The following Structured Product Label (SPL) was submitted to the FDA by Image Amazon Llc for the product Deconimo Reconstitution (NDC 85380-1001). 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 warnings, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Laboratory & Research Use Only.
Not for Human or Animal Use.
Non-Medical.
Non-Injectable.
Not intended for diagnostic, therapeutic, or clinical applications.
Use only in laboratory or research settings.
Keep out of reach of children.
Product Description
DECÓNIMO Reconstitution Solution is formulated for laboratory and research applications requiring a preserved aqueous solution for the reconstitution of research materials.
This product is intended solely for laboratory and research purposes.
Ingredients
Deionized Water
Benzyl Alcohol 0.9%
Storage
Store at controlled room temperature.
Keep container tightly closed when not in use.
Protect from contamination.
Labeler 1 (Mmexport1769616540348)
Labeler 2 (Mmexport1769753835983)
Labeler 3 (Mmexport1769753845268)
Labeler 4 (Mmexport1769616520339)
Warnings
Laboratory & Research Use Only.
Not for Human or Animal Use.
Non-Medical.
Non-Injectable.
Not intended for diagnostic, therapeutic, or clinical applications.
Use only in laboratory or research settings.
Keep out of reach of children.
Directions
Use aseptic laboratory techniques when handling.
Use only as a laboratory reagent for research purposes.
Discard according to laboratory procedures.
Manufacturer
Manufactured for:
DECÓNIMO
(Manufacturer/distributor details are not fully visible in the images.)
Package Information
Net Contents:
30 mL
Package Type:
Glass vial with closure.
Bottom/Back Panel
Lot Number: __________
Manufacture Date (MFG): __________
Expiry Date (EXP): __________
Complete Ingredient Declaration
Ingredient Concentration
Deionized Water q.s.
Benzyl Alcohol 0.9%
Regulatory Statements
Laboratory & Research Use Only
Non-Medical
Non-Injectable
Not for Human or Animal Use
Not for Diagnostic Use
Not for Therapeutic Use
* Please review the disclaimer below.
