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SKLICE®


(ivermectin) Lotion, 0.5% for topical use


Brief Summary of Prescribing Information 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 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 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.


• SKLICE Lotion is for use on scalp hair and scalp only. Do not use SKLICE Lotion in your eyes, mouth or vagina. • 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.


• 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 the Instructions for Use.


• Children will need an adult to apply SKLICE Lotion for them. • 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. SKLICE Lotion should be used in the context of an overall lice management program:


• Wash (in hot water) or dry-clean all recently worn clothing, hats, used bedding and towels. • Wash personal care items such as combs, brushes and hair clips in hot water. • A fine-tooth comb or special nit comb may be used to remove dead lice and nits.


What are the possible side effects of SKLICE Lotion? The most common side effects of SKLICE Lotion include:


• eye redness or soreness • eye irritation • dandruff • 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.


Keep SKLICE Lotion and all medicines out of reach of children.


The risk information provided here is not comprehensive and does not take the place of talking to your healthcare provider about your medical condition or treatment. To learn more, talk about SKLICE with your healthcare provider or pharmacist. The FDA-approved labeling can be found at www.Sklice.com.


Distributed by: Arbor Pharmaceuticals, LLC. Atlanta, GA 30328 U.S. Patent No. 6,103,248 and other patents pending.


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