Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Nystatin and triamcinolone acetonide cream USP supplied in 15 gram, 30 gram and 60 gram tubes. 15 gram Tube NDC 33342-482-15 (1 tube per carton) 30 gram Tube NDC 33342-482-30 (1 tube per carton) 60 gram Tube NDC 33342-482-60 (1 tube per carton) 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: Macleods Pharma USA, Inc. Princeton, NJ 08540 Manufacturer by: Macleods Pharmaceuticals Limited At Oxalis Labs Baddi, Himachal Pradesh, INDIA Rev. 09/2023; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Nystatin and Triamcinolone Acetonide Cream USP, 100,000 units/gram and 1 mg/gram Pack Count: 15 gm Tube NDC: 33342-482-15 Nystatin and Triamcinolone Acetonide Cream USP, 100,000 units/gram and 1 mg/gram Pack Count: 15 gm Carton NDC: 33342-482-15 Nystatin and Triamcinolone Acetonide Cream USP, 100,000 units/gram and 1 mg/gram Pack Count: 30 gm Tube NDC: 33342-482-30 Nystatin and Triamcinolone Acetonide Cream USP, 100,000 units/gram and 1 mg/gram Pack Count: 30 gm Carton NDC: 33342-482-30 Nystatin and Triamcinolone Acetonide Cream USP, 100,000 units/gram and 1 mg/gram Pack Count: 60 gm Tube NDC: 33342-482-60 Nystatin and Triamcinolone Acetonide Cream USP, 100,000 units/gram and 1 mg/gram Pack Count: 60 gm Carton NDC: 33342-482-60 15-gm-tube 15-gm-carton 30-gm-tube 30-gm-carton 60-gm-tube 60-gm-carton
- HOW SUPPLIED Nystatin and triamcinolone acetonide cream USP supplied in 15 gram, 30 gram and 60 gram tubes. 15 gram Tube NDC 33342-482-15 (1 tube per carton) 30 gram Tube NDC 33342-482-30 (1 tube per carton) 60 gram Tube NDC 33342-482-60 (1 tube per carton) 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: Macleods Pharma USA, Inc. Princeton, NJ 08540 Manufacturer by: Macleods Pharmaceuticals Limited At Oxalis Labs Baddi, Himachal Pradesh, INDIA Rev. 09/2023
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Nystatin and Triamcinolone Acetonide Cream USP, 100,000 units/gram and 1 mg/gram Pack Count: 15 gm Tube NDC: 33342-482-15 Nystatin and Triamcinolone Acetonide Cream USP, 100,000 units/gram and 1 mg/gram Pack Count: 15 gm Carton NDC: 33342-482-15 Nystatin and Triamcinolone Acetonide Cream USP, 100,000 units/gram and 1 mg/gram Pack Count: 30 gm Tube NDC: 33342-482-30 Nystatin and Triamcinolone Acetonide Cream USP, 100,000 units/gram and 1 mg/gram Pack Count: 30 gm Carton NDC: 33342-482-30 Nystatin and Triamcinolone Acetonide Cream USP, 100,000 units/gram and 1 mg/gram Pack Count: 60 gm Tube NDC: 33342-482-60 Nystatin and Triamcinolone Acetonide Cream USP, 100,000 units/gram and 1 mg/gram Pack Count: 60 gm Carton NDC: 33342-482-60 15-gm-tube 15-gm-carton 30-gm-tube 30-gm-carton 60-gm-tube 60-gm-carton
Overview
Nystatin and triamcinolone acetonide cream, 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, Freely soluble in dimethylformamide and in dimethyl sulfoxide; very slightly soluble in methanol; practically insoluble or insoluble in water, in alcohol, in n-propyl alcohol, in n-butyl alcohol, in chloroform and in ether. Structural formula: C 47 H 75 NO 17 MW= 926.13 Triamcinolone acetonide, USP is designated chemically as 9-fluoro-11β, 16α, 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, Sparingly soluble in dehydrated alcohol, in chloroform and in methanol, Practically insoluble in water. Structural formula: C 24 H 31 FO 6 MW= 434.50 Nystatin and triamcinolone acetonide cream, USP is a soft, smooth, light yellow to buff colored cream. Each gram provides 100,000 USP Nystatin units and 1 mg Triamcinolone Acetonide USP in a cream base with aluminium hydroxide, ceteareth 15, glyceryl monostearate, methyl paraben, non-crystallizing sorbitol solution, polysorbate 60, polyethylene glycol 400 monostearate, propylene glycol, propyl paraben, simethicone emulsion, sorbic acid, titanium dioxide white petrolatum, purified water. nystatin structure triam structure
Indications & Usage
Nystatin and triamcinolone acetonide cream, 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
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
This preparations is 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.
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