Monistat 1 (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 issue does not get better in 4 weeks, or if it gets worse, contact your health care professional.

In deciding to use a medicine, you and your doctor need to weigh the risks against the benefits. Consider the following for this medicine:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also let your healthcare professional know about any other allergies you may have, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

There is no specific information comparing the use of topical miconazole in children to its use in other age groups, but it is not expected to cause different side effects or issues in children than in adults.

Geriatric

Many medicines have not been specifically studied in older adults. Therefore, it may not be clear if they work the same way as they do in younger adults. There is no specific information comparing the use of topical miconazole in older adults with use in other age groups, but it is not expected to cause different side effects or issues 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. Consider the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together even if an interaction could occur. In these cases, your doctor may need to adjust the dose or take other precautions. It is very important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions are selected for their significance and are not necessarily all-inclusive.

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

• Warfarin

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

• Ethinyl Estradiol

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken at or around mealtime or with certain types of food due to potential interactions. Using alcohol or tobacco with certain 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 occur, but if they do, they may need medical attention.

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

• Blistering, burning, redness, skin rash, or any other sign of skin irritation not present before using this medicine

Other side effects not listed may also occur 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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