NDC 45802-942-02
API & Excipient Details

marketed by Perrigo New York Inc under NDC Code 45802-942-02

NDC Code(s) : 45802-942-02, 45802-942-01
Packager : Perrigo New York Inc

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

sodium sulfacetamide 10 and sulfur 5Sodium Sulfacetamide, Sulfur SOLUTION

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:45802-942
Route of Administration	TOPICAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SULFUR(UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	50 mg in 1 g
SULFACETAMIDE SODIUM(UNII: 4NRT660KJQ) (SULFACETAMIDE - UNII:4965G3J0F5)	SULFACETAMIDE SODIUM	100 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
BUTYLATED HYDROXYTOLUENE(UNII: 1P9D0Z171K)
CETYL ALCOHOL(UNII: 936JST6JCN)
EDETATE DISODIUM(UNII: 7FLD91C86K)
GLYCERYL MONOSTEARATE(UNII: 230OU9XXE4)
LACTIC ACID, UNSPECIFIED FORM(UNII: 33X04XA5AT)
MAGNESIUM ALUMINUM SILICATE(UNII: 6M3P64V0NC)
METHYLPARABEN(UNII: A2I8C7HI9T)
PEG-100 STEARATE(UNII: YD01N1999R)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
WATER(UNII: 059QF0KO0R)
SODIUM C14-16 OLEFIN SULFONATE(UNII: O9W3D3YF5U)
SODIUM THIOSULFATE(UNII: HX1032V43M)
STEARYL ALCOHOL(UNII: 2KR89I4H1Y)
PETROLATUM(UNII: 4T6H12BN9U)
XANTHAN GUM(UNII: TTV12P4NEE)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:45802-942-02	2 in 1 CARTON	06/06/2008
1		170.1 g in 1 TUBE Type 0: Not a Combination Product
2	NDC:45802-942-01	1 in 1 CARTON	06/06/2008
2		170.1 g in 1 TUBE Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
Unapproved drug other		06/06/2008	02/01/2013

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL