NDC Code(s) : 10596-132-85
Packager : Kao USA Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Biore SALICYLIC ACID LIQUID
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10596-132
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SALICYLIC ACID(UNII: O414PZ4LPZ)
(SALICYLIC ACID - UNII:O414PZ4LPZ) 		SALICYLIC ACID4.56 g in 236 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
ISOPROPYL ALCOHOL(UNII: ND2M416302)
HAMAMELIS VIRGINIANA LEAF WATER(UNII: 8FP93ED6H2)
GLYCERIN(UNII: PDC6A3C0OX)
ALCOHOL(UNII: 3K9958V90M)
MENTHOL(UNII: L7T10EIP3A)
SULISOBENZONE(UNII: 1W6L629B4K)
POLYSORBATE 60(UNII: CAL22UVI4M)
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
SODIUM CITRATE(UNII: 1Q73Q2JULR)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
EDETATE DISODIUM(UNII: 7FLD91C86K)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
FD&C RED NO. 4(UNII: X3W0AM1JLX)
EXT. D&C VIOLET NO. 2(UNII: G5UX3K0728)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:10596-132-85236 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product09/11/2011
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333D 11/09/2011

PRINCIPAL DISPLAY PANEL

Biore

BLEMISH TREATING ASTRINGENT

Cleans & Treats

Leaves skin clear by helping treat blemishes

COMPLEXION CLEARING

Salicylic acid acne treatment

OIL-FREE

8.0 FL OZ (236 mL)

10596-132-85 Nov 2017