Nyamyc NYSTATIN UPSHER-SMITH LABORATORIES, LLC FDA Approved 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
FunFoxMeds bottle
Substance Nystatin
Route
TOPICAL
Applications
ANDA065183

Drug Facts

Composition & Profile

Strengths
100000 unit 15 g 30 g 60 g
Treats Conditions
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

Identifiers & Packaging

Container Type BOTTLE
UPC
0308320465159
UNII
BDF1O1C72E
Packaging

HOW SUPPLIED Nyamyc® (Nystatin Topical Powder, USP) 100,000 units nystatin per gram is available as follow: Bottles of 15 g (NDC 0832-0465-15) Bottles of 30 g (NDC 0832-0465-30) Bottles of 60 g (NDC 0832-0465-60) 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. Keep out of reach of children. Nyamyc is a registered trademark of Upsher-Smith Laboratories, LLC.; PRINCIPAL DISPLAY PANEL - 15 gram Bottle Carton NDC 0832-0465-15 Nyamyc ® Nystatin Topical Powder, USP 100,000 USP units per gram FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC USE. NET WT. 15 grams Rx only UPSHER-SMITH label

Package Descriptions
  • HOW SUPPLIED Nyamyc® (Nystatin Topical Powder, USP) 100,000 units nystatin per gram is available as follow: Bottles of 15 g (NDC 0832-0465-15) Bottles of 30 g (NDC 0832-0465-30) Bottles of 60 g (NDC 0832-0465-60) 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. Keep out of reach of children. Nyamyc is a registered trademark of Upsher-Smith Laboratories, LLC.
  • PRINCIPAL DISPLAY PANEL - 15 gram Bottle Carton NDC 0832-0465-15 Nyamyc ® Nystatin Topical Powder, USP 100,000 USP units per gram FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC USE. NET WT. 15 grams Rx only UPSHER-SMITH label

Overview

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 & 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.

Dosage & Administration

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.

Warnings & Precautions
No warnings available yet.
Contraindications

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

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 ].

Storage & Handling

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. Keep out of reach of children. Nyamyc is a registered trademark of Upsher-Smith Laboratories, LLC.


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