Label: SALINE NASAL- sodium chloride 0.65% spray

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated September 12, 2012

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  • Active ingredient

    Sodium Chloride, 0.65%

  • Purpose

    Moisturizer

  • Uses

    For dry nasal membranes

  • Warnings

    Do not use if seal is broken or missing.

    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
  • Inactive ingredients

    Benzalkonium chloride, Disodium phosphate, Phenylcarbinol, Monosodium phosphate, Water

  • PRINCIPAL DISPLAY PANEL

    image of label

  • INGREDIENTS AND APPEARANCE
    SALINE NASAL 
    sodium chloride 0.65% spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:23558-0569
    Route of AdministrationNASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE6.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    SODIUM PHOSPHATE, DIBASIC ANHYDROUS (UNII: 22ADO53M6F)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS (UNII: KH7I04HPUU)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:23558-0569-044 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34907/01/2013
    Labeler - Lee Pharmaceuticals (056425432)
    Registrant - Lee Pharmaceuticals (056425432)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lee Pharmaceuticals056425432manufacture(23558-0569)
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