Clobetasol Propionate Emollient Formulation (Page 4 of 4)

INSTRUCTIONS FOR USE

Clobetasol Propionate Foam, 0.05% (Emulsion)

Important information: Clobetasol Propionate Foam, 0.05% (Emulsion) is for use on the skin only. Do not get Clobetasol Propionate Foam, 0.05% (Emulsion) in your eyes, mouth, or vagina; if contact happens, rinse well with water.

How to apply Clobetasol Propionate Foam, 0.05% (Emulsion)

Step 1:

Before applying Clobetasol Propionate Foam, 0.05% (Emulsion) for the first time, break the tiny plastic piece at the base of the can’s rim by gently pushing back (away from the piece) on the nozzle. See Figure A.

Figure A

Figure A

Step 2:

Shake the can of Clobetasol Propionate Foam, 0.05% (Emulsion) before use. See Figure B.

Figure B

Figure B

Step 3:

Turn the can of Clobetasol Propionate Foam, 0.05% (Emulsion) upside down and press the nozzle. See Figure C.

Figure C

Figure C

Step 4:

Press down on the actuator to dispense a small amount of Clobetasol Propionate Foam, 0.05% (Emulsion) into the palm of your hand. See Figure D.

Figure D

Figure D

Step 5:

Apply a thin layer of Clobetasol Propionate Foam, 0.05% (Emulsion) to cover the affected area. Gently rub the foam into the affected area until the foam disappears. See Figure E.

Figure E
(click image for full-size original)

Figure E

Step 6: Wash your hands after applying Clobetasol Propionate Foam, 0.05% (Emulsion).

Throw away any of the unused medicine that you dispensed out of the can.

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Rx Only

Made in Israel

Manufactured By Perrigo

Yeruham, Israel

Distributed By

Perrigo®

Allegan, MI 49010 ● www.perrigo.com

Rev 08-18

Package/Label Display Panel

Rx Only

NDC 45802-637 -33

Clobetasol Propionate Foam (Emollient Formulation) 0.05%

For Topical Use Only.

Not For Ophthalmic, Oral, or Intravaginal Use.

100 g

Clobetasol Propionate Foam (Emollient Formulation) 0.05% Carton
(click image for full-size original)

The following image is a placeholder representing the product identifier that is either affixed or imprinted on the drug package label during the packaging operation.

//medlibrary.org/lib/images-rx/clobetasol-propionate-emollient-formulation/serialization-template-300x88.jpg
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CLOBETASOL PROPIONATE EMOLLIENT FORMULATION
clobetasol propionate aerosol, foam
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:45802-637
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
GLYCERIN
ISOPROPYL MYRISTATE
POLYOXYL 20 CETOSTEARYL ETHER
POTASSIUM CITRATE
PROPYLENE GLYCOL
WATER
SORBITAN MONOLAURATE
PHENOXYETHANOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:45802-637-33 1 CAN in 1 CARTON contains a CAN
1 100 g in 1 CAN This package is contained within the CARTON (45802-637-33)
2 NDC:45802-637-32 1 CAN in 1 CARTON contains a CAN
2 50 g in 1 CAN This package is contained within the CARTON (45802-637-32)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201402 02/01/2013
Labeler — Padagis Israel Pharmaceuticals Ltd (600093611)

Revised: 12/2021 Padagis Israel Pharmaceuticals Ltd

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