Label: HOT/COLD MENTHOL 16% ROLL-ON liquid

  • NDC Code(s): 0395-9131-97
  • Packager: Humco Holding Group, Inc
  • 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 June 23, 2020

If you are a consumer or patient please visit this version.

  • DOSAGE & ADMINISTRATION

    Adults and children over 12 yrs of age: apply to the affected area no more than 3 to 4 times daily

    IF MEDICINE COMES IN CONTACT WITH HANDS, WASH WITH SOAP AND WATER.

  • WARNINGS

    When using this product: use only as directed. Do not bandage tightly or use with a heating pad. Avoid contact with eyes and mucous membranes. Do not apply to wounds or damaged, broken or irritated skin. If you experience pain, swelling, or blistering of the skin where an OTC topical muscle and joint pain reliever was applied, stop using the product and seek professional attention immediately. These products produce local warmth or coolness.

  • INACTIVE INGREDIENT

    Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Capsaicin, Glycerin, Isopropyl Myristate, Propylene Glycol, SD Alcohol 40 (30%Z), Triethanolamine, Purified Water.

  • INDICATIONS & USAGE

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

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • PURPOSE

    Topical analgesic

  • ACTIVE INGREDIENT

    Menthol 16%

  • Equate Label

    pain

  • INGREDIENTS AND APPEARANCE
    HOT/COLD MENTHOL 16% ROLL-ON 
    hot/cold menthol 16% roll-on liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0395-9131
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL16 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    (C10-C30)ALKYL METHACRYLATE ESTER (UNII: XH2FQZ38D8)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    ALCOHOL (UNII: 3K9958V90M)  
    CAPSAICIN (UNII: S07O44R1ZM)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0395-9131-9774 mL in 1 CONTAINER; Type 0: Not a Combination Product12/21/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34812/21/2018
    Labeler - Humco Holding Group, Inc (825672884)
    Registrant - Humco Holding Group, Inc (825672884)
    Establishment
    NameAddressID/FEIBusiness Operations
    Humco Holding Group, Inc825672884label(0395-9131) , pack(0395-9131) , analysis(0395-9131) , manufacture(0395-9131)