Nystatin Cream 100000 [USP'U]/g
Nystatin Cream · CREAM · Crown Laboratories
Nystatin Cream is a cream containing nystatin cream at 100000 [USP'U]/g, taken topical. Manufactured by Crown Laboratories.
Key Facts
- Brand Name
- Nystatin Cream
- Generic Name
- Nystatin Cream
- NDC Code (Product)
0316-0221- Manufacturer
- Crown Laboratories
- Strength
- 100000 [USP'U]/g
- Dosage Form
- CREAM
- Route
- TOPICAL
- Marketing Status
- Application #
- ANDA207733
- Drug Class
- Polyene Antifungal [EPC]
- Marketing Start
- 10/10/2017
Recall History
Crown Laboratories
Subpotent Drug: Out of specification for assay at the 9-month interval for Nystatin Cream, USP.
Crown Laboratories
Subpotent Drug: Out of specification for assay at the 9-month interval for Nystatin Cream, USP.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Nystatin cream is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species. This cream is not indicated for systemic, oral, intravaginal or ophthalmic use.
Dosage & Administration
DOSAGE AND ADMINISTRATION Adults and Pediatric Patients (Neonates and Older) Apply liberally to affected areas twice daily or as indicated until healing is complete.
Contraindications
CONTRAINDICATIONS Nystatin cream 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 cream 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 .) To report SUSPECTED ADVERSE REACTIONS, contact Crown Laboratories, Inc. at 1-423-926-4413 or FDA at 1-800-FDA-1088 or https://www.fda.gov/Safety/MedWatch/
Frequently Asked Questions
What is Nystatin Cream used for?
Nystatin Cream contains Nystatin Cream. It is a cream taken topical. Consult your doctor for specific uses.
Is Nystatin Cream a controlled substance?
Nystatin Cream is not classified as a controlled substance by the DEA.
What is the generic name for Nystatin Cream?
The generic name for Nystatin Cream is Nystatin Cream. There are 3 other brand versions of Nystatin Cream.
What is the NDC code for Nystatin Cream 100000 [USP'U]/g?
The NDC (National Drug Code) for Nystatin Cream 100000 [USP'U]/g is 0316-0221, listed by Crown Laboratories.