Nix®

Nix®
SPL v2
SPL
SPL Set ID ad967f76-6fda-4ac9-a71f-d0603a6ed71e
Route
TOPICAL
Published
Effective Date 2019-01-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Permethrin (1 g)
Inactive Ingredients
Canada Balsam Cetyl Alcohol Citric Acid Monohydrate Fd&c Yellow No. 6 Hydroxyethyl Cellulose (2000 Mpa.s At 1%) Ceteth-10 Propylene Glycol Stearalkonium Chloride Water Isopropyl Alcohol Methylparaben Propylparaben

Identifiers & Packaging

Pill Appearance
Color: orange
Marketing Status
NDA Active Since 2013-11-15

Description

Drug Facts

Purpose

Lice treatment

How Supplied

Product: 76413-358 NDC: 76413-358-01 1 mL in a CARTON


Medication Information

Purpose

Lice treatment

How Supplied

Product: 76413-358

NDC: 76413-358-01 1 mL in a CARTON

Description

Drug Facts

Use

treats head lice

Section 42229-5

Drug Facts

Active I

Permethrin 280 mg (1%)

Warnings

For external use only

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
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.
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)
If Pregnant Or Bre

ask a health professional before use.

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, methylparaben, and propylparaben

Questions Or Comments?

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

Distributed by:

INSIGHT Pharmaceuticals LLC.

Tarrytown, NY 10591

A Prestige Brands Company

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
Nix (permethrin) Shampoo
Stop Use and See A Doctor If
  • breathing difficulty occurs

  • eye irritation occurs

  • skin or scalp irritation continues or infection occurs
Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Ask A Doctor Before Use If You Are

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


Structured Label Content

Use

treats head lice

Section 42229-5 (42229-5)

Drug Facts

Purpose

Lice treatment

Active I (Active i)

Permethrin 280 mg (1%)

Warnings

For external use only

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
Do Not Use (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.
How Supplied (HOW SUPPLIED)

Product: 76413-358

NDC: 76413-358-01 1 mL in a CARTON

Other Information (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)
If Pregnant Or Bre (If pregnant or bre)

ask a health professional before use.

Inactive Ingredients (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, methylparaben, and propylparaben

Questions Or Comments? (Questions or comments?)

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

Distributed by:

INSIGHT Pharmaceuticals LLC.

Tarrytown, NY 10591

A Prestige Brands Company

When Using This Product (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
Nix (permethrin) Shampoo (NIX (PERMETHRIN) SHAMPOO)
Stop Use and See A Doctor If (Stop use and see a doctor if)
  • breathing difficulty occurs

  • eye irritation occurs

  • skin or scalp irritation continues or infection occurs
Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center right away.

Ask A Doctor Before Use If You Are (Ask a doctor before use if you are)

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


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Raw Label Data

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