Generic Name: ivermectin
Date of Approval: February 7, 2012
Company: Sanofi Pasteur Inc.
Treatment for: Head Lice
FDA Approves Sklice Lotion
The U.S. Food and Drug Administration (FDA) has approved Sklice (ivermectin) lotion, 0.5% for the topical treatment of head lice, in patients 6 months of age and older. Effective and well-tolerated, Sklice Lotion treats lice in most patients with a single 10-minute application of the lotion, without nit combing.
Sklice Lotion contains a broad-spectrum antiparasitic agent, ivermectin, which was developed from a soil bacterium that produces a family of compounds (avermectins) shown to bind selectively and with high affinity to certain ion channels present in invertebrate nerve and muscle cells but not in mammals. The resulting increased permeability of the cell membrane causes paralysis and death in certain parasites.
Widespread oral use of ivermectin began in 1987 to control river blindness (onchocerciasis) in humans. More than one billion treatments of ivermectin tablets have been administered to help alleviate the suffering caused by river blindness and other parasitic conditions.
Sklice Lotion Patient Information
Important: For use on scalp hair and scalp only. Do not use ivermectin 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. It is used to treat head lice in people 6 months of age and older.
It is not known if it is safe and effective for children under 6 months of age.
Before using Sklice Lotion
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 it 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 health care provider if you are breastfeeding.
How should I use Sklice Lotion?
- Use 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 when your hair is dry.
- It is important to use enough lotion to completely coat all of your hair and scalp. Leave on your hair and scalp for a full 10 minutes.
- 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.
- Children will need an adult to apply Sklice Lotion for them.
- Do not swallow. If swallowed, call your healthcare provider or go to the nearest emergency room right away.
- Do not get the lotion into your eyes. If it gets in your eye, gently flush with water.
- Wash your hands after application.
When you complete your dose of Sklice Lotion, do not use again without talking to your healthcare provider first.
Sklice Lotion side effects
The most common side effects 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. 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.
See also: Side effects (in more detail)
How should I store Sklice Lotion?
- Store at room temperature between 68°F to 77°F (20°C to 25°C).
- Do not freeze.
- Safely throw away any unused Sklice Lotion.
Keep all medicines out of reach of children.
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 this lotion for a condition for which it was not prescribed. Do not give it 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.
Instructions for Use
Before you use Sklice Lotion, it is important that you read the Patient Information and the Instructions for Use. Be sure that you read, understand, and follow the 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 application.
- Use the top of cap to break the tamper seal on the tube.
- Apply lotion directly to dry hair and scalp.
- Completely cover your scalp and hair closest to the scalp first, and then apply outwards towards the ends of your hair.
- Rub Sklice Lotion throughout your hair.
- 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 and scalp.
- Allow it 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 the lotion.
- After 10 minutes, completely rinse the lotion from your hair and scalp using only water.
- You or anyone who helps you apply Sklice Lotion should wash their hands after application.
- Do not use 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.