Sterile Water Injection, Solution
Product Images NDC 64253-020

16 FDA label images from Medefil, Inc. · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 16 technical images submitted to the FDA as part of the official labeling for Sterile Water (NDC 64253-020). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Medefil, Inc., these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.

FDA Label Image

Dispenser Box P3043 Rev. 000

Dispenser Box P3043 Rev. 000
Carton packaging label for Sterile Water for Injection, USP by Medefil, Inc., showing 10 x 10 mL individually pouched single-dose prefilled syringes. The label warns that the solution is not isotonic and hemolytic and intended for drug diluent use only. Product NDC 64253-020-91 is displayed with additional storage and usage information.*
FDA Label Image

L4294 Rev001 1ml

L4294 Rev001  1ml
Label for Sterile Water for Injection, USP, 1 mL single-dose pre-filled syringe by Medefil, Inc. The label includes warnings that the solution is not isotonic and is hemolytic. It is for drug diluent use only with no antimicrobial or added substances. Storage and usage instructions are provided along with a barcode and lot/expiration date box.*
FDA Label Image

L4295 Rev001 3 mL

L4295 Rev001 3 mL
Label for Sterile Water for Injection, USP in a 3 mL single-dose pre-filled syringe by Medefil, Inc. The label highlights that this sterile water is for drug diluent use only and is not isotonic or hemolytic. It includes usage warnings, storage instructions, and a barcode, with the product NDC 64253-020-23 indicated.*
FDA Label Image

L4296 Rev001 2.5 mL

L4296 Rev001 2.5 mL
Label for Sterile Water for Injection, USP in a 2.5 mL single-dose pre-filled syringe by Medefil, Inc. It is for drug diluent use only, not isotonic and hemolytic. The label includes warnings, usage instructions, volume graduations up to 2.5 mL, barcode, lot/expiration date box, and storage conditions.*
FDA Label Image

L4297 Rev001 5 mL

L4297 Rev001 5 mL
Label of Medefil, Inc. Sterile Water for Injection, USP, 5 mL single-dose pre-filled syringe. The label includes measurement markings from 1 mL to 5 mL and a warning in red indicating the product is not isotonic and hemolytic. It states the solution is for drug diluent use only and not to be given intravenously unless rendered nearly isotonic. The label notes no antimicrobial or other added substances, sterile and nonpyrogenic with pH 5.0 to 7.0. The label includes storage instructions and a barcode.*
FDA Label Image

L4298 Rev001 10 mL

L4298 Rev001 10 mL
Label for Sterile Water for Injection, USP in a 10 mL single-dose pre-filled syringe by Medefil, Inc. The label states it is for drug diluent use only, warns against intravenous use unless nearly isotonic, and notes no antimicrobial or added substances. It includes a volume scale from 1 mL to approximately 10 mL and a barcode with NDC 64253-020.*
FDA Label Image

L4299 Rev000 1 mL

L4299 Rev000 1 mL
Label for Sterile Water for Injection, USP by Medefil, Inc., NDC 64253-020-21. It contains 60 single-dose pre-filled syringes of 1 mL each. The label warns that the solution is not isotonic and hemolytic, for drug diluent use only, and should not be given intravenously unless rendered nearly isotonic. It is sterile, nonpyrogenic, and contains no preservatives or antimicrobial agents. Recommended storage is controlled room temperature (20 to 25°C).*
FDA Label Image

L4300 Rev000 2.5 mL

L4300 Rev000 2.5 mL
This label text panel for Sterile Water for Injection, USP from Medefil, Inc. highlights warnings that the solution is not isotonic and hemolytic, and should only be administered intravenously if rendered nearly isotonic. It is intended for drug diluent use only, contains no antimicrobial or preservatives, and should be discarded if discolored or cloudy. Storage instructions and usage precautions are included along with symbols indicating single use, latex-free, and sterility.*
FDA Label Image

L4301 Rev000 3 mL

L4301 Rev000 3 mL
Drug facts panel for Sterile Water for Injection, USP, labeled as a drug diluent for single-dose use only. Contains warnings that the solution is not isotonic or hemolytic, and should not be given intravenously unless nearly isotonic. It has no antimicrobial or added substances, with instructions to discard if discolored or containing precipitate. Storage and usage instructions are included along with manufacturer information for Medefil, Inc.*
FDA Label Image

L4302 Rev000 5 mL

L4302 Rev000 5 mL
A drug label panel for Sterile Water for Injection, USP, provided in 5 mL single-dose pre-filled syringes, 60 per package. The label emphasizes warnings about not being isotonic or hemolytic, advises against intravenous use unless rendered nearly isotonic, and indicates usage as a drug diluent only. It includes storage instructions, safety symbols, and manufacturer information from Medefil, Inc., Glendale Heights, IL.*
FDA Label Image

L4303 Rev000 10 mL

L4303 Rev000 10 mL
Drug information panel for Sterile Water for Injection, USP by Medefil, Inc. It states 60 x 10 mL single-dose pre-filled syringes. Warnings include it is not isotonic and hemolytic. The product is for drug diluent use only and should not be given intravenously unless rendered nearly isotonic. It contains no antimicrobial or other added substances and should be stored at 20 to 25°C (68 to 77°F), protected from freezing. The solution is sterile, nonpyrogenic, single use, and contains no preservatives or natural rubber latex. Usual dosage refers to the insert.*
FDA Label Image

L4340 Rev000 5 mL

L4340 Rev000 5 mL
Label for Sterile Water for Injection, USP in a 5 mL single-dose pre-filled syringe, NDC 64253-020-25, by Medefil, Inc. The label includes measurement markings from 1 mL to 5 mL, a warning indicating the solution is not isotonic and hemolytic, usage instructions for drug diluent use only, and storage conditions advising to protect from freezing and store at 20 to 25°C. The label states no antimicrobial or other added substances are included and provides a barcode along with lot and expiration date fields.*
FDA Label Image

L4341 Rev000 5 mL

L4341 Rev000 5 mL
Drug facts text panel for Sterile Water for Injection, USP, labeled for use as a drug diluent only. It includes warnings that the solution is not isotonic and hemolytic, and should not be given intravenously unless made nearly isotonic. The label states the solution is sterile, nonpyrogenic with pH 5.0 to 7.0, contains no antimicrobial or added substances, and is for single use. Storage instructions and manufacturer details for Medefil, Inc. are provided, along with various symbols including 'not made with natural rubber latex' and 'no preservatives.'*
FDA Label Image

Pi L4309 Rev. 002 Page 1

Pi L4309 Rev. 002 Page 1
Text panel for Sterile Water for Injection, USP in a plastic syringe, provided by Medefil, Inc. It includes sections on description, clinical pharmacology, indications and usage, contraindications, warnings, precautions, and drug interactions, focused on the preparation's use for dilution or dissolving drugs for injection with attention to solution concentration, administration, and safety considerations.*
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Pi L4309 Rev. 002 Page 2

Pi L4309 Rev. 002 Page 2
This is a printed text panel from the Sterile Water for Injection product by Medefil, Inc. It includes warnings about adverse reactions, overdose, and dosage and administration guidelines. The panel also lists various NDC numbers for different sizes and configurations of the Sterile Water for Injection product, including single-dose pre-filled syringes and bottles, in 1 mL, 2.5 mL, 5 mL, and 10 mL volumes. Storage instructions to store between 20 to 25°C and protect from freezing are included.*
FDA Label Image

Pouch Label Rev. 003 10 mL

Pouch Label Rev. 003   10 mL
Packaging label for Sterile Water for Injection, USP, 10 mL single-dose pre-filled syringe by Medefil, Inc. The label includes warnings that the solution is not isotonic and hemolytic, for drug diluent use only, and instructions to discard any unused portion. The label also notes the product is sterile, nonpyrogenic, and provides storage temperature guidelines. The back side displays aseptic technique instructions with step-by-step illustrations for preparing the syringe.*

* About these descriptions: Image descriptions on this page are generated by automated AI analysis of the product label images from the manufacturer's FDA label submission (SPL). They are provided for reference only and may contain errors or omissions. Always rely on the printed label itself and the official FDA labeling, and consult a pharmacist or healthcare professional with any questions about this product.