Label: SALINE NASAL- sodium chloride spray

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

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Drug Label Information

Updated December 9, 2013

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  • ACTIVE INGREDIENT

    Sodium Chloride 0.65%

  • Purpose

    Moisturizer

  • Use

    • 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

    Boric acid, edetate disodium, polyhexamethylenebiguanide, purified water, sodium borate

  • PRINCIPAL DISPLAY PANEL

    saline nasal spray

    image of bottle label

  • INGREDIENTS AND APPEARANCE
    SALINE NASAL  
    sodium chloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58988-0184
    Route of AdministrationNASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM CHLORIDE6.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BORIC ACID (UNII: R57ZHV85D4)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    POLYAMINOPROPYL BIGUANIDE (UNII: 322U039GMF)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58988-0184-144 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other12/09/2013
    Labeler - Promex, LLC (789974388)
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