Label: SALISPRAY DAILY SALINE- nasal mist aerosol, spray

  • NDC Code(s): 83376-265-09
  • Packager: PONTIKA AEROTECH LIMITED
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated September 6, 2024

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  • Active ingredient

    Sodium Chloride 0.9%

  • Purpose

    Nasal Moisturizer

  • 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.
    • Helps remove inhaled irritants such as dust, dirt, and pollen.
  • Warnings

    • This product may cause temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge.
    • The use of this dispenser by more than one person may spread infection.
    • Avoid spraying in eyes.
    • Content under pressure.
    • Do not puncture or incinerate.
    • Store between 59º and 86º F (15º and 30º C)

    Keep out of reach of children

  • Directions

    Read HOW TO USE instructions before use

    • Adults and children 4 years of age an older:Use as often as needed or as directed by a physician
    • Children under 4 years: Consult a physician.
  • Other information

    Do not use if the printed safety seal on the bottle is broken or missing.

  • Inactive ingredients

    Purified Water, Sodium Bicarbonate

  • PRINCIPAL DISPLAY PANEL

    Daily Saline Nasal Mist Sodium Chloride 0.9% - NDC 83376-265-09 - Bottle Label

    PRINCIPAL DISPLAY PANEL

  • INGREDIENTS AND APPEARANCE
    SALISPRAY DAILY SALINE 
    nasal mist aerosol, spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83376-265
    Route of AdministrationNASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE0.9 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83376-265-0989 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product09/05/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other09/05/2024
    Labeler - PONTIKA AEROTECH LIMITED (861299010)
    Establishment
    NameAddressID/FEIBusiness Operations
    PONTIKA AEROTECH LIMITED861299010manufacture(83376-265) , analysis(83376-265)