Label: NIX COMPLETE LICE TREATMENT- permethrin kit
- NDC Code(s): 63736-035-01
- Packager: Insight Pharmaceuticals LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated April 23, 2020
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each fluid ounce)
- Purpose
- Uses
-
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
- on children under 2 months of age
-
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 back of neck and behind 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
- Inactive ingredients
- Questions?
- Uses
- Warnings
-
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.
- use after shampooing with lice killing creme rinse
- Other Information
- Ingredients
- Active ingredient:
-
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.
- Do not use in food/feed areas of food/feed handling establishments, restaurants or other areas where food/feed is commercially prepared or processed. Do not use in serving areas while food is exposed or facility is in operation. Serving areas are areas where prepared foods are served such as dining rooms, but excluding areas where foods may be prepared or held.
- 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 into any area like a gutter where drainage to sewers, storms drains, water bodies, or aquatic habitat can occur. Do not allow the product to enter any drain during or after application.
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
- Do not use in food/feed areas of food/feed handling establishments, restaurants or other areas where food/feed is commercially prepared or processed. Do not use in serving areas while food is exposed or facility is in operation. Serving areas are areas where prepared foods are served such as dining rooms, but excluding areas where foods may be prepared or held.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
NIX COMPLETE LICE TREATMENT
permethrin kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63736-035 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63736-035-01 1 in 1 CARTON; Type 0: Not a Combination Product 11/15/2013 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BOTTLE 59 mL Part 2 1 BOTTLE 59 mL Part 3 1 BOTTLE 147 mL Part 1 of 3 NIX CREME
permethrin rinseProduct Information Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PERMETHRIN (UNII: 509F88P9SZ) (PERMETHRIN - UNII:509F88P9SZ) PERMETHRIN 280 mg in 100 mL Inactive Ingredients Ingredient Name Strength 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 Color ORANGE (Light Orange) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 2 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 Part 2 of 3 NIX COMBING
inert gelProduct Information Route of Administration TOPICAL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 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 UNAPPROVED DRUG OTHER 11/15/2013 Part 3 of 3 NIX LICE CONTROL
permethrin sprayProduct Information Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PERMETHRIN (UNII: 509F88P9SZ) (PERMETHRIN - UNII:509F88P9SZ) PERMETHRIN 25 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) 75 mg in 1 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 1 in 1 CARTON 1 147.86 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 UNAPPROVED DRUG OTHER 11/15/2013 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)