CLOBETASOL PROPIONATE (Page 4 of 4)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 71589-018-50

Clobetasol Propionate Foam, 0.05%

Rx only

50 grams

For Topical Use Only.

Not for Ophthalmic, Oral, or Intravaginal Use.

Invert can and then press firmly to dispense.

invert can

Description: Clobetasol Propionate Foam, 0.05%, contains 0.5 mg of clobetasol propionate, USP per gram in a thermolabile hydroethanolic foam vehicle consisting of cetyl alcohol, citric acid, ethanol (60%), polysorbate 60, potassium citrate, propylene glycol, purified water, and stearyl alcohol pressurized with a hydrocarbon (propane/butane) propellant.

Usual Dosage: Use only as prescribed by your physician. See accompanying prescribing information.

WARNING: FLAMMABLE. AVOID FIRE, FLAME, OR SMOKING

50 g can label
(click image for full-size original)
50 g carton label
(click image for full-size original)
CLOBETASOL PROPIONATE clobetasol propionate aerosol, foam
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71589-018
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLOBETASOL PROPIONATE (CLOBETASOL) CLOBETASOL PROPIONATE 0.5 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
CETYL ALCOHOL
ANHYDROUS CITRIC ACID
ALCOHOL
POLYSORBATE 60
POTASSIUM CITRATE
PROPYLENE GLYCOL
WATER
STEARYL ALCOHOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71589-018-50 1 CAN in 1 CARTON contains a CAN
1 50 g in 1 CAN This package is contained within the CARTON (71589-018-50)
2 NDC:71589-018-31 1 CAN in 1 CARTON contains a CAN
2 100 g in 1 CAN This package is contained within the CARTON (71589-018-31)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA215838 04/21/2022
Labeler — Aleor Dermaceuticals Limited (871411532)
Registrant — Aleor Dermaceuticals Limited (871411532)
Establishment
Name Address ID/FEI Operations
Aleor Dermaceuticals Limited 871411532 MANUFACTURE (71589-018), ANALYSIS (71589-018)

Revised: 04/2022 Aleor Dermaceuticals Limited

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