Label: CVS ROLL-ON- capsaisin 0.1% gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 15, 2024

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  • ACTIVE INGREDIENT

    Capsaicin 0.1%

  • PURPOSE

    Topical Analgesic

  • INDICATIONS & USAGE

    Temporarily relieves minor pain associated with arthritis, simple backache, sprains, bruises, muscle strains, and cramps.

  • WARNINGS

    For external use only.

    When using this product do not bandage tightly or cover treated area, do not use with 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 occurs, discontinue use immediately, do not expose the area treated with product to heat or direct sunlight.

    Stop use and ask a doctor if condition worsens, symptoms last more than 7 days or clear up and occur again within a few days, redness is present, or irritation develops.

  • PREGNANCY OR BREAST FEEDING

    Ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    If product is swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Adults and children of 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. WASH HANDS WITH SOAP AND WATER AFTER APPLYING. Children 18 years or younger: ask a doctor.

  • INACTIVE INGREDIENT

    Alcohol denat., aminomethyl propanol, carbomer, glycerin, propylene glycol, water.

  • PRINCIPAL DISPLAY PANEL

    Label

  • INGREDIENTS AND APPEARANCE
    CVS ROLL-ON 
    capsaisin 0.1% gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51316-265
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51316-265-0271 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/22/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01712/22/2022
    Labeler - CVS (062312574)
    Registrant - Derma Care Research Labs, LLC (116817470)
    Establishment
    NameAddressID/FEIBusiness Operations
    Derma Care Research Labs, LLC116817470manufacture(51316-265)
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