Label: ISOTONIC SODIUM CHLORIDE- biofleks isotonic sodium chloride sterile injection
- NDC Code(s): 85184-0001-1, 85184-0001-2, 85184-0001-3, 85184-0001-4
- Packager: HAVER FARMA ILAC ANONIM SIRKETI
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Drug Label Information
Updated May 5, 2025
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GENERAL PRECAUTIONS
ADMINISTERED INTRAVENOUSLY ASEPTICALLY. Do not use if the solution is not clear or the bag is damaged. Please read the package leaflet. Consult your doctor right away if you have any unexpected effect. It is disposable. Partially used solutions should not be stored. Keep out of reach and sight of the children and store in the original package. Store at room temperature below 25°C. Sold with prescription only.
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PRINCIPAL DISPLAY PANEL
biofleks
100 mL
0.9 % ISOTONIC
SODIUM CHLORIDE SOLUTION
STERILEPer 100 mL
Sodium Chloride
Water for InjectionElectrolyte Concentrations (mEq/L)
ADMINISTERED INTRAVENOUSLY ASEPTICALLY. Do not use if the solution is not clear or the bag is damaged. Please read the package leaflet. Consult your doctor right away if you have any unexpected effect. It is disposable. Partially used solutions should not be stored. Keep out of reach and sight of the children and store in the original package. Store at room temperature below 25°C. Sold with prescription only. Distributor: Vin Trading LLC
Phone: (201) 676-3232 / E-Mail: info@vintradingllc.com Address: 203 Lemoine Ave #118, Fort Lee, NJ 07024
OSEL llaç San. ve Tic. A.Ş.
Beykoz / İstanbul / TURKEY100mL Bag
250mL Bag
500 mL Bag
1000mL Bag
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INGREDIENTS AND APPEARANCE
ISOTONIC SODIUM CHLORIDE
biofleks isotonic sodium chloride sterile injectionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:85184-0001 Route of Administration INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS, IRRIGATION Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE 0.9 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:85184-0001-1 100 mL in 1 BAG; Type 0: Not a Combination Product 01/01/2025 2 NDC:85184-0001-2 250 mL in 1 BAG; Type 0: Not a Combination Product 01/01/2025 3 NDC:85184-0001-3 500 mL in 1 BAG; Type 0: Not a Combination Product 01/01/2025 4 NDC:85184-0001-4 1000 mL in 1 BAG; Type 0: Not a Combination Product 01/01/2025 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 01/01/2025 Labeler - HAVER FARMA ILAC ANONIM SIRKETI (365593526) Registrant - HAVER FARMA ILAC ANONIM SIRKETI (365593526) Establishment Name Address ID/FEI Business Operations HAVER FARMA ILAC ANONIM SIRKETI 365593526 manufacture(85184-0001)