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EXTINA- ketoconazole aerosol, foam


  1. Patient Information
  2. What Is Extina Foam?
  3. Before Using Extina Foam, Tell Your Healthcare Provider About All Of Your Medical Conditions, Including If You:
  4. How Should I Use Extina Foam?
  5. Extina Foam May Cause Serious Side Effects, Including:
  6. How Should I Store Extina Foam?
  7. Active Ingredient:
  8. Inactive Ingredients:

Patient Information 

See FDA-approved patient labeling (Patient Package Insert).

Instruct patients on a proper use of EXTINA Foam

Avoid fire, flame and/or smoking during and immediately following application.
Do not apply EXTINA Foam directly to hands. Dispense onto a cool surface, and apply to the affected areas using the fingertips.
Wash their hands after application
EXTINA Foam may cause skin irritation (application site burning and/or reactions)
Instruct a patient to contact a health care provider if the area of application shows signs of increased irritation and report any signs of adverse reactions.

What Is Extina Foam? 

EXTINA Foam is a prescription medicine used on the skin (topical) to treat seborrheic dermatitis in people 12 years of age and older with a normal immune system.

It is not known if EXTINA Foam is safe and effective when used to treat fungal infections.

It is not known if EXTINA Foam is safe and effective in children less than 12 years of age.

Before Using Extina Foam, Tell Your Healthcare Provider About All Of Your Medical Conditions, Including If You: 

are pregnant or plan to become pregnant. It is not known if EXTINA Foam will harm your unborn baby.
are breastfeeding or plan to breastfeed. It is not known if EXTINA passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with EXTINA Foam.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How Should I Use Extina Foam? 

Use EXTINA Foam exactly as your healthcare provider tells you to use it.

EXTINA Foam is flammable.Avoid fire, flames, or smoking during and right after you apply EXTINA Foam to your skin.
Avoid getting EXTINA Foam in or near your eyes, mouth, lips or vagina. If you get EXTINA Foam on your lips or in your eyes, mouth or vagina, rinse well with water.

Extina Foam May Cause Serious Side Effects, Including: 

Skin irritation at the application area(s), including skin reactions caused by exposure to light.Tell your healthcare provider if you develop skin irritation during treatment with EXTINA Foam.

The most common side effects of EXTINA Foam include,burning, dryness, redness, irritation, numbness, itching, rash and warmth at the application site.

These are not all of the possible side effects of EXTINA Foam.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How Should I Store Extina Foam? 

Store EXTINAFoam at room temperature between 68 F to 77 F (20 C to 25 C).
Do not store the EXTINA Foam can in the refrigerator or freezer.
Keep EXTINA Foam away from heat. Never throw the EXTINAFoam can into a fire, even if the can is empty.
Do not store EXTINA Foam at temperatures above 120 F (49 C).
Do not break through (puncture) the EXTINA Foam can.

Keep EXTINA Foam and all medicines out of the reach of children.

General information about the safe and effective use of EXTINA Foam.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use EXTINA Foam for a condition for which it was not prescribed. Do not give EXTINA Foam to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about EXTINA Foam that is written for health professionals.

Active Ingredient: 

ketoconazole

Inactive Ingredients: 

cetyl alcohol, citric acid, ethanol (denatured withtert-butyl alcohol and brucine sulfate) 58%, polysorbate 60, potassium citrate, propylene glycol, purified water, and stearyl alcohol pressurized with a hydrocarbon (propane/butane) propellant

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

For more information, call Mylan at 1-877-446-3679 (1-877-4-INFO-RX) or visit www.extina.com.

This Patient Information leaflet has been approved by the U.S. Food and Drug Administration.

Instructions for Use
EXTINA (ex-TEEN-ah)
(ketoconazole)
Foam, 2%

Important Information: EXTINA Foam is for use on the skin only. Do not use EXTINA Foam in your eyes, mouth or vagina.

Step 1:Remove the clear cap from the EXTINA Foam can.

Instructions for Use Figure 01

Step 2:Hold the can upright and firmly press the nozzle to dispense EXTINA Foam into the clear cap.

Dispense enough EXTINA Foam to cover the entire affected area(s).
Instructions for Use Figure 02
If the can

Store EXTINA Foam at room temperature between 68 F to 77 F (20 C to 25 C).
Do not store the EXTINA Foam can in the refrigerator or freezer.
Keep EXTINA Foam away from heat. Never throw the can into a fire, even if the can is empty.
Do not store EXTINA Foam at temperatures above 120 F (49 C).
Do not break through (puncture) the EXTINA Foam can.

Keep EXTINA Foam and all medicines out of the reach of children.

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

EXTINA is a registered trademark of Stiefel Laboratories, Inc., a GSK Company, exclusively licensed to the Mylan Companies.

2018 Delcor Asset Corporation, a Mylan Company

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

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

140985-0818

Revised 8/2018
DPT:KTCZFO:R2



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