NDC Code(s) : 71563-0400-1
Packager : Norris Ltd

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

AB Skincare Acne Spot TreatmentBenzoyl Peroxide CREAM
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:71563-0400
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 PEROXIDE28.3 g in 100 g
Inactive Ingredients
Ingredient Name Strength
METHOXY PEG-40(UNII: 6AXS45P1QU)
XANTHAN GUM(UNII: TTV12P4NEE)
CARBOXYPOLYMETHYLENE(UNII: 0A5MM307FC)
WATER(UNII: 059QF0KO0R)
DIMETHICONE 1000(UNII: MCU2324216)
SORBITAN MONOSTEARATE(UNII: NVZ4I0H58X)
SODIUM CITRATE(UNII: 1Q73Q2JULR)
DOCUSATE SODIUM(UNII: F05Q2T2JA0)
TETRASODIUM GLUTAMATE DIACETATE(UNII: 5EHL50I4MY)
2-PHENYLPROPANAL PROPYLENE GLYCOL ACETAL(UNII: 1ZRR9A405A)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:71563-0400-128 g in 1 TUBE Type 0: Not a Combination Product10/09/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333D 10/09/2017

LABELER - Norris Ltd(061314247)

PRINCIPAL DISPLAY PANEL

TUBE LABELTUBE LABEL