VETERINARY STERILE WATER FOR IRRIGATION- sterile water irrigant 
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 Irrigation, USP

For Animal Use Only

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 Irrigation, 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

Warm to not more than (500C/1220F) for a maximum of 60 days. Discard unopened bottle after 60 days of warming. Do not use unless solution is clear and seal is intact. Discard unused portion.

How Supplied:

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

 NDC CODE Size (mL) Product Name
 86094-894-01 1000 Sterile Water For Irrigation, 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.

image description

VETERINARY STERILE WATER FOR IRRIGATION 
sterile water irrigant
Product Information
Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:86094-894
Route of AdministrationIRRIGATION
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:86094-894-011000 mL in 1 CONTAINER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other05/11/201511/28/2023
Labeler - Ivali LLC (081136076)
Establishment
NameAddressID/FEIBusiness Operations
LABORATORIOS JAYOR S.R.L.979312485manufacture

Revised: 11/2023
Document Id: 28f73a68-9523-4408-b19d-749c10a0d1ad
Set id: 002d17dd-5257-4a4e-9f18-4d14d3e726cf
Version: 3
Effective Time: 20231128
 
Ivali LLC