NDC 10596-184 Biore Charcoal Acne Scrub

Salicylic Acid

NDC Product Code 10596-184

NDC Code: 10596-184

Proprietary Name: Biore Charcoal Acne Scrub Additional informationCallout TooltipWhat 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: Salicylic Acid Additional informationCallout TooltipWhat 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.


Code Structure
  • 10596 - Kao Usa Inc.
    • 10596-184 - Biore

NDC 10596-184-10

Package Description: 28 g in 1 TUBE

NDC 10596-184-45

Package Description: 127 g in 1 TUBE

NDC 10596-184-56

Package Description: 159 g in 1 TUBE

NDC Product Information

Biore Charcoal Acne Scrub with NDC 10596-184 is a a human over the counter drug product labeled by Kao Usa Inc.. The generic name of Biore 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 Additional informationCallout TooltipWhat 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 Charcoal Acne Scrub Active Ingredient(s)

Additional informationCallout TooltipWhat 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/127g

Inactive Ingredient(s)

Additional informationCallout TooltipAbout 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)
  • 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)
  • CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)
  • 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)

Additional informationCallout TooltipWhat 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

Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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. Additional informationCallout TooltipWhat 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: 12-01-2016 Additional informationCallout TooltipWhat 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: 12-31-2019 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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.

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 Charcoal Acne Scrub Product Label Images

Biore 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 SCRUB exfoliates away acne-causing dirt and absorbs excess oil to help eliminate breakouts.
  • With Natural Charcoal

Drug Facts

Questions? 1-888-BIORE-11
www.biore.comwww.facebook.com/bioreskinBIORE is a trademark of Kao Corp.Distributed by Kao USA Inc.Cincinnati, OH 45214 ©2017Made 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 productusing other topical acne medications at the same time or immediately 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.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, synthetic wax, laureth-4 carboxylic acid, microcrystalline wax, ethylhexylglycerin, acrylates/C10-30 alkyl acrylate crosspolymer, xanthan gum, sodium benzoate, fragrance, sodium hydroxide, menthol, polyquaternium-39, charcoal powder, disodium EDTA, yellow 5 lake, talc, red 30

* Please review the disclaimer below.

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