Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Nystatin and Triamcinolone Acetonide Ointment, USP is supplied in 15g (NDC 21922-031-04), 30g (NDC 21922-031-05) and 60g (NDC 21922-031-07) tubes. STORAGE Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Avoid freezing. To report SUSPECTED ADVERSE REACTIONS, contact Encube Ethicals Private Limited at 1-844-369-4671 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Rx only Manufactured by: Encube Ethicals Pvt. Ltd. Plot No. C-1, Madkaim Industrial Estate, Madkaim, Post: Mardol, Ponda, Goa - 403 404, India. Distributed by: Encube Ethicals, Inc. 200 Meredith Drive, Suite 202, Durham, NC 27713, USA Rev 01 November 2022; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 21922-031-04 Carton-15g Nystatin and Triamcinolone Acetonide Ointment USP FOR DERMATOLOGIC USE ONLY. NOT FOR OPHTHALMIC USE. Keep this and all medications out of the reach of children. NDC 21922-031-05 Carton-30g Nystatin and Triamcinolone Acetonide Ointment USP FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. Keep this and all medications out of the reach of children. NDC 21922-031-07 Carton-60g Nystatin and Triamcinolone Acetonide Ointment USP FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. Keep this and all medications out of the reach of children. 15g - carton 30g - carton 60g - carton
- HOW SUPPLIED Nystatin and Triamcinolone Acetonide Ointment, USP is supplied in 15g (NDC 21922-031-04), 30g (NDC 21922-031-05) and 60g (NDC 21922-031-07) tubes. STORAGE Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Avoid freezing. To report SUSPECTED ADVERSE REACTIONS, contact Encube Ethicals Private Limited at 1-844-369-4671 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Rx only Manufactured by: Encube Ethicals Pvt. Ltd. Plot No. C-1, Madkaim Industrial Estate, Madkaim, Post: Mardol, Ponda, Goa - 403 404, India. Distributed by: Encube Ethicals, Inc. 200 Meredith Drive, Suite 202, Durham, NC 27713, USA Rev 01 November 2022
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 21922-031-04 Carton-15g Nystatin and Triamcinolone Acetonide Ointment USP FOR DERMATOLOGIC USE ONLY. NOT FOR OPHTHALMIC USE. Keep this and all medications out of the reach of children. NDC 21922-031-05 Carton-30g Nystatin and Triamcinolone Acetonide Ointment USP FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. Keep this and all medications out of the reach of children. NDC 21922-031-07 Carton-60g Nystatin and Triamcinolone Acetonide Ointment USP FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. Keep this and all medications out of the reach of children. 15g - carton 30g - carton 60g - carton
Overview
Nystatin and Triamcinolone Acetonide Ointment, USP for dermatologic use contain the antifungal agent nystatin and the synthetic corticosteroid triamcinolone acetonide. Nystatin, USP is a polyene antimycotic obtained from Streptomyces noursei. It is a yellow to light tan powder with a cereallike odor, slightly soluble in methanol, and freely soluble in dimethylformamide, dimethyl sulfoxide, and practically insoluble in n -propyl alcohol, n -bulyl alcohol,water, alcohol, chloroform, ether. Structural formula: Triamcinolone acetonide, USP is designated chemically as 9-fluoro-11β,16a, 17, 21-tetrahydroxypregna-1, 4-diene-3, 20-dione cyclic 16, 17-acetal with acetone. The white to cream crystalline powder has a slight odor, is practically insoluble in water, and sparingly soluble in dehydrated alcohol, chloroform, and slightly soluble in methanol. Structural formula: Each gram of Nystatin and Triamcinolone Acetonide Ointment, USP provides 100,000 USP Nystatin units and 1 mg Triamcinolone Acetonide in an ointment base of mineral oil and white petrolatum. structure-nyst structure-triam
Indications & Usage
Nystatin and Triamcinolone Acetonide Ointment, USP is indicated for the treatment of cutaneous candidiasis; it has been demonstrated that the nystatin-steroid combination provides greater benefit than the nystatin component alone during the first few days of treatment.
Dosage & Administration
A thin film of Nystatin and Triamcinolone Acetonide Ointment, USP is usually applied to the affected areas twice daily in the morning and evening. The preparation should be discontinued if symptoms persist after 25 days of therapy (see PRECAUTIONS, Laboratory Tests ). Nystatin and Triamcinolone Acetonide Ointment, USP should not be used with occlusive dressings.
Warnings & Precautions
No warnings available yet.
Contraindications
These preparations are contraindicated in those patients with a history of hypersensitivity to any of their components.
Adverse Reactions
A single case (approximately one percent of patients studied) of acneiform eruption occurred with use of combined nystatin and triamcinolone acetonide in clinical studies. Nystatin is virtually nontoxic and non sensitizing and is well tolerated by all age groups, even during prolonged use. Rarely, irritation may occur. The following local adverse reactions are reported infrequently with topical corticosteroids (reactions are listed in an approximate decreasing order of occurrence): burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, perioral secondary infection, skin atrophy, striae and miliaria.
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