Benztropine Mesylate
FDA Label NDC 10858-011

The following Structured Product Label (SPL) was submitted to the FDA by Wintac Limited for the product Benztropine Mesylate (NDC 10858-011). 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-10858-011-01

Benztropine Mesylate

Injection, USP

2 mg/2 mL (1 mg/mL)

For Intravenous or Intramuscular use

2 mL Single Dose Vial

Wintac Limited

Rx only

Vial (67ef7746 45bc 466b A7b7 353c8b8702c1 01)

vial

NDC 10858-011-05

Benztropine Mesylate

Injection, USP

2 mg/2 mL (1 mg/mL)

FOR INTRAVENOUS OR INTRAMUSCULAR USE

Wintac Limited

5 X 2 mL Single Dose Vials

Rx only

Carton (67ef7746 45bc 466b A7b7 353c8b8702c1 02)

carton

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