NDC 62742-4195 Dermaclear Bha Spot Treatment

Salicylic Acid

NDC Product Information

Dermaclear Bha Spot Treatment with NDC 62742-4195 is a a human over the counter drug product labeled by Allure Labs. The generic name of Dermaclear Bha Spot Treatment is salicylic acid. The product's dosage form is gel and is administered via topical form.

Labeler Name: Allure Labs

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.

Dermaclear Bha Spot Treatment 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.


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.

  • WATER (UNII: 059QF0KO0R)
  • ALCOHOL (UNII: 3K9958V90M)

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.

Product Labeler Information

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

Labeler Name: Allure Labs
Labeler Code: 62742
FDA Application Number: part333D 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: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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: 12-10-2020 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: 12-31-2021 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 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Dermaclear Bha Spot Treatment Product Label Images

Dermaclear Bha Spot Treatment 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

Otc - Active Ingredient

Active Ingredient: Salicylic Acid - 2%

Otc - Purpose

Purpose: Acne Treatment

Indications & Usage

  • Uses: For the treatment of acne.


  • WarnigsFor external use only

Otc - When Using

  • When using this productAvoid contact with eyes, lips and mouth. Using other topical acne medication at the same time ot immefiately following use of this product may increase dryness or irritation of the skin. If this occurs only one medication should be used unless directed by a doctor. If sensitive to the sun or when increased sun exposure is expected use a sunscreen.

Otc - Stop Use

  • Stop use and ask a doctor:If severe skin irritation occurs.Using other topical medication at the same time

Otc - Keep Out Of Reach Of Children

  • Keep out of reach of children:If swallowed, get medical help or contact a Poison Control Centre right away.

Dosage & Administration

  • DirectionsApply a small portion over the affected area with finger tips and gently massage onto the skin.Reapply as needed.

Inactive Ingredient

Other ingredients: Water (aqua), SD Alcohol 40-B, Butylene Glycol, Hydroxypropylcellulose

* Please review the disclaimer below.