Triple Care EPC (Topical)

Miconazole is an antifungal medicine. Topical miconazole is used to treat certain types of fungal infections.

Some of these products may be available without a prescription.

If your skin problem does not get better within 4 weeks, or if it gets worse, contact your health care professional.

In deciding to use a medicine, you and your doctor will need to consider the risks of taking it against the benefits it may provide. Here are some important points to think about:

Allergies

Inform your doctor if you have ever experienced any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know if you have any other allergies, like to foods, dyes, preservatives, or animals. For over-the-counter products, carefully read the label or package ingredients.

Pediatric

There is no specific information comparing the use of topical miconazole in children to its use in other age groups. However, this medicine is not expected to have different side effects or issues in children compared to adults.

Geriatric

Many medicines have not been specifically studied in older adults, so it may not be known if they work the same way as in younger adults. Although there is no specific information comparing the use of topical miconazole in the elderly with use in other age groups, this medicine is not expected to cause different side effects or problems in older people than in younger adults.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication while breastfeeding. You should weigh the potential benefits against the potential risks before using this medication during breastfeeding.

Interactions with Medicines

Some medicines should not be used together, while others can be used together even if they might interact. If you are taking this medicine, it is very important that your healthcare professional knows if you are taking any of the medicines listed below. The following interactions are based on their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some situations. If both are prescribed together, your doctor may adjust the dose or frequency of one or both medicines.

• Warfarin

Using this medicine with any of the following medicines may increase the risk of certain side effects, but taking both might be the best option for you. If both are prescribed together, your doctor may adjust the dose or frequency of one or both medicines.

• Ethinyl Estradiol

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken around meal times or with specific foods due to potential interactions. Consuming alcohol or tobacco with some medicines may also lead to interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Along with its necessary effects, a medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they may require medical attention.

Contact your doctor as soon as possible if any of the following side effects occur:

• Blistering, burning, redness, skin rash, or other signs of skin irritation that were not present before using this medicine.

Other side effects not listed may also happen in some patients. If you notice any other effects, talk to your healthcare professional.

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

In the U.S.

• Aloe Vesta 2-N-1 Antifungal
• Aloe Vesta Antifungal
• Baza Antifungal
• Carrington Antifungal
• Derma Gran AF
• DiabetAid Antifungal Foot Bath
• Fungoid
• Lotrimin AF
• Micatin
• Micro-Guard
• Mitrazol
• Monistat 1
• Monistat Derm
• Neosporin AF
• QC Miconazole Nitrate
• Secura Antifungal
• Soothe & Cool Inzo Antifungal
• Tetterine
• Therasoft Antifungal
• Triple Care Antifungal
• Triple Care EPC
• Zeasorb-AF

Available Dosage Forms:

• Solution
• Tincture
• Spray
• Tablet, Effervescent
• Cream
• Gel/Jelly
• Powder
• Ointment
• Kit

Therapeutic Class: Antifungal

Chemical Class: Imidazole

Keep this medicine away from the eyes.

Apply enough miconazole to cover the affected area, and rub in gently.

To use the aerosol powder form of miconazole:

• Shake well before using.
• From a distance of 6 to 10 inches, spray the powder on the affected areas. If it is used on the feet, spray it between the toes, on the feet, and in the socks and shoes.
• Do not inhale the powder.
• Do not use near heat, near open flame, or while smoking.

To use the aerosol solution form of miconazole:

• Shake well before using.
• From a distance of 4 to 6 inches, spray the solution on the affected areas. If it is used on the feet, spray it between the toes and on the feet.
• Do not inhale the vapors from the spray.
• Do not use near heat, near open flame, or while smoking.

To use the powder form of miconazole:

• If the powder is used on the feet, sprinkle it between the toes, on the feet, and in the socks and shoes.

When miconazole is used to treat certain types of fungus infections of the skin, an occlusive dressing (airtight covering, such as kitchen plastic wrap) should not be applied over this medicine. To do so may cause irritation of the skin. Do not apply an occlusive dressing over this medicine unless you have been directed to do so by your doctor.

To help clear up your infection completely, keep using this medicine for the full time of treatment, even if your condition has improved. Do not miss any doses.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For aerosol powder, aerosol solution, cream, and powder dosage forms: For fungus infections: Adults and children—Apply to the affected area(s) of the skin two times a day, morning and evening.
• For cream and lotion dosage forms: For sun fungus: Adults and children—Apply to the affected area(s) of the skin once a day.

Missed Dose

If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Store the canister at room temperature, away from heat and direct light. Do not freeze. Do not keep this medicine inside a car where it could be exposed to extreme heat or cold. Do not poke holes in the canister or throw it into a fire, even if the canister is empty.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

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