FDA-approved label information
Reproduced from the FDA Structured Product Label via the openFDA API. Label version: July 9, 2025.
- Status
- Human Prescription Drug
- Brand names
- Nyamyc
- Route
- Topical
- Drug class
- Polyene Antifungal [EPC]
Description
DESCRIPTION Nystatin is a polyene antifungal antibiotic obtained from Streptomyces nursei. Nyamyc® (Nystatin Topical Powder, USP) is for dermatologic use. Nyamyc® (Nystatin Topical Powder, USP) contains 100,000 USP nystatin units per gram dispersed in talc. Chemical Structure
Indications and usage
INDICATIONS AND USAGE 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.
Contraindications
CONTRAINDICATIONS Nyamyc® (Nystatin Topical Powder, USP) is contraindicated in patients with a history of hypersensitivity to any of its components.
Adverse reactions
ADVERSE REACTIONS 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
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.
Paediatric use
Pediatric Use Safety and effectiveness have been established in the pediatric population from birth to 16 years. [see DOSAGE AND ADMINISTRATION ].
Source: US Food and Drug Administration, via the openFDA API. The FDA does not review, endorse or verify third-party reproductions of this data, and label information may have been updated since it was retrieved.
Read the current full label on DailyMed
FDA approval applies to the uses listed on the label. Approval status in your country may differ.
