Label: HOT SPOT POINT RELIEF- capsaicin gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 13, 2011

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  • ACTIVE INGREDIENT

    acitve ingredients: capsaicin
  • INACTIVE INGREDIENT

    aqua (deionized water), carbomer, cassia oil, choldroitin sulfate, ethylhexylglycerine, glucosamine sulfate, glycrrhiza glabra (licorice) extract, phenoxyethanol, polysorbate-20

  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of children. if swallowed consult physician.

  • WARNINGS

    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. if swallowed, consult physician.

    do not bandage tightly

  • PURPOSE

    external analesic

  • INDICATIONS & USAGE

    for temprorary 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 affected area. do not use more than four times per day.

  • PRINCIPAL DISPLAY PANEL

    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) CAPSAICIN.03 mL  in 5 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)  
    CASSIA FISTULA FRUIT (UNII: J65X53KM9E)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51452-010-005 mL in 1 PACKET
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34810/13/2011
    Labeler - Fabrication Enterprises, inc. (070577218)
    Registrant - Pure Source (969241041)
    Establishment
    NameAddressID/FEIBusiness Operations
    pure source969241041manufacture
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