NDC Code(s) : 54569-1125-0
Packager : A-S Medication Solutions LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Nystatinnystatin CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54569-1125(NDC:0603-7818)
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NYSTATIN(UNII: BDF1O1C72E)
(NYSTATIN - UNII:BDF1O1C72E) 		NYSTATIN100000 [USP'U] in 1 g
Inactive Ingredients
Ingredient Name Strength
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
CETOSTEARYL ALCOHOL(UNII: 2DMT128M1S)
GLYCERYL MONOSTEARATE(UNII: 230OU9XXE4)
POLYOXYL 40 STEARATE(UNII: 13A4J4NH9I)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
WATER(UNII: 059QF0KO0R)
SORBIC ACID(UNII: X045WJ989B)
SORBITOL(UNII: 506T60A25R)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
PETROLATUM(UNII: 4T6H12BN9U)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
DIMETHICONE(UNII: 92RU3N3Y1O)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:54569-1125-01 in 1 CARTON
115 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065315 05/31/2006

PRINCIPAL DISPLAY PANEL

NDC 54569-1125-0

Relabeled by:
A-S Medication Solutions
Libertyville, IL 60048


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