![LACTATED RINGERS (SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE) IRRIGANT [BAXTER HEALTHCARE CORPORATION]](https://medic.hrt.org//dailymed/images/f09f80bf-2f8b-4420-865d-aec2d5e5cd4d/image-01.jpg)
![LACTATED RINGERS (SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE) IRRIGANT [BAXTER HEALTHCARE CORPORATION]](https://medic.hrt.org//dailymed/images/f09f80bf-2f8b-4420-865d-aec2d5e5cd4d/image-02.jpg)
| NDC | 0338-0114-04 |
| Set ID | f09f80bf-2f8b-4420-865d-aec2d5e5cd4d |
| Category | HUMAN PRESCRIPTION DRUG LABEL |
| Packager | Baxter Healthcare Corporation |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | NDA018494 |
- DESCRIPTION
- INDICATIONS AND USAGE
- DOSAGE AND ADMINISTRATION
- HOW SUPPLIED
-
PRINCIPAL DISPLAY PANEL - PACKAGING LABELING
Container Label
2F7154
NDC 0338-0114-041000 mL
Baxter Logo
Not for Injection
Lactated Ringer's
IrrigationEach 100 mL contains: 600 mg Sodium
Chloride, USP, 310 mg Sodium Lactate, 30
mg Potassium Chloride, USP, 20 mg Calcium
Chloride, USP. No antimicrobial agent has been
added. pH 6.5 (6.0 to 7.5). Osmolarity 273
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 USAMade in USA
LOT
EXP
FPO
(91)0709000249
Bar Code07-09-00-0249
Bar Code Position Only*
303380114047Carton Label
Lactated Ringer's
Irrigation
Pour Bottle1000 mL
Qty
12NDC 0338-0114-04
2F7154
EXP
LOT#
(01)50303380114042(17)080630(10)G012345
07-06-47-995
-
INGREDIENTS AND APPEARANCE
LACTATED RINGERS
sodium chloride, sodium lactate, potassium chloride, calcium chloride irrigantProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0338-0114 Route of Administration IRRIGATION Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE 600 mg in 100 mL SODIUM LACTATE (UNII: TU7HW0W0QT) (LACTIC ACID - UNII:33X04XA5AT, SODIUM CATION - UNII:LYR4M0NH37) SODIUM LACTATE 310 mg in 100 mL POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152, CHLORIDE ION - UNII:Q32ZN48698) POTASSIUM CHLORIDE 30 mg in 100 mL CALCIUM CHLORIDE (UNII: M4I0D6VV5M) (CALCIUM CATION - UNII:2M83C4R6ZB, CHLORIDE ION - UNII:Q32ZN48698) CALCIUM CHLORIDE 20 mg in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0338-0114-04 12 in 1 CARTON 02/19/1982 1 1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA018494 02/19/1982 Labeler - Baxter Healthcare Corporation (005083209) Establishment Name Address ID/FEI Business Operations Baxter Healthcare Corporation 001728059 ANALYSIS(0338-0114) , MANUFACTURE(0338-0114) , LABEL(0338-0114) , PACK(0338-0114) , STERILIZE(0338-0114) Establishment Name Address ID/FEI Business Operations Baxter Healthcare Corporation 194684502 ANALYSIS(0338-0114) Establishment Name Address ID/FEI Business Operations Baxter Healthcare Corporation 059140764 API MANUFACTURE(0338-0114)
