Label: SODIUM CHLORIDE irrigant
- NDC Code(s): 0338-0047-44, 0338-0047-46, 0338-0047-47
- Packager: Baxter Healthcare Corporation
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated May 4, 2017
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SPL UNCLASSIFIED SECTION
Directions for Use of Flexible Plastic Irrigation Containers
If desired, warm in overwrap to near body temperature in a water bath or oven heated to not more than 45°C.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
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DIRECTIONS FOR USE
Tear overwrap down side at slit and remove solution container. Visually inspect the container. If the outlet port protector is damaged, detached, or not present, discard container as solution path sterility may be impaired. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually. Check for minute leaks by squeezing bag firmly. If leaks are found, discard solution as sterility may be impaired.
Use Aseptic Technique.
- 1.
- Suspend container using hanger hole.
- 2.
- Remove plastic protector from outlet port at bottom of container.
- 3.
- Attach irrigation set. Refer to complete directions accompanying set.
Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended the product be stored at room temperature (25°C): brief exposure up to 40°C does not adversely affect the product.
- SPL UNCLASSIFIED SECTION
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PRINCIPAL DISPLAY PANEL - PACKAGING LABELING
3000 mL
2B77127
NDC 0338-0047-47NOT FOR INJECTION
0.9%
SODIUM CHLORIDE
Irrigation USPEach 100 mL contains 900 mg Sodium
Chloride USP No antimicrobial agent has
been added pH 5.5 (4.5 to 7.0) mEq/L
Sodium 154 Chloride 154 Osmolarity 308
mOsmol/L (calc) Sterile Nonpyrogenic
Single dose containerDo not use unless solution is clear Discard
unused portionCautions Squeeze and inspect inner bag
which maintains product sterility Discard if
leaks are found Rx Only Store unit in
moisture barrier overwrap at room
temperature (25°C) until ready to use Avoid
excessive heat See insert0.9%
Sodium Chloride
NaCl
Irrigation USPUROMATIC container
PL 146 plastic
BAXTER UROMATIC and PL 146 are
trademarks of Baxter International IncFor product information
1-800-933-0303Baxter Logo
Baxter Healthcare Corporation
Deerfield, IL 60015 USAMade in Mexico
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INGREDIENTS AND APPEARANCE
SODIUM CHLORIDE
sodium chloride irrigantProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0338-0047 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 900 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:0338-0047-44 14 in 1 CARTON 05/30/1980 1 1000 mL in 1 BAG; Type 0: Not a Combination Product 2 NDC:0338-0047-46 6 in 1 CARTON 05/30/1980 2 2000 mL in 1 BAG; Type 0: Not a Combination Product 3 NDC:0338-0047-47 4 in 1 CARTON 05/30/1980 3 3000 mL in 1 BAG; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA017867 05/30/1980 Labeler - Baxter Healthcare Corporation (005083209) Establishment Name Address ID/FEI Business Operations Baxter Healthcare Corporation 059140764 ANALYSIS(0338-0047) , LABEL(0338-0047) , MANUFACTURE(0338-0047) , PACK(0338-0047) , STERILIZE(0338-0047) Establishment Name Address ID/FEI Business Operations Baxter Healthcare Corporation 194684502 ANALYSIS(0338-0047) Establishment Name Address ID/FEI Business Operations Baxter, S.A. de C.V. 810432484 ANALYSIS(0338-0047) , MANUFACTURE(0338-0047) , LABEL(0338-0047) , PACK(0338-0047) , STERILIZE(0338-0047)
