Label: THERAPEUTIC MENTHOL- menthol 2.00% 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 August 7, 2018

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  • ACTIVE INGREDIENT

    Active ingredient                                    Purpose
    Menthol 2%...........................................External Analgesic

  • PURPOSE

  • INDICATIONS & USAGE

    Uses

    For the temporary relief of minor aches and pains
    of muscles and joints associated with simple backache,
    arthritis, strains, bruises and sprains

  • WARNINGS

    Warnings
    For external use only
    When using this product • avoid
    contact with eyes • do not bandage tightly • do not apply to
    wounds or damaged skin • do not use with a heating pad
    Stop use and ask doctor if condition worsens or if
    symptoms persist for more than 7 days or clear up and
    occur again within a few days
    Keep out of reach of children. If swallowed, get medical
    help or contact a Poison Control Center right away

  • KEEP OUT OF REACH OF CHILDREN

  • DOSAGE & ADMINISTRATION

    Directions
    • for adults & children 2 years of age and older
    • cleanse and dry skin
    • apply to affected area not more than 3 to 4 times daily
    • children under 2 years of age, consult a doctor

  • INACTIVE INGREDIENT

    Inactive ingredients

    Ammonium Hydroxide,
    Carbomer, Cupric Sulfate, FD&C Blue No. 1, Isopropyl
    Alcohol, Magnesium Sulfate, Purified Water, Sodium
    Hydroxide, Thymol.

  • Questions? 866-483-2846

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    THERAPEUTIC MENTHOL 
    menthol 2.00% gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64048-5117
    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
    AMMONIA (UNII: 5138Q19F1X)  
    CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) (UNII: Z135WT9208)  
    Cupric Sulfate (UNII: LRX7AJ16DT)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Isopropyl Alcohol (UNII: ND2M416302)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    WATER (UNII: 059QF0KO0R)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Thymol (UNII: 3J50XA376E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64048-5117-7227 g in 1 JAR; Type 0: Not a Combination Product03/24/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/24/2017
    Labeler - Product Quest Mfg (927768135)
    Registrant - Product Quest Mfg (927768135)
    Establishment
    NameAddressID/FEIBusiness Operations
    Product Quest Mfg927768135manufacture(64048-5117) , label(64048-5117)
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