Label: SALINE NASAL - sodium chloride spray

  • NDC Code(s): 67510-0667-1, 67510-0667-5
  • Packager: Kareway Product, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

Drug Label Information

Updated 02/13

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  • ACTIVE INGREDIENT

    Sodium Chloride 0.65%

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  • Purpose

    Moisturizer

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  • Use

    • For dry nasal membranes
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  • 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.

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  • Directions

    • Squeeze twice in each nostril as needed
    • Upright delivers a spray, horizontally a stream, upside down a drop
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  • Inactive Ingredients

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

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  • PRINCIPAL DISPLAY PANEL

    saline nasal sprayimage of bottle label

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  • INGREDIENTS AND APPEARANCE
    SALINE NASAL  
    sodium chloride spray
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:67510-0667
    Route of Administration NASAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM CHLORIDE 6.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    BORIC ACID (UNII: R57ZHV85D4)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    POLYAMINOPROPYL BIGUANIDE (UNII: 322U039GMF)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:67510-0667-1 44 mL in 1 BOTTLE
    2 NDC:67510-0667-5 89 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 02/07/2011
    Labeler - Kareway Product, Inc. (121840057)
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