NDC Code(s) : 45802-918-34, 45802-918-01
Packager : Perrigo New York Inc

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Benzoyl PeroxideBenzoyl Peroxide LIQUID
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:45802-918
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
CARBOMER HOMOPOLYMER TYPE C(UNII: 4Q93RCW27E)
EDETATE DISODIUM(UNII: 7FLD91C86K)
GLYCERIN(UNII: PDC6A3C0OX)
IMIDUREA(UNII: M629807ATL)
WATER(UNII: 059QF0KO0R)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
SODIUM C14-16 OLEFIN SULFONATE(UNII: O9W3D3YF5U)
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:45802-918-34227 g in 1 BOTTLE, GLASS
2NDC:45802-918-01142 g in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 05/19/2008

PRINCIPAL DISPLAY PANEL

Rx Only

Benzoyl Peroxide Wash 10%

For Topical Use Only

Benzoyl Peroxide Wash 10% Front LabelBenzoyl Peroxide Wash 10% Front Label Benzoyl Peroxide Wash 10% Front LabelBenzoyl Peroxide Wash 10% Back Label