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

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 02/13

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Sodium Chloride 0.65%

    Close
  • Purpose

    Moisturizer

    Close
  • Use

    • For dry nasal membranes
    Close
  • 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.

    Close
  • Directions

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

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

    Close
  • PRINCIPAL DISPLAY PANEL

    saline nasal sprayimage of bottle label

    Close
  • INGREDIENTS AND APPEARANCE
    SALINE NASAL  
    sodium chloride spray
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:67510-0667
    Route of Administration NASAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SODIUM CHLORIDE (SODIUM CATION) SODIUM CHLORIDE 6.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    BORIC ACID  
    EDETATE DISODIUM  
    POLYAMINOPROPYL BIGUANIDE  
    WATER  
    SODIUM BORATE  
    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)
    Close