Label: MUSCLE PAIN RELIEF GEL- menthol gel

  • NDC Code(s): 61734-060-01
  • Packager: Delon Laboratories (1990) Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 16, 2024

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  • Active ingredient

    Menthol 2.0%

  • Purpose

    Topical analgesic

  • Uses

    • for the temporary relief of minor aches and pains of muscles and joints
  • Warnings

    For external use only

    When using this product

    • avoid contact with the eyes
    • do not apply to wounds or damaged skin
    • do not bandage tightly

    Stop use and ask a doctor if

    • condition worsens
    • 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 2 years of age and older: apply to affected area not more than 3 to 4 times daily
    • children under 2 years of age: consult a doctor
  • Inactive ingredients

    acrylates/C10-30 alkyl acrylate crosspolymer, aminomethyl propanol, denatonium benzoate, ethyl alcohol, FD&C blue no. 1, thymol, water

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  • INGREDIENTS AND APPEARANCE
    MUSCLE PAIN RELIEF GEL 
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61734-060
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)  
    ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S) (UNII: 8Z5ZAL5H3V)  
    ALCOHOL (UNII: 3K9958V90M)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    THYMOL (UNII: 3J50XA376E)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorblueScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61734-060-0190 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product09/09/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01709/09/2024
    Labeler - Delon Laboratories (1990) Ltd. (248364184)
    Establishment
    NameAddressID/FEIBusiness Operations
    Laboratoires Delon208896216manufacture(61734-060) , pack(61734-060) , label(61734-060)