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Sterile Water

Baxter Healthcare Corporation

Directions for Use of Flexible Plastic Irrigation Containers


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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. 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.

  • Suspend container using hanger hole.
  • Remove plastic protector from outlet port at bottom of container.
  • 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.

7-19-4-268

Rev. July 1997

PACKAGE LABEL.PRINCIPLE DISPLAY PANEL

Sterile Water
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 DISTILLATIONNO ANTIMICROBIAL AGENT OR OTHER SUBSTANCE HASBEEN ADDED pH 5.5 (5.0 to 7.0) OSMOLARITY0 mOsmol/L (CALC) STERILE NONPYROGENICSINGLE DOSE CONTAINERDO NOT USE UNLESS SOLUTION IS CLEARDISCARD UNUSED PORTIONCAUTIONS THIS SOLUTION IS NOT ISOTONIC AND ISHEMOLYTIC SQUEEZE AND INSPECT INNER BAGWHICH MAINTAINS PRODUCT STERILITY DISCARD IFLEAKS ARE FOUND RX ONLY STORE UNIT INMOISTURE BARRIER OVERWRAP AT ROOMTEMPERATURE (25°C) UNTIL READY TO USE AVOIDEXCESSIVE 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

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 1 mL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0338-0003-44 1000 in 1 BAG
2 NDC:0338-0003-46 2000 in 1 BAG
3 NDC:0338-0003-47 3000 in 1 BAG
4 NDC:0338-0003-49 5000 in 1 BAG

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA017866 1980-05-30


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