The following Structured Product Label (SPL) was submitted to the FDA by Vin Trading Llc for the product Sodium Chloride (NDC 85036-100). 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 components, user safety warnings, storage and handling, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
1000ml
SODIUM CHLORIDE 0.9%
Isotonic Solution for Infusion UPS
Sterile, nonpyrogenic, Single unit container. Discard unused portion.
Recommended storage. Store at 20-25*C (66-77*F)
Avoid excessive heat. Protect from freezing
Composition:
Each 100ml contains...0.9% (m/v-w/v)
Water for Injection..........................q.s.
Electrolytes (mEq/liter)
Na+ 150 CI 150
Caution:
FOR INTRAVENOUS INFUSION ONLY
Not to be used if container is found leaking or solution is not clear.
Solution containing visible solid particles should not be used.
Any portion of the contents remaining should be discarded.
For use under medical supervision.
Sterile, nonpyrogenic, Single unit container. Discard unused portion.
Recommended storage. Store at 20-25*C (66-77*F)
Avoid excessive heat. Protect from freezing
Carton.jpg (Carton)
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