Nystatin
100000 [USP'U]/g · Cream
- Prescription only
- Polyene Antifungal
- Active substance
- Nystatin
- Made by
- Padagis Israel Pharmaceuticals Ltd
- Source
- Official label
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 · 2024-03-01
- Class II Ongoing · 2026-06-23 — Subpotent Drug: Low out of specification assay results performed during long-term stability testing.Using the product could cause temporary or medically reversible harm.
A recall usually covers specific lots. Check the lot number on your pack against the notice, and ask your pharmacist before you stop a medicine. FDA recalls
Polyene Antifungal
- Nystatin Cream USP is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species. Nystatin Cream USP is not indicated for…
Nystatin Cream USP is contraindicated in patients with a history of hypersensitivity to any of its components.
All warnings ↓- Prescription only
Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed
What it is for
- Nystatin Cream USP is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species. Nystatin Cream USP is not indicated for systemic, oral, intravaginal or ophthalmic use.
From the official label · 2024-03-01 · DailyMed
How it works
From this product’s own US prescribing label.
Nystatin Cream USP 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 · 2024-03-01
Do not take it if
Nystatin Cream USP 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 nystatin topical dusting powder.
- Adults and Pediatric Patients (Neonates and Older):
- Apply liberally to affected areas twice daily or as indicated until healing is complete.
Quoted from the official label, section “Dosage & Administration”.
Other warnings
- General - Nystatin Cream 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.
- Information for Patients - Patients using this medication should receive the following information and instructions:
- 1.
- Laboratory Tests - If there is a 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:
- 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 cream did not include sufficient numbers of subjects aged 65 years and older to determine whether they respond differently than younger subjects.
- General - Nystatin Cream 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.
Quoted from the official label, section “Warnings”.
Pregnancy and breastfeeding
- Teratogenic Effects:
- Category C - 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 preparations 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 cream 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 Cream USP 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
- Patients using this medication should receive the following information and instructions:
- 1.
- 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. 2.
- 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. 3.
- 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 Cream USP (100,000 USP Nystatin Units per gram) is a yellow cream available as follows:
- 15 g tube (NDC 45802- 059 -35) 30 g tube (NDC 45802- 059 -11) STORAGE
- Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature].
Quoted from the official label, section “How Supplied”.
How to store it
Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature].
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 is C 47 H 75 NO 17 , and the molecular weight is 926.13.
- Structural formula: Nystatin Cream USP is for dermatologic use.
- Nystatin Cream USP for topical use, contains 100,000 USP nystatin units per gram.
- Inactive ingredients:
- emulsifying wax, glycerin, isopropyl myristate, lactic acid, purified water, sodium hydroxide, and sorbic acid. chemical structure
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.
This label’s list of inactive ingredients names none of: lactose, wheat or gluten, colour dyes, sugars, sugar alcohols, alcohol (ethanol), aspartame (phenylalanine), gelatin, peanut oil, soy, parabens, sulfites, titanium dioxide.
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 (26)
The same active substance, strength and kind of form, from every company that sells it — with what each label lists.
Showing 26 of 26
- NystatinThis onePrescription onlyPadagis Israel Pharmaceuticals LtdNames none of these
- NystatinPrescription onlyA-S Medication SolutionsNames none of these
- NystatinPrescription onlyA-S Medication SolutionsNo ingredient list on the stored label
- NystatinPrescription onlyA-S Medication SolutionsSugar alcoholsParabensTitanium dioxide
- NystatinPrescription onlyActavis Pharma, Inc.No ingredient list on the stored label
- NystatinPrescription onlyAurobindo Pharma LimitedNo ingredient list on the stored label
- NystatinPrescription onlyBryant Ranch PrepackNo ingredient list on the stored label
- NystatinPrescription onlyBryant Ranch PrepackNames none of these
- NystatinPrescription onlyBryant Ranch PrepackNo ingredient list on the stored label
- NystatinPrescription onlyBryant Ranch PrepackSugar alcoholsParabensTitanium dioxide
- NystatinPrescription onlyDIRECT RXNo ingredient list on the stored label
- MycostatinPrescription onlyDirect_RxNames none of these
- NystatinPrescription onlyLeading Pharma, LLCNo ingredient list on the stored label
- NystatinPrescription onlyNuCare Pharmaceuticals,Inc.No ingredient list on the stored label
- NystatinPrescription onlyPadagis Israel Pharmaceuticals LtdNo ingredient list on the stored label
- NystatinPrescription onlyPreferred Pharmaceuticals Inc.No ingredient list on the stored label
- NystatinPrescription onlyPreferred Pharmaceuticals Inc.Sugar alcoholsParabensTitanium dioxide
- NystatinPrescription onlyProficient Rx LPNo ingredient list on the stored label
- NystatinPrescription onlyProficient Rx LPNo ingredient list on the stored label
- NystatinPrescription onlyProficient Rx LPSugar alcoholsParabensTitanium dioxide
- NystatinPrescription onlyRedPharm Drug, IncSugar alcoholsParabensTitanium dioxide
- NystatinPrescription onlySun Pharmaceutical Industries, Inc.No ingredient list on the stored label
- NystatinPrescription onlyTorrent Pharmaceuticals LimitedNo ingredient list on the stored label
- NystatinPrescription onlyTorrent Pharmaceuticals LimitedSugar alcoholsParabensTitanium dioxide
- NystatinPrescription onlyViona Pharmaceuticals IncNo ingredient list on the stored label
- NystatinPrescription onlyZydus Lifesciences LimitedNo ingredient list on the stored label
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
Details
| Made by | Padagis Israel Pharmaceuticals Ltd |
|---|---|
| Active substance | Nystatin |
| Used in | Antibiotics, antivirals and antifungals taken into the body |
| Strength | 100000 [USP'U]/g |
| Form | Cream |
| Route | Topical |
| Packs | 1 TUBE in 1 CARTON / 30 g in 1 TUBE · 1 TUBE in 1 CARTON / 15 g in 1 TUBE |
| NDC | 45802-059 |
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).
Other strengths and forms
60 products are sold under this name. Grouped by form; a number on a strength means several companies make it.
- Cream18 products
100000 [USP'U]/g11
100000 [USP'U]/g · 11 companies
- A-S Medication Solutions
- Aurobindo Pharma Limited
- Bryant Ranch Prepack
- Cosette Pharmaceuticals, Inc.
- DIRECT RX
- NuCare Pharmaceuticals, Inc.
- NuCare Pharmaceuticals,Inc.
- Padagis Israel Pharmaceuticals Ltd · this page
100000 U/g6
- 100000 1/g
- Suspension17 products
100000 [USP'U]/mL12
100000 U/mL5
- Ointment12 products
100000 [USP'U]/g6
100000 U/g5
- 100000 1/g
- Tablet, Coated5 products
500000 [USP'U]5
Show all forms · 6 forms
- Powder5 products
100000 [USP'U]/g5
100000 [USP'U]/g · 5 companies
- Tablet, Film Coated3 products
500000 [USP'U]3
500000 [USP'U] · 3 companies
Same active substance
These contain the same substance. That does not mean one can replace another — ask a pharmacist.