Label: MYDERM PRO FREEZE COOLING MENTHOL PAIN RELIEF ROLL-ON- menthol gel

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

Drug Label Information

Updated June 24, 2024

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  • ACTIVE INGREDIENT

    Active Ingredient

    Menthol 6%

  • WHEN USING

    When using this product avoid contacts with the eyes or mucous membranes. do not apply to wounds or damaged skin. do not apply to irritated skin. do not bandage. wash hands after use with cool water. do not use with heating pad or device.

  • PURPOSE

    Menthol 6%------------------------------------------------------------Topical Analgesic

  • WARNINGS

    For external use only.

  • STOP USE

    Stop use and ask doctor if condition worsens, or if symtoms persist for more than 7 days, or clean up and reoccur again within a few days.

  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of children if swallowed,get medical help or contact a poson Control Center Immediately.

  • INACTIVE INGREDIENT

    Inactive Ingredient

    Aloe Barbadensis Leaf Juice

    Arctium Lappa Root Extract

    Arnica Montana Flower Extract

    Boswellia Carterii resin Extract

    Calendula Officinalis Extract

    Camellia Sinensis Leaf Extract

    Camphor

    Carbomer

    FD & C Blue #1

    FD & C Yellow #5

    Glycerin

    Isopropyl Alcohol

    Isopropyl Myristate

    llex Paraguariensis Leaf Extract

    Melissa Officinalis Leaf Extract

    Phenoxyethanol

    Silicon dioxide

    Tocopheryl Acetate

    Triethanolamine

    Water

  • DOSAGE & ADMINISTRATION

    Direction: Apply to affectered area not more that 3 to 4 times daily.

  • INDICATIONS & USAGE

  • PRINCIPAL DISPLAY PANEL

    MyDerm Freeze

  • INGREDIENTS AND APPEARANCE
    MYDERM PRO FREEZE COOLING MENTHOL PAIN RELIEF ROLL-ON 
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72667-073
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL6 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    CAMPHOR, (-)- (UNII: 213N3S8275)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    FRANKINCENSE (UNII: R9XLF1R1WM)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
    MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72667-073-0189 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/06/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01703/06/2024
    Labeler - Inspec Solutions (081030372)
    Establishment
    NameAddressID/FEIBusiness Operations
    Inspec Solutions081030372manufacture(72667-073)
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