Label: THERA PLUS COOL AND HEAT PAIN RELIEVING GEL MENTHOL- menthol liquid

  • NDC Code(s): 80684-097-00
  • Packager: Fourstar Group USA, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 30, 2023

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  • Drug Facts

  • Active ingredient

    Menthol 16%

    Purpose

    Topical analgesic

  • Uses

    For the temporarily relief of minor aches and pains of muscles and joints associated with: • simple backache • arthritis • strains • bruises • sprains

  • Warnings

    For external use only.

    Test on a small patch of skin before applying generously.

    Flammable •keep away from fire or flame

    When using this product

    • use only as directed • avoid contact with the eyes and mucous membranes • do not apply to wounds or damaged skin • do not
    bandage tightly • do not use with heating pads or other heating devices • if redness is present, discontinue use and consult a doctor • if skin irritation occurs, discontinue use • a transient burning sensation may occur upon application but generally disappears in several days

    Stop use and ask a doctor if

    condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

    If pregnant or breast-feeding,

    ask a health 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 12 years of age and older: • apply generously to affected area • massage into painful area until thoroughly absorbed into skin • repeat if necessary, but no more than 3 to 4 times daily • IF MEDICINE COMES IN CONTACT WITH HANDS, WASH WITH SOAP AND WATER. Children 12 years or younger: ask a doctor 

  • Other information

    • store at 20° - 25°C (68° - 77°F)
    • store in a cool dry place away from direct sunlight
  • Inactive ingredients

    acrylates/c10-30 alkyl acrylate crosspolymer, capsaicin, glycerin, isopropyl myristate, propylene glycol, sd alcohol, triethanoamine, water

  • Questions or comments?

    1-800-639-3803 Weekdays 9 AM to 4 PM EST

  • Package Labeling:

    Outer PackageInner Package

  • INGREDIENTS AND APPEARANCE
    THERA PLUS COOL AND HEAT PAIN RELIEVING GEL MENTHOL 
    menthol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80684-097
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL160 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CAPSAICIN (UNII: S07O44R1ZM)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80684-097-0074 mL in 1 BOTTLE; Type 0: Not a Combination Product02/01/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01702/01/2024
    Labeler - Fourstar Group USA, Inc. (140099503)
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