STERILE WATER- sterile water irrigant 
Baxter Healthcare Corporation

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DESCRIPTION

Sterile Water for Irrigation, USP

Prepared by distillation. No antimicrobial agent or other substance has been added. pH 5.5 (5.0 to 7.0). Osmolarity 0 mOsmol/L (calc.). Sterile, nonpyrogenic. Pour Bottle.

INDICATIONS AND USAGE

For irrigation only. Not for injection.

WARNINGS

This solution is not isotonic and is hemolytic.

DOSAGE AND ADMINISTRATION

As directed by a physician.

Cautions: Warm in oven to not more than 50°C for a maximum of 60 days. Discard after 60 days of warming. Do not use unless solution is clear and seal is intact. Discard unused portion. Rx only.

HOW SUPPLIED

Recommended storage: Room temperature (25°C). Avoid excessive heat.

PRINCIPAL DISPLAY PANEL - PACKAGING LABELING

Sterile Water for Irrigation, USP Representative Container Label

Container Label

2F7112
NDC 0338-0004-02

250 mL

Baxter Logo

Not for Injection
For Irrigation Only

Sterile Water for
Irrigation, USP

Prepared by distillation. No antimicrobial
agent or other substance has been added.
pH 5.5 (5.0 to 7.0). Osmolarity 0 mOsmol/L
(calc.). Sterile, nonpyrogenic. Pour Bottle.
Warning: This solution is not isotonic and is
hemolytic. Dosage and Administration: As
directed by a physician. Cautions: Warm in
oven to not more than 50°C for a maximum
of 60 days. Discard after 60 days of warming.
Do not use unless solution is clear and seal
is intact. Discard unused portion. Rx only.
Recommended storage: Room temperature
(25°C). Avoid excessive heat.

PL 325 plastic

Baxter Healthcare Corporation
Deerfield, IL 60015 USA

Made in USA

07-09-64-068

Bar Code Position Only*
303380004027

LOT

EXP

Sterile Water for Irrigation, USP Representative Carton Label

Carton Label (07-06-47-986)

Sterile Water for
Irrigation, USP
Pour Bottle

NDC 0338-0004-02

2F7112

EXP JUN 08

LOT # G012345

250 mL

Qty
24

Bar Code
(01)50303380004022(17)080630(10)G012345

STERILE WATER 
sterile water irrigant
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0338-0004
Route of AdministrationIRRIGATION
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER100 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0338-0004-0224 in 1 CARTON
1250 mL in 1 BOTTLE, PLASTIC
2NDC:0338-0004-0318 in 1 CARTON
2500 mL in 1 BOTTLE, PLASTIC
3NDC:0338-0004-0412 in 1 CARTON
31000 mL in 1 BOTTLE, PLASTIC
4NDC:0338-0004-059 in 1 CARTON
41500 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01742812/31/1974
Labeler - Baxter Healthcare Corporation (005083209)
Establishment
NameAddressID/FEIBusiness Operations
Baxter Healthcare Corporation001728059ANALYSIS(0338-0004) , MANUFACTURE(0338-0004) , LABEL(0338-0004) , PACK(0338-0004) , STERILIZE(0338-0004)

Revised: 2/2014
Document Id: 2ba47d77-e661-48e2-a844-a2447e94daeb
Set id: fb20b834-4ca2-4ef0-ab16-8c7e1e3cd3b9
Version: 2
Effective Time: 20140221
 
Baxter Healthcare Corporation