Label: SALINE NASAL 1 FL OZ- sodium chloride 2.65% spray

  • Category: HUMAN OTC DRUG LABEL

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Drug Label Information

Updated January 11, 2021

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  • Active ingredient

    Sodium Chloride, 2.65%

  • Purpose

    Nasal Wash to flush allergens and dust from Nasal Passages

  • Uses

    Nasal congestion
    Removes inhaled irritants (dust, dirt, pollen)
    Moisturizes dry nasal passages

  • Warnings

    Do not use if seal is broken or missing.

    Warnings

    Use of this product by more than one person may spread infection
    Contents under pressure
    Do not puncture or incinerate
    Avoid spraying in eyes

    Keep out of reach of children. The use of this dispenser by more than one person may spread infection.

  • Directions

    • Squeeze twice in each nostril as needed
    • Upright delivers a spray, horizontally a stream, upside down a drop
    • Take care not to aspirate nasal contents back into bottle
    • If spray tip touches nose, rinse with hot water before replacing cap
  • Inactive ingredients

    A hypertonic solution of purified water, potassium phosphate/Sodium
    hydroxide buffer, disodium ethylenediaminetetraacetic acid, benzalkonium chloride

  • Label

    Untitled

  • INGREDIENTS AND APPEARANCE
    SALINE NASAL   1 FL OZ
    sodium chloride 2.65% spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73492-701
    Route of AdministrationNASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE2.65 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73492-701-3024 in 1 BOX11/19/2019
    130 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other11/19/2019
    Labeler - ALAINA HEALTHCARE PRIVATE LIMITED (858720927)
    Establishment
    NameAddressID/FEIBusiness Operations
    ALAINA HEALTHCARE PRIVATE LIMITED858720927manufacture(73492-701)
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