Nystatin powder

This medication is used to treat fungal infections of the mouth or intestines. Nystatin is an antifungal that works by stopping the growth of fungus.Nystatin powder for suspension should not be used to treat fungal infections of the blood.

Unless otherwise instructed by your doctor, use this medication as follows: Add the prescribed amount (usually 1/8 teaspoonful) of dry powder to a half glass (4 ounces or about 120 milliliters) of water. Stir well and divide the mixture into a number of smaller portions as your doctor directs. Use all portions for each treatment. Each treatment must be used immediately after mixing. Do not mix and store for later use.Place one portion of the liquid in the mouth. Swish it around the mouth and gargle if so directed. Keep the liquid in your mouth for as long as possible, then swallow or spit out as directed. Use the other portions as your doctor directs. Ask your doctor or pharmacist for more details. Avoid eating for 5-10 minutes after using this medication.This medication is most often used four times a day or as directed by your doctor. It may take from several days to several months to complete treatment. Use this medication regularly in order to get the most benefit from it. Remember to use it at the same times each day. Dosage is based on your medical condition and response to therapy.Continue to use this medication until the full prescribed amount is finished, even if symptoms disappear after a few days. Stopping the medication too early may allow the infection to continue, resulting in a return of the infection.Inform your doctor if your condition persists after several days of treatment or worsens at any time.

Mouth irritation, diarrhea, nausea, vomiting, or stomach upset may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Do not share this medication with others.This medication has been prescribed for your current condition only. Do not use it later for another infection unless told to do so by your doctor. A different medication may be necessary in those cases.

Pharmacokinetics

Nystatin is not absorbed from intact skin or mucous membrane.

Microbiology

Fluocinolone Acetonide Topical Solution USP, 0.01% is generally applied to the affected area as a thin film from two to four times daily depending on the severity of the condition.  In hairy sites, the hair should be parted to allow direct contact with the lesion.

Occlusive dressing may be used for the management of psoriasis or recalcitrant conditions.

If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.

Very moist lesions are best treated with the topical dusting powder.

Adults and Pediatric Patients (Neonates and Older)

Apply to candidal lesions two or three times daily until healing is complete. For fungal infection of the feet caused by Candida species, the powder should be dusted on the feet, as well as, in all foot wear.

Nystatin topical powder, USP is supplied as 100,000 units nystatin per gram in plastic squeeze bottles:

15 g (NDC 43386-530-01)

30 g (NDC 43386-530-02)

56.7 g (NDC 43386-530-05)

60 g (NDC 43386-530-06)

STORAGE

Store at 20°C to 25°C (68°F to 77°F)[see USP Controlled Room Temperature]; avoid excessive heat (40°C/104°F).

Keep tightly closed.

Manufactured by:

Novel Laboratories, Inc.

Somerset, NJ 08873 USA

Distributed by:

Lupin Pharmaceuticals, Inc.

Somerset, NJ 08873 USA

Rev. 06/2017

15 g

NDC 43386-530-01

30 g

NDC 43386-530-02

60 g

NDC 43386-530-06

NYSTATIN  Nystatin Powder

Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:43386-530 Route of Administration TOPICAL DEA Schedule

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

Inactive Ingredients Ingredient Name Strength TALC

Product Characteristics Color YELLOW (greenish yellow) Score no score Shape Size Flavor Imprint Code Contains

Packaging # Item Code Package Description 1 NDC:43386-530-01 15 g in 1 BOTTLE, PLASTIC 2 NDC:43386-530-02 30 g in 1 BOTTLE, PLASTIC 3 NDC:43386-530-05 56.7 g in 1 BOTTLE, PLASTIC 4 NDC:43386-530-06 60 g in 1 BOTTLE, PLASTIC

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA065138 09/26/2014

Labeler - Lupin Pharmaceuticals,Inc. (089153071)

Registrant - Novel Laboratories, Inc. (793518643)

Establishment
Name	Address	ID/FEI	Operations
Novel Laboratories, Inc.		793518643	ANALYSIS(43386-530), MANUFACTURE(43386-530), PACK(43386-530)

Revised: 09/2017   Lupin Pharmaceuticals,Inc.