Label: BIORE PORE UNCLOGGING SCRUB- salicylic acid liquid
- NDC Code(s): 10596-161-15, 10596-161-38, 10596-161-50
- 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 December 2, 2021
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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, sodium cocoyl isethionate, glycerin, glycol disearate, synthetic wax, ethoxydiglycol, PEG-6 caprylic/capric glycerides, microcrystalline wax, cetyl alcohol, PEG-12 dimethicone, sodium lauroyl lactylate, sodium hydroxide, acrylates/C10-30 alkyl acrylate crosspolymer, xanthan gum, sodium benzoate, fragrance, menthol, benzophenone-4, ferric ferrocyanide
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INGREDIENTS AND APPEARANCE
BIORE PORE UNCLOGGING SCRUB
salicylic acid liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10596-161 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 2.8 g in 141 g Inactive Ingredients Ingredient Name Strength PEG-6 CAPRYLIC/CAPRIC GLYCERIDES (UNII: GO50W2HWO8) CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) WATER (UNII: 059QF0KO0R) SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493) GLYCERIN (UNII: PDC6A3C0OX) GLYCOL DISTEARATE (UNII: 13W7MDN21W) SYNTHETIC WAX (1200 MW) (UNII: Q3Z4BCH099) DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) CETYL ALCOHOL (UNII: 936JST6JCN) PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95) SODIUM HYDROXIDE (UNII: 55X04QC32I) SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO) XANTHAN GUM (UNII: TTV12P4NEE) MENTHOL (UNII: L7T10EIP3A) SULISOBENZONE (UNII: 1W6L629B4K) FERRIC FERROCYANIDE (UNII: TLE294X33A) SODIUM BENZOATE (UNII: OJ245FE5EU) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10596-161-50 141 g in 1 TUBE; Type 0: Not a Combination Product 12/28/2011 2 NDC:10596-161-38 108 g in 1 TUBE; Type 0: Not a Combination Product 11/04/2016 3 NDC:10596-161-15 3 in 1 PACKAGE 12/02/2021 3 141 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 12/28/2011 Labeler - Kao USA Inc. (004251617)