NDC 10596-192 Biore Mens Charcoal Acne Scrub

Salicylic Acid

NDC Product Information

Biore Mens Charcoal Acne Scrub with NDC 10596-192 is a a human over the counter drug product labeled by Kao Usa Inc.. The generic name of Biore Mens Charcoal Acne Scrub is salicylic acid. The product's dosage form is gel and is administered via topical form.

Labeler Name: Kao Usa Inc.

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.

Biore Mens 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 g/100g

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 COPOLYMER TYPE A (UNII: 71DD5V995L)
  • SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
  • ALUMINUM (UNII: CPD4NFA903)
  • POLYQUATERNIUM-39 (22.5/51/26.5 ACRYLIC ACID/ACRYLAMIDE/DADMAC; 1600000 MW) (UNII: X2NH1K9F8K)
  • WATER (UNII: 059QF0KO0R)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • MENTHOL (UNII: L7T10EIP3A)
  • D&C RED NO. 30 (UNII: 2S42T2808B)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
  • TALC (UNII: 7SEV7J4R1U)
  • COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
  • SORBITOL (UNII: 506T60A25R)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • ACTIVATED CHARCOAL (UNII: 2P3VWU3H10)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • SYNTHETIC WAX (1200 MW) (UNII: Q3Z4BCH099)
  • LAURETH-4 CARBOXYLIC ACID (UNII: DW3PIY647Y)

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.
  • 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: Kao Usa Inc.
Labeler Code: 10596
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: 10-01-2019 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: 12-31-2020 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’.

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Information for Patients

Salicylic Acid Topical

Salicylic Acid Topical is pronounced as (sal'' i sil' ik as' id)

Why is salicylic acid topical medication prescribed?
Topical salicylic acid is used to help clear and prevent pimples and skin blemishes in people who have acne. Topical salicylic acid is also used to treat skin conditions ...
[Read More]

* Please review the disclaimer below.

Biore Mens Charcoal Acne Scrub Product Label Images

Biore Mens 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

Other

  • BIORE CHARCOAL ACNE CLEARING SCRUB cleans and exfoliates away acne-causing dirt and absorbs excess oil to help eliminate breakouts for clear skin.
  • With Natural Charcoal

Drug Facts

Questions? 1-888-BIORE-11
www.biore.com @bioreusBIORE is a trademark of Kao Corp.Distributed by Kao USA Inc.Cincinnati, OH 45214 ©2019Made in USA of US & Imported Ingredients

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

Warnings

WarningsFor external use only.

Otc - When Using

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

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 facerinse thoroughlyfor optimal results, use up to 2-3 times per week

Storage And Handling

Other informationstore at room temperature

Inactive Ingredient

Inactive ingredients Water, Glycerin, Sodium Laureth Sulfate, Alumina, Cocamidopropyl Betaine, Sorbitol, Laureth-4 Carboxylic Acid, Synthetic Wax, Microcrystalline Wax, Ethylhexylglycerin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Xanthan Gum, Fragrance, Sodium Hdroxide, Menthol, Polyquaternium-39, Charcoal Powder, Disodium EDTA, Talc, Sodium Benzoate,Red 30, Yellow 5 lake

* Please review the disclaimer below.