VETERINARY STERILE WATER - sterile water injection 
Ivali LLC

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Veterinary Sterile Water For Injection, USP

For Animal Use Only

Indications

Veterinary Sterile Water for Injection is suitable for use as a diluent for the preparation of pharmaceutical solutions

Description

Prepared by distillation. Contains no antimicrobial agents or other substance has been added. Discard unused portion. Sterile, nonpyrogenic. Osmolarity and pH are shown in Table 1:

TABLE 1

 Veterinary Sterile Water for Injection, USP
 Size (mL) 1000
 Osmolarity (mOsmol/L) (calc) 0
 pH 5.5 (5.0 to 7.0)

Contraindications:

None known

Warnings

This solution is not isotonic and is hemolytic.

Dosage and administration:

As directed by a veterinarian.

Cautions

Sterile water for Injection is not suitable for intravascular injection without first having been made isotonic by addition of suitable solutes. Do not use unless solution is clear and seal is intact. Discard unused portion.

How Supplied:

Veterinary Sterile Water for Injection, USP in plastic container is available as follows:

 NDC Code Size (mL) Product Name
 86094-891-01 1000 Sterile Water For Injection, USP

Plastic Container:PVC Free, DEHP Free, Latex Free. The volumetric scales on the single dose plastic container should only be used as a reference. For precise dosage of volumes it is recommeded the use of IV Infusion pump or IV Burrette.

Storage

Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended the product be stored in the moisture overwrap at room temperature (250C/770F), brief exposure up to (400C/1040F)does not adversely affect the product.

Directions for use of plastic container

To Open

Tear overwrap down side at slit and remove solution container. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually. Check for minute leaks by squeezing inner bag firmly. If leaks are found, discard solution as sterility may be impaired.

Not for injection, for irrigation only.

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

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Manufactured for:

IVALI LLC
18205 Biscayne Blvd., Suite 2202
Aventura Florida

Printed in Argentina
For a copy of the Safety Data Sheet (SDS) or to report adverse reactions call IVALI LLC. Customer service at 1-305-692-7665
IVALI is a trademark of IVALI LLC., all rights reserved.
© 2018 IVALI LLC.

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Principal Display Panel

NDC 86094-891-01

IVALI

Veterinary Sterile Water for Injection, USP

1000 mL

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VETERINARY STERILE WATER  
sterile water injection
Product Information
Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:86094-891
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER100 g  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:86094-891-011000 mL in 1 CONTAINER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other05/11/201810/28/2024
Labeler - Ivali LLC (081136076)
Establishment
NameAddressID/FEIBusiness Operations
LABORATORIOS JAYOR S.R.L.979312485manufacture

Revised: 10/2024
Document Id: 818207c3-3831-4c10-b172-ce3191f6a34b
Set id: 3e30e57d-fcfb-4470-82ae-f2743e84b405
Version: 2
Effective Time: 20241028
 
Ivali LLC