PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 71589-002-15

Aleor Dermaceuticals Ltd.

Clobetasol Propionate Ointment USP, 0.05%

Rx only

FOR DERMATOLOGIC USE ONLY

NOT FOR OPHTHALMIC USE.

NET WT 15 grams

NDC 71589-002-15

Aleor Dermaceuticals Ltd.

Clobetasol Propionate Ointment USP, 0.05%

Rx only

FOR DERMATOLOGIC USE ONLY

NOT FOR OPHTHALMIC USE.

NET WT 15 grams

CLOBETASOL PROPIONATE
clobetasol propionate ointment

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CLOBETASOL PROPIONATE (UNII: 779619577M) (CLOBETASOL - UNII:ADN79D536H)	CLOBETASOL PROPIONATE	0.5 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
PETROLATUM (UNII: 4T6H12BN9U)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:71589-002-15	1 in 1 CARTON	03/12/2019
1		15 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC:71589-002-30	1 in 1 CARTON	03/12/2019
2		30 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC:71589-002-45	1 in 1 CARTON	03/12/2019
3		45 g in 1 TUBE; Type 0: Not a Combination Product
4	NDC:71589-002-60	1 in 1 CARTON	03/12/2019
4		60 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA211800	03/12/2019

Labeler - Aleor Dermaceuticals Limited (871411532)

Registrant - Aleor Dermaceuticals Limited (871411532)

Name	Address	ID/FEI	Business Operations
Establishment
Encube Ethicals Pvt. Ltd.		725076298	MANUFACTURE(71589-002)

Clobetasol Propionate Ointment USP, 0.05%(Potency expressed as clobetasol propionate) Rx OnlyFOR DERMATOLOGIC USE ONLY.NOT FOR OPHTHALMIC, ORAL OR INTRAVAGINAL USE.