Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Nystatin and triamcinolone acetonide cream, USP is light yellow to buff color cream supplied as follows: 15 g tube (NDC 62332-606-15) 30 g tube (NDC 62332-606-30) 60 g tube (NDC 62332-606-60). STORAGE Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Avoid freezing. Manufactured for: Alembic Pharmaceuticals, Inc. Bedminster, NJ 07921, USA Manufactured by; Alembic Pharmaceuticals Limited (Derma Division), Karakhadi, Vadodara 391450, India. Mfg. License No.: G/28/1626 Revised: 12/2023; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 62332-606- 15 15 g Tube Nystatin and Triamcinolone Acetonide Cream USP FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. Rx only Keep out of reach of children. Alembic Pharmaceuticals, Inc. NDC 62332-606- 15 15 g Carton Nystatin and Triamcinolone Acetonide Cream USP FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. Rx only Keep out of reach of children. Alembic Pharmaceuticals, Inc. 15 g tube 15 g carton
- HOW SUPPLIED Nystatin and triamcinolone acetonide cream, USP is light yellow to buff color cream supplied as follows: 15 g tube (NDC 62332-606-15) 30 g tube (NDC 62332-606-30) 60 g tube (NDC 62332-606-60). STORAGE Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Avoid freezing. Manufactured for: Alembic Pharmaceuticals, Inc. Bedminster, NJ 07921, USA Manufactured by; Alembic Pharmaceuticals Limited (Derma Division), Karakhadi, Vadodara 391450, India. Mfg. License No.: G/28/1626 Revised: 12/2023
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 62332-606- 15 15 g Tube Nystatin and Triamcinolone Acetonide Cream USP FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. Rx only Keep out of reach of children. Alembic Pharmaceuticals, Inc. NDC 62332-606- 15 15 g Carton Nystatin and Triamcinolone Acetonide Cream USP FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. Rx only Keep out of reach of children. Alembic Pharmaceuticals, Inc. 15 g tube 15 g carton
Overview
Nystatin and triamcinolone acetonide cream, USP for dermatologic use contain the antifungal agent nystatin and the synthetic corticosteroid triamcinolone acetonide. Nystatin is a polyene antimycotic obtained from Streptomyces noursei . It is a yellow to light tan powder with a cereal-like odor, practically insoluble or insoluble in water and in alcohol. Structural formula: C 47 H 75 NO 17 MW = 926.23 Triamcinolone acetonide is designated chemically as pregna-1,4-diene-3,20-dione, 9-fluoro-11,21-dihydroxy-16,17- [(1-methylethylidene)bis(oxy)]-, (11β,16α)-9-fluoro-11b,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 very soluble in alcohol. Structural formula: C 24 H 31 FO 6 MW = 434.51 Nystatin and triamcinolone acetonide cream, USP is a soft, smooth cream having a light yellow to buff color. Each gram contains 100,000 USP nystatin units and 1 mg triamcinolone acetonide USP in a cream base of polysorbate-60, aluminum hydroxide gel, titanium dioxide, mono-and di-glycerides, polyoxyl 8 stearate, simethicone emulsion, sorbic acid, propylene glycol, white petrolatum, polyoxyl 20- cetostearyl ether, methylparaben, propylparaben, noncrystallizing sorbitol solution and purified water. Image Image
Dosage & Administration
Nystatin and triamcinolone acetonide cream is usually applied to the affected areas twice daily in the morning and evening by gently and thoroughly massaging the preparation into the skin. The cream should be discontinued if symptoms persist after 25 days of therapy (see PRECAUTIONS, Laboratory Tests ). Nystatin and triamcinolone acetonide cream 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 nonsensitizing 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. To report SUSPECTED ADVERSE REACTIONS, contact Alembic Pharmaceuticals, Inc. at 1-866-210-9797 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
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