Nix Rinse
NDC 63736-030

Permethrin 1 g/100mL · Rinse (topical)
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 63736-030?
  5. Nix Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes
  9. NDC to RxNorm Crosswalk
  10. Pharmacologic Classes
  11. Patient Education

Product Information

Nix (permethrin) is a NDA-approved product labeled by Insight Pharmaceuticals Llc. This medication is typically used as a pyrethrins [cs]. It is supplied as a orange rinse for topical administration. This product entry covers the primary NDC 63736-030 and 2 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
63736-030
Proprietary Name:
Nix
Non-Proprietary Name: [1]
Permethrin
Substance Name: [2]
Permethrin
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
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Clinical Specifications

Dosage Form:
Rinse - A liquid used to cleanse by flushing.
Administration Route(s): [4]
Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Labeler & Regulatory Data

Labeler Name: [5]
Insight Pharmaceuticals Llc
Labeler Code:
63736
Product Label ID:
d6dfa64a-bb88-4438-b4e2-30c6fbb28f3e
FDA Application Number: [6]
NDA019918
Marketing Category: [8]
NDA - A product marketed under an approved New Drug Application.

Marketing Timeline

Start Marketing Date: [9]
11-15-2013
Listing Expiration Date: [11]
12-31-2027
Exclude Flag: [12]
N

Product Characteristics

Color(s):
ORANGE (C48331 - LIGHT ORANGE)

Code Structure Chart

Product Details

What is NDC 63736-030?

The NDC code 63736-030 is assigned by the FDA to the product Nix. It is commonly known by its generic name, permethrin. This pharmaceutical product is labeled by Insight Pharmaceuticals Llc and is currently categorized as listed product. The medication is a rinse administered via topical route. In terms of distribution, this product is available in 2 different package configurations. The associated package NDC(s) include: 63736-030-01, 63736-030-02. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

Important: Read warnings before use■       Adults and children 2 months of age and over: Inspectall 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 hairlook for tiny nits near the scalp, beginning at the back of the neck and behind the earssmall sections of hair (1-2 inches wide) should be examined at a timeunlike dandruff, nits stick to the hair. Dandruff should move when lightly touched.if either lice or nits (eggs) are found, treat with Nix® Creme RinseTreatwash 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 wetshake the bottle of Nix® wellcompletely 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 longerrinse with warm watertowel dry hair and comb out tanglesif live lice are seen seven days or more after the first treatment, a second treatment should be givenRemove Lice/Nitsremove 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 nitsif the hair dries during combing, dampen it slightly with waterpart 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 pickedwith 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 nitsclean 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 necessarycheck the affected head daily to remove any nits that you might have missed

What are Active Ingredients of this product?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
  • PERMETHRIN 1 g/100mL - A pyrethroid insecticide commonly used in the treatment of LICE INFESTATIONS and SCABIES.

Which are the associated UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are the Inactive Ingredients associated UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for this product?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

Which are the Pharmacologic Classes of this product?

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

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Patient Education

Permethrin Topical


Permethrin is used to treat scabies ('mites that attach themselves to the skin) in adults and children 2 months of age and older. Over-the-counter permethrin is used to treat lice (small insects that attach themselves to the skin on the head) in adults and children 2 months of age and older. Permethrin is in a class of medications called scabicides and pediculicides. It works by killing lice and mites.
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Product & Regulatory Definitions
What is the Non-Proprietary Name? The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
What is the Substance Name? An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
What kind of product is this? Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
What are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
What is the FDA Application Number? This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
What is the Marketing Category? Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
What is the Listing Expiration Date? This is the date when the listing record will expire if not updated or certified by the product labeler.
What is the NDC Exclude Flag? This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".