Label: THROAT-RELEEV (HONEY AND LEMON)- benzalkonium chloride liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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 April 10, 2012

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  • ACTIVE INGREDIENTS

    Benzalkonium  Chloride
  • USES:


    • For the relive of symtoms associated with sore throat including:

                        pain, Burning, Itching and tingling

    • First aid to help guard against secondary skin infection due to sore
      throat.







  • WARNINGS:


    For external used only. Not for ingestion.

    Do not used- in yeast infections- do not spray directly on the eyes

    When using this product, may tingle on contact.

    Stop used and ask doctor if - condition worsens- symptoms

    last more then 7 days







  • KEEP OUT OF REACH OF CHILDREN:


    In case of overdose, or accidental poisoning,

    get medical help or contact a Poison Control Center right away.





  • DIRECTIONS:

    Adults and children 12  years or older. Shake well.





  • DOSAGE & ADMINISTRATION


    Direct nozzel to sore throat area and spray 3-4  times.
    Do not swallow.
    Hold for 15 seconds or longer then spit remaining liquid out.




  • Other Ingredients

    Viracea (proprietary Echinacea purpurea extract). Methylparaben

    Potassium Sorbate (natural preservative ). Propylparaben , water (purified)

    Stevia, Natural honey and lemon flavors.










  • PRINCIPAL DISPLAY PANEL

    Throat Releev Honey Lemon label

    Throat Releev Honey Lemon cropped

  • INGREDIENTS AND APPEARANCE
    THROAT-RELEEV (HONEY AND LEMON) 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63287-211
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Benzalkonium Chloride (UNII: F5UM2KM3W7) (Benzalkonium - UNII:7N6JUD5X6Y) Benzalkonium Chloride1.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Methylparaben (UNII: A2I8C7HI9T)  
    Potassium Sorbate (UNII: 1VPU26JZZ4)  
    Propylparaben (UNII: Z8IX2SC1OH)  
    Echinacea purpurea flowering top (UNII: 2EMS3QFX65)  
    STEVIA LEAF (UNII: 6TC6NN0876)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorHONEY (Honey Flavor) , LEMON (Lemon flavosr) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63287-211-036.0 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/14/2010
    Labeler - Merix Pharmaceutical Corp. (158385687)
    Registrant - Topical Pharmaceutiocals Inc. (831530683)
    Establishment
    NameAddressID/FEIBusiness Operations
    Topical Pharmaceutiocals Inc.831530683manufacture
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