STERILE WATER by Baxter Healthcare Corporation STERILE WATER irrigant

STERILE WATER by

Drug Labeling and Warnings

STERILE WATER by is a Prescription medication manufactured, distributed, or labeled by Baxter Healthcare Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

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

INGREDIENTS AND APPEARANCE

STERILE WATER 
sterile water irrigant

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 0338-0004
Route of Administration	IRRIGATION

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R)	WATER	100 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0338-0004-02	24 in 1 CARTON
1		250 mL in 1 BOTTLE, PLASTIC
2	NDC: 0338-0004-03	18 in 1 CARTON
2		500 mL in 1 BOTTLE, PLASTIC
3	NDC: 0338-0004-04	12 in 1 CARTON
3		1000 mL in 1 BOTTLE, PLASTIC
4	NDC: 0338-0004-05	9 in 1 CARTON
4		1500 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA017428	12/31/1974

Labeler - Baxter Healthcare Corporation (005083209)

Establishment
Name	Address	ID/FEI	Business Operations
Baxter Healthcare Corporation		001728059	ANALYSIS(0338-0004) , MANUFACTURE(0338-0004) , LABEL(0338-0004) , PACK(0338-0004) , STERILIZE(0338-0004)