SODIUM CHLORIDE irrigant

Sodium Chloride by

Drug Labeling and Warnings

Sodium Chloride by is a Prescription medication manufactured, distributed, or labeled by Baxter Healthcare Corporation, Baxter, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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.

SPL UNCLASSIFIED SECTION

Baxter Healthcare Corporation
Deerfield, IL 60015 USA

Printed in Mexico

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

Rev. May 2017

88-80-31-833

PRINCIPAL DISPLAY PANEL - PACKAGING LABELING

3000 mL
2B77127
NDC: 0338-0047-47

NOT FOR INJECTION

0.9%
SODIUM CHLORIDE
Irrigation USP

Each 100 mL contains 900 mg Sodium
Chloride USP No antimicrobial agent has
been added pH 5.5 (4.5 to 7.0) mEq/L
Sodium 154 Chloride 154 Osmolarity 308
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

0.9%

Sodium Chloride
NaCl
Irrigation USP

UROMATIC container

PL 146 plastic

BAXTER UROMATIC and PL 146 are
trademarks of Baxter International Inc

For product information
1-800-933-0303

Baxter Logo
Baxter Healthcare Corporation
Deerfield, IL 60015 USA

Made in Mexico

2700

2400

2100

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900

600

300

2B7127
4-3000 ML

VIAFLEX® CONTAINER

0.9% SODIUM CHLORIDE
IRRIGATION, USP

EXP
BAR CODE
( 17 ) 180400 ( 10 ) V16028A

LOT
BAR CODE
(01) 50303380047470

INGREDIENTS AND APPEARANCE

SODIUM CHLORIDE 
sodium chloride irrigant

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 0338-0047
Route of Administration	IRRIGATION

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698)	SODIUM CHLORIDE	900 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0338-0047-44	14 in 1 CARTON	05/30/1980
1		1000 mL in 1 BAG; Type 0: Not a Combination Product
2	NDC: 0338-0047-46	6 in 1 CARTON	05/30/1980
2		2000 mL in 1 BAG; Type 0: Not a Combination Product
3	NDC: 0338-0047-47	4 in 1 CARTON	05/30/1980
3		3000 mL in 1 BAG; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA017867	05/30/1980

Labeler - Baxter Healthcare Corporation (005083209)

Establishment
Name	Address	ID/FEI	Business Operations
Baxter Healthcare Corporation		059140764	ANALYSIS(0338-0047) , LABEL(0338-0047) , MANUFACTURE(0338-0047) , PACK(0338-0047) , STERILIZE(0338-0047)

Establishment
Name	Address	ID/FEI	Business Operations
Baxter Healthcare Corporation		194684502	ANALYSIS(0338-0047)

Establishment
Name	Address	ID/FEI	Business Operations
Baxter, S.A. de C.V.		810432484	ANALYSIS(0338-0047) , MANUFACTURE(0338-0047) , LABEL(0338-0047) , PACK(0338-0047) , STERILIZE(0338-0047)