EXTRA STRENGTH STOPAIN COLD PAIN RELIEVING ROLL ON (MENTHOL) LIQUID [TROY MANUFACTURING, INC]

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EXTRA STRENGTH STOPAIN COLD PAIN RELIEVING ROLL ON (MENTHOL) LIQUID [TROY MANUFACTURING, INC]
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NDC 63936-8523-1
Set ID 895896dc-0762-40a7-8313-cca10ce68984
Category HUMAN OTC DRUG LABEL
Packager TROY MANUFACTURING, INC
Generic Name
Product Class
Product Number
Application Number PART348
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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 • strains  • bruises  • sprains

  • Warnings

    For external use only. Avoid contact with eyes.

    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

    Adults and children over 12 years: • roll directly onto affected area without the need to rub, massage or bandage

    • repeat if necessary, but do not apply more than 4 times daily

    Children 12 years or younger: ask a doctor.

  • Other information

    • Store at room temperature.

  • Inactive Ingredients

    boswellia serrata extract, carbomer, dimethylsulfone (MSM), eucalyptus oil, glucosamine sulfate, glycerin, peppermint oil, SD alcohol 39C, triethanolamine, water.

  • Package Labeling:

    Label2Label3

  • INGREDIENTS AND APPEARANCE
    EXTRA STRENGTH STOPAIN COLD PAIN RELIEVING ROLL ON 
    menthol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63936-8523
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL80 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    ALCOHOL (UNII: 3K9958V90M)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63936-8523-188 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product10/13/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34810/13/2010
    Labeler - TROY MANUFACTURING, INC (160075248)
    Registrant - TROY MANUFACTURING, INC (160075248)
    Establishment
    NameAddressID/FEIBusiness Operations
    TROY MANUFACTURING, INC160075248manufacture(63936-8523)
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