NDC Code(s) : 52125-720-52
Packager : REMEDYREPACK INC.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Silver Sulfadiazene Silver Sulfadiazine CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52125-720(NDC:0591-0810)
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SILVER SULFADIAZINE(UNII: W46JY43EJR)
(SULFADIAZINE - UNII:0N7609K889) 		SILVER SULFADIAZINE10 g in 1000 g
Inactive Ingredients
Ingredient Name Strength
ISOPROPYL MYRISTATE(UNII: 0RE8K4LNJS)
POLYOXYL 40 STEARATE(UNII: 13A4J4NH9I)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
METHYLPARABEN(UNII: A2I8C7HI9T)
SORBITAN MONOOLEATE(UNII: 06XEA2VD56)
CETYL ALCOHOL(UNII: 936JST6JCN)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
STEARYL ALCOHOL(UNII: 2KR89I4H1Y)
PETROLATUM(UNII: 4T6H12BN9U)
WATER(UNII: 059QF0KO0R)
Product Characteristics
Color white Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:52125-720-5225 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA018578 09/26/2013

PRINCIPAL DISPLAY PANEL

DRUG: Silver Sulfadiazene


GENERIC: Silver Sulfadiazine


DOSAGE: CREAM


ADMINSTRATION: TOPICAL


NDC: 52125-720-52


ACTIVE INGREDIENT(S):

  • SILVER SULFADIAZINE 10g in 1000g


INACTIVE INGREDIENT(S):

  • ISOPROPYL MYRISTATE
  • POLYOXYL 40 STEARATE
  • PROPYLENE GLYCOL
  • METHYLPARABEN
  • SORBITAN MONOOLEATE
  • CETYL ALCOHOL
  • SODIUM HYDROXIDE
  • STEARYL ALCOHOL
  • PETROLATUM
  • WATER


COLOR: white


PACKAGING: 25 g in 1 TUBE



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