Label: BIORE MENS CHARCOAL ACNE SCRUB- salicylic acid gel
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Contains inactivated NDC Code(s)
NDC Code(s): 10596-192-45 - Packager: Kao USA Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated September 29, 2019
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- SPL UNCLASSIFIED SECTION
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- WHEN USING
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
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INACTIVE INGREDIENT
Inactive ingredients
Water, Glycerin, Sodium Laureth Sulfate, Alumina, Cocamidopropyl Betaine, Sorbitol, Laureth-4 Carboxylic Acid, Synthetic Wax, Microcrystalline Wax, Ethylhexylglycerin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Xanthan Gum, Fragrance, Sodium Hdroxide, Menthol, Polyquaternium-39, Charcoal Powder, Disodium EDTA, Talc, Sodium Benzoate,Red 30, Yellow 5 lake
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BIORE MENS CHARCOAL ACNE SCRUB
salicylic acid gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10596-192 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 1 g in 100 g Inactive Ingredients Ingredient Name Strength CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L) 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) 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10596-192-45 127 g in 1 TUBE; Type 0: Not a Combination Product 10/01/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 10/01/2019 Labeler - Kao USA Inc. (004251617)