FDA Label for Sodium Chloride
View Indications, Usage & Precautions
Sodium Chloride Product Label
The following document was submitted to the FDA by the labeler of this product Baxter Healthcare Corporation. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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.
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
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.