NDC 36800-088 Adapalene

Gel Topical

  1. Labeler Index
  2. Top Care (topco Associates Llc)
  3. NDC: 36800-088 Adapalene

NDC Product Code 36800-088

NDC CODE: 36800-088

Proprietary Name: Adapalene What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name: Adapalene 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.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.
  • This medication is used to treat acne. It may decrease the number and severity of acne pimples and promote quick healing of pimples that do develop. Adapalene belongs to a class of medications called retinoids. It works by affecting the growth of cells and decreasing swelling and inflammation.

NDC Code Structure

NDC 36800-088-05

Package Description: 1 TUBE in 1 CARTON > 15 g in 1 TUBE

NDC Product Information

Adapalene with NDC 36800-088 is a human over the counter drug product labeled by Top Care (topco Associates Llc). The product's dosage form is gel and is administered via topical form.

Dosage Form: Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.

Product Type: Human Otc Drug 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.

Adapalene Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

RxNorm Crosswalk

What is RxNorm?
RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) (RxCUI) to each NDC.

The RxNorm Crosswalk for this NDC code indicates a single concept unique identifier (RXCUI) is associated with this product:


Inactive Ingredient(s)

About the Inactive Ingredient(s)
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.
  • CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • POLOXAMER 182 (UNII: JX0HIX6OAG)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Pharmacologic Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Product Labeler Information

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

Labeler Name: Top Care (topco Associates Llc)
Labeler Code: 36800
FDA Application Number: ANDA091314 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.
Marketing Category: ANDA - A product marketed under an approved Abbreviated New Drug Application. 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.
Start Marketing Date: 07-30-2020 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
Listing Expiration Date: 12-31-2022 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.
Exclude Flag: N - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Adapalene Product Label Images

Adapalene Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredient

Agapalene USP 0.1% (retinoid)**read consumer information leaflet

Purpose

Acne treatment

Use

  • For the treatment of acne

Warnings

For external use only

Do Not Use

  • On damaged skin (cuts, abrasions eczema, sunburn)if you are allergic to adapalene or any of the ingredients in this product

Pregnancy/Breastfeeding,

Ask a doctor before use.

When Using This Product

  • Limit sun exposure, including light from tanning beds, and use sunscreen when going outdoors.do not wax to remove hair in areas where the product has been appliedduring the early weeks of use, your acne may appear to worsen before it improves (this is normal); continue using as directed, unless you get irritation that become severeirritation (redness, itching, dryness, burning) is more likely to occur:in the first few weeks of useif using more than one topical acne medication at a timebut irritation usually lessens with continued use of this productit may take up to 3 months of once daily use to see resultavoid product contact eyes, lips, and month. If contact occurs immediately flush the area with water.wash hands after use

Stop Use And Ask A Doctor If

  • You become pregnant, or planning to become pregnant while using this productyou have symptoms of an allergic reaction (such as itching, rash, hives, swelling of the lips, eyelids, and shortness of breath)irritation become severeyou see no improvement after 3 months of once daily 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

  • Adults and children 12 years of age and older:use once dailyclean the skin gently and pat dry before applying the productcover the entire affected area with a thin layer. For example, if your acne in on the face, apply the product to the entire face.do not use more than one time a day. Applying more than directed will not provide faster or better results, but may worsen skin irritation.Children under 12 years of age: ask a doctor

Other Information

  • Store at rooms temperature 68º to 77ºFprotect from freezing

Inactive Ingredients

Carbomer homopolymer, edetate disodium, methylparabem, poloxamer 182, propylene glycol, purified water, sodium hydroxide

Product Label

TOPCARE beauty Adapalene Gel Acne Treatment

* Please review the disclaimer below.