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  • Ringers CALCIUM CHLORIDE 33 mg/100mL Baxter Healthcare Corporation
FDA Drug information

Ringers

Read time: 1 mins
Marketing start date: 26 Jan 2025
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Summary of product characteristics


Indications And Usage

INDICATIONS AND USAGE Isotonic solution for irrigation only. Not for injection.

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.

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.

Effective Time

20120613

Version

11

Spl Product Data Elements

Ringers sodium chloride, calcium chloride, potassium chloride, SODIUM CHLORIDE SODIUM CATION CHLORIDE ION CALCIUM CHLORIDE CALCIUM CATION CHLORIDE ION POTASSIUM CHLORIDE POTASSIUM CATION CHLORIDE ION WATER

Application Number

NDA018495

Brand Name

Ringers

Generic Name

sodium chloride, calcium chloride, potassium chloride,

Product Ndc

0338-0104

Product Type

HUMAN PRESCRIPTION DRUG

Route

IRRIGATION

Package Label Principal Display Panel

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 Ringers Irrigation USP Representative Container Label

How Supplied

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

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Disclaimer

The drug Prescribing Information (PI), including indications, contra-indications, interactions, etc, has been developed using the U.S. Food & Drug Administration (FDA) as a source (www.fda.gov).

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Drugs appearing in this section are approved by the FDA. For regions outside of the United States, this content is for informational purposes only and may not be aligned with local regulatory approvals or guidance.