Description
0.9% Sodium Chloride Irrigation, USP
Each 100 mL contains: 900 mg Sodium Chloride, USP. No antimicrobial agent has been added. pH 5.5 (4.5 to 7.0). Osmolarity 308 mOsmol/L (calc.). Sterile, nonpyrogenic. Pour Bottle.
Sodium Chloride Irrigant
FDA Label NDC 0338-0048
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 Sodium Chloride (NDC 0338-0048). 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
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
0.9% Sodium Chloride Irrigation, Usp Representative Container Label (Image 01)
Container Label
2F7124
NDC 0338-0048-04
1000 mL
Baxter Logo
Not for Injection
0.9% Sodium Chloride Irrigation, USP
Each 100 mL contains: 900 mg Sodium
Chloride, USP. No antimicrobial agent has
been added. pH 5.5 (4.5 to 7.0). Osmolarity
308 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
07-09-00-0243
Bar Code Position Only*
303380048045
FPO
(91)0709000243
* Please review the disclaimer below.
