DOSAGE & ADMINISTRATION SECTION.

Directions. Important: Read warnings before usechildren months of age to under 12 years of age: an adult should supervise useadults and children months of age and over:Inspectall household members should be checked by another person for lice and/or nits (eggs)use magnifying glass in bright light to help you see the lice and/or nits (eggs)use tool, such as comb or two unsharpened pencils to lift and part the hairlook for tiny nits near the scalp, beginning at the back of the neck and behind the earsexamine small sections of the hair (1-2 inches wide) at timeunlike dandruff, nits stick to the hair. Dandruff should move when lightly touched.if either lice or nits (eggs) are found, treat with productTreatyour hair and scalp must be DRY before applying productuse the top of cap to break the tamper seal on the tubeapply product directly to dry hair and scalpcompletely cover your scalp and hair closest to the scalp first, and then apply outwards towards the ends of your hairuse only amount to completely cover hair and scalp, up to entire tube, and discard the remainingrub product throughout your hairit 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 rinseallow product to stay on your hair and scalp for 10 minutes after it has been applied. Use 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 waterafter rinsing, dry and style as usual. Wait 24 hours before applying shampoo.After treatmentwash your hands after applying productnit combing is not necessary when treating with product for it to work, but if desired, fine-tooth comb or special nit comb may be used to remove dead lice and nitsthis is single use product. Discard tube after use.do not use again on the same person and same lice infestation without talking to healthcare provider firstif infestation continues, see doctor for other treatmentsmachine wash any bedding and clothing used by anyone having lice. Machine wash at high temperatures (150F) and tumble in 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.. children months of age to under 12 years of age: an adult should supervise use. adults and children months of age and over:. all household members should be checked by another person for lice and/or nits (eggs). use magnifying glass in bright light to help you see the lice and/or nits (eggs). use tool, such as 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 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. 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 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.. allow product to stay on your hair and scalp for 10 minutes after it has been applied. Use 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.. wash your hands after applying product. nit combing is not necessary when treating with product for it to work, but if desired, fine-tooth comb or special nit comb may be used to remove dead lice and nits. this is single use product. Discard tube after use.. do not use again on the same person and same lice infestation without talking to healthcare provider first. if infestation continues, see doctor for other treatments. machine wash any bedding and clothing used by anyone having lice. Machine wash at high temperatures (150F) and tumble in 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.

INACTIVE INGREDIENT SECTION.

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.

INDICATIONS & USAGE SECTION.

Use. treats head lice.

OTC - ACTIVE INGREDIENT SECTION.

Active ingredient. Ivermectin 0.5%.

OTC - ASK DOCTOR SECTION.

Ask doctor before use if you. have any skin conditions or sensitivitiesare 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.. 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.

OTC - DO NOT USE SECTION.

Do not use. on children under months of agenear the eyesinside the nose, ear, mouth, or vaginaon lice in eyebrows or eyelashes. See doctor if lice are present in these areas.. on children under months of age. near the eyes. inside the nose, ear, mouth, or vagina. on lice in eyebrows or eyelashes. See doctor if lice are present in these areas.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION.

Keep out of reach of children.If swallowed, get medical help or contact Poison Control Center (1-800-222-1222) right away.

OTC - PREGNANCY OR BREAST FEEDING SECTION.

If pregnant or breastfeeding, ask health professional before use.

OTC - PURPOSE SECTION.

Purpose. Lice treatment.

OTC - QUESTIONS SECTION.

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

OTC - STOP USE SECTION.

Stop use and ask doctor if. breathing difficulty occurseye irritation occursskin or scalp irritation continues or infection occursrash develops. breathing difficulty occurs. eye irritation occurs. skin or scalp irritation continues or infection occurs. rash develops.

OTC - WHEN USING SECTION.

When using this product. keep eyes tightly closed and protect eyes with washcloth or towelif product gets into eyes, gently flush with watereye redness, soreness, or irritation can occurdandruff, dry skin, or burning sensation of the skin can occur. keep eyes tightly closed and protect eyes with 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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

PRINCIPAL DISPLAY PANEL 117 Tube Carton. NDC 24338-185-04NEWSklice(R) Ivermectin Lotion 0.5% Lice TreatmentOriginal Prescription StrengthNow available without prescriptionOne tube, one time, 10 minutesSKLICE KILLS LICENo nit combing requiredNo second application requiredIncludes: Tube Net Wt. oz (117 g). PRINCIPAL DISPLAY PANEL 117 Tube Carton.

SPL UNCLASSIFIED SECTION.

Drug Facts.

STORAGE AND HANDLING SECTION.

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

WARNINGS SECTION.

Warnings. For external use only. Use only on the scalp.. Do not use. on children under months of agenear the eyesinside the nose, ear, mouth, or vaginaon lice in eyebrows or eyelashes. See doctor if lice are present in these areas.. on children under months of age. near the eyes. inside the nose, ear, mouth, or vagina. on lice in eyebrows or eyelashes. See doctor if lice are present in these areas.. Ask doctor before use if you. have any skin conditions or sensitivitiesare 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.. 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 washcloth or towelif product gets into eyes, gently flush with watereye redness, soreness, or irritation can occurdandruff, dry skin, or burning sensation of the skin can occur. keep eyes tightly closed and protect eyes with 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 doctor if. breathing difficulty occurseye irritation occursskin or scalp irritation continues or infection occursrash develops. breathing difficulty occurs. eye irritation occurs. skin or scalp irritation continues or infection occurs. rash develops. If pregnant or breastfeeding, ask health professional before use.. Keep out of reach of children.If swallowed, get medical help or contact Poison Control Center (1-800-222-1222) right away.