmacist.
• If any adverse reaction occurs, discontinue use and consult a doctor.
N I TO L I C h e a d l i c e t r e a t m e n t s y s t e m c o n t a i n s :
1
NITOLIC®
2
NITOLIC® nit remover
medical device intended for the treatment of head lice infestations (Pediculus humanus capitis)
7
2
3
intended for use as an aid in the treatment of pediculosis caused by head
lice (Pediculus humanus capitis). It facilitates removal of the eggs attached to the hair, making
combing and moisturizing easier.
3
NITOLIC® wash
4
NITOLIC® removal comb
laundry additive for the removal of head lice and their eggs from cloth (clothes, bed linen, etc.)
used by patients with head lice.
for visual diagnostic examination of the hair and removal of lice, eggs, and nits after treatment
5
6
7
5
6
NITOLIC® protective cap
Contact Tracking Chart
NITOLIC® booklet for children
1
4
this will make time pass more pleasantly for your child during treatment, it will also explain that
the head lice problem is not as scary as it seems to be
U S E F U L I N F O R M AT I O N regarding head lice and the NITOLIC® head lice treatment system.
The head louse is a small (2.0 to 4.7 mm), wingless
insect with a flattened profile. Head lice range in
colour from yellowish-white to dark brown and tend
to match the colour of the host's hair. Head lice feed
on human blood several times a day and live close to
the human scalp. They move about by clinging to
hair with three pairs of claw-like legs. The adult head
louse breathes through 7 paired spiracles on the
thorax and abdomen.
IOO%
all developmental stages
of head lice and eggs
The key characteristic of this
medical device for head lice
treatment is quick and even
spreading on the scalp and hair
NITOLIC® spreads quickly and evenly
on the scalp, tightly covering lice
(o-effect® technology).
By filling the spiracles of lice, it quickly
eliminates them.
L I F E C YC L E
OF HEAD LICE
Day
0
eggs are
laid
Days
7-8
nymphs
hatch
The human head louse attaches its eggs (7-10 a day) to the base of the hair close
to the scalp (it may lay up to 300 eggs during its life cycle).
These eggs (also called nits) look like tiny (ca. 0.8 mm) yellow, tan or brown oval dots
and have a special lid on the eggshell, which the young louse lifts when it hatches.
100
Days
8-16
development of the
nymphs (3 stages)
HEAD LICE RESISTANCE AND
THE NITOLIC® MEDICAL DEVICE
Days
17-19
reproduction
Days
19-32
Eggs are laid by the female close
to the base of the hair near the
scalp and they are firmly
cemented to the hair.
Head lice have developed resistance to traditional insecticides,
that act by disrupting their physiological processes, which results
in treatment failure. The mechanical blockage of the louse’s
breathing apparatus, the concept on which NITOLIC® is based,
eliminates the possibility of lice becoming resistant to this
specific treatment.
eggs are
laid
Days
33-35
end of
natural life
A louse's life cycle is ca. 40 days,
although it cannot normally survive for more
than 24-48 hours outside the human head.
up to 14 days.
NITOLIC® removal comb helps remove
lice and eggs (nits) after treatment.
nit remover
20 ml
NITOLIC® nit remover
dissolves the cement-like
substance that the louse uses
to attach eggs, and making
combing and removing eggs
easier after the treatment.
wash
20 ml
KEEP OUT OF REACH OF CHILDREN
NITOLIC® wash prevents head lice from
spreading. It is recommended for primary and
secondary prevention against head lice as
a laundry additive to wash personal items that
may have been in contact with the head of the
person with head lice (clothes, bed linen,
blankets, etc.)
DIRECTIONS FOR USE
IMPORTANT HINTS
To provide complete lice elimination and avoid a re-infestation, the treatment needs to be administered at the same time to all
members of the family who could have an infestation. Head lice treatment should be performed in good lighting. It is important
to apply the treatment from the scalp to the ends of the hair. For effective treatment apply NITOLIC® thorougly to the entire scalp
and hair. First apply behind the ear, to the back of the neck, around the hair on the neck and around the hair-line.
1
In case of long hair,
divide the hair into
four sections from the front to
the back and from
ear to ear.
5
Remove the
NITOLIC®
protective cap
and wash your
hair with water
and shampoo.
2
Apply NITOLIC®
thoroughly on dry hair
starting from the root
to the end of the hair.
First apply behind the ears,
to the back of the neck
and around the hair line.
6
Remove the lice and
nits from your hair
using NITOLIC®
removal comb.
Saturate the hair and
scalp with NITOLIC®
to ensure that all lice
and nits are
completely covered.
COMBING HINTS
Divide long hair into sections
and pin each section.
Lift a small section of hair from
the bigger section to make the
scalp visible.
Begin combing through strands
carefully, dragging NITOLIC®
removal comb firmly from the
root to the ends of the hair.
Pin back the strand you have
finished combing.
Wipe eggs and nits from the
teeth of the NITOLIC® removal
comb with a tissue.
nit remover
?
3
20 ml
How to remove nits from hair?
Depending on the length of the hair, nits can still remain
attached to the hair even after treatment.
NITOLIC® nit remover dissolves the cement-like substance that
the louse uses to attach eggs, thus making combing and removal
of the eggs easier with NITOLIC® removal comb. Information for
NITOLIC® nit remover is included on the device package.
4
1h
7
wash
20 ml
KEEP OUT OF REACH OF CHILDREN
After treatment, put
NITOLIC® protective
cap included in the
NITOLIC® head lice
treatment system on
your head for 1 hour.
CAUTION! Please observe
the guidelines and
exposure time carefully.
All cloth
(clothes, bed linens,
blankets, etc.) that
may have come in
contact with the
head of the person
with lice should be
washed in NITOLIC®
wash.
Product information
for NITOLIC® wash
is included on the
device package.
!
If you have any further
questions, consult
your doctor, health
care provider
or pharmacist.
I M P O R TA N T I N F O R M AT I O N
NITOLIC® has proven that even a single use of this device provides 100% efficacy against all active developmental stages of head lice including nits, with no requirement to repeat
the treatment.
The most common way of getting head lice is to come into contact with somebody who already has the condition, thus a re-infestation may occur, e.g. in nursery or at school.
It is important to inspect hair for lice carefully and regularly, at least once a week.
NITOLIC® head lice treatment system is a multiple use medical device. Unlike other head lice products, thanks to its specific mode of action, it eliminates the possibility of head lice
becoming resistant to the treatment.
NITOLIC® treatment causes the head lice eggs (nits) to dehydrate, thus resulting in a clicking sound when squeezed. Comb out lice eggs (nits) thoroughly after treatment.
For more information concerning NITOLIC® head lice treatment system, please visit www.nitolic.com
I N F O R M AT I O N A B O U T T H E A P P L I C AT I O N
WA R N I N G S
C O N T R A- I N D I C AT I O N S
NITOLIC® head lice treatment system use only as directed, follow the directions
in these instructions.
Avoid getting any device included in NITOLIC® head lice treatment system in the eyes,
or inside the mouth, nose or throat. In case of contact with eyes, rinse for 10 to 15 minutes
with plenty of water. If irritation persists, consult your doctor or pharmacist.
NITOLIC® head lice treatment system is for external use only. Do not apply to cuts,
wounds or irritated skin.
Before using NITOLIC® and NITOLIC® nit remover, apply a small amount of NITOLIC®
and NITOLIC® nit remover to your palm to check for any adverse reaction.
Use treatment on children only under the direct supervision of an adult.
POSSIBLE
SIDE EFFECTS
Do not use if allergic to any
of the ingredients in NITOLIC®
head lice treatment system.
Do not apply to cuts, wounds
or irritated skin.
irritation, redness and skin swelling.
In the unlikely event that such symptoms
occur, stop using NITOLIC®
head lice treatment system
immediately and contact your doctor.
Do not use any device included
in NITOLIC® head lice treatment
system after the expiry date
Use NITOLIC® head lice treatment system with extreme caution to prevent any leaks
or spills.
shown on the package.
The NITOLIC® and NITOLIC® nit remover devices may react to certain hair care and hair
tinting lotions.
Do not use on children
under 2 years of age.
IMPORTANT INFORMATION
CONTENT:
• NITOLIC®: cyclomethicone, • NITOLIC® wash:
polysorbate 80, isopropyl
1.25% benzyl benzoate,
myristate
0.02% 1,2-benzisothiazol-3
(2H)-one
• NITOLIC® nit remover:
aqua, acetic acid,
• NITOLIC® protective cap:
quaternium-91,
low-density polyethylene
behentrimonium chloride,
(LDPE) film, 100% natural
myrystyl myristate, cetearyl
rubber
alcohol, tocopheryl acetate,
fragrance
MANUFACTURER:
ICB PHARMA
Tomasz Świętosławski,
Paweł Świętosławski
Spółka Jawna
6a Moździerzowców St.
43-602 Jaworzno
Poland
STORAGE:
Store NITOLIC® head lice
treatment system in dry,
dark conditions, at
temperature between
5°C–40°C. The empty
packaging is recyclable.
SEE
THE LABEL
i
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ON THIS PRODUCT. SHARE YOUR OPINION WITH US AT:
@ [email protected]
© 2015 All rights reserved.
NITOLIC® is a registered trademark of the ICB PHARMA.
Issue date instruction: IFU/ZPN/03.2015