Label: BIORE DAILY DETOX ACNE TONER- salicylic acid liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 10596-193-80 - 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 June 25, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- WHEN USING
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
Directions
- Cleanse skin thoroughly before applying product
- Cover the entire affected area with a thin layer 1 to 3 times daily using a cotton ball or pad.
- Because excessive drying of the skin may occur, start with 1 application daily, then gradually increase to 2 or 3 times daily if needed or as directed by a doctor.
- if bothersome dryness or peeling occurs, reduce application to once a day or every other day.
- STORAGE AND HANDLING
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INACTIVE INGREDIENT
Inactive ingredientsWater, Alcohol Denat., Isopropyl Alcohol, PEG-7 Glyceryl Cocoate, Hamamelis Virginiana (Witch Hazel) Water, Glycerin, Polysorbate 20, Sodium hydroxide, Sodium Citrate, Alcohol, Citric Acid, Menthol, Benzophenonone-4, Disodium EDTA, Fragrance, Cannabis Sativa (Hemp) Seed Oil, Propylene Glycol, Camelia Sinensis Leaf Extract.
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BIORE DAILY DETOX ACNE TONER
salicylic acid liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10596-193 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 g in 100 mL Inactive Ingredients Ingredient Name Strength PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) GREEN TEA LEAF (UNII: W2ZU1RY8B0) ALCOHOL (UNII: 3K9958V90M) ISOPROPYL ALCOHOL (UNII: ND2M416302) PEG-7 GLYCERYL COCOATE (UNII: VNX7251543) WITCH HAZEL (UNII: 101I4J0U34) BENZOPHENONE (UNII: 701M4TTV9O) SODIUM CITRATE (UNII: 1Q73Q2JULR) POLYSORBATE 20 (UNII: 7T1F30V5YH) SODIUM HYDROXIDE (UNII: 55X04QC32I) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) EDETATE DISODIUM (UNII: 7FLD91C86K) CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10596-193-80 236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 07/01/2020 Labeler - Kao USA Inc. (004251617)