Nystatin Cream USP and Nystatin Ointment USP are for dermatologic use.

Nystatin Cream USP contains 100,000 USP Nystatin Units per gram in an aqueous cream base of emulsifying wax, isopropyl myristate, glycerin, lactic acid, sodium hydroxide and sorbic acid.

Nystatin Ointment USP contains 100,000 USP Nystatin Units per gram in an ointment base of light mineral oil and white petrolatum.

Nystatin topical preparations are indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida (Monilia) albicans and other Candida species.

Nystatin preparations should be applied liberally to affected areas twice a day or as indicated until healing is complete, Nystatin cream is usually preferred to nystatin ointment in candidiasis involving intertriginous area; very moist lesions, however, are best treated with nystatin topical powder.

The preparations do not stain skin or mucous membranes and they provide simple, convenient means of treatment.

As light yellow products Nystatin Cream USP, (100,000 USP Nystatin Units/gram), and Nystatin Ointment USP, (100,000 USP Nystatin Units/gram) are supplied in both 15 g and 30 g tubes.

Storage: Store at controlled room temperature 15°-30°C (59°-86°F).

DISTRIBUTED BY PERRIGO®, ALLEGAN, MI 49010. FDA rev date: 9/5/2000

Nystatin is virtually nontoxic and non sensitizing and is well tolerated by all age groups including debilitated infants, even on prolonged administration. If irritation on topical application should occur, discontinue medication.

No information provided.

No information provided.

Should a reaction of hypersensitivity occur the drug should be immediately withdrawn and appropriate measures taken.

These preparations are not for ophthalmic use.

No information provided.

Nystatin topical preparations are contraindicated in patients with a history of hypersensitivity to any of their components.

Nystatin is an antifungal antibiotic which is both fungistatic and fungicidal in vitro against a wide variety of yeasts and yeast-like fungi. It probably acts by binding to sterols in the cell membrane of the fungus with a resultant change in membrane permeability allowing leakage of intracellular components. Nystatin is a polyene antibiotic of undetermined structural formula that is obtained from Streptomyces noursei, and is the first well tolerated antifungal antibiotic of dependable efficacy for the treatment of cutaneous, oral and intestinal infections caused by Candida (Monilia) albicans and other Candida species. It exhibits no appreciable activity against bacteria.

Nystatin provides specific therapy for all localized forms of candidiasis. Symptomatic relief is rapid, often occurring within 24 to 72 hours after initiation of treatment. Cure is effected both clinically and mycologically in most cases of localized candidiasis.

No information provided. Please refer to the PRECAUTIONS section.

IMPORTANT NOTE: This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your health care professional. Always seek the advice of your health care professional if you have any questions about this product or your medical condition. This information is not intended as individual medical advice and does not substitute for the knowledge and judgment of your health care professional. This information does not contain any assurances that this product is safe, effective, or appropriate for you.

NYSTATIN - TOPICAL

(NYE-stat-in)

COMMON BRAND NAME(S): Mycostatin

USES: Nystatin is used to treat fungal skin infections. Nystatin is an antifungal that works by stopping the growth of fungus.

HOW TO USE: Use this medication on the skin only. Clean and thoroughly dry the area to be treated. Apply this medication to the affected skin, usually twice a day or as directed by your doctor. Dosage and length of treatment depends on the type of infection being treated. Do not apply this more often than prescribed.

Apply enough medication to cover the affected area and some of the surrounding skin. After applying this medication, wash your hands unless you are using this medication to treat the hands. Do not wrap, cover or bandage the area unless directed to do so by your doctor. If used in the diaper area on an infant, do not use tight-fitting diapers or plastic pants.

Do not apply this medication in the eyes, nose, mouth, or vagina.

Use this medication regularly in order to get the most benefit from it. Remember to use it at the same times each day.

Continue to use this medication until the full prescribed amount is finished, even if symptoms disappear after starting nystatin. Stopping the medication too early may allow the fungus to continue to grow, which may result in a return of the infection.

Inform your doctor if your condition persists after 2 weeks of treatment or worsens at any time.

SIDE EFFECTS: Skin irritation or redness may occur. If either of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching, swelling, severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Food and Drug Administration (FDA) at 1-800-FDA-1088. In Canada, you may call Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using nystatin, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies.

Before using this medication, tell your doctor or pharmacist your medical history.

This medication should be used only if clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop or change the dosage of any medicine before checking with them first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use.

Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: This medicine may be harmful if swallowed. If swallowing or overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly. Symptoms that may occur after swallowing include: nausea, vomiting or stomach upset.

NOTES: Do not share this medication with others.

This medication should be used for your current condition only. Do not use it later for another infection unless told to do so by your doctor. A different medication may be necessary in those cases.

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature between 59-86 degrees F (15-30 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised July 2008 Copyright(c) 2008 First DataBank, Inc.