NDC Code(s) : 45802-910-96, 45802-910-01
Packager : Perrigo New York Inc

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Perrigo Benzoyl Peroxide Benzoyl Peroxide GEL
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:45802-910
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 PEROXIDE5 g in 100 g
Inactive Ingredients
Ingredient Name Strength
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)(UNII: 4Q93RCW27E)
DIMETHICONE(UNII: 92RU3N3Y1O)
DISODIUM LAURYL SULFOSUCCINATE(UNII: P160Q81342)
EDETATE DISODIUM(UNII: 7FLD91C86K)
GLYCERIN(UNII: PDC6A3C0OX)
HYDRATED SILICA(UNII: Y6O7T4G8P9)
METHYLPARABEN(UNII: A2I8C7HI9T)
POLOXAMER 182(UNII: JX0HIX6OAG)
WATER(UNII: 059QF0KO0R)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
Product Characteristics
Color WHITE Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:45802-910-961 in 1 CARTON 07/08/2008
160 g in 1 TUBE Type 0: Not a Combination Product
2NDC:45802-910-011 in 1 CARTON 08/09/2008
290 g in 1 TUBE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 08/07/2008 02/01/2014

PRINCIPAL DISPLAY PANEL

Rx Only

Benzoyl Peroxide Gel, 5%

For Topical Use Only

Aqueous Base Acne Gel

Benzoyl Peroxide Gel, 5% CartonBenzoyl Peroxide Gel, 5% Carton

Benzoyl Peroxide Gel, 5% Carton

PRINCIPAL DISPLAY PANEL

Rx Only

Benzoyl Peroxide Gel, 5%

For Topical Use Only

Aqueous Base Acne Gel

Benzoyl Peroxide Gel, 5% TubeBenzoyl Peroxide Gel, 5% Tube

Benzoyl Peroxide Gel, 5% Tube