NIX COMPLETE LICE TREATMENT- permethrin 
Insight Pharmaceuticals LLC

----------

Nix Complete Lice Treatment Kit

[1 Eliminate] Creme Rinse

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 right away.

Directions

Important: Read warnings before use

Inspect

Treat

Remove Lice/Nits

Other information

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, propylparaben

Questions?

1-888-542-3546

[2 Remove] Combing Gel & Comb

Product Facts

Uses

To detangle and comb the hair

Warnings

For external use only. Avoid contact with the eyes.

Keep out of reach of children.

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

Directions

Other Information

Ingredients

water, propylene glycol, glycerin, polyquaternium-10, diazolidinyl urea, hydroxyethylcellulose, sodium citrate dihydrate, citric acid, methylparaben, propylparaben, disodium EDTA

[3 Control] Nix ® Lice Control Spray

Active ingredient:

PERMETHRIN 0.25%

(CAS # 52645-53-1)

Other ingredients: 

99.75%

100.00%

NOT FOR USE ON HUMANS. READ ENTIRE LABEL BEFORE EACH USE. SHAKE BOTTLE WELL BEFORE USING.

Precautionary Statements

ENVIRONMENTAL HAZARDS

This product is extremely toxic to fish and aquatic organisms. To protect the environment, do not allow pesticide to enter or run off into storm drains, drainage ditches, gutters or surface waters.

Directions For Use

It is a violation of Federal law to use this product in a manner inconsistent with its labeling.

For Use in Non-food Areas of Homes

Indoor Application

Surface Spraying: To kill lice and louse eggs, spray in an inconspicuous area to test for possible staining or discoloration. Inspect again after drying, then proceed to spray entire area to be treated. Spray from a distance of 8 to 10 inches. Treat only those garments and parts of bedding, including mattresses and furniture, that cannot be either laundered or dry cleaned. Allow all treated articles to dry thoroughly before use.

To control bedbugs: Spray mattresses lightly, particularly around tufts and seams. Take beds apart and spray in all joints. Allow all sprayed articles to dry thoroughly before use.

Storage and Disposal

Do not contaminate water, food or feed by storing or disposal.

Pesticide Storage and Spill Procedures: Keep from freezing. Store upright at room temperature. Avoid exposure to extreme temperatures. In case of spill or leakage, soak up with an absorbent material such as sand, sawdust, earth, fuller's earth, etc. Dispose of with chemical waste.

Pesticide Disposal: If partly filled – Call your local solid waste agency for disposal instructions. Never place unused product down any indoor or outdoor drain. Container Disposal: If empty – Nonrefillable container.

Do not reuse or refill this container. Place in trash or offer for recycling if available.

EPA REG. NO. 64321-1-75406

EPA EST. NO. 91705-NJ-001

PRINCIPAL DISPLAY PANEL

Nix® Complete Lice Treatment Kit
Permethrin Creme Rinse (1%)

Creme Rinse 2 Bottles 2 fl oz (59 mL) EACH, Combing Gel 2 fl oz (59 mL), Lice Comb, Lice Control Spray 5 fl oz (147.86 mL)

PRINCIPAL DISPLAY PANEL 
Nix® Complete Lice Treatment Kit
Permethrin Creme Rinse (1%)

Creme Rinse 2 Bottles 2 fl oz (59 mL) EACH,
Combing Gel 2 fl oz (59 mL), Lice Comb, Lice Control Spray 5 fl oz (147.86 mL)
nixlice.com

NIX COMPLETE LICE TREATMENT 
permethrin kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63736-035
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63736-035-011 in 1 CARTON; Type 0: Not a Combination Product11/15/2013
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE 59 mL
Part 21 BOTTLE 59 mL
Part 31 BOTTLE 147 mL
Part 1 of 3
NIX CREME 
permethrin rinse
Product Information
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PERMETHRIN (UNII: 509F88P9SZ) (PERMETHRIN - UNII:509F88P9SZ) PERMETHRIN280 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
CANADA BALSAM (UNII: K304VI98I3)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
CETETH-10 (UNII: LF9X1PN3XJ)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
STEARALKONIUM CHLORIDE (UNII: 0OUO26BB88)  
WATER (UNII: 059QF0KO0R)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
Product Characteristics
ColorORANGE (Light Orange) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
12 in 1 CARTON
159 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01991811/15/2013
Part 2 of 3
NIX COMBING 
inert gel
Product Information
Route of AdministrationTOPICAL
Inactive Ingredients
Ingredient NameStrength
POLYQUATERNIUM-10 (125 MPA.S AT 2%) (UNII: L45WU8S981)  
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
GLYCERIN (UNII: PDC6A3C0OX)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
11 in 1 CARTON
159 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER11/15/2013
Part 3 of 3
NIX LICE CONTROL 
permethrin spray
Product Information
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PERMETHRIN (UNII: 509F88P9SZ) (PERMETHRIN - UNII:509F88P9SZ) PERMETHRIN25 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R) 75 mg  in 1 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
11 in 1 CARTON
1147.86 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER11/15/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01991811/15/2013
Labeler - Insight Pharmaceuticals LLC (055665422)

Revised: 4/2020
Document Id: f369cf99-ff7c-402a-b4a1-ca06bd5788e7
Set id: cca42777-01bf-4352-acdb-441160d69557
Version: 2
Effective Time: 20200423
 
Insight Pharmaceuticals LLC