NDC Code 10596-184-45 | pharmacompass.com

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

Biore SALICYLIC ACID GEL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SALICYLIC ACID(UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	1.3 g in 127 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:10596-184-45	127 g in 1 TUBE Type 0: Not a Combination Product	12/01/2016
2	NDC:10596-184-10	28 g in 1 TUBE Type 0: Not a Combination Product	12/01/2016
3	NDC:10596-184-56	159 g in 1 TUBE Type 0: Not a Combination Product	12/01/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M006	12/01/2016	06/30/2024

LABELER - Kao USA Inc.(004251617)

NDC 10596-184-45
API & Excipient Details