NDC Code(s) : 10596-162-45, 10596-162-56
Packager : Kao USA Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Biore SALICYLIC ACID GEL
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10596-162
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 ACID1.27 g in 127 g
Inactive Ingredients
Ingredient Name Strength
ALUMINUM OXIDE(UNII: LMI26O6933)
GLYCERIN(UNII: PDC6A3C0OX)
WATER(UNII: 059QF0KO0R)
SODIUM LAURETH SULFATE(UNII: BPV390UAP0)
COCAMIDOPROPYL BETAINE(UNII: 5OCF3O11KX)
SORBITOL(UNII: 506T60A25R)
SYNTHETIC WAX (1200 MW)(UNII: Q3Z4BCH099)
LAURETH-4 CARBOXYLIC ACID(UNII: DW3PIY647Y)
MICROCRYSTALLINE WAX(UNII: XOF597Q3KY)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
CARBOMER INTERPOLYMER TYPE A (55000 CPS)(UNII: 59TL3WG5CO)
XANTHAN GUM(UNII: TTV12P4NEE)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
METHYLPARABEN(UNII: A2I8C7HI9T)
MENTHOL(UNII: L7T10EIP3A)
POLYQUATERNIUM-39 (22.5/51/26.5 ACRYLIC ACID/ACRYLAMIDE/DADMAC; 1600000 MW)(UNII: X2NH1K9F8K)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
EDETATE DISODIUM(UNII: 7FLD91C86K)
FD&C YELLOW NO. 5(UNII: I753WB2F1M)
TALC(UNII: 7SEV7J4R1U)
METHYLISOTHIAZOLINONE(UNII: 229D0E1QFA)
D&C RED NO. 30(UNII: 2S42T2808B)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:10596-162-45127 g in 1 TUBE Type 0: Not a Combination Product01/01/2012
2NDC:10596-162-56159 g in 1 TUBE Type 0: Not a Combination Product01/01/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333D 01/01/2012

PRINCIPAL DISPLAY PANEL

Biore

free your pores!

ACNE CLEARING SCRUB
clears and polishes without damaging skin

salicylic acid acne treatment/oil free

skin purifying technology

acne's outta here!™

NET WT 4.5 OZ (127 g)

10596-162-45