Clotrimazole and Betamethasone Dipropionate
Clotrimazole and Betamethasone Dipropionate Cream, USP Clotrimazole and Betamethasone Dipropionate Lotion
Approved
Approval ID
030a1460-3522-43af-a75d-29c99570698f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 1, 2012
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Clotrimazole and Betamethasone Dipropionate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-5232
Application NumberANDA076493
Product Classification
M
Marketing Category
C73584
G
Generic Name
Clotrimazole and Betamethasone Dipropionate
Product Specifications
Route of AdministrationTOPICAL
Effective DateMay 1, 2012
FDA Product Classification
INGREDIENTS (12)
ceteareth-30Inactive
Code: 1R9DCZ5FOX
Classification: IACT
mineral oilInactive
Code: T5L8T28FGP
Classification: IACT
propylene glycolInactive
Code: 6DC9Q167V3
Classification: IACT
ClotrimazoleActive
Quantity: 10 mg in 1 mL
Code: G07GZ97H65
Classification: ACTIB
Betamethasone DipropionateActive
Quantity: 0.64 mg in 1 mL
Code: 826Y60901U
Classification: ACTIB
cetyl alcoholInactive
Code: 936JST6JCN
Classification: IACT
phosphoric acidInactive
Code: E4GA8884NN
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
sodium phosphate, monobasicInactive
Code: 3980JIH2SW
Classification: IACT
stearyl alcoholInactive
Code: 2KR89I4H1Y
Classification: IACT
petrolatumInactive
Code: 4T6H12BN9U
Classification: IACT
benzyl alcoholInactive
Code: LKG8494WBH
Classification: IACT
Clotrimazole and Betamethasone Dipropionate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-4546
Application NumberANDA075673
Product Classification
M
Marketing Category
C73584
G
Generic Name
Clotrimazole and Betamethasone Dipropionate
Product Specifications
Route of AdministrationTOPICAL
Effective DateMay 1, 2012
FDA Product Classification
INGREDIENTS (11)
ClotrimazoleActive
Quantity: 10 mg in 1 g
Code: G07GZ97H65
Classification: ACTIB
ceteareth-30Inactive
Code: 1R9DCZ5FOX
Classification: IACT
Betamethasone DipropionateActive
Quantity: 0.64 mg in 1 g
Code: 826Y60901U
Classification: ACTIB
phosphoric acidInactive
Code: E4GA8884NN
Classification: IACT
propylene glycolInactive
Code: 6DC9Q167V3
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
cetostearyl alcoholInactive
Code: 2DMT128M1S
Classification: IACT
mineral oilInactive
Code: T5L8T28FGP
Classification: IACT
benzyl alcoholInactive
Code: LKG8494WBH
Classification: IACT
sodium phosphate, monobasicInactive
Code: 3980JIH2SW
Classification: IACT
petrolatumInactive
Code: 4T6H12BN9U
Classification: IACT