Sterile Water 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. 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.

7-19-4-268

Rev. July 1997

PACKAGE LABEL.PRINCIPLE DISPLAY PANEL

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

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 NDC Product Code (Source) 0338-0003 Route of Administration IRRIGATION DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength WATER (WATER) WATER 1 mL  in 1 mL

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0338-0003-44 1000 mL In 1 BAG None 2 0338-0003-46 2000 mL In 1 BAG None 3 0338-0003-47 3000 mL In 1 BAG None 4 0338-0003-49 5000 mL In 1 BAG None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA017866	05/30/1980

Labeler - BAXTER HEALTHCARE CORPORATION (005083209)

Establishment
Name	Address	ID/FEI	Operations
BAXTER HEALTHCARE CORPORATION		059140764	MANUFACTURE

Revised: 12/2009BAXTER HEALTHCARE CORPORATION

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