MedPath
FDA Product

Clobetasol Propionate

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Clobetasol Propionate

50090-2405

Regulatory Information

50090-2405

ANDA074220

C73584

May 3, 2018

USA

Clobetasol Propionate Cream, USP, 0.05% Clobetasol Propionate Ointment, USP, 0.05%

HUMAN PRESCRIPTION DRUG LABEL

9

Company Information

830016429

Active Ingredients

CLOBETASOL PROPIONATE

Quantity: 0.5 mg in 1 g

Code: 779619577M

Class Code: ACTIB

ANHYDROUS CITRIC ACID

Code: XF417D3PSL

Class Code: IACT

METHYLPARABEN

Code: A2I8C7HI9T

Class Code: IACT

LANOLIN

Code: 7EV65EAW6H

Class Code: IACT

PEG-8 STEARATE

Code: 2P9L47VI5E

Class Code: IACT

PROPYLENE GLYCOL

Code: 6DC9Q167V3

Class Code: IACT

POLYSORBATE 60

Code: CAL22UVI4M

Class Code: IACT

WATER

Code: 059QF0KO0R

Class Code: IACT

STEARYL ALCOHOL

Code: 2KR89I4H1Y

Class Code: IACT

PETROLATUM

Code: 4T6H12BN9U

Class Code: IACT

SODIUM HYDROXIDE

Code: 55X04QC32I

Class Code: IACT

CETYL ALCOHOL

Code: 936JST6JCN

Class Code: IACT

GLYCOL STEARATE

Code: 0324G66D0E

Class Code: IACT

PROPYLPARABEN

Code: Z8IX2SC1OH

Class Code: IACT

SODIUM CITRATE, UNSPECIFIED FORM

Code: 1Q73Q2JULR

Class Code: IACT

Active Moieties

CLOBETASOL

Code: ADN79D536H

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