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 needed 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 needed 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. butylated hydroxyanisole, castor oil, cetyl alcohol, citric acid anhydrous, crodalan AWS, cyclomethicone, glycerin, imidurea, lanolin alcohols, methylparaben, oleyl alcohol, olive oil, propylene glycol, propylparaben, purified water, shea butter, sodium citrate anhydrous, sorbitan tristearate and stearyl alcohol.

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. 1-866-923-4914.

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. Compare to theactive ingredientin Sklice(R) NDC 51672-4230-8IvermectinLotion, 0.5%Lice TreatmentOriginal Prescription StrengthNow available withouta prescriptionOne tube, one time,10 minutesIVERMECTIN LOTION KILLS LICENo nit combing requiredNo second application requiredIncludes:1 TubeNet Wt. oz (117 g). PRINCIPAL DISPLAY PANEL 117 Tube Carton.

PATIENT MEDICATION INFORMATION SECTION.

Ivermectin Lotion, 0.5%Lice Treatment Lotion. THE FACTS OF LICEPlease read all information before using Ivermectin Lotion.If you or member of your household has head lice, dont panic. Keep calm.Anyone can get head lice it has nothing to do with cleanliness or poor hygiene. Head lice are treatable and very rarely cause serious health problems.What are head liceHead lice are small insects that live and feed on the human scalp.They may get as big as sesame seeds and are brown.Lice do not fly or jump from one person to another. They can only crawl.What are nitsNits are lice eggs laid on the hair near the scalp. One louse may lay over 100 nits.Nits are oval shaped, tiny and greyish-white.They are attached to hair with waterproof glue-like substance that cannot be washed out or blown away.How do head lice spreadHead lice spread easily from close head-to-head or hand-to-head contact with persons who have lice.They may also be spread by sharing hats, helmets, scarves, headphones, brushes, combs, bedding and clothing.How do you know if you have liceItching is the most common symptom.Scratching behind the ears or the back of the neck is sign that you should check for head lice.Scabs or blood spots may be seen.How do you prevent the spread of liceAvoid 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 texts 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.How do use Ivermectin LotionImportant: 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 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.TreatYour hair and scalp must be DRY before applying product.Figure AUse the top of cap to break the tamper seal on the tube (see Figure A).Apply product directly to dry hair and scalp (see 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).Use only amount needed to completely cover hair and scalp, up to entire tube, and discard the remaining.Rub product throughout your hair (see Figure D).Figure BFigure CFigure DIt 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 (see Figure E).After 10 minutes, rinse product completely from your hair and scalp using only water (see Figure F).Figure EFigure FAfter rinsing, dry and style as usual. Wait 24 hours before applying shampoo.After treatmentWash 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.WARNINGSFor external use only. Use only on the scalp.Do not useOn 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.Ask doctor before use if youHave 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.When using this productKeep 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 ifBreathing difficulty occursEye irritation occursSkin or scalp irritation continues or infection occursRash developsIf 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.Questions or comments Call 1-866-923-4914Mfd. by: Taro Pharmaceutical Industries Ltd.Haifa Bay, Israel 2624761Made in IsraelIssued: November 2020. Head lice are small insects that live and feed on the human scalp.. They may get as big as sesame seeds and are brown.. Lice do not fly or jump from one person to another. They can only crawl.. Nits are lice eggs laid on the hair near the scalp. One louse may lay over 100 nits.. Nits are oval shaped, tiny and greyish-white.. They are attached to hair with waterproof glue-like substance that cannot be washed out or blown away.. Head lice spread easily from close head-to-head or hand-to-head contact with persons who have lice.. They may also be spread by sharing hats, helmets, scarves, headphones, brushes, combs, bedding and clothing.. Itching is the most common symptom.. Scratching behind the ears or the back of the neck is sign that you should check for head lice.. Scabs or blood spots may be seen.. 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 texts 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.. 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 (see Figure A).. Apply product directly to dry hair and scalp (see 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).. Use only amount needed to completely cover hair and scalp, up to entire tube, and discard the remaining.. Rub product throughout your hair (see 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.. 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 (see Figure E).. After 10 minutes, rinse product completely from your hair and scalp using only water (see Figure F).. 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.. 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.. 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.. 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.. Breathing difficulty occurs. Eye irritation occurs. Skin or scalp irritation continues or infection occurs. Rash develops. figure A. figure B. figure C. figure D. figure E. figure F.

SPL UNCLASSIFIED SECTION.

Drug Facts.

STORAGE AND HANDLING SECTION.

Other information. TAMPER EVIDENT: DO NOT USE IF THE TAMPER SEAL ON THE TUBE HAS BEEN BROKEN.store at room temperature 68o-77oF (20o-25oC)do not freezekeep carton and see Consumer Information Leaflet and warnings before use. TAMPER EVIDENT: DO NOT USE IF THE TAMPER SEAL ON THE TUBE HAS BEEN BROKEN.. store at room temperature 68o-77oF (20o-25oC). 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.