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Nystatin

Nyamyc® (Nystatin Topical Powder, USP) is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and o.

Checked against the official label · Updated

Prescription medicine Topical Safety alerts on record

How to use Nystatin

Ce que dit la notice officielle. Si un médecin vous l'a prescrit, suivez l'ordonnance. La notice de votre boîte prime si elle est différente.

Pour qui

Nyamyc® (Nystatin Topical Powder, USP) is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species. Nyamyc® (Nystatin Topical Powder, USP) is not indicated for systemic, oral, intravaginal or ophthalmic use.

Comment le prendre et à quelle fréquence
  • Very moist lesions are best treated with the topical dusting powder
  • Adults and Pediatric Patients (Neonates and Older) Apply to candidal lesions two or three times daily until healing is complete
  • For fungal infection of the feet caused by Candida species, the powder should be dusted on the feet, as well as, in all foot wear
Children

Safety and effectiveness have been established in the pediatric population from birth to 16 years. [see DOSAGE AND ADMINISTRATION ].

Older adults

Clinical studies with nystatin topical powder did not include sufficient numbers of subjects aged 65 years and older to determine whether they respond differently than younger subjects. Other reported clinical experience has not identified differences in responses between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

While you are taking it
  • INFORMATION FOR THE PATIENT Patients using this medication should receive the following information and instructions: The patient should be instructed to use this medication as directed (including the replacement of missed doses)
  • This medication is not for any disorder other than that for which it is prescribed
  • Even if symptomatic relief occurs within the first few days of treatment, the patient should be advised not to interrupt or discontinue therapy until the prescribed course of treatment is completed
  • If symptoms of irritation develop, the patient should be advised to notify the physician promptly
Talk to a doctor first if

Nyamyc® (Nystatin Topical Powder, USP) is contraindicated in patients with a history of hypersensitivity to any of its components.

Warnings

PRECAUTIONS General Nyamyc® (Nystatin Topical Powder, USP) should not be used for the treatment of systemic, oral, intravaginal or ophthalmic infections. If irritation or sensitization develops, treatment should be discontinued and appropriate measures taken as indicated. It is recommended that KOH smears, cultures, or other diagnostic methods be used to confirm the diagnosis of cutaneous or mucocutaneous candidiasis and to rule out infection caused by other pathogens. …

Effets secondaires possibles

The frequency of adverse events reported in patients using nystatin topical preparations is less than 0.1%. The more common events that were reported include allergic reactions, burning, itching, rash, eczema, and pain on application. [see PRECAUTIONS: General ].

Pregnancy and breastfeeding

Pregnancy Teratogenic Effects Animal reproduction studies have not been conducted with any nystatin topical preparation. It also is not known whether theses preparations can cause fetal harm when used by a pregnant woman or can affect reproductive capacity. Nyamyc® (Nystatin Topical Powder, USP) should be prescribed for a pregnant woman only if the potential benefit to the mother outweighs the potential risk to the fetus.

How to store it

STORAGE Nyamyc® (Nystatin Topical Powder, USP) 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]. Avoid excessive heat (40°C/104°F). Keep tightly closed. …

En cas d'oubli

Prenez-le dès que vous y pensez, sauf s'il est presque l'heure de la dose suivante. Dans ce cas, sautez la dose oubliée. Ne prenez jamais deux doses à la fois pour compenser. Vérifiez votre notice, certains médicaments font exception.

From the official U.S. FDA label for this active ingredient. Your pack may have a different strength, so always read its leaflet. If a doctor prescribed it, follow the prescription. Ask a pharmacist if you are unsure. Label dated 2025-07-09.

Marques dans le monde

Products with Nystatin as the active ingredient. Names differ between countries.

Registered products

United States (FDA)

NystatinNYSTATIN 100000 [USP'U]/mL · Suspension · Bryant Ranch Prepack
NDC 63629-8520Label
NystatinNYSTATIN 100000 [USP'U]/g · Cream · NuCare Pharmaceuticals, Inc.
NDC 68071-3911Label
Nystatin And Triamcinolone AcetonideNYSTATIN 100000 [USP'U]/g, TRIAMCINOLONE ACETONIDE 1 mg/g · Ointment · Bryant Ranch Prepack
NDC 72162-1275Label
NystatinNYSTATIN 1 kg/kg · Powder · Antibiotice SA
NDC 65415-1371Label
NystatinNYSTATIN 1 kg/kg · Powder · Antibiotice SA
NDC 65415-1372Label

Nigeria (NAFDAC)

NAFDACNystatin Oral Drops B4-8497NAFDACMCN Insert C4-1523NAFDACRestatin Tablet A4-0451NAFDACVardstin Tablet 04-6074NAFDACCloneocol Cream A4-100690NAFDACDonystatin Cream B4-5863NAFDACKenstatin Tablets B4-7914NAFDACPolygynax Capsule 04-3009NAFDACTimec Nystatin Tablets A4-1450NAFDACBiomestatin Suspension A4-3246NAFDACMyconys Oral Suspension A11-0671NAFDACMystatin Oral Suspension A4-4634

Other countries: check your pack's registration number and we point you to your regulator.

Safety alerts and recalls

Nystatin Cream USP, (100,000 USP Nystatin Units), NET WT 15 g, Rx only, 15 g tube, Manufactured by Padagis, Yeruham, Israel, NDC 45802-059-35U.S. FDA Class II
23 Jun 2026 · Padagis US LLC · OngoingSubpotent Drug: Low out of specification assay results performed during long-term stability testing.
NYSTATIN 5BU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only, For Prescription Compounding, Fagron, Inc. - 2400 Pilot Knob Rd. St Paul, MN 55120. NDC 51552-0041-5U.S. FDA Class II
11 Dec 2023 · Fagron, Inc · OngoingLabeling: Label Error on Declared Strength: Assay value on the label is incorrect.
NYSTATIN 500 MU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only, For Prescription Compounding, Fagron, Inc. - 2400 Pilot Knob Rd. St Paul, MN 55120. NDC 51552-004U.S. FDA Class II
11 Dec 2023 · Fagron, Inc · OngoingLabeling: Label Error on Declared Strength: Assay value on the label is incorrect.
NYSTATIN 2 BU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only, For Prescription Compounding, Fagron, Inc. - 2400 Pilot Knob Rd. St Paul, MN 55120. NDC 51552-0041-U.S. FDA Class II
11 Dec 2023 · Fagron, Inc · OngoingLabeling: Label Error on Declared Strength: Assay value on the label is incorrect.

A recall usually affects certain batches only. Compare the lot number on your pack.

Check your pack of Nystatin

Type the registration number on the pack, or scan it with your camera.

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Encore 3 vérifications gratuites aujourd'hui Official sources: U.S. FDA · EMA (EU) · Health Canada · WHO alerts

Questions about Nystatin

What is Nystatin used for?

Nyamyc® (Nystatin Topical Powder, USP) is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species. Nyamyc® (Nystatin Topical Powder, USP) is not indicated for systemic, oral, intravaginal or ophthalmic use. (From the official U.S. FDA label.)

How do I take Nystatin?

Follow your prescription or the leaflet in your pack. The official label says: Very moist lesions are best treated with the topical dusting powder. Adults and Pediatric Patients (Neonates and Older) Apply to candidal lesions two or three times daily until healing is complete. For fungal infection of the feet caused by Candida species, the powder should be dusted on the feet, as well as, in all foot wear.…

Do I need a prescription for Nystatin?

Usually yes. Nystatin is a prescription medicine in most countries. Rules differ by country.

What brands contain Nystatin?

Nystatin is sold under names such as Bio-statin, Nystop, Nyamyc. Brand names differ between countries.

What are the side effects of Nystatin?

The official label lists: The frequency of adverse events reported in patients using nystatin topical preparations is less than 0.1%. The more common events that were reported include allergic reactions, burning, itching, rash, eczema, and pain on application. [see PRECAUTIONS: General ]. Tell your doctor about any side effect that bothers you or does not go away.

Can children take Nystatin?

Safety and effectiveness have been established in the pediatric population from birth to 16 years. [see DOSAGE AND ADMINISTRATION ]. Always use the dose for the child's age or weight on the pack or prescription.

Can I take Nystatin when pregnant or breastfeeding?

Pregnancy Teratogenic Effects Animal reproduction studies have not been conducted with any nystatin topical preparation. It also is not known whether theses preparations can cause fetal harm when used by a pregnant woman or can affect reproductive capacity. Nyamyc® (Nystatin Topical Powder, USP) should be prescribed for a pregnant woman only if the potential benefit to the moth… Ask your doctor or midwife first.

How should I store Nystatin?

Nyamyc® (Nystatin Topical Powder, USP) 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]. Avoid excessive heat (40°C/104°F). Keep tightly closed. …

How can I check that my Nystatin is genuine?

Scan the registration number on your pack with PillVera (NAFDAC number in Nigeria, NDC in the United States, DIN in Canada), check the expiry date and buy only from licensed pharmacies.

Sources

This page shows what official sources say, in plain words. It is not medical advice: your prescription and your doctor or pharmacist come first. Brand names, strengths and rules differ between countries.