NDC Code(s) : 61786-842-46
Packager : REMEDYREPACK 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:61786-842(NDC:0168-0258)
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
WATER(UNII: 059QF0KO0R)
MINERAL OIL(UNII: T5L8T28FGP)
PETROLATUM(UNII: 4T6H12BN9U)
CETOSTEARYL ALCOHOL(UNII: 2DMT128M1S)
CETEARETH-30(UNII: 1R9DCZ5FOX)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SODIUM PHOSPHATE, MONOBASIC(UNII: 3980JIH2SW)
BENZYL ALCOHOL(UNII: LKG8494WBH)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:61786-842-4645 g in 1 TUBE Type 0: Not a Combination Product23/08/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075502 08/23/2016 03/03/2017

PRINCIPAL DISPLAY PANEL

DRUG: Clotrimazole and Betamethasone Dipropionate

GENERIC: Clotrimazole and Betamethasone Dipropionate

DOSAGE: CREAM

ADMINSTRATION: TOPICAL

NDC: 61786-842-46

PACKAGING: 45 g in 1 TUBE

ACTIVE INGREDIENT(S):

  • BETAMETHASONE DIPROPIONATE 0.5mg in 1g
  • clotrimazole 10mg in 1g

INACTIVE INGREDIENT(S):

  • BENZYL ALCOHOL
  • PROPYLENE GLYCOL
  • CETEARETH-30
  • SODIUM PHOSPHATE, MONOBASIC
  • CETOSTEARYL ALCOHOL
  • MINERAL OIL
  • PETROLATUM
  • WATER

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