NDC Code(s) : 65113-2372-2
Packager : G.S. COSMECEUTICAL USA, INC.

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

AGE INTERVENTION DUALITYBENZOYL PEROXIDE CREAM
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:65113-2372
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZOYL PEROXIDE(UNII: W9WZN9A0GM)
(BENZOYL PEROXIDE - UNII:W9WZN9A0GM) 		BENZOYL PEROXIDE10 g in 100 g
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
GLYCERIN(UNII: PDC6A3C0OX)
GLYCERYL STEARATE CITRATE(UNII: WH8T92A065)
POLYSORBATE 20(UNII: 7T1F30V5YH)
POLYSORBATE 60(UNII: CAL22UVI4M)
STEARYL ALCOHOL(UNII: 2KR89I4H1Y)
RETINOL(UNII: G2SH0XKK91)
SORBITOL(UNII: 506T60A25R)
CAMELLIA OLEIFERA LEAF(UNII: 5077EL0C60)
PALMITOYL TETRAPEPTIDE-7(UNII: Q41S464P1R)
PALMITOYL HEXAPEPTIDE-12(UNII: HO4ZT5S86C)
CHRYSIN(UNII: 3CN01F5ZJ5)
DIMETHICONE(UNII: 92RU3N3Y1O)
STEARETH-20(UNII: L0Q8IK9E08)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
HEXYLENE GLYCOL(UNII: KEH0A3F75J)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
Product Characteristics
Color YELLOW (VERY PALE YELLOW) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:65113-2372-228 g in 1 BOTTLE, PUMP Type 0: Not a Combination Product05/01/2011
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph drug M006 05/01/2011

LABELER - G.S. COSMECEUTICAL USA, INC.(017014734)

Establishment
Name Address ID/FEI Business Operations
G.S. COSMECEUTICAL USA, INC. 017014734 MANUFACTURE(65113-2372)

PRINCIPAL DISPLAY PANEL

AGE INTERVENTION ®
DUALITY™

Benzoyl Peroxide 10%
Adult Acne Treatment Cream
and Anti-Aging Complex

JANMARINI
 SKIN RESEARCH®

28 g / 1 oz.

PRINCIPAL DISPLAY PANEL - 28 g Carton