Label: SIMPLY SALINE NETI POT SINUS WASH- sinus wash powder, for solution

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

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Drug Label Information

Updated September 30, 2022

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  • Active Ingredients

    Sodium Bicarbonate USP 515 mg

    Sodium Chloride USP 1685 mg

  • Purpose

    Nasal Wash

  • Uses

    • Restores vital moisture to provide prompt relief for dry , crusted and inflamed nasal membranes due to chronic sinusitis, colds, low humidity, overuse of nasal decongestant drops and sprays, allergies, minor nose bleeds and other minor nasal irritations.
    • Temporarily relieves nasal stuffiness.
    • Reduces swelling of nasal passages; shrinks swollen membranes.
    • Promotes nasal and/or sinus drainage; temporarily relieves sinus congestion and pressure.
  • Warnings

    • Do not exceed recommended dosage.
    • This product may cause temporary discomfort such as burning, stinging, sneezing or an increase in nasal discharge.
    • The use of this container by more than one person may spread infection.
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • Directions

    • Adults and children 4 years and over : Use 1-2 packets per 240 ml up to every 2 hours as needed
    • Children under 4 years : Consult a physician
  • Other Information

    • Inspect saline packets for integrity
    • Do not use saline packets if open or torn
    • Protect saline packets from excessive heat and moisture
    • See saline packets or box for lot# and expiration date
  • Inactive Ingredients

    None

  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL

  • INGREDIENTS AND APPEARANCE
    SIMPLY SALINE NETI POT SINUS WASH 
    sinus wash powder, for solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70708-269
    Route of AdministrationNASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37, BICARBONATE ION - UNII:HN1ZRA3Q20) SODIUM BICARBONATE515 mg  in 2200 mg
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM CHLORIDE1685 mg  in 2200 mg
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Colorwhite (WHITE CRYSTALLINE GRANULE POWDER) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70708-269-5050 in 1 BOX10/01/2022
    12200 mg in 1 POUCH; Type 1: Convenience Kit of Co-Package
    2NDC:70708-269-1010 in 1 BOX10/01/2022
    22200 mg in 1 POUCH; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other10/01/2022
    Labeler - GURUNANDA, LLC (079671169)
    Registrant - GURUNANDA, LLC (079671169)
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