NDC Code(s) : 71589-018-50, 71589-018-31
Packager : Aleor Dermaceuticals Limited

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

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(UNII: 779619577M)
(CLOBETASOL - UNII:ADN79D536H) 		CLOBETASOL PROPIONATE0.5 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
CETYL ALCOHOL(UNII: 936JST6JCN)
ANHYDROUS CITRIC ACID(UNII: XF417D3PSL)
ALCOHOL(UNII: 3K9958V90M)
POLYSORBATE 60(UNII: CAL22UVI4M)
POTASSIUM CITRATE(UNII: EE90ONI6FF)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
WATER(UNII: 059QF0KO0R)
STEARYL ALCOHOL(UNII: 2KR89I4H1Y)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:71589-018-501 in 1 CARTON 21/04/2022
150 g in 1 CAN Type 0: Not a Combination Product
2NDC:71589-018-311 in 1 CARTON 21/04/2022
2100 g in 1 CAN Type 0: Not a Combination Product
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 Business Operations
Aleor Dermaceuticals Limited 871411532 MANUFACTURE(71589-018), ANALYSIS(71589-018)

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

invert caninvert can