Label: NYSTATIN ointment
- NDC Code(s): 0168-0007-15, 0168-0007-30
- Packager: E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Updated November 1, 2018
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- SPL UNCLASSIFIED SECTION
Nystatin is an antifungal antibiotic which is both fungistatic and fungicidal in vitro against a wide variety of yeasts and yeast-like fungi. It probably acts by binding to sterols in the cell membrane of the fungus with a resultant change in membrane permeability allowing leakage of intracellular components. Nystatin is a polyene antibiotic that is obtained from Streptomyces noursei, and is the first well tolerated antifungal antibiotic of dependable efficacy for the treatment of cutaneous, oral and intestinal infections caused by Candida [Monilia]albicans and other Candida species. It exhibits no appreciable activity against bacteria.
Nystatin provides specific therapy for all localized forms of candidiasis. Symptomatic relief is rapid, often occurring within 24 to 72 hours after the initiation of treatment. Cure is effected both clinically and mycologically in most cases of localized candidiasis.
- INDICATIONS AND USAGE
- ADVERSE REACTIONS
DOSAGE AND ADMINISTRATION
Nystatin Ointment should be applied liberally to affected areas twice a day or as indicated until healing is complete. Nystatin cream is usually preferred to nystatin ointment in candidiasis involving intertriginous areas; very moist lesions, however, are best treated with nystatin topical powder.
This preparation does not stain skin or mucous membranes and provides a simple, convenient means of treatment.
Nystatin Ointment (100,000 USP Nystatin Units per gram) is a yellow ointment available as follows:
NDC 0168-0007-15 15 gram tube
NDC 0168-0007-30 30 gram tube
Store at controlled room temperature 15°- 30°C (59°-86°F).
E. FOUGERA & CO.
A division of Fougera Pharmaceuticals Inc.
Melville, New York 11747
- PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 15 G CONTAINER
- PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 15 G CARTON
INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0168-0007 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength nystatin (UNII: BDF1O1C72E) (nystatin - UNII:BDF1O1C72E) nystatin 100000 [USP'U] in 1 g Inactive Ingredients Ingredient Name Strength HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) Mineral Oil (UNII: T5L8T28FGP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0168-0007-15 15 g in 1 TUBE; Type 0: Not a Combination Product 09/23/1982 2 NDC:0168-0007-30 30 g in 1 TUBE; Type 0: Not a Combination Product 09/23/1982 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA062124 09/23/1982 Labeler - E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. (043838424)