NDC Code(s) : 66993-904-45
Packager : Prasco Laboratories

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Prascion Sodium Sulfacetamide and Sulfur CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66993-904
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SULFACETAMIDE SODIUM (UNII: 4NRT660KJQ)
(SULFACETAMIDE - UNII:4965G3J0F5) 		SULFACETAMIDE SODIUM 100 mg in 1 g
SULFUR(UNII: 70FD1KFU70)
(SULFUR - UNII:70FD1KFU70) 		SULFUR50 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
AVOBENZONE(UNII: G63QQF2NOX)
BENZYL ALCOHOL(UNII: LKG8494WBH)
CETYL ALCOHOL(UNII: 936JST6JCN)
COCO-GLYCERIDES(UNII: ISE9I7DNUG)
DIMETHICONE(UNII: 92RU3N3Y1O)
EDETATE DISODIUM(UNII: 7FLD91C86K)
GLYCERYL MONOSTEARATE(UNII: 230OU9XXE4)
POLYOXYL 100 STEARATE (UNII: YD01N1999R)
ISOPROPYL MYRISTATE(UNII: 0RE8K4LNJS)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
OCTINOXATE(UNII: 4Y5P7MUD51)
POLYSORBATE 60(UNII: CAL22UVI4M)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
WATER(UNII: 059QF0KO0R)
SODIUM THIOSULFATE(UNII: HX1032V43M)
SORBITAN MONOSTEARATE(UNII: NVZ4I0H58X)
STEARYL ALCOHOL(UNII: 2KR89I4H1Y)
XANTHAN GUM (UNII: TTV12P4NEE)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:66993-904-451 in 1 CARTON 22/12/2010
145 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 12/22/2010 04/30/2012

PRINCIPAL DISPLAY PANEL

Manufactured for: Prasco Laboratories
                           Mason, OH 45040 USA
Manufactured by: Groupe Parima, Inc.
                           Montreal, QC H4S 1X6 CANADA

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