NDC 10596-190 Biore Blue Agave Baking Soda Acne Cleansing Foam

Salicylic Acid

NDC Product Code 10596-190

NDC Code: 10596-190

Proprietary Name: Biore Blue Agave Baking Soda Acne Cleansing Foam 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.

NDC Code Structure

  • 10596 - Kao Usa Inc.
    • 10596-190 - Biore

NDC 10596-190-67

Package Description: 200 mL in 1 BOTTLE, WITH APPLICATOR

NDC Product Information

Biore Blue Agave Baking Soda Acne Cleansing Foam with NDC 10596-190 is a a human over the counter drug product labeled by Kao Usa Inc.. The generic name of Biore Blue Agave Baking Soda Acne Cleansing Foam is salicylic acid. The product's dosage form is suspension and is administered via topical form.

Labeler Name: Kao Usa Inc.

Dosage Form: Suspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.

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 Blue Agave Baking Soda Acne Cleansing Foam 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 .5 g/100mL

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)
  • SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • 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)
  • SODIUM BICARBONATE (UNII: 8MDF5V39QO)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • AGAVE TEQUILANA LEAF (UNII: 05545M0E3M)

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: 04-22-2019 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 Blue Agave Baking Soda Acne Cleansing Foam Product Label Images

Biore Blue Agave Baking Soda Acne Cleansing Foam 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 ©2018Made in Canada

Otc - Active Ingredient

Active ingredientSalicylic acid 0.5%

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 productskin 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 topical 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 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 c14-16 olefin sulfonate, sorbitol, polysorbate 20, laureth-4 carboxylic acid, sodium laureth sulfate, ethyhexylglycerin, citric acid, fragrance, sodium hydroxide, polyquaternium-39, disodium EDTA, sodium bicarbonate, agave tequilana leaf extract, sodium benzoate

* Please review the disclaimer below.

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