Nix Rinse
FDA Label NDC 63736-030

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Insight Pharmaceuticals Llc for the product Nix (NDC 63736-030). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient (in each fluid ounce), purpose, use, warnings, do not use, ask a doctor before use if you are, when using this product, stop use and see a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (In Each Fluid Ounce)

Permethrin 280 mg (1%)

Purpose

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 (1-800-222-1222) right away.

Directions

Important: Read warnings before use

■       Adults and children 2 months of age and over: 

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

canada balsam, 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

Principal Display Panel

Nix® 
Lice Killing Creme Rinse
includes 1 bottle plus 1 nit comb
NET WT 2 FL OZ (59 mL)

Principal Display Panel Nix® Lice Killing Creme Rinseincludes 1 Bottle Plus 1 Nit Combnet Wt 2 Fl Oz (59 mL) (Nix Creme Rinse 63736 030 01)

Principal Display Panel Nix® Lice Killing Creme Rinseincludes 1 Bottle Plus 1 Nit Combnet Wt 2 Fl Oz (59 mL) (Nix Creme Rinse 63736 030 01)

Nix® 
Creme Rinse – Family Pack
Permethrin /Lice Treatment
Family Pack - NET WT 4 FL OZ (2 - 2 FL OZ (59 mL)

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