SPL v11
SPL
SPL Set ID b3b4b176-41f0-4ca8-90d4-3fba5707564a
Route
IRRIGATION
Published
Effective Date 2014-02-21
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Chloride Ion (900 mg)
Inactive Ingredients
Water

Identifiers & Packaging

Marketing Status
NDA Active Since 1974-12-31 Until 2022-10-31

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.


Medication Information

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.

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.

Principal Display Panel Packaging Labeling
Container Label

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


Structured Label Content

Description (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.

How Supplied (HOW SUPPLIED)

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

Indications and Usage (INDICATIONS AND USAGE)

Isotonic solution for irrigation only. Not for injection.

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.

Principal Display Panel Packaging Labeling (PRINCIPAL DISPLAY PANEL - PACKAGING LABELING)
Container Label

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)