NDC Code(s) : 43538-140-60
Packager : Medimetriks Pharmaceuticals, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Pacnex Benzoyl Peroxide CLOTH
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43538-140
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 PEROXIDE70 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
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)
GREEN TEA LEAF(UNII: W2ZU1RY8B0)
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:43538-140-6060 in 1 CARTON
16 g in 1 POUCH
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 07/09/2010

PRINCIPAL DISPLAY PANEL

HP sachet
HP sachet