SPL v9
SPL
SPL Set ID f09f80bf-2f8b-4420-865d-aec2d5e5cd4d
Route
IRRIGATION
Published
Effective Date 2012-06-12
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Chloride Ion (600 mg) Sodium Cation (310 mg)
Inactive Ingredients
Water

Identifiers & Packaging

Marketing Status
NDA Active Since 1982-02-19

Description

Lactated Ringer’s Irrigation Each 100 mL contains: 600 mg Sodium Chloride, USP, 310 mg Sodium Lactate, 30 mg Potassium Chloride, USP, 20 mg Calcium Chloride, USP. No antimicrobial agent has been added. pH 6.5 (6.0 to 7.5). Osmolarity 273 mOsmol/L (calc.). Sterile, nonpyrogenic. Pour Bottle.

Indications and Usage

Isotonic solution for irrigation only. Not for injection.

Dosage and Administration

As directed by a physician. Cautions: Warm in oven to not more than 50°C for a maximum of 60 days. Discard after 60 days of warming. Do not use unless solution is clear and seal is intact. Discard unused portion. Rx only.

How Supplied

Recommended storage: Room temperature (25°C). Avoid excessive heat.


Medication Information

Indications and Usage

Isotonic solution for irrigation only. Not for injection.

Dosage and Administration

As directed by a physician.

Cautions: Warm in oven to not more than 50°C for a maximum of 60 days. Discard after 60 days of warming. Do not use unless solution is clear and seal is intact. Discard unused portion. Rx only.

How Supplied

Recommended storage: Room temperature (25°C). Avoid excessive heat.

Description

Lactated Ringer’s Irrigation

Each 100 mL contains: 600 mg Sodium Chloride, USP, 310 mg Sodium Lactate, 30 mg Potassium Chloride, USP, 20 mg Calcium Chloride, USP. No antimicrobial agent has been added. pH 6.5 (6.0 to 7.5). Osmolarity 273 mOsmol/L (calc.). Sterile, nonpyrogenic. Pour Bottle.

Principal Display Panel Packaging Labeling
Container Label

Container Label

2F7154

NDC 0338-0114-04

1000 mL

Baxter Logo

Not for Injection

Lactated Ringer's

Irrigation

Each 100 mL contains: 600 mg Sodium

Chloride, USP, 310 mg Sodium Lactate, 30

mg Potassium Chloride, USP, 20 mg Calcium

Chloride, USP. No antimicrobial agent has been

added. pH 6.5 (6.0 to 7.5). Osmolarity 273

mOsmol/L (calc.). Sterile, nonpyrogenic. Pour

Bottle. Isotonic solution for irrigation only.

Dosage and Administration: As directed by a

physician. Cautions: Warm in oven to not more

than 50°C for a maximum of 60 days. Discard

after 60 days of warming. Do not use unless

solution is clear and seal is intact. Discard

unused portion. Rx only. Recommended

storage: Room temperature (25°C). Avoid

excessive heat.

PL 325 plastic

Baxter Healthcare Corporation

Deerfield, IL 60015 USA

Made in USA

LOT

EXP

FPO

(91)0709000249

Bar Code

07-09-00-0249

Bar Code Position Only*

303380114047


Structured Label Content

Description (DESCRIPTION)

Lactated Ringer’s Irrigation

Each 100 mL contains: 600 mg Sodium Chloride, USP, 310 mg Sodium Lactate, 30 mg Potassium Chloride, USP, 20 mg Calcium Chloride, USP. No antimicrobial agent has been added. pH 6.5 (6.0 to 7.5). Osmolarity 273 mOsmol/L (calc.). Sterile, nonpyrogenic. Pour Bottle.

How Supplied (HOW SUPPLIED)

Recommended storage: Room temperature (25°C). Avoid excessive heat.

Indications and Usage (INDICATIONS AND USAGE)

Isotonic solution for irrigation only. Not for injection.

Dosage and Administration (DOSAGE AND ADMINISTRATION)

As directed by a physician.

Cautions: Warm in oven to not more than 50°C for a maximum of 60 days. Discard after 60 days of warming. Do not use unless solution is clear and seal is intact. Discard unused portion. Rx only.

Principal Display Panel Packaging Labeling (PRINCIPAL DISPLAY PANEL - PACKAGING LABELING)
Container Label

Container Label

2F7154

NDC 0338-0114-04

1000 mL

Baxter Logo

Not for Injection

Lactated Ringer's

Irrigation

Each 100 mL contains: 600 mg Sodium

Chloride, USP, 310 mg Sodium Lactate, 30

mg Potassium Chloride, USP, 20 mg Calcium

Chloride, USP. No antimicrobial agent has been

added. pH 6.5 (6.0 to 7.5). Osmolarity 273

mOsmol/L (calc.). Sterile, nonpyrogenic. Pour

Bottle. Isotonic solution for irrigation only.

Dosage and Administration: As directed by a

physician. Cautions: Warm in oven to not more

than 50°C for a maximum of 60 days. Discard

after 60 days of warming. Do not use unless

solution is clear and seal is intact. Discard

unused portion. Rx only. Recommended

storage: Room temperature (25°C). Avoid

excessive heat.

PL 325 plastic

Baxter Healthcare Corporation

Deerfield, IL 60015 USA

Made in USA

LOT

EXP

FPO

(91)0709000249

Bar Code

07-09-00-0249

Bar Code Position Only*

303380114047


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)