Nix COMPLETE Lice Treatment Kit

Nix COMPLETE Lice Treatment by

Drug Labeling and Warnings

Nix COMPLETE Lice Treatment by is a Otc medication manufactured, distributed, or labeled by Geodis Logistics LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

NIX COMPLETE LICE TREATMENT- permethrin 
Geodis Logistics LLC

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Nix COMPLETE Lice Treatment 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

Active ingredient:

PERMETHRIN 0.25%

Other ingredients: 99.75%

100.00%

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

Precautionary Statements

HAZARDS TO HUMANS AND DOMESTIC ANIMALS

CAUTION User Safety Recommendations: Wear long-sleeved shirt and long pants, socks and shoes. User should wash hands before eating, drinking, chewing gum, using tocacco, or using the toilet. User should remove clothing immediately if persticide gets inside. Then wash thoroughly and put on clean clothing.

Directions For Use

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

Use Restrictions:For use as a surface spray, do not allow adults, children or pets to enter until sprays have dried. Do not apply as a broadcast treatment to indoor surfaces at residential sites, including nurseries, day care centers, schools, hospitals and nursing homes.

FOR USE IN NON-FOOD AREAS INDOORS AND OUTSIDE PREMISES OF HOMES, HOBBY GREENHOUSES AND STORAGE BUILDINGS, CAMPERS, MOBILE HOMES, AUTOMOBILES, TRUCKS AND BOATS.

INDOOR APPLICATIONS: In the home, cover all food handling surfaces, cover or remove all food and cooking utensils or wash thoroughly after treatment. Application is prohibited directly into sewers or drains, or to any area like a gutter where drainage to sewers, storm drains, water bodies, or aquatic habitat can occur. Do not allow the product to enter any drain during or after application. Do not enter or allow others to enter until sprays have dried.

Surface Spraying: To kill lice and louse eggs: Treat only those garments and parts of bedding, including mattresses and furniture, that cannot be either laundered or dry cleaned. 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. Allow all treated articles to dry thoroughly before use.

To kill 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 & Disposal

Pesticide Storage: Keep from freezing. Store upright at room temperature. out of reach of children and pets. 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 Handling: If empty - Nonrefillable container. Do not reuse or refill this container. Place in trash or offer for recycling if available.

NOTICE: To the extent consistent with applicable law, buyer assumes all risks of use, storage or handling of this product not in stirct accordance with directions given herewith.

EPA REG. NO. 64321-1-75406

EPA EST. NO. 91705-NJ-001

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

  • use after shampooing with lice killing creme rinse
  • towel dry hair
  • apply combining gel until all the hair and scalp is thoroughly wet with product
  • make sure product covers the area behind the ears and at the nape of the neck where there are more likely to be nits
  • part hair into sections and clip back
  • use the enclosed special-toothed comb to comb out dead lice and nits
  • comb out one section at a time
  • it is extremely important to comb out dead lice and nits
  • if hair begins to dry, reapply additional product
  • when you finish combing, rinse hair thoroughly with warm water.

Other Information

  • Nix Combing Gel does not kill lice and nits
  • Pesticide free
  • Keep carton for full information and warnings. Read all warnings and directions before use.
  • Visit our website at nixlice.com

Ingredients

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

Package Labeling:63471-3020-0

Kit3KitKit2

NIX COMPLETE LICE TREATMENT 
permethrin kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 63471-3020(NDC: 63736-035)
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 63471-3020-01 in 1 KIT11/15/2013
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 12 BOTTLE 118 mL  in 2 
Part 21 BOTTLE 147.86 mL
Part 1 of 2
NIX LICE KILLING CREME RINSE 
permethrin rinse
Product Information
Item Code (Source)NDC: 63471-3006(NDC: 63736-030)
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PERMETHRIN (UNII: 509F88P9SZ) (PERMETHRIN - UNII:509F88P9SZ) PERMETHRIN1 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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
Colororange (Light Orange) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 63471-3006-21 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 2
NIX LICE KILLING 
permethrin spray
Product Information
Item Code (Source)NDC: 63471-3008
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)  
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
1NDC: 63471-3008-51 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
NDANDA01991811/15/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01991811/15/2013
Labeler - Geodis Logistics LLC (877844097)

Revised: 2/2022
 

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