Clobetasol Propionate: Package Insert and Label Information (Page 3 of 3)

PRINCIPAL DISPLAY PANEL – 0.05%

NDC 0378-8055-50

Clobetasol
Propionate
Foam
0.05%

Emulsion
Formulation

FOR TOPICAL USE ONLY.
NOT FOR OPHTHALMIC, ORAL,
OR INTRAVAGINAL USE.

Shake can before use.

Invert can
and then
press firmly
to dispense.

Description: Each gram of Clobetsol
Propionate Foam contains 0.5 mg
clobetasol propionate, USP.

The foam also contains anhydrous
citric acid, cetyl alcohol,
cyclomethicone, isopropyl myristate,
light mineral oil, polyoxyl 20
cetostearyl ether, potassium citrate
monohydrate, propylene glycol,
purified water, sorbitan monolaurate,
white petrolatum, and phenoxyethanol
as a preservative, and is 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 DURING AND
IMMEDIATELY FOLLOWING
APPLICATION.

Contents under pressure. Do not
puncture or incinerate. Do not
expose to heat or store at
temperatures above 120°F (49°C).

Avoid contact with eyes or other
mucous membranes. Keep this and
all medication out of the reach of
children.

Store at 20° to 25°C (68° to 77°F).
[See USP Controlled Room
Temperature.]

CFC FREE

Manufactured for:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Manufactured by:
DPT Laboratories, Ltd.
San Antonio, TX 78215 U.S.A.

For more information, call
Mylan Pharmaceuticals Inc. at1-877-446-3679 (1-877-4-INFO-RX).

DPT:8055:50:1C:R1

117492-0917

Mylan.com

CLOBETASOL PROPIONATE clobetasol propionate aerosol, foam

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0378-8055 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 ANHYDROUS CITRIC ACID CETYL ALCOHOL CYCLOMETHICONE ISOPROPYL MYRISTATE LIGHT MINERAL OIL POLYOXYL 20 CETOSTEARYL ETHER POTASSIUM CITRATE PROPYLENE GLYCOL WATER SORBITAN MONOLAURATE PETROLATUM PHENOXYETHANOL

Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0378-8055-50 1 CAN in 1 CARTON contains a CAN 1 50 g in 1 CAN This package is contained within the CARTON (0378-8055-50) 2 NDC:0378-8055-01 1 CAN in 1 CARTON contains a CAN 2 100 g in 1 CAN This package is contained within the CARTON (0378-8055-01)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA authorized generic NDA022013 01/14/2019

Labeler — Mylan Pharmaceuticals Inc. (059295980)

Revised: 05/2018 Mylan Pharmaceuticals Inc.