Label: HOT SPOT POINT RELIEF- capsaicin gel

  • 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 October 5, 2010

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  • ACTIVE INGREDIENT

    Active Ingredients: Capsaicin

  • INACTIVE INGREDIENT

    Inactive Ingredients: deionized water, oil of Cassia, chondroitin sulfate, glucosamine sulfate,Glycrrhiza Glabra (licorice) extract, Carbomer, Triethanolamine,  polysorbate-20, Phenoxyethanol, Ethylhexylglycrine.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed consult physician

  • WARNINGS

    Warnings Section: For external use only, avoid contact with eyes, do not apply to open wounds or damaged skin, if symptoms persist for more than seven days discontinue use and consult physician, keep out of reach of children and if swallowed consult physician, do not bandage tightly.

  • PURPOSE

    Pain relieving gel
  • INDICATIONS & USAGE

    Use: For temporary relief of minor aches and pains of the muscles and joints associated with simple backache, arthritis, bruises, strains and/or sprains.



     
  • DOSAGE & ADMINISTRATION

    Apply directly to effected area. Do not use more than four times per day.

  • PRINCIPAL DISPLAY PANEL

    HotSpot Point Relief Pain Relieving gel, all natural ingredients.
    carton image
  • INGREDIENTS AND APPEARANCE
    HOT SPOT  POINT RELIEF
    capsaicin gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51452-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.5 mL  in 90 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    polysorbate 20 (UNII: 7T1F30V5YH)  
    CHONDROITIN SULFATE (BOVINE) (UNII: 6IC1M3OG5Z)  
    Glucosamine sulfate (UNII: 1FW7WLR731)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    CARBOMER 1342 (UNII: 809Y72KV36)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51452-010-0390 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34808/24/2010
    Labeler - fabrication enterprises (070577218)
    Registrant - fabrication enterprises (070577218)
    Establishment
    NameAddressID/FEIBusiness Operations
    fabrication enterprises070577218relabel
    Establishment
    NameAddressID/FEIBusiness Operations
    Pure Source969241041manufacture
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