Nix FAMILY PACK Lice Killing Creme Rinse Kit

Nix FAMILY PACK Lice Killing Creme Rinse Kit by

Drug Labeling and Warnings

Nix FAMILY PACK Lice Killing Creme Rinse Kit by is a Otc medication manufactured, distributed, or labeled by Geodis Logistics LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

NIX FAMILY PACK LICE KILLING CREME RINSE KIT- permethrin 
Geodis Logistics LLC

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Nix FAMILY PACK Lice Killing Creme Rinse Kit

Drug Facts

Active ingredient (in each fluid ounce)

Permethrin 280 mg (1%)

Purpose

Lice treatment

Uses

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 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.

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

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, 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

Package Labeling: 63471-3010-0

Package Labeling:63471-3006-2

NIX FAMILY PACK LICE KILLING CREME RINSE KIT 
permethrin kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63471-3010

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63471-3010-0	1 in 1 KIT	11/15/2013

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	2 BOTTLE	118 mL  in 2

Part 1 of 1

NIX LICE KILLING CREME RINSE 
permethrin rinse

Product Information
Item Code (Source)	NDC: 63471-3006(NDC: 63736-030)
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, UNSPECIFIED (UNII: T4V6TWG28D)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
METHYLPARABEN (UNII: A2I8C7HI9T)
CETETH-10 (UNII: LF9X1PN3XJ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
STEARALKONIUM CHLORIDE (UNII: 0OUO26BB88)
WATER (UNII: 059QF0KO0R)

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: 63471-3006-2	1 in 1 CARTON
1		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

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

Labeler - Geodis Logistics LLC (877844097)

Revised: 2/2022

Document Id: d76d4779-5871-c676-e053-2a95a90ada97

34390-5

Set id: 89f07050-487b-4bf1-ad90-e08fa1044aa6

Version: 2

Effective Time: 20220207