NDC Code(s) : 42808-102-06, 42808-102-12
Packager : Exact-Rx, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Exact-Rx Sodium Sulfacetamide Wash 10%SODIUM SULFACETAMIDE LIQUID
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42808-102
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 mL
Inactive Ingredients
Ingredient Name Strength
COCAMIDOPROPYL BETAINE(UNII: 5OCF3O11KX)
EDETATE DISODIUM ANHYDROUS(UNII: 8NLQ36F6MM)
GLYCERYL MONOSTEARATE(UNII: 230OU9XXE4)
METHYLPARABEN(UNII: A2I8C7HI9T)
PEG-6 CAPRYLIC/CAPRIC GLYCERIDES(UNII: GO50W2HWO8)
PEG-150 PENTAERYTHRITYL TETRASTEARATE(UNII: 8L4OOQ76AM)
POLYSORBATE 60(UNII: CAL22UVI4M)
WATER(UNII: 059QF0KO0R)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
SODIUM THIOSULFATE(UNII: HX1032V43M)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:42808-102-06177 mL in 1 BOTTLE Type 0: Not a Combination Product08/01/2011
2NDC:42808-102-12354.8 mL in 1 BOTTLE Type 0: Not a Combination Product08/01/2011
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 08/01/2011

PRINCIPAL DISPLAY PANEL

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PRINCIPAL DISPLAY PANEL

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