CLOBETASOL PROPIONATE spray

Clobetasol Propionate by

Drug Labeling and Warnings

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

Drug Details [pdf]

MEDICATION GUIDE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Rx Only

NDC: 71589-003-59

Clobetasol Propionate Spray, 0.05%

For topical use only

2 FL OZ

(59 mL)

Aleor Dermaceuticals Ltd.,

WARNING: FLAMMABLE AVOID FIRE, FLAME OR SMOKING DURING AND IMMEDIATELY FOLLOWING APPLICATION

Not for eye use.

Usual dosage: Apply twice daily, once in the morning and once at night.

Use only enough to cover the affected areas. Do not exceed 26 sprays per application or 52 sprays per day. Do not apply to face, underarms, or groin and avoid contact with eyes and lips. See package insert for complete prescribing information. See lot number and expiration date on the bottom of the carton.

TO THE PHARMACIST

• Ensure the patient receives the Patient Information.
• Replace cap with spray pump prior to dispensing .

Each gram contains: Active: clobetasol propionate (0.5 mg).

Inactive: alcohol, isopropyl myristate, sodium lauryl sulfate, and undecylenic acid.

Store at controlled room temperature 68° to 77°F (20° to 25°C), excursions permitted between 59° to 86°F (15° to 30°C).

Protect from freezing.

Do not refrigerate or store above 86° (30°C).

Keep out of reach of children.

Marketed By:

Aleor Dermaceuticals Ltd.,

Karakhadi, Vadodara 391450 India.

Rx Only

NDC: 71589-003-12

Clobetasol Propionate Spray, 0.05%

For topical use only

4.25 FL OZ

(125 mL)

Aleor Dermaceuticals Ltd.,

WARNING: FLAMMABLE AVOID FIRE, FLAME OR SMOKING DURING AND IMMEDIATELY FOLLOWING APPLICATION

Not for eye use.

Usual dosage: Apply twice daily, once in the morning and once at night.

Use only enough to cover the affected areas. Do not exceed 26 sprays per application or 52 sprays per day. Do not apply to face, underarms, or groin and avoid contact with eyes and lips. See package insert for complete prescribing information. See lot number and expiration date on the bottom of the carton.

TO THE PHARMACIST

• Ensure the patient receives the Patient Information.
• Replace cap with spray pump prior to dispensing .

Each gram contains: Active: clobetasol propionate (0.5 mg).

Inactive: alcohol, isopropyl myristate, sodium lauryl sulfate, and undecylenic acid.

Store at controlled room temperature 68° to 77°F (20° to 25°C), excursions permitted between 59° to 86°F (15° to 30°C).

Protect from freezing.

Do not refrigerate or store above 86° (30°C).

Keep out of reach of children.

Marketed By:

Aleor Dermaceuticals Ltd.,

Karakhadi, Vadodara 391450 India.

INGREDIENTS AND APPEARANCE

CLOBETASOL PROPIONATE 
clobetasol propionate spray

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 71589-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CLOBETASOL PROPIONATE (UNII: 779619577M) (CLOBETASOL - UNII:ADN79D536H)	CLOBETASOL PROPIONATE	0.05 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
UNDECYLENIC ACID (UNII: K3D86KJ24N)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71589-003-59	1 in 1 CARTON	10/31/2019
1		59 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 71589-003-12	1 in 1 CARTON	10/31/2019
2		125 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	ANDA211191	10/31/2019

Labeler - Aleor Dermaceuticals Limited (871411532)

Registrant - Aleor Dermaceuticals Limited (871411532)

Establishment
Name	Address	ID/FEI	Business Operations
Contract Pharmaceuticals Limited Canada		248761249	MANUFACTURE(71589-003)