Label: FLEXALL PAIN RELIEVING- menthol gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated December 1, 2019

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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 not finalpart34801/01/1997
    Labeler - Proficient Rx LP (079196022)
    Establishment
    NameAddressID/FEIBusiness Operations
    Proficient Rx LP079196022RELABEL(63187-107) , REPACK(63187-107)