Label: SALINE NASAL 3OZ- sodium chloride spray 

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

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 11/13

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  • Active ingredient

    Sodium Chloride, 0.65%

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  • Purpose

    Moisturizer

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  • Uses

    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

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

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  • INGREDIENTS AND APPEARANCE
    SALINE NASAL  3OZ
    sodium chloride 0.65% spray
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:23558-6895
    Route of Administration NASAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SODIUM CHLORIDE (CHLORIDE ION) SODIUM CHLORIDE 6.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    BENZALKONIUM CHLORIDE  
    SODIUM PHOSPHATE, DIBASIC ANHYDROUS  
    BENZYL ALCOHOL  
    SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS  
    WATER  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:23558-6895-1 88 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part349 10/01/2013
    Labeler - Lee Pharmaceuticals (056425432)
    Registrant - Lee Pharmaceuticals (056425432)
    Establishment
    Name Address ID/FEI Business Operations
    Lee Pharmaceuticals 056425432 manufacture(23558-6895)
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