NDC 21130-085 Signature Care Lice Treatment

View Dosage, Usage, Ingredients, Routes, UNII

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Get all the details for National Drug Code (NDC) 21130-085 in one place. This page breaks down everything you need to know about the NDC, including proprietary name, active and inactive substances, package configurations, billing units, labeler information, and routes of administration. It also includes enhanced data such as HCPCS codes, FDA product labels with images, UNIIs, and RxNorm cross-references. Whether you're a healthcare professional verifying drug data or a consumer researching medication, this NDC page helps you make informed, accurate decisions.

NDC Product Code:
21130-085
Proprietary Name:
Signature Care Lice Treatment
Product Type: [3]
Labeler Name: [5]
Labeler Code:
21130
FDA Application Number: [6]
M031
Marketing Category: [8]
OTC MONOGRAPH DRUG -
Start Marketing Date: [9]
11-11-2015
End Marketing Date: [10]
10-31-2024
Listing Expiration Date: [11]
10-31-2024
Exclude Flag: [12]
D
Code Navigator:

Product Characteristics

Color(s):
YELLOW (C48330 - CLOUDY TO TRANSPARENT, CREAM TO STRAW)

Code Structure Chart

Product Details

What is NDC 21130-085?

The NDC code 21130-085 is assigned by the FDA to the product Signature Care Lice Treatment which is product labeled by Safeway. The product's dosage form is . The product is distributed in 2 packages with assigned NDC codes 21130-085-26 1 bottle in 1 carton / 118 ml in 1 bottle, 21130-085-34 1 bottle in 1 carton / 236 ml in 1 bottle. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Signature Care Lice Treatment?

•Important: Read warnings before useAdults and children 2 years and over:Inspect•check each household member with a magnifying glass in bright light for lice/nits (eggs)•look for tiny nits near scalp, beginning at back of neck and behind ears•examine small sections of hair at a time•unlike dandruff which moves when touched, nits stick to the hair•if either lice or nits are found, treat with this productTreat•shake well before using•apply thoroughly to DRY HAIR or other affected area. For head lice, first apply behind ears and to back of neck.•allow product to remain for 10 minutes, but no longer•use warm water to form a lather, shampoo, then thoroughly rinse•for head lice, towel dry hair and comb out tanglesRemove lice and their eggs (nits)•use a fine-tooth or special lice/nit comb. Remove any remaining nits by hand (using a throw-away glove).•hair should remain slightly damp while removing nits if hair dries during combing, dampen slightly with water•if hair dries during combing, dampen slightly with water•for head lice, part hair into sections. Do one section at a time starting on top of head. Longer hair may take 1 to 2 hours.•lift a 1- to 2-inch wide strand of hair. Place comb as close to scalp as possible and comb with a firm, even motion away from scalp.•pin back each strand of hair after combing•clean comb often. Wipe nits away with tissue and discard in a plastic bag. Seal bag and discard to prevent lice from coming back.•after combing, thoroughly recheck for lice/nits. Repeat combing if necessary.•check daily for any lice/nits that you missed•a second treatment must be done in 7 to 10 days to kill any newly hatched lice•if infestation continues, see a doctor for other treatmentsChildren under 2 years: ask a doctor

Which are Signature Care Lice Treatment UNII Codes?

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

Which are Signature Care Lice Treatment Inactive Ingredients 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:

* Please review the disclaimer below.

Patient Education

Pyrethrin and Piperonyl Butoxide Topical


Pyrethrin and piperonyl butoxide shampoo is used to treat lice (small insects that attach themselves to the skin on the head, body, or pubic area ['crabs']) in adults and children 2 years of age and older. Pyrethrin and piperonyl butoxide is in a class of medications called pediculicides. It works by killing lice.
[Learn More]


* Please review the disclaimer below.

Product Footnotes

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[6] 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.

[8] 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.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[10] What is the End Marketing Date? - This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.

[11] 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.

[12] 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".