NDC 76772-025 Bath And Beauty Charcoal Acne Scrub

Salicylic Acid

NDC Product Code 76772-025

NDC 76772-025-91

Package Description: 91 g in 1 TUBE

NDC Product Information

Bath And Beauty Charcoal Acne Scrub with NDC 76772-025 is a a human over the counter drug product labeled by Tsm Ithalat Ihracat Sanayi Ve Dis Ticaret Limited Sirketi. The generic name of Bath And Beauty Charcoal Acne Scrub is salicylic acid. The product's dosage form is gel and is administered via topical form.

Labeler Name: Tsm Ithalat Ihracat Sanayi Ve Dis Ticaret Limited Sirketi

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.

Bath And Beauty Charcoal Acne Scrub 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.

  • SALICYLIC ACID 1.3 g/91g

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.

  • SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
  • COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
  • POLYQUATERNIUM-39 (22.5/51/26.5 ACRYLIC ACID/ACRYLAMIDE/DADMAC; 1600000 MW) (UNII: X2NH1K9F8K)
  • CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
  • WATER (UNII: 059QF0KO0R)
  • SORBITOL (UNII: 506T60A25R)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • SYNTHETIC WAX (1200 MW) (UNII: Q3Z4BCH099)
  • MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • MENTHOL (UNII: L7T10EIP3A)
  • CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • ACTIVATED CHARCOAL (UNII: 2P3VWU3H10)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)

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: Tsm Ithalat Ihracat Sanayi Ve Dis Ticaret Limited Sirketi
Labeler Code: 76772
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: 03-10-2021 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.

Bath And Beauty Charcoal Acne Scrub Product Label Images

Bath And Beauty Charcoal Acne Scrub 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 ingredientSalicylic acid 1%

Otc - Purpose

PurposeAcne treatment

Indications & Usage

  • Usesclears up acne blemishespenetrates pores to control acne blemisheshelps prevent new acne blemishes from forming For the treatment of acne

Warnings

WarningsFor external use only.

Otc - When Using

  • When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water.skin irritation and dryness are more likely to occur if you use another topical acne medication at the same time.If irritation occurs, only use one topical acne medication at a time.

Otc - Keep Out Of Reach Of Children

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

Dosage & Administration

  • DirectionsWet faceSqueeze product into handsMassage over entire face and rinse thoroughlyBecause excessive drying of gradually increase to 2 or 3 times daily if needed or as directed by a doctor.If bothersome dryness or peeling occurs, reduce application to once a day or every other day.

Storage And Handling

Other informationstore at room temperature

Inactive Ingredient

Inactive ingredients Water, Glycerin, Sodium laureth Sulfate, Cocamidopropyl Betaine, Sorbitol,  Synthetic Wax, Microcrystalline Wax, Charcola Powder , Xanthan gum, fragrance, Sodium hydroxide, menthol, polyquaternium-39, charcoal powder, Disodium EDTA, Iodopropynyl Butylcarbamate,  Sodium Benzoate

* Please review the disclaimer below.