SALINE SPRAY [HEALTHLIFE OF USA]

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SALINE SPRAY [HEALTHLIFE OF USA]
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NDC 69517-609-19
Set ID 70bfb707-e86e-44da-9a2e-f18f81348180
Category HUMAN OTC DRUG LABEL
Packager Healthlife of USA
Generic Name
Product Class
Product Number
Application Number PART349
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  • Drug Facts

  • Active Ingredients

    Sodium Chloride 0.65%

  • Purpose 

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

  • Ingredients 

    A solution of sodium chloride 0.65% in purified water (USP), made isotonic with sodium phosphate dibasic and sodium phosphate monobasic, with benzyl alcohol and benzalkonium chloride as preservatives.

  • Uses

    for dry nasal membranes squeeze twice in each nostril as needed.

  • Directions

    upright delivers as a spray, horizontally as a stream, upside down as a drop.

  • Warnings

    If pregnant or breast-feeding, ask a healthcare 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 Center right away.

  • Questions or comments?

    Call 1-844-832-1138

    *This product is not manufactured or distributed by Valeant Consumer Products, Distributors of Ocean Saline Nasal Spray.

  • Saline Nasal Spray 

    Distributed by:

    Healthlife of USA

    1600 Hart Street,

    Rahway, NJ 07065

    www.healthlifeofusa.com

    image description

  • INGREDIENTS AND APPEARANCE
    SALINE 
    saline spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69517-609
    Route of AdministrationNASAL
    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 (UNII: 3980JIH2SW)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69517-609-191 in 1 CARTON01/10/2018
    144 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34901/10/2018
    Labeler - Healthlife of USA (079656178)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kingston Pharma LLC080386521manufacture(69517-609)
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