NDC 10596-185 Biore Charcoal Acne Clearing Cleanser

Salicylic Acid

NDC Product Code 10596-185

NDC CODE: 10596-185

Proprietary Name: Biore Charcoal Acne Clearing Cleanser 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: Salicylic Acid 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 on the skin to treat common skin and foot (plantar) warts. Salicylic acid helps cause the wart to gradually peel off. This medication is also used to help remove corns and calluses. This product should not be used on the face or on moles, birthmarks, warts with hair growing from them, or genital/anal warts. Salicylic acid is a keratolytic. It belongs to the same class of drugs as aspirin (salicylates). It works by increasing the amount of moisture in the skin and dissolving the substance that causes the skin cells to stick together. This makes it easier to shed the skin cells. Warts are caused by a virus. Salicylic acid does not affect the virus.

NDC Code Structure

NDC 10596-185-11

Package Description: 338 mL in 1 BOTTLE, PUMP

NDC 10596-185-50

Package Description: 147 mL in 1 BOTTLE, WITH APPLICATOR

NDC 10596-185-67

Package Description: 200 mL in 1 BOTTLE, PUMP

NDC 10596-185-85

Package Description: 250 mL in 1 BOTTLE, PUMP

NDC Product Information

Biore Charcoal Acne Clearing Cleanser with NDC 10596-185 is a a human over the counter drug product labeled by Kao Usa Inc.. The generic name of Biore Charcoal Acne Clearing Cleanser is salicylic acid. The product's dosage form is gel and is administered via topical form. The RxNorm Crosswalk for this NDC code indicates multiple RxCUI concepts are associated to this product: 1038982 and 1803724.

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 Charcoal Acne Clearing Cleanser 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.

  • SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
  • SORBITOL (UNII: 506T60A25R)
  • COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • WATER (UNII: 059QF0KO0R)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • MENTHOL (UNII: L7T10EIP3A)
  • CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • LAURETH-4 CARBOXYLIC ACID (UNII: DW3PIY647Y)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • POLYQUATERNIUM-39 (22.5/51/26.5 ACRYLIC ACID/ACRYLAMIDE/DADMAC; 1600000 MW) (UNII: X2NH1K9F8K)
  • ACTIVATED CHARCOAL (UNII: 2P3VWU3H10)

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: 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: 12-01-2016 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 - 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".

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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]

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Biore Charcoal Acne Clearing Cleanser Product Label Images

Biore Charcoal Acne Clearing Cleanser 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

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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©2016Made in Canada

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. Using 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.

Otc - When Using

When using this product 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 facepump product into handsmassage over entire face and neckrinse thoroughlyfor optimal results, use daily

Storage And Handling

Other informationstore at room temperature

Inactive Ingredient

Inactive ingredients water, sodium laureth sulfate, cocamidopropyl betaine, sorbitol, glycerin, laureth-4 carboxylic acid, ethyhexylglycerin, acrylates/C10-30 alkyl acrylate crosspolymer, sodium benzoate, fragrance, menthol, sodium hydroxide, polyquaternium-39, disodium EDTA, charcoal powder

* Please review the disclaimer below.