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Sterile Water Irrigation

Dosage Form: irrigation

Directions for Use of Flexible Plastic Irrigation Containers

If desired, warm in overwrap to near body temperature in a water bath or oven heated to not more than 45°C.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

DIRECTIONS FOR USE

Tear overwrap down side at slit and remove solution container. Visually inspect the container. If the outlet port protector is damaged, detached, or not present, discard container as solution path sterility may be impaired. 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 bag firmly. If leaks are found, discard solution as sterility may be impaired.

Use Aseptic Technique.

1.
Suspend container using hanger hole.
2.
Remove plastic protector from outlet port at bottom of container.
3.
Attach irrigation set. Refer to complete directions accompanying set.

Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended the product be stored at room temperature (25°C): brief exposure up to 40°C does not adversely affect the product.

Baxter Healthcare Corporation

Deerfield, IL 60015 USA

Printed in USA

©Copyright 1980, 1984, 1989, Baxter Healthcare Corporation.
All rights reserved.

07-19-73-064

Rev. April 2014

PACKAGE LABEL.PRINCIPLE DISPLAY PANEL

Sterile Water for Irrigation USP Container Label

Sterile Water for Irrigation USP Container Label

NOT FOR INJECTION

5000 mL

2B7119

NDC 0338-0003-49

STERILE WATER

For Irrigation USP

FOR IRRIGATION ONLY 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

SINGLE DOSE CONTAINER

DO NOT USE UNLESS SOLUTION IS CLEAR

DISCARD UNUSED PORTION

CAUTIONS THIS SOLUTION IS NOT ISOTONIC AND IS

HEMOLYTIC SQUEEZE AND INSPECT INNER BAG

WHICH MAINTAINS PRODUCT STERILITY DISCARD IF

LEAKS ARE FOUND RX ONLY STORE UNIT IN

MOISTURE BARRIER OVERWRAP AT ROOM

TEMPERATURE (25°C) UNTIL READY TO USE AVOID

EXCESSIVE HEAT SEE INSERT

Sterile Water

H2O

For Irrigation USP

UROMATIC CONTAINER PL 146 PLASTIC

BAXTER HEALTHCARE CORPORATION

DEERFIELD IL 60015 USA

MADE IN USA

BAXTER UROMATIC AND

PL 146 ARE TRADEMARKS OF

BAXTER INTERNATIONAL INC

FOR PRODUCT INFORMATION

1-800-933-0303

Sterile Water for Irrigation USP Carton Label

Sterile Water for Irrigation USP Carton Label

STERILE WATER FOR IRRIGATION, USP

UROMATIC CONT

2-5000ML

SECONDARY BAR CODE

(17) YYMM00 (10) XXXXX

PRIMARY BAR CODE

(01) 50303380003490

LOT XXXXX

EXP XXXXX

2B7119

STERILE WATER 
water irrigant
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0338-0003
Route of Administration IRRIGATION DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
WATER (WATER) WATER 100 mL  in 100 mL
Packaging
# Item Code Package Description
1 NDC:0338-0003-44 14 BAG in 1 CARTON
1 1000 mL in 1 BAG
2 NDC:0338-0003-46 6 BAG in 1 CARTON
2 2000 mL in 1 BAG
3 NDC:0338-0003-47 4 BAG in 1 CARTON
3 3000 mL in 1 BAG
4 NDC:0338-0003-49 2 BAG in 1 CARTON
4 5000 mL in 1 BAG
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA017866 05/30/1980
Labeler - Baxter Healthcare Corporation (005083209)
Establishment
Name Address ID/FEI Operations
Baxter Healthcare Corporation 059140764 ANALYSIS(0338-0003), MANUFACTURE(0338-0003), LABEL(0338-0003), PACK(0338-0003), STERILIZE(0338-0003)
Establishment
Name Address ID/FEI Operations
Baxter Healthcare Corporation 194684502 ANALYSIS(0338-0003)
Revised: 07/2014
 
Baxter Healthcare Corporation



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