Label: FAST RESULTS GENITAL HERPES TREATMENT- benzalkonium chloride,allantoin 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 May 22, 2012

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  • ACTIVE INGREDIENTS:

    Benzalkonium chloride 0.13 %
    Allantoin 0.5 %
  • USES:

    For the relief of symptoms associated with genital herpes
    First Aid to guard against secondary skin infection





  • WARNINGS:

    Use only as directed. For external use only. Do not use if allergic to daisies.
    Stop use and ask doctor if condition worsens or last more than 10 days.
    Do not use on yeast infections.


  • KEEP OUT OF REACH OF CHILDREN:


    Keep this and all drugs out of reach of children.

    In case of accidental ingestion other then intended use, seek professional assistance
    or call a poison control center.




  • DIRECTIONS:

    Adults or adolescents 12 or older apply to clean dry area free of soap or cleanser residue.



  • DOSAGE & ADMINISTRATION

    Apply to area as need  3-4 times daily. Do no use cotton to apply.
    Allow to dry.




  • Other Ingredients:

    Purified water, Viracea ( a patented blend of Bensalkonium chloride and Echinacea)
    Methylparaben, Propylparaben, Potassium sorbate.
  • PRINCIPAL DISPLAY PANEL

    Fast Results label
    Fast Results label


  • INGREDIENTS AND APPEARANCE
    FAST RESULTS GENITAL HERPES TREATMENT 
    benzalkonium chloride,allantoin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63287-425
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Benzalkonium Chloride (UNII: F5UM2KM3W7) (Benzalkonium - UNII:7N6JUD5X6Y) Benzalkonium Chloride1.3 mL  in 1 mL
    Allantoin (UNII: 344S277G0Z) (Allantoin - UNII:344S277G0Z) Allantoin5 mL  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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63287-425-251 in 1 BOX
    125 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/01/2006
    Labeler - Merix Pharmaceutical Corp. (158385687)
    Registrant - Topical Pharmaceutiocals Inc. (831530683)
    Establishment
    NameAddressID/FEIBusiness Operations
    Topical Pharmaceutiocals Inc.831530683manufacture
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