NDC Code(s) : 70764-105-11, 70764-105-51
Packager : CONTROL CORRECTIVE SKINCARE INC

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

ACNE SPOT TREATMENTSALICYLIC ACID GEL
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:70764-105
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 ACID2 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
GLYCOLIC ACID(UNII: 0WT12SX38S)
ALCOHOL(UNII: 3K9958V90M)
ALOE VERA LEAF(UNII: ZY81Z83H0X)
WITCH HAZEL(UNII: 101I4J0U34)
GLYCERIN(UNII: PDC6A3C0OX)
TROLAMINE(UNII: 9O3K93S3TK)
METHYL GLUCETH-20(UNII: J3QD0LD11P)
SODIUM LACTATE(UNII: TU7HW0W0QT)
SODIUM PYRROLIDONE CARBOXYLATE(UNII: 469OTG57A2)
FRUCTOSE(UNII: 6YSS42VSEV)
UREA(UNII: 8W8T17847W)
NIACINAMIDE(UNII: 25X51I8RD4)
INOSITOL(UNII: 4L6452S749)
SODIUM BENZOATE(UNII: OJ245FE5EU)
LACTIC ACID(UNII: 33X04XA5AT)
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)(UNII: R33S7TK2EP)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
PANTHENOL(UNII: WV9CM0O67Z)
ALLANTOIN(UNII: 344S277G0Z)
GLUCOSAMINE SULFATE(UNII: 1FW7WLR731)
METHYLISOTHIAZOLINONE(UNII: 229D0E1QFA)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:70764-105-511 in 1 BOX 06/09/2016
1NDC:70764-105-1130 mL in 1 BOTTLE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M006 06/09/2016

LABELER - CONTROL CORRECTIVE SKINCARE INC(023999357)

PRINCIPAL DISPLAY PANEL

01b UC_Acne Spot Treatment