SODIUM CHLORIDE- sodium chloride irrigant 
Baxter Healthcare Corporation

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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

0.9% Sodium Chloride Irrigation, USP Representative Container Label

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

SODIUM CHLORIDE 
sodium chloride irrigant
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0338-0048
Route of AdministrationIRRIGATION
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE900 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0338-0048-0224 in 1 CARTON12/31/1974
1250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC:0338-0048-0318 in 1 CARTON12/31/1974
2500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3NDC:0338-0048-0412 in 1 CARTON12/31/1974
31000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
4NDC:0338-0048-059 in 1 CARTON12/31/197410/31/2022
41500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01742712/31/1974
Labeler - Baxter Healthcare Corporation (005083209)
Establishment
NameAddressID/FEIBusiness Operations
Baxter Healthcare Corporation001728059ANALYSIS(0338-0048) , MANUFACTURE(0338-0048) , LABEL(0338-0048) , PACK(0338-0048) , STERILIZE(0338-0048)
Establishment
NameAddressID/FEIBusiness Operations
Baxter Healthcare Corporation194684502ANALYSIS(0338-0048)

Revised: 2/2014
Document Id: 9f13743a-bc8c-41e2-8741-a688458fca3b
Set id: b3b4b176-41f0-4ca8-90d4-3fba5707564a
Version: 6
Effective Time: 20140221
 
Baxter Healthcare Corporation