Nix Lice Killing Creme Rinse

Nix Lice Killing Creme Rinse
SPL v1
SPL
SPL Set ID cf7c2429-9ae0-4435-b695-aafd5f207d27
Route
TOPICAL
Published
Effective Date 2022-02-04
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, Unspecified Isopropyl Alcohol Methylparaben Ceteth-10 Propylene Glycol Propylparaben Stearalkonium Chloride Water

Identifiers & Packaging

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

Description

Permethrin 280 mg (1%)

Purpose

Lice treatment


Medication Information

Purpose

Lice treatment

Description

Permethrin 280 mg (1%)

Uses

treats head lice

Warnings

For external use only

Directions

Important: Read warnings before use

  • Adults and children 2 months old and older

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/or nits (eggs)
  • use a tool, such as a comb or two unsharpened pencils to lift and part the hair
  • look for tiny nits near 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 (or 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.
Active Ingredient

Permethrin 280 mg (1%)

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)
Package Labeling:

Inactive Ingredients

canada balsam, cetyl alcohol, citric acid, FD&C yellow no. 6, hydrolyzed animal protein, hydroxyethylcellulose, isopropyl alcohol, methylparaben, polyoxyethylene 10 cetyl ether, propylene glycol, propylparaben, stearalkonium chloride, water

Questions Or Comments?

call 1-888- LICE (1-888-542-3546).

Monday to Friday, 9 AM - 5 PM EST

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 Ask 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 (1-800-222-1222) right away.

Ask A Doctor Before Use If You Are

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


Structured Label Content

Uses

treats head lice

Purpose

Lice treatment

Warnings

For external use only

Directions

Important: Read warnings before use

  • Adults and children 2 months old and older

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/or nits (eggs)
  • use a tool, such as a comb or two unsharpened pencils to lift and part the hair
  • look for tiny nits near 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 (or 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.
Active Ingredient (Active ingredient)

Permethrin 280 mg (1%)

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)
Package Labeling:

Inactive Ingredients (Inactive ingredients)

canada balsam, cetyl alcohol, citric acid, FD&C yellow no. 6, hydrolyzed animal protein, hydroxyethylcellulose, isopropyl alcohol, methylparaben, polyoxyethylene 10 cetyl ether, propylene glycol, propylparaben, stearalkonium chloride, water

Questions Or Comments? (Questions or comments?)

call 1-888- LICE (1-888-542-3546).

Monday to Friday, 9 AM - 5 PM EST

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
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • breathing difficulty occurs

  • eye irritation occurs

  • skin or scalp irritation continues or infection occurs
If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) 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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