Soothe & Cool Inzo Antifungal (Topical)

Miconazole is part of a group of medicines known as antifungals. 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 need to think about the risks and benefits. For this medicine, consider the following:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also inform your healthcare professional if you have any other allergies, 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 with its use in other age groups, but this medicine is not expected to cause different side effects or problems in children than it does in adults.

Geriatric

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

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Weigh 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 in other cases, two different medicines may be used together even if an interaction might occur. In these situations, your doctor may need to adjust the dose, or other precautions may be necessary. When taking this medicine, it is especially important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions have been chosen for their potential significance and are not necessarily a complete list.

Using this medicine with any of the following medicines is usually 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 drugs may be the best treatment 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 used at or around the time of eating food or certain types of food due to potential interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Along with its necessary effects, a medicine can cause some unwanted effects. Not all of these side effects may happen, but if they do, they might need 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, consult 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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