Label: VORTEX MOISTURIZER NASAL- sodium chloride liquid

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

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Drug Label Information

Updated March 7, 2022

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  • Drug Facts

  • Active Ingredients:

    Sodium Chloride 0.65%

    Purpose:

    Moisturizer

  • Inactive Ingredient:

    Purified mineral water

  • Uses

    Temporary relief of dry irritated nasal passages
    Promotes healthy nasal passages
    Clears and invigorates breathing

  • Directions:

    Sniff and inhale deeply while spraying into nostril.
    12 years old- adult: 3 sprays in each nostril.
    6 - 12 years old: 2 sprays in each nostril.
    3 - 6 years old: 1 spray in each nostril.
    Children under age 3: 1 spray. Consult a
    physician.
    To use, remove cap, insert the nozzle into
    the nostril and depress the pump completely
    while sniffing deeply.
    Day 1: every 3 hours, minimum 5 doses/day
    Day 2: every 3 hours, minimum 5 doses/day
    Day 3: 3 times a day.
    Day 4: at bedtime.
    Day 5: at bedtime.
    Day 6 - 9: skip.
    Day 10: Final dose at bedtime.
    For moderate to severe symptoms every 3 hours (minimum 5 doses/24 hrs) until symptoms have significantly reduced. Then,
    resume at day 3 schedule.

  • WARNING:

    Use only as directed.

    If pregnant or breastfeeding,

    consult with a physician before use.

    Keep out of reach of children.

    Stop use and consult with a physician

    if you experience any discomfort while using this product.

    In case of overdose, get medical help or contact a Poison Control Center at 1-800-222-2222 right away.

  • Other Information:

    Store and use at room temperature Inspect bottle for integrity Do not use if safety seal is broken

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    VORTEX MOISTURIZER NASAL 
    sodium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82529-000
    Route of AdministrationNASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE6.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82529-000-011 in 1 BOX03/01/2022
    115 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other03/01/2022
    Labeler - Vortex Life Sciences, Inc. (118489121)
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