Label: NYSTATIN- nystatin ointment
- NDC Code(s): 42254-284-15
- Packager: Rebel Distributors Corp
- This is a repackaged label.
- Source NDC Code(s): 0168-0007
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Updated August 28, 2012
If you are a consumer or patient please visit this version.
- SPL UNCLASSIFIED SECTION
Nystatin Ointment USP, for topical use only, contains 100,000 USP Nystatin Units per gram, in a polyethylene and mineral oil base. The structural formula is as follows:
- CLINICAL PHARMACOLOGY
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.Close
- INDICATIONS AND USAGE
Nystatin Ointment is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida [Monilia]albicans and other Candida species.Close
Nystatin Ointment is contraindicated in patients with a history of hypersensitivity to any of its components.Close
Should a reaction of hypersensitivity occur the drug should be immediately withdrawn and appropriate measures taken.
This preparation is not for ophthalmic use.Close
- ADVERSE REACTIONS
Nystatin is virtually non-toxic and nonsensitizing and is well tolerated by all age groups including debilitated infants, even on prolonged administration. If irritation on topical application should occur, discontinue medication.Close
- 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.Close
- HOW SUPPLIED
Nystatin Ointment (100,000 USP Nystatin Units per gram) is a yellow ointment available as follows:
NDC 42254-284-15 15 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
REBEL DISTRIBUTORS CORP.
Thousand Oaks, CA 91320
- PRINCIPAL DISPLAY PANEL
- INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42254-284(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:42254-284-15 15 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA062124 09/23/1982 Labeler - Rebel Distributors Corp (118802834) Registrant - PSS World Medical, Inc. (101822862) Establishment Name Address ID/FEI Business Operations PSS World Medical, Inc. 791528623 REPACK(42254-284) Establishment Name Address ID/FEI Business Operations STAT RX USA LLC 786036330 REPACK(42254-284) Establishment Name Address ID/FEI Business Operations Dispensing Solutions, Inc. 066070785 RELABEL(42254-284) , REPACK(42254-284) Establishment Name Address ID/FEI Business Operations SCRIPT PAK 964420108 RELABEL(42254-284) , REPACK(42254-284) Establishment Name Address ID/FEI Business Operations Keltman Pharmaceuticals, Inc. 362861077 REPACK(42254-284) Establishment Name Address ID/FEI Business Operations Rebel Distirbutors Corp. 118802834 RELABEL(42254-284) , REPACK(42254-284)