The following Structured Product Label (SPL) was submitted to the FDA by Baxter Healthcare Corporation for the product Ringers (NDC 0338-0104). 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.
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. Not for injection.
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.
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
07-09-64-078
Bar Code Position Only*
303380104048
LOT
EXP
Ringer's Irrigation, USP Pour Bottle
1000 mL
Qty 12
NDC 0338-0104-04
2F7164
EXP
LOT#
(01)50303380104043(17)080630(10)G012345
07-06-47-996
* Please review the disclaimer below.
