NDC Code(s) : 68462-298-17, 68462-298-55
Packager : Glenmark Pharmaceuticals Inc. USA

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:68462-298
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
BENZYL ALCOHOL(UNII: LKG8494WBH)
CETOSTEARYL ALCOHOL(UNII: 2DMT128M1S)
CETEARETH-30(UNII: 1R9DCZ5FOX)
MINERAL OIL(UNII: T5L8T28FGP)
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE(UNII: 593YOG76RN)
PHOSPHORIC ACID(UNII: E4GA8884NN)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
PETROLATUM(UNII: 4T6H12BN9U)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68462-298-1715 g in 1 TUBE Type 0: Not a Combination Product11/06/2015
2NDC:68462-298-5545 g in 1 TUBE Type 0: Not a Combination Product11/06/2015
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202894 11/06/2015

LABELER - Glenmark Pharmaceuticals Inc. USA(130597813)

Establishment
Name Address ID/FEI Business Operations
Glenmark Pharmaceuticals Limited 676115028 ANALYSIS(68462-298), MANUFACTURE(68462-298)

PRINCIPAL DISPLAY PANEL

NDC 68462-298-55

Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05% (base)

FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC, ORAL, OR INTRAVAGINAL USE. NOT RECOMMENDED FOR PATIENTS UNDER THE AGE OF 17 YEARS AND NOT RECOMMENDED FOR DIAPER DERMATITIS.

tube45g

PRINCIPAL DISPLAY PANEL

NDC 68462-298-17

Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05% (base)

FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC, ORAL, OR INTRAVAGINAL USE. NOT RECOMMENDED FOR PATIENTS UNDER THE AGE OF 17 YEARS AND NOT RECOMMENDED FOR DIAPER DERMATITIS.

tube15g