SPL v13
SPL
SPL Set ID e1953d54-818d-46a6-8532-518ebae6d84e
Route
IRRIGATION
Published
Effective Date 2012-06-13
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Chloride Ion (860 mg)
Inactive Ingredients
Water

Identifiers & Packaging

Marketing Status
NDA Active Since 1982-02-19

Description

Ringer’s Irrigation, USP Each 100 mL contains: 860 mg Sodium Chloride, USP, 33 mg Calcium Chloride, USP, 30 mg Potassium Chloride, USP. No antimicrobial agent has been added. pH 6.0 (5.0 to 7.5). Osmolarity 309 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

Ringer’s Irrigation, USP

Each 100 mL contains: 860 mg Sodium Chloride, USP, 33 mg Calcium Chloride, USP, 30 mg Potassium Chloride, USP. No antimicrobial agent has been added. pH 6.0 (5.0 to 7.5). Osmolarity 309 mOsmol/L (calc.). Sterile, nonpyrogenic. Pour Bottle.

Principal Display Panel Packaging Labeling
Container Label

Container Label

2F7164

NDC 0338-0104-04

1000 mL

Baxter Logo

Not for Injection

Ringer's Irrigation, USP

Each 100 mL contains: 860 mg Sodium Chloride,

USP, 33 mg Calcium Chloride, USP, 30 mg

Potassium Chloride, USP. No antimicrobial agent

has been added. pH 6.0 (5.0 to 7.5). Osmolarity

309 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

07-09-00-0250

Bar Code Position Only*

303380104048

LOT

EXP


Structured Label Content

Description (DESCRIPTION)

Ringer’s Irrigation, USP

Each 100 mL contains: 860 mg Sodium Chloride, USP, 33 mg Calcium Chloride, USP, 30 mg Potassium Chloride, USP. No antimicrobial agent has been added. pH 6.0 (5.0 to 7.5). Osmolarity 309 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

2F7164

NDC 0338-0104-04

1000 mL

Baxter Logo

Not for Injection

Ringer's Irrigation, USP

Each 100 mL contains: 860 mg Sodium Chloride,

USP, 33 mg Calcium Chloride, USP, 30 mg

Potassium Chloride, USP. No antimicrobial agent

has been added. pH 6.0 (5.0 to 7.5). Osmolarity

309 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

07-09-00-0250

Bar Code Position Only*

303380104048

LOT

EXP


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)