Nystatin Ointment [Rpk Pharmaceuticals, Inc.] -

NYSTATIN OINTMENT [RPK PHARMACEUTICALS, INC.]
PDF | XML

NDC	53002-8220-1
Set ID	0ee89f89-e90d-4706-9fa5-a61b5fde4470
Category	HUMAN PRESCRIPTION DRUG LABEL
Packager	RPK Pharmaceuticals, Inc.
Generic Name
Product Class
Product Number
Application Number	ANDA062472

View All Sections

SPL UNCLASSIFIED SECTION

For Dermatologic Use Only

Not For Ophthalmic Use

Rx Only
DESCRIPTION

Nystatin Ointment USP for topical use only, contains 100,000 USP Nystatin units per gram, in an ointment base of light mineral oil and white petrolatum. The structural formula is as follows:

Molecular Weight 926.13

Molecular Formula C47H75NO17
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 Ointment USP 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

Nystatin Ointment USP is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida [Monilia]albicans and other Candida species.
CONTRAINDICATIONS

Nystatin Ointment USP is contraindicated in patients with a history of hypersensitivity to any of its components.
PRECAUTIONS

Should a reaction of hypersensitivity occur, the drug should be immediately withdrawn and appropriate measures taken.

This preparation is not for ophthalmic use.
ADVERSE REACTIONS

Nystatin Ointment USP 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.
DOSAGE AND ADMINISTRATION

Nystatin Ointment USP 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.
HOW SUPPLIED

Product: 53002-8220

NDC: 53002-8220-1 15 g in a TUBE
Nystatin Topical Ointment 100,000 U/GM

INGREDIENTS AND APPEARANCE

NYSTATIN
nystatin ointment

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:53002-8220(NDC:45802-048)
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
NYSTATIN (UNII: BDF1O1C72E) (NYSTATIN - UNII:BDF1O1C72E)	NYSTATIN	100000 [USP'U] in 1 g

Ingredient Name	Strength
Inactive Ingredients
LIGHT MINERAL OIL (UNII: N6K5787QVP)
PETROLATUM (UNII: 4T6H12BN9U)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:53002-8220-1	15 g in 1 TUBE; Type 0: Not a Combination Product	10/01/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA062472	09/15/2006

Labeler - RPK Pharmaceuticals, Inc. (147096275)

Name	Address	ID/FEI	Business Operations
Establishment
RPK Pharmaceuticals, Inc.		147096275	RELABEL(53002-8220) , REPACK(53002-8220)

View All Sections

Medic

NYSTATIN OINTMENT [RPK PHARMACEUTICALS, INC.]

Related Drugs