Lactated Ringers Irrigant
FDA Label NDC 0338-0114

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Baxter Healthcare Corporation for the product Lactated Ringers (NDC 0338-0114). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding description, indications and usage, dosage and administration, how supplied, principal display panel - packaging labeling, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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.

Principal Display Panel - Packaging Labeling

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, non-
pyrogenic. 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

Bar Code Position Only*
303380114047

LOT
EXP

07-09-64-077

Carton Label

Lactated Ringer's
Irrigation
Pour Bottle

1000 mL

Qty
12

NDC 0338-0114-04

2F7154

EXP

LOT#

(01)50303380114042(17)080630(10)G012345

07-06-47-995

* Please review the disclaimer below.