NDC Code(s) : 67405-435-06, 67405-435-12
Packager : Harris Pharmaceutical, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Topical Cleanser Benzoyl Peroxide SOAP
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67405-435
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 PEROXIDE60 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
CARBOMER INTERPOLYMER TYPE A (55000 CPS)(UNII: 59TL3WG5CO)
CETYL ALCOHOL(UNII: 936JST6JCN)
DISODIUM OLEAMIDO MEA-SULFOSUCCINATE(UNII: 5M1101WGSY)
EDETATE DISODIUM(UNII: 7FLD91C86K)
GLYCERIN(UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE(UNII: 230OU9XXE4)
POLYOXYL 100 STEARATE(UNII: YD01N1999R)
LAURETH-12(UNII: OAH19558U1)
MAGNESIUM ALUMINUM SILICATE(UNII: 6M3P64V0NC)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
WATER(UNII: 059QF0KO0R)
SODIUM COCO-SULFATE(UNII: 3599J29ANH)
SODIUM LAUROAMPHOACETATE(UNII: SLK428451L)
XANTHAN GUM(UNII: TTV12P4NEE)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:67405-435-06170.3 g in 1 BOTTLE
2NDC:67405-435-12340.2 g in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 11/18/2010

PRINCIPAL DISPLAY PANEL

Manufactured for:
HARRIS Pharmaceutical, Inc.
Ft. Myers, FL
33908
877-RX4-DERM
www.HarrisPharmaceutical.com
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Manufactured by:
Groupe Parima
Montreal,QC H4S 1X6
CANADA
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