Label: SALINE NASAL spray

  • Category: HUMAN OTC DRUG LABEL

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 February 7, 2015

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  • ACTIVE INGREDIENT

    Active Ingredient: Sodium Chloride 0.65%

  • PURPOSE

    For allergies, cold, flu, sinusitis, rhinitis and dry irritated nasal passages

  • INDICATIONS & USAGE

    Indications: For relief of dry nasal passages caused by sinus, cold and allergy medications, nasal surgery and dry air. Also relieves congestion by thinning mucus.

  • WARNINGS

    WARNING:
    If pregnant or breast feeding, ask a health professional before use.

    Use of this container by more than one person may spread infection.

    Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Centre right away.

  • DOSAGE & ADMINISTRATION

    Directions: For children and adults, squeeze bottle twice in each nostril as often as needed or as directed by doctor. For infants, use drop application. Hold bottle upright for spray, horizontally for stream and upside down for drop.

  • INACTIVE INGREDIENT

    INGREDIENTS:
    Sodium phosphate dibasic and sodium phosphate monobasic, with benzyl alcohol and benzalkonium chloride as preservatives.

  • PRINCIPAL DISPLAY PANEL

    Made in USA

    Manufactured by Purinepharma LLC
    Massena, NY 13662 U.S.A.
     *This product is not manufactured or distributed by Valeant Consumer Products, distributors of Ocean Saline Nasal Spray

    44mL
  • INGREDIENTS AND APPEARANCE
    SALINE NASAL 
    saline nasal spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58599-036
    Route of AdministrationORAL, Type 0: Not a Combination Product
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE6.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
    SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS (UNII: KH7I04HPUU)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58599-036-1944 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34902/07/2015
    Labeler - PURINEPHARMA LLC (019950491)
    Registrant - PURINEPHARMA LLC (019950491)
    Establishment
    NameAddressID/FEIBusiness Operations
    PURINEPHARMA LLC019950491manufacture(58599-036)
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