Nix by Insight Pharmaceuticals LLC NIX- permethrin shampoo

Nix by

Drug Labeling and Warnings

Nix by is a Otc medication manufactured, distributed, or labeled by Insight Pharmaceuticals LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

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 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, 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

PRINCIPAL DISPLAY PANEL

63736-024-02
Nix®
Creme Rinse
Permethrin /Lice Treatment
NET WT 2 FL OZ (59 mL)

PRINCIPAL DISPLAY PANEL

63736-024-04

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

INGREDIENTS AND APPEARANCE

NIX 
permethrin shampoo

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PERMETHRIN (UNII: 509F88P9SZ) (PERMETHRIN - UNII:509F88P9SZ)	PERMETHRIN	1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CANADA BALSAM (UNII: K304VI98I3)
CETYL ALCOHOL (UNII: 936JST6JCN)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16)
CETETH-10 (UNII: LF9X1PN3XJ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
STEARALKONIUM CHLORIDE (UNII: 0OUO26BB88)
WATER (UNII: 059QF0KO0R)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63736-024-02	1 in 1 CARTON	11/15/2013
1		59 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 63736-024-04	2 in 1 CARTON	11/15/2013
2		59 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA019918	11/15/2013

Labeler - Insight Pharmaceuticals LLC (055665422)