Label: NIX- permethrin shampoo
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Contains inactivated NDC Code(s)
NDC Code(s): 76413-358-01 - Packager: Central Texas Community Health Centers
- This is a repackaged label.
- Source NDC Code(s): 63736-024
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated January 15, 2019
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each fluid ounce)
- Purpose
- Use
-
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
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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
- all household members should be checked by another person for lice and/or nits (eggs)
- Other information
- Inactive ingredients
- Questions or comments?
- HOW SUPPLIED
- NIX (PERMETHRIN) SHAMPOO
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INGREDIENTS AND APPEARANCE
NIX
permethrin shampooProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76413-358(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 MPA.S 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:76413-358-01 1 mL in 1 CARTON; Type 0: Not a Combination Product 01/15/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA019918 11/15/2013 Labeler - Central Texas Community Health Centers (079674019) Establishment Name Address ID/FEI Business Operations Central Texas Community Health Centers 079674019 RELABEL(76413-358) , REPACK(76413-358)
