Nystatin Cream (Page 2 of 2)

15 gram carton

NDC 0316-0221-15

Rx Only

Nystatin Cream, USP

100,000 units per gram

WARNING: Keep out of reach of children.

For external use only.

Not for ophthalmic use.

15 grams

Each gram contains: 100,000 USP Nystatin Units in an aqueous, cream base consisting of purified water, emulsifying wax, mineral oil, propylene glycol, sorbitol solution, cetyl palmitate, sorbic acid and potassium sorbate.

Directions for puncturing tube seal: Remove cap. Turn cap upside down and place puncture tip onto tube seal. Push cap down until seal is punctured. Screw cap back on to close.

IMPORTANT: Do not use if seal has been punctured or is not visible.

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Avoid freezing.

Usual Dosage: Apply liberally to affected area twice daily. See package insert for full prescribing information.

See end of carton for Lot Number and Expiration Date.

Manufactured and Distributed by:

Crown Laboratories, Inc., Johnson City, TN 37604

P9515.00

NYSTATIN CREAM nystatin cream cream

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0316-0221 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NYSTATIN (NYSTATIN) NYSTATIN 100000 [USP’U] in 1 g

Inactive Ingredients Ingredient Name Strength MINERAL OIL SORBIC ACID PROPYLENE GLYCOL WATER SORBITOL CETYL PALMITATE POTASSIUM SORBATE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0316-0221-15 1 TUBE in 1 CARTON contains a TUBE 1 15 g in 1 TUBE This package is contained within the CARTON (0316-0221-15) 2 NDC:0316-0221-30 1 TUBE in 1 CARTON contains a TUBE 2 30 g in 1 TUBE This package is contained within the CARTON (0316-0221-30)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA207733 10/10/2017

Labeler — Crown Laboratories (079035945)

Establishment
Name	Address	ID/FEI	Operations
Crown Laboratories		079035945	manufacture (0316-0221)

Revised: 02/2023 Crown Laboratories