Nix Shampoo

Dosage Form: shampoo
NIX®

Permethrin

LICE TREATMENT

Drug Facts

Active ingredient (in each fluid ounce) Purpose

Permethrin 280 mg (1%).......................Lice treatment

Use

treats head lice

Warnings

For external use only

Do not use

• on children under 2 months of age


• near the eyes


• inside the nose, ear, mouth, or vagina


• on lice in eyebrows or eyelashes. See your doctor.

Ask a doctor before use if you are

• allergic to ragweed. May cause breathing difficulty or an asthmatic episode.

When using this product

• keep eyes tightly closed and protect eyes with a washcloth or towel


• if product gets into the eyes, immediately flush with large amounts of water


• scalp itching or redness may occur

Stop use and see a doctor if

• breathing difficulty occurs


• eye irritation occurs


• skin or scalp irritation continues or infection occurs

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

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 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


• small sections of hair (1-2 inches wide) should be examined 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 Nix Creme Rinse

Treat

• wash hair with a shampoo without conditioner. Do not use a shampoo that contains a conditioner or a conditioner alone since this may decrease the activity of Nix. Rinse with water.


• towel dry hair so it is damp but not wet


• shake the bottle of Nix well


• completely saturate the hair and scalp with Nix. Begin to apply Nix behind the ears and at the back of the neck.


• keep Nix out of the eyes. Protect the eyes with a washcloth or towel.


• leave Nix 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, a 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 a 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 4 sections. Work on one section at a 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 a 1-2 inch wide strand of hair. Get the teeth of the comb as close to the scalp as possible and comb with a 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 a tissue and throw away the tissue in a 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

Other 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 25°C (68° to 77°F)

Inactive ingredients

balsam canada, cetyl alcohol, citric acid, FD&C yellow no. 6, fragrance, hydrolyzed animal protein, hydroxyethylcellulose, polyoxyethylene 10 cetyl ether, propylene glycol, stearalkonium chloride, water, isopropyl alcohol 5.6 g (20%), methylparaben 56 mg (0.2%), and propylparaben 22 mg (0.08%)

Questions or comments?

call 1-888-LICE LINE (1-888-542-3546), Monday to Friday, 9 AM - 5 PM EST

LIMITED CONSUMER WARRANTY

If you are not satisfied with Nix, we will refund your purchase price. Send cash register receipt, original UPC code, and reason for dissatisfaction to:

INSIGHT Pharmaceuticals Corp. 1170 Wheeler Way, Suite 150 Langhorne, PA 19047-1749

Distributed by:

INSIGHT Pharmaceuticals Corp.

Langhorne, PA 19047-1749

For a description of all of our products visit us at www.insightpharma.com

Nix®

Permethrin 1%

Lice Treatment Creme Rinse

THE FACTS OF LICE

Please read all information before using Nix Creme Rinse.

If you or a member of your household has head lice, don't 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 lice?

• 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 a waterproof glue-like substance that cannot be washed out or blown away

Because 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 clothing

How do you know if you have lice?

• itching is the most common symptom


• scratching behind the ears or the back of the neck is a sign that you should check for head lice


• scabs or blood spots may be seen

How do you prevent the spread of lice?

• do not share or borrow personal items 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 people's hats and coats


• wash under fingernails when you first see lice or nits (eggs)


• check your child's head daily when you hear of a lice outbreak in day care or school

I. Inspect

If 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 a magnifying glass in bright light to help you see the lice and 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
small sections of hair (1-2 inches wide) should be examined 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 Nix Creme Rinse

II. Treat

wash hair with a shampoo without conditioner. Do not use a shampoo that contains a conditioner or a conditioner alone since this may decrease the activity of Nix. Rinse with water. towel dry hair so it is damp but not wet shake the bottle of Nix well
completely saturate the hair and scalp with Nix. Begin to apply Nix behind the ears and at the back of the neck. keep Nix out of the eyes. Protect the eyes with a washcloth or towel. leave Nix 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, a second treatment should be given

III. 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 a 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 4 sections. Work on one section at a 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 a 1-2 inch wide strand of hair. Get the teeth of the comb as close to the scalp as possible and comb with a 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 a tissue and throw away the tissue in a 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

IV. Clean home and personal items

After using Nix Creme Rinse, it is very important to clean personal items 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 1 day.

all personal head gear (hats, hair ribbons, etc.), scarves, coats, towels and bed linens should be washed in hot water (above 130°F), 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 130°F) 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 a plastic bag for a period of at least 4 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 a plastic bag, spray with Nix Lice Control Spray. vacuum everywhere. Vacuum all carpets, mattresses, upholstered furniture and car seats that may have been used by infested household members.

Warnings

For external use only

Do not use

• on children under 2 months of age


• near the eyes


• inside the nose, ear, mouth, or vagina


• on lice in eyebrows or eyelashes. See your doctor.

Ask a doctor before use if you are

• allergic to ragweed. May cause breathing difficulty or an asthmatic episode.

When using this product

• keep eyes tightly closed and protect eyes with a washcloth or towel


• if product gets into the eyes, immediately flush with large amounts of water


• scalp itching or redness may occur

Stop use and see a doctor if

• breathing difficulty occurs


• eye irritation occurs


• skin or scalp irritation continues or infection occurs

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Questions or comments?

call 1-888-LICE LINE (1-888-542-3546),

Monday to Friday, 9 AM - 5 PM EST

www.insightpharma.com

Distributed by:

INSIGHT Pharmaceuticals Corp.

Langhorne, PA 19049-1749

66623A

PRINCIPAL DISPLAY PANEL - 2 oz Carton

SAFE

Approved for use on children

over 2 months of age

Nix®

Permethrin

LICE TREATMENT

PROFESSIONALLY

#1

RECOMMENDED

With A Single Application

• Kills Lice & Their Eggs

Prevents Reinfestation for 14 Days

• Full Prescription Strength

Creme Rinse and Nit Removal Comb

Instrucciones En Español Incluidas

2 FL OZ (59 mL)

PRINCIPAL DISPLAY PANEL - 4 oz Carton

SAFE

Approved for use on children

over 2 months of age

Nix®

Permethrin

LICE TREATMENT

PROFESSIONALLY

#1

RECOMMENDED

With A Single Application

• Kills Lice & Their Eggs

Prevents Reinfestation for 14 Days

• Full Prescription Strength

2 Bottles Creme Rinse and 2 Nit Removal Combs

Instrucciones En Español Incluidas

2 BOTTLES

2 FL OZ (59 mL) EACH

FAMILY PACK

NIX  permethrin  shampoo

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 63736-024 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Permethrin (Permethrin) Permethrin 560 mg  in 59 mL

Inactive Ingredients Ingredient Name Strength Cetyl alcohol   Citric Acid Monohydrate   FD&C yellow no. 6   Propylene glycol   Stearalkonium chloride   Water   Isopropyl Alcohol   Methylparaben   Propylparaben

Product Characteristics Color ORANGE (Light Orange) Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 63736-024-02 59 mL In 1 BOTTLE None 2 63736-024-04 2 BOTTLE In 1 CARTON contains a BOTTLE 2 59 mL In 1 BOTTLE This package is contained within the CARTON (63736-024-04)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA019918	06/05/2009

Labeler - Insight Pharmaceuticals (176792315)

Revised: 06/2009Insight Pharmaceuticals

More Nix Shampoo resources

• Nix Shampoo Side Effects (in more detail)
• Nix Shampoo Use in Pregnancy & Breastfeeding
• Nix Shampoo Support Group
• 2 Reviews for Nix - Add your own review/rating

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