Nystatin Powder
FDA Label NDC 70771-1585

The following Structured Product Label (SPL) was submitted to the FDA by Zydus Lifesciences Limited for the product Nystatin (NDC 70771-1585). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Package Label.Principal Display Panel

NDC 70771-1585-1

Nystatin Topical Powder, USP

FOR TOPICAL USE ONLY

100,000 units per gram

Rx Only

15 GRAMS

15 Gm Label (A549e359 6277 490e 80e5 02e536e22362 01)

NDC 70771-1585-2

Nystatin Topical Powder, USP

FOR TOPICAL USE ONLY

100,000 units per gram

Rx Only

30 GRAMS

30 Gm Label (A549e359 6277 490e 80e5 02e536e22362 02)

NDC 70771-1585-3

Nystatin Topical Powder, USP

FOR TOPICAL USE ONLY

100,000 units per gram

Rx Only

60 GRAMS

60 Gm Label (A549e359 6277 490e 80e5 02e536e22362 03)

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