DermacinRx Therazole Pak

Clotrimazole and betamethasone dipropionate cream is a combination of an azole antifungal and corticosteroid and is indicated for the topical treatment of symptomatic inflammatory tinea pedis, tinea cruris, and tinea corporis due to Epidermophyton floccosum, Trichophyton mentagrophytes, and Trichophyton rubrum in patients 17 years and older.

Treatment of tinea corporis or tinea cruris:

• Apply a thin film of clotrimazole and betamethasone dipropionate cream into the affected skin areas twice a day for one week.
• Do not use more than 45 grams per week. Do not use with occlusive dressings.
• If a patient shows no clinical improvement after 1 week of treatment with clotrimazole and betamethasone dipropionate cream, the diagnosis should be reviewed.
• Do not use longer than 2 weeks.

Treatment of tinea pedis:

• Gently massage a sufficient amount of clotrimazole and betamethasone dipropionate cream into the affected skin areas twice a day for two weeks.
• Do not use more than 45 grams per week. Do not use with occlusive dressings.
• If a patient shows no clinical improvement after 2 week of treatment with clotrimazole and betamethasone dipropionate cream, the diagnosis should be reviewed.
• Do not use longer than 4 weeks.

Clotrimazole and betamethasone dipropionate cream is for topical use only. It is not for oral, ophthalmic, or intravaginal use.

Cream, 1%/0.05% (base). Each gram of clotrimazole and betamethasone dipropionate cream, USP contains 10 mg of clotrimazole, USP and 0.64 mg of betamethasone dipropionate USP, (equivalent to 0.5 mg of betamethasone) in a white to off-white hydrophilic cream.

Clotrimazole and betamethasone dipropionate cream, USP is available as follows:

15 gram tube in a carton (NDC 0472-0379-15)

45 gram tube in a carton (NDC 0472-0379-45)

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].

Clotrimazole (kloe trim' a zole) and
Betamethasone Dipropionate (bay" ta meth' a sone dye proe' pee oh nate)
Cream USP, 1%/0.05% (base)

Important information: Clotrimazole and betamethasone dipropionate cream is for use on skin only. Do not use clotrimazole and betamethasone dipropionate cream in your eyes, mouth, or vagina.

What is clotrimazole and betamethasone dipropionate cream?

• Clotrimazole and betamethasone dipropionate cream is a prescription medication used on the skin (topical) to treat fungal infections of the feet, groin, and body in people 17 years of age and older. Clotrimazole and betamethasone dipropionate cream is used for fungal infections that are inflamed and have symptoms of redness or itching.
• Clotrimazole and betamethasone dipropionate cream should not be used in children under 17 years of age.

Before using clotrimazole and betamethasone dipropionate cream, tell your healthcare provider about all your medical conditions, including if you:

• are pregnant or plan to become pregnant. It is not known if clotrimazole and betamethasone dipropionate cream will harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if clotrimazole and betamethasone dipropionate passes into your breast milk.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take other corticosteroid medicines by mouth or use other products on your skin or scalp that contain corticosteroids.

What should I avoid while using clotrimazole and betamethasone dipropionate cream?

Clotrimazole and betamethasone dipropionate cream should not be used to treat diaper rash or redness. You should avoid applying clotrimazole and betamethasone dipropionate cream in the diaper area.

How should I use clotrimazole and betamethasone dipropionate cream?

• Use clotrimazole and betamethasone dipropionate cream exactly as your healthcare provider tells you to use it.
• Use clotrimazole and betamethasone dipropionate cream for the prescribed treatment time, even if your symptoms get better.
• Do not use more than 45 grams of clotrimazole and betamethasone dipropionate cream in 1 week.
• Do not bandage, cover, or wrap the treated area unless your healthcare provider tells you to. Wear loose-fitting clothing if you use clotrimazole and betamethasone dipropionate cream in the groin area.
• Do not use clotrimazole and betamethasone dipropionate cream on your face or underarms (armpits).
• For treatment of fungal infections of the groin and body:
  • Apply a thin layer of clotrimazole and betamethasone dipropionate cream to the affected skin area 2 times a day for 1 week.
  • Tell your healthcare provider if the treated skin area does not improve after 1 week of treatment.
  • Do not use clotrimazole and betamethasone dipropionate cream for longer than 2 weeks.
• For treatment of fungal infections of the feet:
  • Apply a thin layer of clotrimazole and betamethasone dipropionate cream to the affected skin area 2 times a day for 2 weeks.
  • Tell your healthcare provider if the treated skin area does not improve after 2 weeks of treatment. Do not use clotrimazole and betamethasone dipropionate cream longer than 4 weeks.
  • Wash your hands after applying clotrimazole and betamethasone dipropionate cream.

What are the possible side effects of clotrimazole and betamethasone dipropionate cream?

Clotrimazole and betamethasone dipropionate cream may cause serious side effects, including:

• Clotrimazole and betamethasone dipropionate cream can pass through your skin. Too much clotrimazole and betamethasone dipropionate cream passing through your skin can cause your adrenal glands to stop working. Your healthcare provider may do blood tests to check for adrenal gland problems.

The most common side effects of clotrimazole and betamethasone dipropionate cream include burning, tingling, rash, swelling, and infections.

These are not all the possible side effects of clotrimazole and betamethasone dipropionate cream.

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 clotrimazole and betamethasone dipropionate cream?

• Store clotrimazole and betamethasone dipropionate cream at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep clotrimazole and betamethasone dipropionate cream and all medicines out of the reach of children.

General information about the safe and effective use of clotrimazole and betamethasone dipropionate cream.

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

What are the ingredients in clotrimazole and betamethasone dipropionate cream?

Active ingredients: clotrimazole, USP and betamethasone dipropionate, USP

Inactive ingredients: Ceteareth-30, cetyl alcohol, mineral oil, propylene glycol, purified water, sodium phosphate monobasic monohydrate, stearyl alcohol and white petrolatum; benzyl alcohol as preservative.

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

Manufactured by:
G&W Laboratories, Inc.
111 Coolidge Street
South Plainfield, NJ 07080 USA

Distributed by:
Actavis Pharma, Inc.
Parsippany, NJ 07054 USA

I600-5511/14A GW7100

Revised – July 2016