NDC Code(s) : 68788-6990-1, 68788-6990-4
Packager : Preferred Pharmaceuticals Inc.

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:68788-6990(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:68788-6990-115 g in 1 TUBE Type 0: Not a Combination Product13/07/2017
2NDC:68788-6990-445 g in 1 TUBE Type 0: Not a Combination Product13/07/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202894 07/13/2017

LABELER - Preferred Pharmaceuticals Inc.(791119022)

REGISTRANT - Preferred Pharmaceuticals Inc.(791119022)

Establishment
Name Address ID/FEI Business Operations
Preferred Pharmaceuticals Inc. 791119022 RELABEL(68788-6990)

PRINCIPAL DISPLAY PANEL

NDC 68788-6990

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.

Clotrimazole/Betamethasone Dipropionate Cream 1%/0.05%