Other
For drug diluent use only. Sterile, nonpyrogenic.
Use only if clear and seal is intact and undamaged.
Cleanse stopper with antiseptic.
Bacteriostatic Injection
FDA Label NDC 88095-101
13 label sections · Submitted to the FDA by Elementco, S.a.p.i. De C.v. · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Elementco, S.a.p.i. De C.v. for the product Bacteriostatic (NDC 88095-101). 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 other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Benzyl Alcohol (0.9%)
Otc - Purpose
For drug diluent use only.
Indications & Usage
For drug diluent use only.
Sterile, nonpyrogenic.
Use only if clear and seal is intact and undamaged.
Warnings
Use only if clear and seal is intact and undamaged.
Otc - Do Not Use
NOT FOR USE IN NEONATES
Otc - When Using
Use only if clear and seal is intact and undamaged.
Cleanse stopper with antiseptic.
Otc - Stop Use
If you do not use the entire contents, discart the excess.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
For drug diluent use only.
Sterile, nonpyrogenic.
Storage And Handling
Store at room temperature.
Inactive Ingredient
Purified Water USP.
Package Label.Principal Display Panel
88095-101-01
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