ICB PHARMA Head Lice Treatment User Manual

INSTRUCTIONS
FOR USE
NITOLIC® with removal comb – medical device intended for the treatment
of head lice infestations (Pediculus humanus capitis).
HOW IT WORKS:
kills all active developmental stages of head lice
kills lice eggs (nits)
makes it easier to comb out lice and nits
!
Always read the instructions before use. For effective treatment please follow the instructions below:
• Keep these instructions for future use.
• Use only as directed and follow the directions in these instructions.
• If you have any further questions, ask your doctor, health care provider or pharmacist.
• If any adverse reaction occurs, discontinue use and consult a doctor.
U S E F U L I N F O R M AT I O N regarding head lice (Pediculus humanus capitis) and NITOLIC® medical device.
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
the 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 the 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 O F
THE HEAD LICE
Day
0
eggs are
laid
Days
7-8
nymphs
hatch
H E A D L I C E R E S I S TA N C E
A N D T H E N I TO L I C ®
MEDICAL DEVICE
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.
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)
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.
eggs are
laid
Days
33-35
end of
natural life
A louse's life cycle is ca. 40 days,
although it cannot normally stay outside
the human head for more than 24-48 hours.
NITOLIC® removal comb helps
remove lice and eggs (nits)
after treatment.
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®
thoroughly to the entire scalp and hair. First apply behind the ears, to the back of the neck, around the hair on the neck
and around the hair-line.
1
4
2
In case of long hair,
divide the hair into four
sections - from the
front to the back and
from ear to ear.
1h
5
After treatment, put
a shower cap on your
head for 1 hour.
(CAUTION! Please observe
the guidelines and exposure
time carefully).
Apply NITOLIC® thoroughly
on dry hair to the entire area
of the scalp and 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.
3
Remove the shower cap
and wash your hair with water
and shampoo.
Saturate the hair and
scalp with NITOLIC®
to ensure that all lice
and nits are
completely covered.
6
Remove the lice and
nits from your hair
using NITOLIC®
removal comb.
!
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.
If you have
any further questions,
consult your doctor,
health care provider
or pharmacist.
I M P O RTA 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® with removal comb 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 head lice treatment with NITOLIC® with removal comb, 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
Use only as directed, follow the directions in these instructions.
Avoid getting NITOLIC® 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® is for external use only. Do not apply to cuts, wounds or irritated skin.
Before using NITOLIC®, apply a small amount of NITOLIC® to your palm to check for any
adverse reaction.
Use treatment on children only under the direct supervision of an adult.
Do not use if allergic to any of
the ingredients in NITOLIC®.
Do not apply NITOLIC® to cuts,
wounds or irritated skin.
POSSIBLE
SIDE EFFECTS
irritation, redness and skin swelling.
In the unlikely event that such symptoms
occur, stop using NITOLIC®
immediately and contact your doctor.
Do not use NITOLIC® after
the expiry date shown on the pack.
Floors will become slippery if they come into contact with the medical device.
Wipe up spills immediately.
Do not use on children
under 2 years of age.
This medical device may react to certain hair care and hair tinting lotions.
M E D I C A L D E V I C E D E TA I L S
STORAGE
Store NITOLIC® in dry,
dark conditions,
at temperature between
5oC–40 oC. The empty
packaging is recyclable.
CONTENT
cyclomethicone,
polysorbate 80,
isopropyl myristate
Available packaging sizes*:
20 ml, 25 ml, 30 ml, 50 ml,
100 ml, 150 ml, 200 ml,
250 ml, 300 ml, 500 ml
*Not all packing sizes might
be available in certain markets.
MANUFACTURER
ICB PHARMA
Tomasz Świętosławski,
Paweł Świętosławski
Spółka Jawna
6a Moździerzowców St.
43-602 Jaworzno
Poland
SEE
THE LABEL
i
WE ARE COMMITTED TO YOUR SATISFACTION
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/PNG/04.2015
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