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
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SULFUR(UNII: 70FD1KFU70)
(SULFUR - UNII:70FD1KFU70) 		SULFUR50 mg in 1 g
SULFACETAMIDE SODIUM(UNII: 4NRT660KJQ)
(SULFACETAMIDE - UNII:4965G3J0F5) 		SULFACETAMIDE SODIUM100 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
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)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:45802-942-022 in 1 CARTON 06/06/2008
1170.1 g in 1 TUBE Type 0: Not a Combination Product
2NDC:45802-942-011 in 1 CARTON 06/06/2008
2170.1 g in 1 TUBE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 06/06/2008 02/01/2013

PRINCIPAL DISPLAY PANEL

Sodium Sulfacetamide 10% and Sulfur 5% Wash

Rx Only

Sodium Sulfacetamide 10% and Sulfur 5% Wash Carton Image 1Sodium Sulfacetamide 10% and Sulfur 5% Wash Carton Image 1 Sodium Sulfacetamide 10% and Sulfur 5% Wash Carton Image 1Sodium Sulfacetamide 10% and Sulfur 5% Wash Carton Image 1

Sodium Sulfacetamide 10% and Sulfur 5% Wash Carton Image 2

PRINCIPAL DISPLAY PANEL

Sodium Sulfacetamide 10% and Sulfur 5% Wash

Rx Only

Sodium Sulfacetamide 10% and Sulfur 5% Wash Tube Image 1Sodium Sulfacetamide 10% and Sulfur 5% Wash Tube Image 1 Sodium Sulfacetamide 10% and Sulfur 5% Wash Tube Image 1Sodium Sulfacetamide 10% and Sulfur 5% Wash Tube Image 1

Sodium Sulfacetamide 10% and Sulfur 5% Wash Tube Image 2