Mediclarum
Medicine guide

Nystatin

100000 [USP'U]/g · Powder

  • Prescription only
  • Polyene Antifungal
Active substance
Nystatin
Made by
Dr. Reddy's Labratories Inc.

Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.

At a glance

Quoted from the official label · 2024-04-12

What it is

Polyene Antifungal

Used for
  • Nystatin topical powder is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species.
Do not take it if

Nystatin topical powder is contraindicated in patients with a history of hypersensitivity to any of its components.

All warnings ↓
Good to know
  • Prescription only
  • Mediclarum could not reach the FDA to check for recalls just now. This is not a result.
  • Mediclarum could not reach the FDA to check for shortages just now.
61other products contain Nystatin — compare makers, forms and strengths

Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed

What it is for

  • Nystatin topical powder is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species.
  • Nystatin topical powder is not indicated for systemic, oral, intravaginal or ophthalmic use.

From the official label · 2024-04-12 · DailyMed

How it works

From this product’s own US prescribing label.

Nystatin is not absorbed from intact skin or mucous membrane.

Microbiology Nystatin is an antibiotic which is both fungistatic and fungicidal in vitro against a wide variety of yeasts and yeast-like fungi, including Candida albicans, C. parapsilosis, C. tropicalis, C. guilliermondi, C. pseudotropicalis, C. krusei, Torulopsis glabrata, Tricophyton rubrum, T. mentagrophytes.

Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2024-04-12

Do not take it if

Nystatin topical powder is contraindicated in patients with a history of hypersensitivity to any of its components.

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

  • 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.

Quoted from the official label, section “Dosage & Administration”.

Other warnings

  • General Nystatin topical powder 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.
  • Laboratory Tests If there is lack of therapeutic response, KOH smears, cultures, or other diagnostic methods should be repeated.
  • Carcinogenesis, Mutagenesis, Impairment of Fertility No long-term animal studies have been performed to evaluate the carcinogenic potential of nystatin.
  • No studies have been performed to determine the mutagenicity of nystatin or its effects on male or female fertility.
  • Pregnancy Teratogenic Effects Animal reproduction studies have not been conducted with any nystatin topical preparation.
  • Nursing Mothers It is not known whether nystatin is excreted in human milk.
  • Pediatric Use Safety and effectiveness have been established in the pediatric population from birth to 16 years.
  • (See DOSAGE AND ADMINISTRATION .) Geriatric Use 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.
  • General Nystatin topical powder 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.

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

  • Teratogenic Effects Animal reproduction studies have not been conducted with any nystatin topical preparation.
  • It also is not known whether these preparations can cause fetal harm when used by a pregnant woman or can affect reproductive capacity.
  • Nystatin topical powder should be prescribed for a pregnant woman only if the potential benefit to the mother outweighs the potential risk to the fetus.
  • It is not known whether nystatin is excreted in human milk. Caution should be exercised when nystatin is prescribed for a nursing woman.

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Use in children

Safety and effectiveness have been established in the pediatric population from birth to 16 years. (See DOSAGE AND ADMINISTRATION .)

Quoted from the official label, section “Pediatric Use”.

Use in older people

  • 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.

Quoted from the official label, section “Geriatric Use”.

Side effects

The frequency of adverse events reported in patients using nystatin topical powder 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 .)

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

  • 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.

Quoted from the official label, section “Patient Counseling Information”.

What it looks like and how it is packed

  • Nystatin topical powder, USP is supplied as 100,000 units nystatin per gram in plastic squeeze bottles:
  • 15g (NDC 75907-060-44) 30g (NDC 75907-060-30) 60g (NDC 75907-060-60) STORAGE
  • Store at 20°C to 25°C (68°F to 77°F)[see USP Controlled Room Temperature];
  • avoid excessive heat (40°C/104°F).
  • Keep tightly closed.

Quoted from the official label, section “How Supplied”.

How to store it

  • Store at 20°C to 25°C (68°F to 77°F)[see USP Controlled Room Temperature];
  • avoid excessive heat (40°C/104°F). Keep tightly closed.

Quoted from the official label, section “Storage and Handling”.

What is in it

  • Nystatin is a polyene antifungal antibiotic obtained from Streptomyces noursei .
  • The molecular formula for Nystatin is C 47 H 75 NO 17 .
  • The molecular weight of Nystatin is 926.1.
  • Structural formula: Nystatin topical powder is for dermatologic use.
  • Nystatin topical powder contains 100,000 USP nystatin units per gram dispersed in talc.

Quoted from the official label, section “Description”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

The stored label for this product has no list of inactive ingredients. The list on the pack is the one to check.

Quoted from the FDA label. A label that does not name an ingredient is not a guarantee that the product is free of it, and formulations change. With an allergy, check the pack and ask a pharmacist.

Every version of this medicine (8)

The same active substance, strength and kind of form, from every company that sells it — with what each label lists.

Showing 8 of 8

Same active substance, strength and form in other countries

Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.

Medicine passport: one printable page to show a pharmacist abroad

CanadaNo exact match for this strength and form

Every strength and form (6)

Details

Made byDr. Reddy's Labratories Inc.
Active substanceNystatin
Used inAntibiotics, antivirals and antifungals taken into the body
Strength100000 [USP'U]/g
FormPowder
RouteTopical
Packs30 g in 1 BOTTLE, PLASTIC · 15 g in 1 BOTTLE, PLASTIC
NDC75907-060

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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Other strengths and forms

60 products are sold under this name. Grouped by form; a number on a strength means several companies make it.

Show all forms · 6 forms

Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.

Mycostatin100000 [USP'U]/gPrescription onlyCream Direct_Rx · NystatinNyamyc100000 [USP'U]/gPrescription onlyPowder Upsher-Smith Laboratories, LLC · NystatinNystatin500000 [USP'U]Prescription onlyTablet, Film Coated Teva Pharmaceuticals USA, Inc. · NystatinNystatin100000 [USP'U]/mLPrescription onlySuspension Pharmaceutical Associates, Inc. · NystatinNystatin100000 [USP'U]/mLPrescription onlySuspension PAI Holdings, LLC dba PAI Pharma · NystatinNystatin100000 [USP'U]/gPrescription onlyOintment Actavis Pharma, Inc. · Nystatin

See every product with Nystatin