DOSAGE & ADMINISTRATION SECTION.


DIRECTIONS Inspect 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 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 earssmall sections of hair (1-2 inches wide) should be examined at timeunlike dandruff, nits stick to the hair. Dandruff should move when lightly touched.if either lice or nits (eggs) are found, treat with Permethrin Lotion 1%. 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 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. small sections of hair (1-2 inches wide) should be examined 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 Permethrin Lotion 1%. Treat wash hair with shampoo without conditioner. Do not use shampoo that contains conditioner or conditioner alone since this may decrease the activity of Permethrin Lotion 1%. Rinse with water.towel dry hair so it is damp but not wetshake the bottle of Permethrin Lotion 1% wellcompletely saturate the hair and scalp with Permethrin Lotion 1%. Begin to apply Permethrin Lotion 1% behind the ears and at the back of the neck.keep Permethrin Lotion 1% out of the eyes. Protect the eyes with washcloth or towel.leave Permethrin Lotion 1% on the hair for 10 minutes, but no longerrinse with warm watertowel dry hair and comb out tanglesif live lice are seen seven days or more after the first treatment, second treatment should be given. wash hair with shampoo without conditioner. Do not use shampoo that contains conditioner or conditioner alone since this may decrease the activity of Permethrin Lotion 1%. Rinse with water.. towel dry hair so it is damp but not wet. shake the bottle of Permethrin Lotion 1% well. completely saturate the hair and scalp with Permethrin Lotion 1%. Begin to apply Permethrin Lotion 1% behind the ears and at the back of the neck.. keep Permethrin Lotion 1% out of the eyes. Protect the eyes with washcloth or towel.. leave Permethrin Lotion 1% on the hair for 10 minutes, but no longer. rinse with warm water. towel dry hair and comb out tangles. if live lice are seen seven days or more after the first treatment, second treatment should be given. Remove Lice/Nits remove nits by combing the hair with the special small tooth comb provided. Remaining nits may be removed by hand (using throw-away glove), or cutting the nits out.use the nit comb provided and make sure the hair remains slightly damp while removing nitsif the hair dries during combing, dampen it slightly with waterpart the hair into sections. Work on one section at time. Longer hair may take more time (1-2 hours).start at the top of the head on the section you have pickedwith one hand, lift 1-2 inch wide strand of hair. Get the teeth of the comb as close to the scalp as possible and comb with firm, even motion away from the scalp to the end of the hair.use clips to pin back each strand of hair after you have combed out the nitsclean the comb completely as you go. Wipe the nits from the comb with tissue and throw away the tissue in sealed plastic bag to prevent the lice from coming back.after combing, recheck the entire head for nits and repeat combing if necessarycheck the affected head daily to remove any nits that you might have missedOther information read all the directions in the Consumer Information Insert and warnings before use. Keep the carton. It contains important information.store at 20 to 25C (68 to 77F). remove nits by combing the hair with the special small tooth comb provided. Remaining nits may be removed by hand (using throw-away glove), or cutting the nits out.. use the nit comb provided and make sure the hair remains slightly damp while removing nits. if the hair dries during combing, dampen it slightly with water. part the hair into sections. Work on one section at time. Longer hair may take more time (1-2 hours).. start at the top of the head on the section you have picked. with one hand, lift 1-2 inch wide strand of hair. Get the teeth of the comb as close to the scalp as possible and comb with firm, even motion away from the scalp to the end of the hair.. use clips to pin back each strand of hair after you have combed out the nits. clean the comb completely as you go. Wipe the nits from the comb with tissue and throw away the tissue in sealed plastic bag to prevent the lice from coming back.. after combing, recheck the entire head for nits and repeat combing if necessary. check the affected head daily to remove any nits that you might have missedOther information read all the directions in the Consumer Information Insert and warnings before use. Keep the carton. It contains important information.. store at 20 to 25C (68 to 77F).

INACTIVE INGREDIENT SECTION.


INACTIVE INGREDIENTS Balsam fir canada, cetyl alcohol, citric acid, FD&C yellow 6, fragrance, hydrolyzedanimal protein, hydroxyethylcellulose, isopropyl alcohol, methylparaben, polyoxyethylene10 cetyl ether, propylene glycol, propylparaben, purified water, stearalkonium chloride.

INDICATIONS & USAGE SECTION.


USE Treats head lice.

INSTRUCTIONS FOR USE SECTION.


Patient Information. Single ApplicationLice TreatmentPermethrin Lotion 1%With Single Application:Kills Lice Their EggsPrevents Reinfestation for 14 DaysCreme Rinse With Nit Removal Comb FL OZ (59 mL) Kills Lice Their Eggs. Prevents Reinfestation for 14 DaysCreme Rinse With Nit Removal Comb FL OZ (59 mL) Information for Patients Consumer Information InsertPermethrin Lotion 1%Lice TreatmentPlease read all information before using Permethrin Lotion 1%.If you or member of your household has 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 scalpthey may get as big as sesame seeds and are brownlice do not fly or jump from one person to another. They can only crawl.What are nits 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-whitethey are attached to hair with waterproof glue-like substance that cannot be washed out or blown awayBecause nits (eggs) hatch in about one week, all nits must be removed to stop lice. How do head lice spread head lice spread easily from close head-to-head or hand-to-head contact with persons who have licethey may also spread by sharing hats, helmets, scarves, headphones, brushes, combs, bedding and clothingHow do you know if you have lice itching is the most common symptomscratching behind the ears or the back of the neck is sign that you should check for head licescabs or blood spots may be seenHow do you prevent the spread of lice do not share or borrow personal texts like combs, brushes, or headbandsdo not share or borrow hats, sweaters, coats, scarves, helmets, headphones, pillows or stuffed animalsstore hats in coat sleeves and hang coats separately, so that they do not touch other peoples hats and coatswash under fingernails when you first see lice or nits (eggs)check your childs head daily when you hear of lice outbreak in day care or schoolHow to use Permethrin Lotion 1% InspectIf you suspect head lice check. Head lice may be hard to locate because they avoid light. Nits are easier to see. 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 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 earssmall sections of hair (1-2 inches wide) should be examined at timeunlike dandruff, nits stick to the hair. Dandruff should move when lightly touched. PICTURE OF MOTHER CHECKING FOR LICE if either lice or nits (eggs) are found, treat with Permethrin Lotion 1%Treat wash hair with shampoo without conditioner. Do not use shampoo that contains conditioner or conditioner alone since this may decrease the activity of Permethrin Lotion 1%. Rinse with water.towel dry hair so it is damp but not wetshake the bottle of Permethrin Lotion 1% wellcompletely saturate the hair and scalp with Permethrin Lotion 1%. Begin to apply Permethrin Lotion 1% behind the ears and at the back of the neck.keep Permethrin Lotion 1% out of the eyes. Protect the eyes with washcloth or towel.leave Permethrin Lotion 1% on the hair for 10 minutes, but no longerrinse with warm watertowel dry hair and comb out tanglesif live lice are seen seven days or more after the first treatment, second treatment should be given PICTURE OF CHILD WITH SHAMPOO ON HAIR Remove Lice/Nits Treatment kills lice but does not remove the nits. remove nits by combing the hair with the special small tooth comb provided. Remaining nits may be removed by hand (using throw-away glove), or cutting the nits out.use the nit comb provided and make sure the hair remains slightly damp while removing nitsif the hair dries during combing, dampen it slightly with waterpart the hair into sections. Work on one section at time. Longer hair may take more time (1-2 hours).start at the top of the head on the section you have pickedwith one hand, lift 1-2 inch wide strand of hair. Get the teeth of the comb as close to the scalp as possible and comb with firm, even motion away from the scalp to the end of the hair.use clips to pin back each strand of hair after you have combed out the nitsclean the comb completely as you go. Wipe the nits from the comb with tissue and throw away the tissue in sealed plastic bag to prevent the lice from coming back.after combing, recheck the entire head for nits and repeat combing if necessarycheck the affected head daily to remove any nits that you might have missed PICTURE SHOWING HOW TO COMB HAIR Clean home and personal texts After using Permethrin Lotion 1%, it is very important to clean personal texts and your home to prevent the spread of lice. Nits may live away from the human head for about 7-12 days. Lice may live away from the human head for about day. all personal head gear (hats, hair ribbons, etc.), scarves, coats, towels and bed linens should be washed in hot water (above 130F), then dried in the dryer using the hottest cycle for at least 20 minutespersonal combs, including nit combs, and brushes should be soaked in hot water (above 130F) for at least 10 minutespersonal articles such as clothing, bedspreads, blankets, pillows or stuffed animals that cannot be washed should be dry-cleaned or sealed tightly in plastic bag for period of at least weeks. Items should be taken out of the plastic bag outdoors and shaken out very hard before using again.for anything you cannot wash, dry-clean or store in plastic bag, spray with product that kills licevacuum everywhere. Vacuum all carpets, mattresses, upholstered furniture and car seats that may have been used by infested household members. PICTURE OF MOTHER CLEANING WARNINGSFor external use onlyDo not use. 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.What are nits 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 awayBecause nits (eggs) hatch in about one week, all nits must be removed to stop lice. How do head lice spread head lice spread easily from close head-to-head or hand-to-head contact with persons who have lice. they may also spread by sharing hats, helmets, scarves, headphones, brushes, combs, bedding and clothingHow do you know if you have lice 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 seenHow do you prevent the spread of lice do not share or borrow personal texts like combs, brushes, or headbands. do not share or borrow hats, sweaters, coats, scarves, helmets, headphones, pillows or stuffed animals. store hats in coat sleeves and hang coats separately, so that they do not touch other peoples hats and coats. wash under fingernails when you first see lice or nits (eggs). check your childs head daily when you hear of lice outbreak in day care or schoolHow to use Permethrin Lotion 1% InspectIf you suspect head lice check. Head lice may be hard to locate because they avoid light. Nits are easier to see. InspectIf you suspect head lice check. Head lice may be hard to locate because they avoid light. Nits are easier to see.. 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 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. small sections of hair (1-2 inches wide) should be examined at time. unlike dandruff, nits stick to the hair. Dandruff should move when lightly touched. PICTURE OF MOTHER CHECKING FOR LICE if either lice or nits (eggs) are found, treat with Permethrin Lotion 1%Treat Treat. wash hair with shampoo without conditioner. Do not use shampoo that contains conditioner or conditioner alone since this may decrease the activity of Permethrin Lotion 1%. Rinse with water.. towel dry hair so it is damp but not wet. shake the bottle of Permethrin Lotion 1% well. completely saturate the hair and scalp with Permethrin Lotion 1%. Begin to apply Permethrin Lotion 1% behind the ears and at the back of the neck.. keep Permethrin Lotion 1% out of the eyes. Protect the eyes with washcloth or towel.. leave Permethrin Lotion 1% on the hair for 10 minutes, but no longer. rinse with warm water. towel dry hair and comb out tangles. if live lice are seen seven days or more after the first treatment, second treatment should be given. PICTURE OF CHILD WITH SHAMPOO ON HAIR Remove Lice/Nits Treatment kills lice but does not remove the nits. Remove Lice/Nits Treatment kills lice but does not remove the nits. remove nits by combing the hair with the special small tooth comb provided. Remaining nits may be removed by hand (using throw-away glove), or cutting the nits out.. use the nit comb provided and make sure the hair remains slightly damp while removing nits. if the hair dries during combing, dampen it slightly with water. part the hair into sections. Work on one section at time. Longer hair may take more time (1-2 hours).. start at the top of the head on the section you have picked. with one hand, lift 1-2 inch wide strand of hair. Get the teeth of the comb as close to the scalp as possible and comb with firm, even motion away from the scalp to the end of the hair.. use clips to pin back each strand of hair after you have combed out the nits. clean the comb completely as you go. Wipe the nits from the comb with tissue and throw away the tissue in sealed plastic bag to prevent the lice from coming back.. after combing, recheck the entire head for nits and repeat combing if necessary. check the affected head daily to remove any nits that you might have missed. PICTURE SHOWING HOW TO COMB HAIR Clean home and personal texts After using Permethrin Lotion 1%, it is very important to clean personal texts and your home to prevent the spread of lice. Nits may live away from the human head for about 7-12 days. Lice may live away from the human head for about day. Clean home and personal texts After using Permethrin Lotion 1%, it is very important to clean personal texts and your home to prevent the spread of lice. Nits may live away from the human head for about 7-12 days. Lice may live away from the human head for about day. all personal head gear (hats, hair ribbons, etc.), scarves, coats, towels and bed linens should be washed in hot water (above 130F), then dried in the dryer using the hottest cycle for at least 20 minutes. personal combs, including nit combs, and brushes should be soaked in hot water (above 130F) for at least 10 minutes. personal articles such as clothing, bedspreads, blankets, pillows or stuffed animals that cannot be washed should be dry-cleaned or sealed tightly in plastic bag for period of at least weeks. Items should be taken out of the plastic bag outdoors and shaken out very hard before using again.. for anything you cannot wash, dry-clean or store in plastic bag, spray with product that kills lice. vacuum everywhere. Vacuum all carpets, mattresses, upholstered furniture and car seats that may have been used by infested household members.. PICTURE OF MOTHER CLEANING WARNINGSFor external use onlyDo not use. on children under months of age. near the eyesinside the nose, ear, mouth, or vaginaon lice in eyebrows or eyelashes. See your doctor.Ask doctor before use if you are allergic to ragweed. May cause breathing difficulty or an asthmatic episode.When using this productkeep eyes tightly closed and protect eyes with washcloth or towelif product gets into the eyes, immediately flush with large amounts of waterscalp itching or redness may occurStop use and see doctor ifbreathing difficulty occurseye irritation occursskin or scalp irritation continues or infection occursIf pregnant or breast-feeding, ask health professional before use.Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away.Questions 1-800-432-8534 (select option 2).Form No. 5242-PIRev. 8/08VC 3202. near the eyes. inside the nose, ear, mouth, or vagina. on lice in eyebrows or eyelashes. See your doctor.Ask doctor before use if you are allergic to ragweed. May cause breathing difficulty or an asthmatic episode.. keep eyes tightly closed and protect eyes with washcloth or towel. if product gets into the eyes, immediately flush with large amounts of water. scalp itching or redness may occur. breathing difficulty occurs. eye irritation occurs. skin or scalp irritation continues or infection occurs. T:\Maryland\NJ\Juan\ANDA 075014\mother-n-child.jpg. T:\Maryland\NJ\Juan\ANDA 075014\childs-head.jpg. T:\Maryland\NJ\Juan\ANDA 075014\child-shampoo.jpg. T:\Maryland\NJ\Juan\ANDA 075014\child-comb.jpg. T:\Maryland\NJ\Juan\ANDA 075014\mom-laundry.jpg.

OTC - ACTIVE INGREDIENT SECTION.


ACTIVE INGREDIENT Active ingredient (in each fluid ounce)Permethrin 280 mg (1%).

OTC - ASK DOCTOR SECTION.


ASK DOCTOR BEFORE USE IF YOU ARE allergic to ragweed. May cause breathing difficulty or an asthmatic episode.. allergic to ragweed. May cause breathing difficulty or an asthmatic episode.

OTC - DO NOT USE SECTION.


DO NOT USE on children under months of age. near the eyesinside the nose, ear, mouth, or vaginaon lice in eyebrows or eyelashes. See your doctor.. near the eyes. inside the nose, ear, mouth, or vagina. on lice in eyebrows or eyelashes. See your doctor.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION.


KEEP OUT OF REACH OF CHILDREN If swallowed, get medical help or contact Poison Control Center right away.

OTC - PREGNANCY OR BREAST FEEDING SECTION.


PREGNANCY OR BREAST FEEDING If pregnant or breast-feeding, ask health professional before use.

OTC - PURPOSE SECTION.


PURPOSE Lice treatment.

OTC - QUESTIONS SECTION.


QUESTIONS 1-800-432-8534 (select option 2) between am and pm EST, Monday Friday.

OTC - STOP USE SECTION.


STOP USE AND SEE DOCTOR IF side effects occur.. breathing difficulty occurs. eye irritation occurs. skin or scalp irritation continues or infection occurs. skin or scalp irritation continues or infection occurs.

OTC - WHEN USING SECTION.


WHEN USING THIS PRODUCT keep eyes tightly closed and protect eyes with washcloth or towelif product gets into the eyes, immediately flush with large amounts of waterscalp itching or redness may occur. keep eyes tightly closed and protect eyes with washcloth or towel. if product gets into the eyes, immediately flush with large amounts of water. scalp itching or redness may occur.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.


PRINCIPAL DISPLAY PANEL . Lice Treatment (Permethrin Lotion) 1%.

SPL UNCLASSIFIED SECTION.


on children under months of age. near the eyesinside the nose, ear, mouth, or vaginaon lice in eyebrows or eyelashes. See your doctor.. near the eyes. inside the nose, ear, mouth, or vagina. on lice in eyebrows or eyelashes. See your doctor.

WARNINGS SECTION.


WARNINGS For external use only.