(ivermectin) Lotion, 0.5%
Important: For use on scalp hair and scalp only. Do
not use SKLICE Lotion in your eyes, mouth or vagina.
Read the Patient Information that comes with SKLICE
Lotion. This leaflet does not take the place of talking to your healthcare
provider about your medical condition or treatment.
What is SKLICE Lotion?
SKLICE Lotion is a prescription medicine for topical use
on the hair and scalp only. SKLICE Lotion is used to treat head lice in people
6 months of age and older.
It is not known if SKLICE Lotion is safe and effective
for children under 6 months of age.
What should I tell my healthcare provider before using
Before using SKLICE Lotion, tell your healthcare provider
if you or your child:
- have any skin conditions or sensitivities,
- have any other medical conditions,
- are pregnant or plan to become pregnant. It is not known
if SKLICE Lotion can harm your unborn baby, and
- are breastfeeding or plan to breastfeed. It is not known
if SKLICE Lotion passes into your breast milk. Talk to your healthcare provider
if you are breastfeeding.
How should I use SKLICE Lotion?
- Use SKLICE Lotion exactly as prescribed. Your healthcare
provider will prescribe the treatment that is right for you. Do not change your
treatment unless you talk to your healthcare provider.
- Use SKLICE Lotion when your hair is dry.
- It is important to use enough SKLICE Lotion to completely
coat all of your hair and scalp. Leave SKLICE Lotion on your hair and scalp for
a full 10 minutes. See the detailed “Patient Instructions for Use” at the
end of this leaflet.
- You need to completely cover all the scalp and hair with
lotion. Make sure that you and anyone who helps you apply SKLICE Lotion reads and
understands this leaflet and the Patient Instructions for Use.
- Children will need an adult to apply SKLICE Lotion for
- Do not swallow SKLICE Lotion. If swallowed, call your
healthcare provider or go to the nearest emergency room right away.
- Do not get SKLICE Lotion into your eyes. If SKLICE Lotion
gets in your eye, gently flush with water.
- Wash your hands after applying SKLICE Lotion.
When you complete your dose of SKLICE Lotion, do not use
SKLICE Lotion again without talking to your healthcare provider first.
What are the possible side effects of SKLICE Lotion?
The most common side effects of SKLICE Lotion include:
- eye redness or soreness
- eye irritation
- dry skin
- burning sensation of the skin
Tell your healthcare provider if you have any side effect
that bothers you or that does not go away.
These are not all the possible side effects of SKLICE
Lotion. For more information, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects.
You may report side effects to the FDA at 1-800-FDA-1088.
How should I store SKLICE Lotion?
- Store SKLICE Lotion at room temperature between 68° to
77°F (20° to 25°C).
- Do not freeze SKLICE Lotion.
- Safely throw away any unused SKLICE Lotion.
Keep SKLICE Lotion and all medicines out of reach of
What are the ingredients in SKLICE Lotion?
Active ingredient: ivermectin
Inactive ingredients: water, olive oil, oleyl alcohol,
Crodalan AWS, lanolin alcohol, cyclomethicone, shea butter, sodium citrate,
sorbitan tristearate, methylparaben, propylparaben, and citric acid
General information about SKLICE Lotion
Medicines are sometimes prescribed for purposes other
than those listed in a Patient Information leaflet. Do not use SKLICE Lotion
for a condition for which it was not prescribed. Do not give SKLICE Lotion to
other people, even if they have the same symptoms you have. It may harm them.
This Patient Information leaflet summarizes the most important information
about SKLICE Lotion. If you would like more information, talk to your
healthcare provider. You can also ask your healthcare provider or pharmacist
for information about SKLICE Lotion that is written for health professionals.
Patient Instructions for Use
Before you use SKLICE Lotion, it is important that you
read the Patient Information and these Patient Instructions for Use. Be sure
that you read, understand, and follow these Patient Instructions for Use so
that you use SKLICE Lotion the right way. Ask your healthcare provider or
pharmacist if you have questions about the right way to use SKLICE Lotion.
- Your hair and scalp must be dry before applying SKLICE
- Use the top of cap to break the tamper seal on the tube
(see Figure A).
- Apply SKLICE Lotion directly to dry hair and scalp (see
Figure A and Figure B
- Completely cover your scalp and hair closest to the scalp
first, and then apply outwards towards the ends of your hair (see Figure C).
- Rub SKLICE Lotion throughout your hair (see Figure D).
Figure C and Figure D
- It is important to completely cover your entire head so
that all lice and eggs are exposed to the lotion. Be sure that each hair is
coated from the scalp to the tip.
- Use up to 1 entire tube (4 oz) to completely cover hair
- Allow SKLICE Lotion to stay on your hair and scalp for 10
minutes after it has been applied. Use a timer or clock. Start timing after you
have completely covered your hair and scalp with SKLICE Lotion (see Figure E).
- After 10 minutes, completely rinse SKLICE Lotion from
your hair and scalp using only water (see Figure F).
Figure E and Figure F
- You or anyone who helps you apply SKLICE Lotion should
wash their hands after application.
- Do not use SKLICE Lotion again without talking to your
healthcare provider first.
How do I stop the spread of lice?
To help prevent the spread of lice from one person to
another, here are some steps you can take:
- Avoid direct head-to-head contact with anyone known to
have live, crawling lice.
- Do not share combs, brushes, hats, scarves, bandannas,
ribbons, barrettes, hair bands, towels, helmets, or other hair-related personal
items with anyone else, whether they have lice or not.
- Avoid sleepovers and slumber parties during lice
outbreaks. Lice can live in bedding, pillows, and carpets that have recently
been used by someone with lice.
- After finishing treatment with lice medicine, check
everyone in your family for lice after one week. Be sure to talk to your
healthcare provider about treatments for those who have lice.
- Machine wash any bedding and clothing used by anyone
having lice. Machine wash at high temperatures (150°F) and tumble in a hot
dryer for 20 minutes.
This Patient Information has been approved by the U.S.
Food and Drug Administration.