NDC Code(s) : 49999-223-15
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

Clotrimazole and Betamethasone DipropionateClotrimazole and Betamethasone Dipropionate CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49999-223(NDC:51672-4048)
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Clotrimazole(UNII: G07GZ97H65)
(Clotrimazole - UNII:G07GZ97H65) 		Clotrimazole10 mg in 1 g
BETAMETHASONE DIPROPIONATE(UNII: 826Y60901U)
(BETAMETHASONE - UNII:9842X06Q6M) 		BETAMETHASONE0.5 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
ceteareth-30(UNII: 1R9DCZ5FOX)
cetostearyl alcohol(UNII: 2DMT128M1S)
mineral oil(UNII: T5L8T28FGP)
phosphoric acid(UNII: E4GA8884NN)
propylene glycol(UNII: 6DC9Q167V3)
water(UNII: 059QF0KO0R)
sodium phosphate, monobasic(UNII: 3980JIH2SW)
petrolatum(UNII: 4T6H12BN9U)
benzyl alcohol(UNII: LKG8494WBH)
Product Characteristics
Color WHITE Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:49999-223-1515 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075673 03/26/2012

PRINCIPAL DISPLAY PANEL

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