Label: FLEXALL PAIN RELIEVING- menthol gel

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

Drug Label Information

Updated December 1, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Menthol 16%

  • Purpose

    Topical analgesic

  • Uses

    temporarily relieves minor pain associated with:

    •
    arthritis
    •
    simple backache
    •
    muscle strains
    •
    sprains
    •
    bruises
    •
    cramps
  • Warnings

    For external use only

    Allergy alert:

    do not use

    if you are allergic to salicylates (including aspirin) unless directed by a doctor.

    When using this product

    •
    use only as directed
    •
    do not bandage tightly or use with a heating pad
    •
    avoid contact with eyes and mucous membranes
    •
    do not apply to wounds or damaged, broken or irritated skin

    Stop use and ask a doctor if

    •
    condition worsens
    •
    redness is present
    •
    irritation develops
    •
    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 over 12 years:

    •
    apply generously to affected area
    •
    massage into painful area until thoroughly absorbed into skin
    •
    repeat as necessary, but no more than 3 to 4 times daily

    children 12 years or younger: ask a doctor

  • Inactive ingredients

    allantoin, aloe barbadensis leaf juice, carbomer, diisopropyl adipate, eucalyptus globulus leaf oil, glycerin, mentha piperita (peppermint) oil, methyl salicylate, SD alcohol 40 (15% w/w), steareth-2, steareth-21, thymus vulgaris (thyme) oil, tocopheryl acetate, triethanolamine, water (234-166)

  • PRINCIPAL DISPLAY PANEL

    63187-107-03
  • INGREDIENTS AND APPEARANCE
    FLEXALL PAIN RELIEVING 
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63187-107(NDC:41167-1602)
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM0.16 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALLANTOIN (UNII: 344S277G0Z)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)  
    CORYMBIA CITRIODORA LEAF OIL (UNII: M63U6N96EB)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    STEARETH-2 (UNII: V56DFE46J5)  
    STEARETH-21 (UNII: 53J3F32P58)  
    THYME OIL (UNII: 2UK410MY6B)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63187-107-031 in 1 CARTON07/01/2014
    185 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01701/01/1997
    Labeler - Proficient Rx LP (079196022)
    Establishment
    NameAddressID/FEIBusiness Operations
    Proficient Rx LP079196022RELABEL(63187-107) , REPACK(63187-107)
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