Label: ARTHRITIS PAIN RELIEF- capsaicin 0.15 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 November 30, 2017

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  • Active ingredient

    Capsaicin 0.15%

  • Purpose

    Topical analgesic

  • Uses

    Temporarily relieves minor pain associated with:

    • arthritis
    • simple backache
    • muscle strains
    • muscle sprains
    • bruises
    • cramps
  • Warnings

    ​For external use only

  • When using this product

    • Use only as directed
    • Do not bandage tightly
    • Do not use with a heating pad
    • Avoid contact with eyes and mucous membranes
    • Do not apply to wounds, damaged, broken or irritated skin
    • A transient burning sensation may occur upon application but generally disappears in several days
    • If severe burning sensation occurs, discontinue use immediately and read packate insert for importan information
    • Do not expose the area treated with product to hear or direct sunlight
    • Avoid taking a bath or shower within 1 hour before or after applying
  • Stop use and ask a doctor if

    • Condition worsens
    • Redness is present
    • Irritation develops
    • Symptoms persist for more than 7 days or clear up and occur again within a few days
  • Flammable

    keep away form fire or flame

  • If pregnant or breast-feeding,

    ask a healthcare professional before use.

  • Keep out of reach of children.

    If swallowed, get medical help or contact a Poison COntrol Center right away.

  • Directions

    ​​Adults and children over 18 years:

    • Apply to affected area
    • Massage into painful area until thoroughly absorbed
    • Repeat as necessary, but no more than 3 to 4 times daily
    • ​IF MEDICINE COMES IN CONTACT WITH HANDS, WASH WITH SOAP AND WATER

    ​

    Children 18 years or younger: ask a doctor

  • Inactive ingredients

    Carbomer, Glycerin, Propylene Glycol, SD Alcohol 40-2 (35%), Triethanolamine, Water.

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    ARTHRITIS PAIN RELIEF 
    capsaicin 0.15 liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-237
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN.15 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALCOHOL (UNII: 3K9958V90M)  
    TROMETHAMINE (UNII: 023C2WHX2V)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-237-011 in 1 CARTON11/11/2014
    130 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34811/11/2014
    Labeler - CVS (062312574)
    Registrant - Product Quest Mfg, LLC (927768135)
    Establishment
    NameAddressID/FEIBusiness Operations
    Product Quest Mfg, LLC927768135manufacture(59779-237) , label(59779-237)
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