FDA.reportPublic FDA data

STERILE WATER FOR INJECTION

Manufacturer
Vedco
Effective date
2019-03-12
Label type
PRESCRIPTION ANIMAL DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:40:22

Label at a glance#

ProductSterile Water
Active ingredientWATER
Label structure11 sections

Storage and handling

Store between 15°C and 30°C (59°F-86°F).

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

STERILE WATER- sterile water for injection injection


Vedco

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA.

STERILE WATER FOR INJECTION


FOR ANIMAL USE ONLY

SOLD TO VETERINARIANS ONLY

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Contains:


Water For Injection, USP................ 100%

INDICATIONS:

INDICATIONS & USAGE SECTION

Sterile water for injection is intended for use as a sterile diluent for preparation of injectable solutions.

CAUTION:

PRECAUTIONS SECTION

Sterile water for injection is not suitable for intravascular injection without first having been made isotonic by the addition of suitable solute.

STORAGE

STORAGE AND HANDLING SECTION

Store between 15°C and 30°C (59°F-86°F).

VETERINARY INDICATIONS SECTION

KEEP OUT OF REACH OF CHILDREN

CAUTION:

WARNINGS AND PRECAUTIONS SECTION

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

WARNING:

WARNINGS SECTION

Do not use this product if seal is broken or if solution is not clear. This is a sterile single dose vial. No preservatives have been added. Discard unused portion after use. Solutions made from this water should be used promptly or sterilized with adequate precautions for maintaining sterility.

DOSAGE & ADMINISTRATION SECTION

TAKE TIME OBSERVE LABEL DIRECTIONS

INFORMATION FOR OWNERS/CAREGIVERS SECTION

Distributed By


VEDCO, INC.

St. Joseph, MO 64507
Made in El Salvador

STERILE SOLUTION
 CONTENT NDC VINV #
 250 mL 50989-887-15 VINV-SH20-250M
 500 mL 50989-887-16 VINV-SH20-500M
 1000 mL 50989-887-17 VINV-SH20-1000

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 50989-887-15

ULTIGIENE TERMINALLY STERILIZED

STERILE WATER FOR INJECTION

NET CONTENTS: 250 mL

VEDCO

FOR ANIMAL USE ONLY

KEEP OUT OF REACH OF CHILDREN

CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian

LabelLabel

NDC 50989-887-16

ULTIGIENE TERMINALLY STERILIZED

STERILE WATER FOR INJECTION

NET CONTENTS: 500 mL

VEDCO

FOR ANIMAL USE ONLY

KEEP OUT OF REACH OF CHILDREN

CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian

Label 1Label 1

NDC 50989-887-17

ULTIGIENE TERMINALLY STERILIZED

STERILE WATER FOR INJECTION

NET CONTENTS: 1000 mL

VEDCO

FOR ANIMAL USE ONLY

KEEP OUT OF REACH OF CHILDREN

CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian

Label 2Label 2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50989-887-15Sterile Water250 mL in 1 BOTTLE, PLASTICINJECTION2502
50989-887-16Sterile Water500 mL in 1 BOTTLE, PLASTICINJECTION5002
50989-887-17Sterile Water1000 mL in 1 BOTTLE, PLASTICINJECTION10002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50989-887STERILE WATER (STERILE WATER FOR INJECTION) INJECTION [VEDCO]23 package rows20190313_56184433-e40e-4f57-90dc-0d21744ce1ae.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50989-88750989-887-15, 50989-887-16, 50989-887-17

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 4 · 69 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sterile WaterWATERREMEDYREPACK INC.5dd5d148-6e23-41de-bff5-551b2aea95982026-08-24Warnings, Adverse reactionsName fallback
brand name: Sterile Water
generic name: WATER
NINA WATER (Rich anions,Alkaline Balancing Water)WATERDMBIO.CO.,LTD.58cbda7e-70c9-af85-e063-6394a90a0d172026-08-11WarningsName fallback
generic name: WATER
NINA WATER (Rich anions,Alkaline Balancing Water)WATERDMBIO.CO.,LTD.58b9b24c-7014-eb45-e063-6294a90ae4822026-08-10WarningsName fallback
generic name: WATER
Sterile WaterWATERCardinal Health 107, LLC48d75a7c-8329-48a8-bea0-a8c144ddf6372026-08-07Warnings, Adverse reactionsName fallback
brand name: Sterile Water
generic name: WATER
Sterile WaterWATERCardinal Health 107, LLC9655cd02-82b5-4a75-813b-854b195514812026-07-21Warnings, Adverse reactionsName fallback
brand name: Sterile Water
generic name: WATER
RemodulinTREPROSTINILUnited Therapeutics Corporation6c80bb38-e8db-4138-9f0d-dbbf9c6731852026-07-02Warnings, Adverse reactionsName fallback
generic name: WATER
Sterile WaterWATERHospira, Inc.3a6422e1-feee-4095-8883-2b0837039e6e2026-05-07Warnings, Adverse reactionsName fallback
brand name: Sterile Water
generic name: WATER
NINA WATER (Rich anions)WATERBIOHERB Co., Ltd.16053e79-189e-4cdf-e063-6394a90ac7762026-04-11WarningsName fallback
generic name: WATER
Sterile WaterWATERHospira, Inc.2b9ea23a-f9e9-48a8-25b7-519e3bbd68282026-03-18Warnings, Adverse reactionsName fallback
brand name: Sterile Water
generic name: WATER
INSULIN DILUTING MEDIUM FOR KirstyWATERBiocon Biologics Inc.3db1d482-7e1f-aec6-79ef-3f305b4d82772026-01-20Warnings, Adverse reactionsName fallback
generic name: WATER
pH Neutral Emergency EyewashWATERINNOVATIVE SAFETY SUPPLY INC.29a1bd1e-d0dd-478f-e063-6394a90ab0aa2026-01-08WarningsName fallback
generic name: WATER
Quality Choice Eye WashWATERChain Drug Marketing Assoc., Inc.1fb8a109-351b-7039-e063-6394a90a73112025-12-30WarningsName fallback
generic name: WATER
OCUFRESHWATEROptics Laboratory Inc.b8e477a9-66b9-496b-92fb-3d4bbd7b36b52025-12-29WarningsName fallback
generic name: WATER
Sterile WaterWATERProPharma Distribution386a0a2f-4ff7-f128-e063-6294a90a7d4d2025-12-18Warnings, Adverse reactionsName fallback
brand name: Sterile Water
generic name: WATER
PUR-WASHWATERNiagara Pharmaceuticals Inc.beda35c3-9a8b-47ad-e053-2995a90a7b1b2025-11-24WarningsName fallback
generic name: WATER
Easy Care First Aid EyewashWATERTender Corporationa070aac8-e6d2-ef10-e053-2a95a90aa5b12025-11-24WarningsName fallback
generic name: WATER
PUR-WASHWATERNiagara Pharmaceuticals Inc.e07a064b-f680-405c-bbcd-24fac430951e2025-11-24WarningsName fallback
generic name: WATER
PUR-WASHWATERNiagara Pharmaceuticals Inc.777e1559-786f-8d54-e053-2991aa0aa98d2025-11-24WarningsName fallback
generic name: WATER
PUR-WASHWATERNiagara Pharmaceuticals Inc.7289103a-5cbf-42f4-8848-e827149a43ca2025-11-24WarningsName fallback
generic name: WATER
Sterile WaterWATERFresenius Kabi USA, LLCfd823bef-c14c-4708-a18a-8aaa8470412f2025-11-18Warnings, Adverse reactionsName fallback
brand name: Sterile Water
generic name: WATER

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.