NDC 10596-153 Biore Warming Anti-blackhead Cleanser
Salicylic Acid
NDC Product Code 10596-153
Proprietary Name: Biore Warming Anti-blackhead 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.
Code Structure
- 10596 - Kao Usa Inc.
- 10596-153 - Biore
NDC 10596-153-45
Package Description: 127 g in 1 TUBE
NDC Product Information
Biore Warming Anti-blackhead Cleanser with NDC 10596-153 is a a human over the counter drug product labeled by Kao Usa Inc.. The generic name of Biore Warming Anti-blackhead Cleanser is salicylic acid. The product's dosage form is liquid and is administered via topical form.
Labeler Name: Kao Usa Inc.Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
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 Warming Anti-blackhead 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.
- CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)
- DIATOMACEOUS EARTH (UNII: 2RF6EJ0M85)
- POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
- BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
- DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
- POWDERED CELLULOSE (UNII: SMD1X3XO9M)
- SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)
- CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
- DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)
- HYDROXYPROPYL CELLULOSE (UNII: RFW2ET671P)
- BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
- FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
- HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)
- CETETH-20 PHOSPHATE (UNII: 921FTA1500)
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 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: 12-28-2011
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: 12-31-2019
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’.
* 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 Warming Anti-blackhead Cleanser Product Label Images
Biore Warming Anti-blackhead 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
- Other
- Otc - Active Ingredient
- Otc - Purpose
- Indications & Usage
- Warnings
- Otc - When Using
- Otc - Keep Out Of Reach Of Children
- Dosage & Administration
- Storage And Handling
- Inactive Ingredient
Other
Drug Facts
Questions?1-888-BIORE-11www.biore.comwww.facebook.com/bioreskinBIORE is a trademark of Kao Corp.Distributed by Kao USA Inc.Cincinnati, OH 45214©2016Made in U.S.A.
Otc - Active Ingredient
Active ingredientSalicylic acid 2%
Otc - Purpose
PurposeAcne treatment
Indications & Usage
Useclears up acne blemishes and blackheads
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, flush 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 dry handsmassage over entire facerinse thoroughly
Storage And Handling
Other information store at room temperature
Inactive Ingredient
Inactive ingredientszeolite, PEG-8, butylene glycol, ethoxydiglycol, cellulose, sodium lauroyl lactylate, helianthus annuus (sunflower) seed wax, cetearyl alcohol, hydroxypropylcellulose, ceteth-20 phosphate, cetyl dimethicone, dicetyl phosphate, fragrance, BHT, blue 1 lake.
* Please review the disclaimer below.