NDC Code(s) : 43538-160-16
Packager : Medimetriks Pharmaceuticals, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Sumaxin Sodium Sulfacetamide and Sulfur LOTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43538-160
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SULFACETAMIDE SODIUM(UNII: 4NRT660KJQ)
(SULFACETAMIDE - UNII:4965G3J0F5) 		SULFACETAMIDE SODIUM80 mg in 1 mL
SULFUR(UNII: 70FD1KFU70)
(SULFUR - UNII:70FD1KFU70) 		SULFUR40 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
ALOE(UNII: V5VD430YW9)
BUTYLATED HYDROXYTOLUENE(UNII: 1P9D0Z171K)
CETYL ALCOHOL(UNII: 936JST6JCN)
DISODIUM OLEAMIDO MEA-SULFOSUCCINATE(UNII: 5M1101WGSY)
EDETATE DISODIUM(UNII: 7FLD91C86K)
GLYCERYL MONOSTEARATE(UNII: 230OU9XXE4)
GREEN TEA LEAF(UNII: W2ZU1RY8B0)
MAGNESIUM ALUMINUM SILICATE(UNII: 6M3P64V0NC)
METHYLPARABEN(UNII: A2I8C7HI9T)
POLYOXYL 100 STEARATE(UNII: YD01N1999R)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
WATER(UNII: 059QF0KO0R)
SODIUM COCOYL ISETHIONATE(UNII: 518XTE8493)
SODIUM THIOSULFATE(UNII: HX1032V43M)
STEARYL ALCOHOL(UNII: 2KR89I4H1Y)
XANTHAN GUM(UNII: TTV12P4NEE)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43538-160-161 in 1 CARTON
1473 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 09/02/2010

PRINCIPAL DISPLAY PANEL


label

label