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 Mexico

Rev. May 2017

88-80-31-833

PRINCIPAL DISPLAY PANEL - PACKAGING LABELING

Representative Container Label 0338-0047-44

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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1500

1200

900

600

300

SODIUM CHLORIDE
sodium chloride irrigant

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

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

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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
NDA	NDA017867	05/30/1980

Labeler - Baxter Healthcare Corporation (005083209)

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

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

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