Label: RINGERS- sodium chloride, calcium chloride, potassium chloride, irrigant
- NDC Code(s): 0338-0104-04
- Packager: Baxter Healthcare Corporation
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated June 13, 2012
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- DESCRIPTION
- INDICATIONS AND USAGE
- DOSAGE AND ADMINISTRATION
- HOW SUPPLIED
-
PRINCIPAL DISPLAY PANEL - PACKAGING LABELING
Container Label
2F7164
NDC 0338-0104-04
1000 mLBaxter Logo
Not for Injection
Ringer's Irrigation, USP
Each 100 mL contains: 860 mg Sodium Chloride,
USP, 33 mg Calcium Chloride, USP, 30 mg
Potassium Chloride, USP. No antimicrobial agent
has been added. pH 6.0 (5.0 to 7.5). Osmolarity
309 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
07-09-00-0250
Bar Code Position Only*
303380104048LOT
EXP -
INGREDIENTS AND APPEARANCE
RINGERS
sodium chloride, calcium chloride, potassium chloride, irrigantProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0338-0104 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 860 mg in 100 mL CALCIUM CHLORIDE (UNII: M4I0D6VV5M) (CALCIUM CATION - UNII:2M83C4R6ZB, CHLORIDE ION - UNII:Q32ZN48698) CALCIUM CHLORIDE 33 mg in 100 mL POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152, CHLORIDE ION - UNII:Q32ZN48698) POTASSIUM CHLORIDE 30 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:0338-0104-04 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 NDA018495 02/19/1982 Labeler - Baxter Healthcare Corporation (005083209) Establishment Name Address ID/FEI Business Operations Baxter Healthcare Corporation 001728059 ANALYSIS(0338-0104) , MANUFACTURE(0338-0104) , LABEL(0338-0104) , PACK(0338-0104) , STERILIZE(0338-0104) Establishment Name Address ID/FEI Business Operations Baxter Healthcare Corporation 194684502 ANALYSIS(0338-0104)
