NDC Code(s) : 42808-111-45
Packager : Exact-Rx, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Sodium Sulfacetamide, Sulfur Sodium Sulfacetamide, Sulfur GEL
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42808-111
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
UREA(UNII: 8W8T17847W)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
ISOPROPYL MYRISTATE(UNII: 0RE8K4LNJS)
MINERAL OIL(UNII: T5L8T28FGP)
POLYSORBATE 60(UNII: CAL22UVI4M)
SORBITAN MONOSTEARATE(UNII: NVZ4I0H58X)
CETYL ALCOHOL(UNII: 936JST6JCN)
COCO-GLYCERIDES(UNII: ISE9I7DNUG)
STEARYL ALCOHOL(UNII: 2KR89I4H1Y)
BENZYL ALCOHOL(UNII: LKG8494WBH)
GLYCERYL MONOSTEARATE(UNII: 230OU9XXE4)
POLYOXYL 100 STEARATE(UNII: YD01N1999R)
DIMETHICONE(UNII: 92RU3N3Y1O)
EDETATE DISODIUM(UNII: 7FLD91C86K)
XANTHAN GUM(UNII: TTV12P4NEE)
PYRITHIONE ZINC(UNII: R953O2RHZ5)
SODIUM THIOSULFATE(UNII: HX1032V43M)
WATER(UNII: 059QF0KO0R)
MAGNESIUM ALUMINUM SILICATE(UNII: 6M3P64V0NC)
METHYLPARABEN(UNII: A2I8C7HI9T)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:42808-111-451 in 1 CARTON
145 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 08/01/2011

PRINCIPAL DISPLAY PANEL

For External Use Only

NDC 42808-0111-45        Rx Only

Sodium
Sulfacetamide
& Sulfur

(Sodium Sulfacetamide 10%
& Sulfur 5% in a Urea Vehicle)

10%/5%

AQUEOUS GEL

Exact-Rx.
INCORPORATED

Net Wt. 1.5 oz (45 g)

Carton