NDC Code(s) : 16781-201-06, 16781-201-96
Packager : Onset Dermatologics LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

BenzEFoam UltraBENZOYL PEROXIDE AEROSOL, FOAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16781-201
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 PEROXIDE9.8 g in 100 g
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
GLYCERIN(UNII: PDC6A3C0OX)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
CETOSTEARYL ALCOHOL(UNII: 2DMT128M1S)
DIMETHICONE(UNII: 92RU3N3Y1O)
METHYLPARABEN(UNII: A2I8C7HI9T)
ALKYL (C12-15) BENZOATE(UNII: A9EJ3J61HQ)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
EDETATE DISODIUM(UNII: 7FLD91C86K)
BUTYLATED HYDROXYTOLUENE(UNII: 1P9D0Z171K)
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
STEARETH-10(UNII: FD0913P475)
SODIUM CITRATE, UNSPECIFIED FORM(UNII: 1Q73Q2JULR)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:16781-201-066 in 1 CARTON 04/03/2011
15 g in 1 CAN Type 0: Not a Combination Product
2NDC:16781-201-961 in 1 CARTON 04/03/2011
2100 g in 1 CAN Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 03/04/2011 06/02/2015

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - BenzEFoamUltraTM 5 Grams Carton Label

NDC 16781-201-06

Rx Only

BenzEFoamTM Ultra    

Short Contact Foam

benzoyl peroxide 9.8%

For topical treatment of mild to moderate acne vulgaris

Onset THERAPEUTICS

Professional Samples

Enclosed: Six 5g Samples

Available in 100g Cans

 benzefoamultra_3664_Rev.0

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - BenzEFoamUltraTM 5 Grams Can Label

NDC 16781-201-06

Rx Only

Professional Sample

Not for Sale

Net Weight 5g

BenzEFoamTM Ultra

Short contact Foam

benzoyl peroxide 9.8%

Will not dispense entire contents. Container is overfilled to guarantee dispensing a minimum of 5 grams.

benzefoamultra_2145_Rev.0 Sample