NDC Code(s) : 49999-218-15
Packager : Lake Erie Medical DBA Quality Care Products LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Betamethasone Valeratebetamethasone valerate CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49999-218(NDC:0168-0040)
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BETAMETHASONE VALERATE(UNII: 9IFA5XM7R2)
(BETAMETHASONE - UNII:9842X06Q6M) 		BETAMETHASONE1 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
MINERAL OIL(UNII: T5L8T28FGP)
PETROLATUM(UNII: 4T6H12BN9U)
CETETH-20(UNII: I835H2IHHX)
CETOSTEARYL ALCOHOL(UNII: 2DMT128M1S)
SODIUM PHOSPHATE, MONOBASIC(UNII: 3980JIH2SW)
PHOSPHORIC ACID(UNII: E4GA8884NN)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
CHLOROCRESOL(UNII: 36W53O7109)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:49999-218-1515 g in 1 TUBE Type 0: Not a Combination Product31/08/1983
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA018861 08/31/1983 06/01/2014

PRINCIPAL DISPLAY PANEL

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