Label: STOPAIN EXTRA STRENGTH- menthol gel

  • NDC Code(s): 63936-8801-1
  • Packager: Troy Manufacturing, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 25, 2023

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  • Drug Facts

  • Active Ingredient

    Menthol 8.0%

    Purpose

    Topical Analgesic

  • Uses

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

  • Warnings

    Avoid contact with eyes. For external use only.

    Flammable: Keep away from fire or flame.

    When using this product

    • use only as directed • do not bandage tightly or use a heating pad • do not apply to wounds or damaged skin

    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 • redness is present • excessive irritation of the skin develops

    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

    • apply directly onto affected area without the need to bandage • repeat if necessary, but do not apply more than 4 times daily. Adults and children over 12 years: 

    ask a doctor. Children 12 years of younger:

  • Other Information

    • Store at room temperature

  • Inactive Ingredients

    acrylic acid/vinyl ester copolymer, dimethylsulfone (MSM), eucalyptus oil, glucosamine sulfate, hydroxypropylcellulose, PEG-8 dimethicone, pentylene glycol, peppermint oil, SD alcohol 39C, triethanolamine, water (USP).

  • Package Labeling:

    Label0

  • INGREDIENTS AND APPEARANCE
    STOPAIN EXTRA STRENGTH 
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63936-8801
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL80 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)  
    HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
    PEG-8 DIMETHICONE (UNII: GIA7T764OD)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63936-8801-13 g in 1 PACKET; Type 0: Not a Combination Product01/31/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01701/31/2023
    Labeler - Troy Manufacturing, Inc. (160075248)
    Establishment
    NameAddressID/FEIBusiness Operations
    Troy Manufacturing, Inc.160075248manufacture(63936-8801)
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