Zinc Sulfate Injection, Solution - FDA Label NDC 70771-1849

The following Structured Product Label (SPL) was submitted to the FDA by Zydus Lifesciences Limited for the product Zinc Sulfate (NDC 70771-1849). 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 70771-1848-1

Zinc Sulfate Injection, USP

10 mg/10 mL (1 mg/mL) of zinc

For intravenous use after dilution and admixing

PHARMACY BULK PACKAGE-Not for Direct Infusion

STERILE

10 mL

Rx only

Vial Label (4a7d1f4a 5a38 48a6 9eae 0616d6c77ecd 01)

NDC 70771-1848-7

Zinc Sulfate Injection, USP

10 mg/10 mL (1 mg/mL) of zinc

For intravenous use after dilution and admixing

PHARMACY BULK PACKAGE-Not for Direct Infusion

25 x 10 mL Vials

STERILE

10 mL

Rx only

Carton Label (4a7d1f4a 5a38 48a6 9eae 0616d6c77ecd 02)

NDC 70771-1849-1

Zinc Sulfate Injection, USP

30 mg/10 mL (3 mg/mL) of zinc

For intravenous use after dilution and admixing

PHARMACY BULK PACKAGE-Not for Direct Infusion

STERILE

10 mL

Rx only

Vial Label (4a7d1f4a 5a38 48a6 9eae 0616d6c77ecd 03)

NDC 70771-1849-7

Zinc Sulfate Injection, USP

30 mg/10 mL (3 mg/mL) of zinc

For intravenous use after dilution and admixing

PHARMACY BULK PACKAGE-Not for Direct Infusion

25 X 10 mL Vials

STERILE

10 mL

Rx only

Carton Label (4a7d1f4a 5a38 48a6 9eae 0616d6c77ecd 04)

NDC 70771-1850-1

Zinc Sulfate Injection, USP

25 mg/5 mL (5 mg/mL) of zinc

For intravenous use after dilution and admixing

PHARMACY BULK PACKAGE-Not for Direct Infusion

STERILE

5 mL

Rx only

Vial Label (4a7d1f4a 5a38 48a6 9eae 0616d6c77ecd 05)

NDC 70771-1850-7

Zinc Sulfate Injection, USP

25 mg/5 mL (5 mg/mL) of zinc

For intravenous use after dilution and admixing

PHARMACY BULK PACKAGE-Not for Direct Infusion

25 X 5 mL Vials

STERILE

5 mL

Rx only

Carton Label (4a7d1f4a 5a38 48a6 9eae 0616d6c77ecd 06)

Zinc Sulfate Injection, Solution
FDA Label NDC 70771-1849

Structured Product Label

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Package Label.Principal Display Panel