Tovet (emollient Formulation) (Page 3 of 4)

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

Tovet® (clobetasol propionate) Foam, 0.05% (Emulsion) contains 0.5 mg of clobetasol propionate, USP per gram. The white emulsion aerosol foam is available as follows:

  • 100 g aluminum can
NDC 43538-952-10

16.2 Storage and Handling

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

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).

Keep out of reach of children.

17 PATIENT COUNSELING INFORMATION

See FDA-Approved Patient Labeling (Patient Information)

Effects on Endocrine System

Tovet Foam may cause HPA axis suppression. Advise patients that use of topical corticosteroids, including Tovet Foam, may require periodic evaluation for HPA axis suppression. Topical corticosteroids may have other endocrine effects. Concomitant use of multiple corticosteroid-containing products may increase the total systemic exposure to topical corticosteroids. Patients should inform their physician(s) that they are using Tovet Foam if surgery is contemplated [see Warnings and Precautions (5.1)].

Ophthalmic Adverse Reactions

Advise patients to report any visual symptoms to their healthcare providers [see Warnings and Precautions (5.3)].

Local Adverse Reactions

Report any signs of local adverse reactions to the physician. Advise patients that local reactions and skin atrophy are more likely to occur with occlusive use or prolonged use [see Warnings and Precautions (5.2)].

Pregnancy

Advise a pregnant woman that use of Tovet Foam may cause fetal harm and to use Tovet Foam on the smallest area of skin and for the shortest duration possible [see Use in Specific Populations (8.1)].

Lactation

Advise a woman to use Tovet Foam on the smallest area of skin and for the shortest duration possible while breastfeeding. Advise breastfeeding women not to apply Tovet Foam directly to the nipple and areola to avoid direct infant exposure [see Use in Specific Populations (8.2)].

Important Administration Instructions

Patients using topical corticosteroids should receive the following information and instructions:

  • This medication is to be used as directed by the physician. It is for external use only. Unless directed by the prescriber, it should not be used on the face, or in skin-fold areas, such as the underarms or groin. Avoid contact with the eyes or other mucous membranes. Wash hands after use.
  • As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, contact the physician.
  • Do not use for more than 50 grams per week of Tovet Foam, or an amount greater than 21 capfuls per week [see Dosage and Administration (2)].
  • This medication is flammable; avoid heat, flame, or smoking when applying this product.

Rx Only

Manufactured for: Medimetriks Pharmaceuticals, Inc., 383 Route 46 West, Fairfield, NJ 07004 USA
Manufactured by: Perrigo, Yeruham, Israel • Made in Israel

Rev.: 9/20
IP052 6C700 EK J3

PATIENT INFORMATION Tovet® (clobetasol propionate) Foam, 0.05% (Emollient Formulation)
IMPORTANT: For skin use only. Do not get Tovet Foam in your eyes, mouth, or vagina.
What is Tovet Foam?
Tovet Foam is a prescription corticosteroid medicine used on the skin (topical) to treat people 12 years of age and older with certain skin conditions that cause red, flaky, and itchy skin.
Tovet Foam is not recommended for use in children under 12 years of age.
Tovet Foam should not be used:
  • on your face, underarms, or groin area.
  • if you have skin thinning (atrophy) at the treatment area.
You should not use Tovet Foam for longer than 2 weeks in a row.
You should not use more than 50 grams or 21 capfuls of Tovet Foam in 1 week.
Before using Tovet Foam, tell your healthcare provider about all of your medical conditions, including if you:
  • have had irritation or other skin reaction to a steroid medicine in the past.
  • have a skin infection. You may need medicine to treat the skin infection before using Tovet Foam.
  • have diabetes.
  • have adrenal gland problems.
  • have liver problems.
  • plan to have surgery.
  • are pregnant or plan to become pregnant. It is not known if Tovet Foam will harm your unborn baby. If you use Tovet Foam during pregnancy, use Tovet Foam on the smallest area of skin and for the shortest time needed.
  • are breastfeeding or plan to breastfeed. It is not known if Tovet Foam passes into your breast milk. If you use Tovet Foam while breastfeeding, use Tovet Foam on the smallest area of skin and for the shortest time needed. Do not apply Tovet Foam directly to the nipple and areola to avoid getting Tovet Foam into your baby’s mouth.
Tell your healthcare provider about all the medicine you take including prescription and over-the-counter medicines, vitamins, and herbal supplements. Do not use other products containing a corticosteroid medicine during treatment with Tovet Foam without talking to your healthcare provider first.
How should I use Tovet Foam?
See the “Instructions for Use” for detailed information about the right way to apply Tovet Foam.
  • Use Tovet Foam exactly as your healthcare provider tells you to use it.
  • Apply a thin layer of Tovet Foam to the affected area 2 times each day, 1 time in the morning and 1 time at night, or as directed by your healthcare provider.
  • Do not bandage, wrap or cover your treated area unless your healthcare provider tells you to.
  • Talk to your healthcare provider if your skin does not improve after 2 weeks of treatment with Tovet Foam.
  • Wash your hands after using Tovet Foam.
What should I avoid while using Tovet Foam?
Tovet Foam is flammable. Avoid heat, flame, or smoking during and right after you apply Tovet Foam to your skin.
What are the possible side effects of Tovet Foam?
Tovet Foam may cause serious side effects, including:
  • Tovet Foam can pass through your skin. Too much Tovet Foam passing through your skin can cause adrenal glands to stop working.
  • Cushing’s syndrome, a condition that happens when the body is exposed to too much of the hormone cortisol.
  • High blood sugar (hyperglycemia)
  • Vision problems. Tovet Foam may increase your chance of developing vision problems such as cataract(s) and glaucoma. Tell your healthcare provider if you develop blurred vision or other vision problems during your treatment with Tovet Foam.
  • Skin reactions at the treated site. Tell your healthcare provider if you get any skin reactions or skin infections.
  • Effects on growth and weight in children.
Your healthcare provider may do certain blood tests to check for side effects.
The most common side effects of Tovet Foam include:
  • thinning of skin
  • burning
  • redness
  • itching
  • dryness
These are not all the side effects of Tovet Foam.
Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store Tovet Foam?
  • Store Tovet Foam at room temperature between 68° to 77°F (20° to 25°C).
  • Do not break through (puncture) Tovet Foam can.
  • Never throw the can into a fire, even if the can is empty.
  • Do not store Tovet Foam near heat or at temperatures above 120°F (49°C).
Keep Tovet Foam and all medicines out of the reach of children.
General information about the safe and effective use of Tovet Foam
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Tovet Foam for a condition for which it was not prescribed. Do not give Tovet Foam to other people, even if they have the same condition that you have. It may harm them. You can ask your healthcare provider or pharmacist for information about Tovet Foam that is written for health professionals.
What are the ingredients in Tovet Foam?
Active ingredient: clobetasol propionate
Inactive ingredients: anhydrous citric acid, cetyl alcohol, cyclomethicone, glycerin, isopropyl myristate, polyoxyl 20 cetostearyl ether, potassium citrate monohydrate, propylene glycol, purified water, sorbitan monolaurate, and phenoxyethanol as a preservative; pressurized with a hydrocarbon (propane/butane) propellant.
For more information, call Medimetriks at 1-973-882-7512.
This Patient Information has been approved by the U.S. Food and Drug Administration.
INSTRUCTIONS FOR USETovet® (clobetasol propionate) Foam, 0.05% (Emollient Formulation)
Important information: Tovet Foam is for use on the skin only. Do not get Tovet Foam in your eyes, mouth, or vagina; if contact happens, rinse well with water.
How to apply Tovet Foam

Figure A

Step 1: Before applying Tovet Foam 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 B

Step 2: Shake the can of Tovet Foam before use. See Figure B.
Figure B

Figure C

Step 3: Turn the can of Tovet Foam upside down and press the nozzle. See Figure C.
Figure C

Figure D

Step 4: Press down on the actuator to dispense a small amount of Tovet Foam into the palm of your hand. See Figure D.
Figure D

Figure E

Step 5: Apply a thin layer of Tovet Foam to cover the affected area. Gently rub the foam into the affected area until the foam disappears. See Figure E.
Figure E
Step 6: Wash your hands after applying Tovet Foam.
  • 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
Manufactured for: Medimetriks Pharmaceuticals, Inc., 383 Route 46 West, Fairfield, NJ 07004 USAManufactured by: Perrigo, Yeruham, Israel • Made in Israel
Rev.: 9/20 IP052

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