SPL v12
SPL
SPL Set ID 886f889b-f3cf-4197-b307-6cfa88c89436
Route
IRRIGATION
Published
Effective Date 2017-05-04
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Chloride Ion (900 mg)
Inactive Ingredients
Water

Identifiers & Packaging

Marketing Status
NDA Active Since 1980-05-30

Description

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.


Medication Information

Description

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.

Section 42229-5

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.

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

1800

1500

1200

900

600

300


Structured Label Content

Section 42229-5 (42229-5)

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 (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.

Principal Display Panel Packaging Labeling (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

1800

1500

1200

900

600

300


Advanced Ingredient Data


Raw Label Data

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