Label: COOLING- menthol gel

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

Drug Label Information

Updated January 30, 2024

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  • ACTIVE INGREDIENT

    MENTHOL 1.2%

  • PURPOSE

    TOPICAL ANALGESIC

  • USE

    Temporary relief from minor aches and pain such as cramps, sore muscles, arthritis, muscle strains, and bruises

  • WARNINGS

    For external use only


    Flammable: Keep away from excessive heat and open flame


    Ask a doctor before use if you have: Sensitive skin


    When using this product: Avoid contact with eyes or mucous membranes

    • Do not apply to wounds or damaged skin
    • Do not use with other ointments, creams, sprays, or liniments
    • Do not apply to irritated skin or if excessive irritation develops
    • Do not bandage
    • Wash hands after use with cool water
    • Do not use with heating pad or device

    Stop use and ask a doctor if: Condition worsens, or if symptoms persist for more than 7 days, or clear up and recur


    If pregnant or breast-feeding: Ask a doctor before use

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.

  • DIRECTIONS

    Adults 18 years of age and older: Massage into skin at affected areas before bed & when symptoms arise

  • INACTIVE INGREDIENTS

    Purified water, Glycerin, SD Alcohol, Carbomer, Olive Oil, Tetrasodium EDTA, Spearmint Oil, Lemongrass oil, Eucalyptus Oil, Peppermint Oil, Camphor, Triethanolamine, F D & C Blue #1, DMDM Hydantoin

  • QUESTIONS OR COMMENTS?

    704-461-3009 • help@fulleight.com

  • PRINCIPAL DISPLAY PANEL

    LBL COOLING GEL

  • INGREDIENTS AND APPEARANCE
    COOLING 
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82551-119
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1.2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CAMPHOR OIL (UNII: 75IZZ8Y727)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    EDETATE SODIUM TETRAHYDRATE (UNII: L13NHD21X6)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SPEARMINT OIL (UNII: C3M81465G5)  
    EAST INDIAN LEMONGRASS OIL (UNII: UP0M8M3VZW)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82551-119-14118 mL in 1 BOTTLE; Type 0: Not a Combination Product01/26/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01701/26/2022
    Labeler - FULL EIGHT LLC (096786623)
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