Label: STERILE HYPERTONIC SALINE SOLUTION 7 SODIUM CHLORIDE- sodium chloride liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated February 21, 2024

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  • Drug Facts

  • Active ingredient

    Sodium Chloride 7%

    Purpose

    Moisturizer

  • Uses:

    For dry nasal membranes

  • Warnings

    • NOT FOR INJECTION
    • Only use sealed vials do not use if vial is broken or already open

    Keep out of reach of children

    • Do not use after expiration date
    • Discontinue if you experience any adverse reaction and call your physician
  • Directions

    • Apply Solution with fingers or swab directly into the nose.
    • Apply 2-3 rounds per nostril to sanitize and moisturize nasal passages 
  • Inactive ingredients

    USP Water

  • Package Labeling:

    Label0

  • INGREDIENTS AND APPEARANCE
    STERILE HYPERTONIC SALINE SOLUTION 7 SODIUM CHLORIDE 
    sodium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80327-009
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE70 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80327-009-011 in 1 CARTON04/01/2022
    15 mL in 1 VIAL; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other04/01/2022
    Labeler - JOONEM LLC (117633878)
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