CLOBETASOL PROPIONATE solution

Clobetasol Propionate by

Drug Labeling and Warnings

Clobetasol Propionate by is a Prescription medication manufactured, distributed, or labeled by Aleor Dermaceuticals Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

MEDICATION GUIDE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BOTTLE LABEL

Rx Only

NDC: 71589-004-25

Clobetasol Propionate Topical Solution USP, 0.05%

FOR USE ON THE SCALP

FOR DERMATOLOGIC USE ONLY.

NOT FOR OPHTHALMIC USE.

NET WT 25 mL

PRINCIPAL DISPLAY PANEL

CARTON LABEL

Rx Only

NDC: 71589-004-25

Clobetasol Propionate Topical Solution USP, 0.05%

FOR USE ON THE SCALP

FOR DERMATOLOGIC USE ONLY.

NOT FOR OPHTHALMIC USE.

NET WT 25 mL

INGREDIENTS AND APPEARANCE

CLOBETASOL PROPIONATE 
clobetasol propionate solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 71589-004
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302)
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71589-004-25	1 in 1 CARTON	11/02/2019
1		25 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 71589-004-50	1 in 1 CARTON	11/02/2019
2		50 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA212881	11/02/2019

Labeler - Aleor Dermaceuticals Limited (871411532)

Registrant - Aleor Dermaceuticals Limited (871411532)

Establishment
Name	Address	ID/FEI	Business Operations
Aleor Dermaceuticals Limited		871411532	MANUFACTURE(71589-004) , ANALYSIS(71589-004)