NDC Code(s) : 42792-104-01
Packager : AUSTIN PHARMACEUTICALS, LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

SODIUM SULFACETAMIDE, SULFUR SODIUM SULFACETAMIDE, SULFUR SUSPENSION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42792-104
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SULFACETAMIDE SODIUM(UNII: 4NRT660KJQ)
(SULFACETAMIDE - UNII:4965G3J0F5) 		SULFACETAMIDE SODIUM100 mg in 1 g
SULFUR(UNII: 70FD1KFU70)
(SULFUR - UNII:70FD1KFU70) 		SULFUR50 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
BENZYL ALCOHOL(UNII: LKG8494WBH)
MEDIUM-CHAIN TRIGLYCERIDES(UNII: C9H2L21V7U)
CETYL ALCOHOL(UNII: 936JST6JCN)
DIMETHICONE(UNII: 92RU3N3Y1O)
EDETATE DISODIUM(UNII: 7FLD91C86K)
GLYCERIN(UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE(UNII: 230OU9XXE4)
PEG-100 STEARATE(UNII: YD01N1999R)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
METHYLPARABEN(UNII: A2I8C7HI9T)
BUTYLPARABEN(UNII: 3QPI1U3FV8)
ETHYLPARABEN(UNII: 14255EXE39)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
POLYACRYLAMIDE (1500 MW)(UNII: 5D6TC4BRWV)
C13-14 ISOPARAFFIN(UNII: E4F12ROE70)
LAURETH-7(UNII: Z95S6G8201)
SODIUM THIOSULFATE(UNII: HX1032V43M)
WATER(UNII: 059QF0KO0R)
ZINC OXIDE(UNII: SOI2LOH54Z)
Product Characteristics
Color white Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:42792-104-0130 g in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 06/04/2011

PRINCIPAL DISPLAY PANEL

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