Label: BIORE WITCH HAZEL PORE CLARIFYING TONER- salicylic acid liquid
- NDC Code(s): 10596-187-80
- 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 March 28, 2023
If you are a consumer or patient please visit this version.
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- 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 medication.
- 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 one 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
- INACTIVE INGREDIENT
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SPL UNCLASSIFIED SECTION
what it does:
BIORE PORE CLARIFYING TONER teams up with Witch Hazel & Salicylic Acid. This refreshing formula helps restore skin's balance as it penetrates and deep cleans pores for clear skin.
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
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BIORE WITCH HAZEL PORE CLARIFYING TONER
salicylic acid liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10596-187 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 ALCOHOL (UNII: 3K9958V90M) ISOPROPYL ALCOHOL (UNII: ND2M416302) WITCH HAZEL (UNII: 101I4J0U34) BENZOPHENONE (UNII: 701M4TTV9O) EDETATE DISODIUM (UNII: 7FLD91C86K) WATER (UNII: 059QF0KO0R) SODIUM HYDROXIDE (UNII: 55X04QC32I) POLYSORBATE 20 (UNII: 7T1F30V5YH) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) GLYCERIN (UNII: PDC6A3C0OX) SODIUM CITRATE (UNII: 1Q73Q2JULR) MENTHOL (UNII: L7T10EIP3A) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10596-187-80 236 mL in 1 BOTTLE; Type 0: Not a Combination Product 06/18/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 06/18/2018 Labeler - Kao USA Inc. (004251617)