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 - PRINCIPAL DISPLAY PANEL

900

800

700

600

500

400

300

200

100

LOT EXP

1000 mL
NOT FOR INJECTION 2B7634
NDC 0338-0189-44

Tis-U-Sol Solution
(Pentalyte Irrigation)

EACH 100 mL CONTAINER 800 mg SODIUM CHLORIDE USP
40 mg POTASSIUM CHLORIDE USP 20 mg MAGNESIUM
SULFATE USP 8.75 mg DIBASIC SODIUM PHOSPHATE
HELTAHYDRATE NF NO ANTIMICROBIAL AGENT HAS BEEN
ADDED pH 6.0 (4.0 TO 7.0) OSMOLARITY 288 mOsmol/L
(CALC) STERILE NONPYROGENIC SINGLE DOSE
CONTAINER

DO NOT USE UNLESS SOLUTION IS CLEAR DISCARD
UNUSED PORTION

CAUTIONS 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

Tis-U-Sol Solution
(Pentalyte Irrigation)

Baxter Logo
BAXTER HEALTHCARE CORPORATION
DEERFIELD, IL 60015 USA

MADE IN USA

PL 146 PLASTIC

TIS-U-SOL AND PL 146 ARE
TRADEMARKS OF BAXTER
INTERNATIONAL INC

FOR PRODUCT INFORMATION
1-800-933-0303

07-25-27-636

900

800

700

600

500

400

300

200

100

2B7634 12-1000 ML
VIAFLEX CONTAINER

TIS-U-SOL SOLUTION
PENTALYTE IRRIGATION

EXP
XXXXX

SECONDARY BAR CODE

(17) YYMM00 (10) XXXXX

LOT
XXXXX

PRIMARY BAR CODE

(01) 50303380189446