NDC Code(s) : 10596-184-45, 10596-184-10, 10596-184-56
Packager : Kao USA Inc.

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Biore SALICYLIC ACID GEL
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:10596-184
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 ACID1.3 g in 127 g
Inactive Ingredients
Ingredient Name Strength
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
ACTIVATED CHARCOAL(UNII: 2P3VWU3H10)
EDETATE DISODIUM(UNII: 7FLD91C86K)
SYNTHETIC WAX (1200 MW)(UNII: Q3Z4BCH099)
LAURETH-4 CARBOXYLIC ACID(UNII: DW3PIY647Y)
SODIUM LAURETH SULFATE(UNII: BPV390UAP0)
ALUMINUM(UNII: CPD4NFA903)
POLYQUATERNIUM-39 (22.5/51/26.5 ACRYLIC ACID/ACRYLAMIDE/DADMAC; 1600000 MW)(UNII: X2NH1K9F8K)
WATER(UNII: 059QF0KO0R)
GLYCERIN(UNII: PDC6A3C0OX)
MICROCRYSTALLINE WAX(UNII: XOF597Q3KY)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
XANTHAN GUM(UNII: TTV12P4NEE)
MENTHOL(UNII: L7T10EIP3A)
CARBOMER COPOLYMER TYPE A(UNII: 71DD5V995L)
D&C RED NO. 30(UNII: 2S42T2808B)
SODIUM BENZOATE(UNII: OJ245FE5EU)
FD&C YELLOW NO. 5(UNII: I753WB2F1M)
TALC(UNII: 7SEV7J4R1U)
COCAMIDOPROPYL BETAINE(UNII: 5OCF3O11KX)
SORBITOL(UNII: 506T60A25R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:10596-184-45127 g in 1 TUBE Type 0: Not a Combination Product12/01/2016
2NDC:10596-184-1028 g in 1 TUBE Type 0: Not a Combination Product12/01/2016
3NDC:10596-184-56159 g in 1 TUBE Type 0: Not a Combination Product12/01/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M006 12/01/2016 06/30/2024

LABELER - Kao USA Inc.(004251617)

PRINCIPAL DISPLAY PANEL

Biore

free your pores!

CHARCOAL

GREAT FOR OILY SKIN

scrubs out acne-causing dirt & oil

CHARCOAL ACNE SCRUB

SALICYLIC ACID ACNE TREATMENT

skin purifying technology/oil-free

acne's outta here!

NET WT 5.63 OZ (159 g)

10596-184 03-2021