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Biore charcoal acne clearing cleanser - Medication Information

Product NDC Code 10596-185
Drug Name

Biore charcoal acne clearing cleanser

Type Brand
Active Ingredients
Salicylic acid 2 g/200ml
Route TOPICAL
Dosage Form GEL
RxCUI drug identifier 1038982,
1803724
Application Number part333D
Labeler Name Kao USA Inc.
Packages
Package NDC Code Description
10596-185-11 338 ml in 1 bottle, pump (10596-185-11)
10596-185-50 147 ml in 1 bottle, with applicator (10596-185-50)
10596-185-67 200 ml in 1 bottle, pump (10596-185-67)
10596-185-85 250 ml in 1 bottle, pump (10596-185-85)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient Salicylic acid 1%

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
Directions wet face pump product into hands massage over entire face and neck rinse thoroughly for optimal results, use daily

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
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

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
Uses clears up acne blemishes penetrates pores to control acne blemishes helps prevent new acne blemishes from forming

Purpose

Information about the drug product’s indications for use.
Purpose Acne treatment

Spl product data elements

Usually a list of ingredients in a drug product.
Biore Charcoal Acne Clearing Cleanser SALICYLIC ACID SODIUM LAURETH SULFATE SORBITOL COCAMIDOPROPYL BETAINE EDETATE DISODIUM WATER GLYCERIN SODIUM HYDROXIDE MENTHOL SALICYLIC ACID SALICYLIC ACID CARBOMER COPOLYMER TYPE A SODIUM BENZOATE LAURETH-4 CARBOXYLIC ACID ETHYLHEXYLGLYCERIN POLYQUATERNIUM-39 (22.5/51/26.5 ACRYLIC ACID/ACRYLAMIDE/DADMAC; 1600000 MW) ACTIVATED CHARCOAL

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
Biore free your pores! CHARCOAL GREAT FOR OILY SKIN absorbs oil and clears breakouts CHARCOAL ACNE CLEARING CLEANSER SALICYLIC ACID ACNE TREATMENT skin purifying technology/oil-free acne's outta here! NET WT 11.45 FL. OZ. (338 mL) 19596-185-11- NEW SIZE

Spl unclassified section

Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.
BIORE CHARCOAL ACNE CLEARING CLEANSER deep cleans, penetrates pores and absorbs oil to help stop breakouts. with Natural Charcoal Drug Facts Questions? 1-888-BIORE-11 www.biore.com BIORE is a trademark of Kao Corp. Distributed by Kao USA Inc. Cincinnati, OH 45214 ©2018 Made in Canada

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

When using

Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.
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 this occurs, only use one topical acne medication at a time. avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Storage and handling

Information about safe storage and handling of the drug product.
Other information store at room temperature

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
Warnings For external use only.

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API