NDC Code(s) : 10742-1365-1, 10742-1365-2
Packager : The Mentholatum Company

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Oxy Rapid Treatment Face Wash benzoyl peroxide CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10742-1365
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 PEROXIDE100 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS CITRIC ACID(UNII: XF417D3PSL)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
CAPRYL/CAPRAMIDOPROPYL BETAINE(UNII: 231H3ZT9NE)
CETOSTEARYL ALCOHOL(UNII: 2DMT128M1S)
COCAMIDOPROPYL BETAINE(UNII: 5OCF3O11KX)
DIAZOLIDINYL UREA(UNII: H5RIZ3MPW4)
DISODIUM LAURETH SULFOSUCCINATE(UNII: D6DH1DTN7E)
SOY PROTEIN(UNII: R44IWB3RN5)
HYDROXYPHENYL PROPAMIDOBENZOIC ACID(UNII: 25KRT26H77)
METHYLPARABEN(UNII: A2I8C7HI9T)
PEG-8 DIMETHICONE(UNII: GIA7T764OD)
PENTYLENE GLYCOL(UNII: 50C1307PZG)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
WATER(UNII: 059QF0KO0R)
SODIUM C14-16 OLEFIN SULFONATE(UNII: O9W3D3YF5U)
SODIUM CITRATE, UNSPECIFIED FORM(UNII: 1Q73Q2JULR)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
SODIUM LAUROYL SARCOSINATE(UNII: 632GS99618)
XANTHAN GUM(UNII: TTV12P4NEE)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:10742-1365-1147.7 mL in 1 TUBE Type 0: Not a Combination Product01/01/2015
2NDC:10742-1365-2185 mL in 1 TUBE Type 0: Not a Combination Product01/01/2015
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333D 01/01/2015 06/30/2018

PRINCIPAL DISPLAY PANEL

Oxy Rapid Treatment Face Wash