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Description for Sklice

SKLICE (ivermectin) Lotion, for topical administration, is an off-white/tan lotion containing 0.5% ivermectin. Ivermectin, the active ingredient, is a pediculicide, derived from the fermentation of a soil dwelling actinomycete, Streptomyces avermitilis.

Ivermectin is a mixture containing at least 90% 5-O-demethyl-22,23-dihydroavermectin A1a and less than 10% 5-O-demethyl-25-de(1-methylpropyl)-22,23-dihydro25- (1-methylethyl) avermectin A1a, generally referred to as 22,23-dihydroavermectin B1a and B1b, or H2B1a and H2B1b, respectively. The respective empirical formulas are C48H74O14 and C47H72O14, with molecular weights of 875.10 and 861.07, respectively. The structural formulas are:

SKLICE Lotion contains the following inactive ingredients: water, olive oil, oleyl alcohol, Crodalan AWS, lanolin alcohol, cyclomethicone, shea butter, sodium citrate, sorbitan tristearate, methylparaben, propylparaben, and citric acid.

Uses for Sklice

Purpose

Lice treatment

Use

Treats head lice

Dosage for Sklice

Directions

Important: Read warnings before use

children 6 months of age to under 12 years of age: an adult should supervise use adults and children 6 months of age and over:

Inspect

• all household members should be checked by another person for lice and/or nits (eggs)
• use a magnifying glass in bright light to help you see the lice and/or nits (eggs)
• use a tool, such as a comb or two unsharpened pencils to lift and part the hair
• look for tiny nits near the scalp, beginning at the back of the neck and behind the ears
• examine small sections of the hair (1-2 inches wide) at a time
• unlike dandruff, nits stick to the hair. Dandruff should move when lightly touched.
• if either lice or nits (eggs) are found, treat with product

Treat

• your hair and scalp must be DRY before applying product
• use the top of cap to break the tamper seal on the tube
• apply product 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
• use only amount to completely cover hair and scalp, up to 1 entire tube, and discard the remaining
• rub product 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.

Wait and rinse

• allow product 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 product.
• after 10 minutes, rinse product completely from your hair and scalp using only water
• after rinsing, dry and style as usual. Wait 24 hours before applying shampoo

.After treatment

• wash your hands after applying product
• nit combing is not necessary when treating with product for it to work, but if desired, a fine-tooth comb or special nit comb may be used to remove dead lice and nits
• this is a single use product. Discard tube after use.
• do not use again on the same person and same lice infestation without talking to a healthcare provider first
• if infestation continues, see a doctor for other treatments
• 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.
• after finishing treatment with lice medicine, check everyone in your family for lice after one week. Consider treatment for those who have lice

HOW SUPPLIED

Other Information

• store at room temperature 68°-77°F. Excursions permitted to 59°-86°F.
• do not freeze
• keep carton and see Consumer Information Leaflet and warnings before use

Inactive Ingredients

acetylated lanolin alcohol, cetyl acetate, citric acid, cyclomethicone, lanolin alcohol, methylparaben, oleyl alcohol, olive oil, polysorbate 80, propylparaben, shea butter, sodium citrate, sorbitan tristearate, and water

Questions: 1-866-516-4950., Monday – Friday: 9 am – 5 pm EST

Distributed by: arbor® PHARMACEUTICALS, LLC., Atlanta, GA 30328. Manufactured by: Jubilant HollisterStier., General Partnership 16751 Trans-Canada Highway Kirkland, Quebec, Canada H9H 4J4. Revised: Sep 2022

Side Effects for Sklice

No information provided.

Drug Interactions for Sklice

No information provided.

Warnings for Sklice

For external use only. Use only on the scalp.

Precautions for Sklice

Do not use

• on children under 6 months of age
• near the eyes
• inside the nose, ear, mouth, or vagina
• on lice in eyebrows or eyelashes. See a doctor if lice are present in these areas.

Ask a doctor before use if you

• have any skin conditions or sensitivities
• are pregnant or plan to become pregnant. It is not known if product can harm your unborn baby.
• are currently or planning to breastfeed. Avoid getting product on your breast to help prevent contact by your baby.

When using this product

• keep eyes tightly closed and protect eyes with a washcloth or towel
• if product gets into eyes, gently flush with water
• eye redness, soreness, or irritation can occur
• dandruff, dry skin, or burning sensation of the skin can occur

Stop use and ask a doctor if

• breathing difficulty occurs
• eye irritation occurs
• skin or scalp irritation continues or infection occurs
• rash develops

If pregnant or breastfeeding, ask a health professional before use.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Overdose Information for Sklice

No information provided.

Contraindications for Sklice

No information provided.

Clinical Pharmacology for Sklice

No information provided.

Patient Information for Sklice

No information provided. Please refer to the WARNINGS AND PRECAUTIONS section.