Label: BEING WELL EXTRA STRENGTH MENTHOL HEAT- menthol patch

  • 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 June 30, 2013

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  • ACTIVE INGREDIENT

    Active ingredient                                                                         Purpose

    Menthol 5.0%......................................................Topical Analgesic Patch

  • PURPOSE

    Uses For the temporary relief of minor aches and pains of muscles and joints associated with:

    • simple backache
    • arthritis
    • strains
    • bruises
    • sprains
  • WARNINGS

    Warnings for external use only

  • WHEN USING

    When using this product

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

    Stop use and ask a 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

    Keep out of reach of children if swallowed, get medical help or contact a Poison Control Center immediately

  • INDICATIONS & USAGE

    Directions

    • Adults and children 12 years of age and over: apply to affected area, not more than 3 to 4 times daily
    • Children under 12 years of age: do not use, consult a doctor
    • For easy application: partially peel back protective film and apply exposed patch to site of pain. Carefully remove remaining film while pressing patch to skin for secure adhesion.
  • INACTIVE INGREDIENT

    Inactive ingredients Aloe Vera, Aluminum Hydroxide, Disodium Edatate, Gelatin, Kaolin, Methylparaben, Polysorbate 80, Titanium Dioxide, Isopropyl Myristate, Purified Water, Polyvinyl Pyrrolidone, Polyvinyl Alcohol, Glycerin, Magnesium Aluminometasilicate, Caster Oil, Tartaric Acid, Polyethylene Glyco Monostearate, Sodium Polyacrylate, BHT, Tocopherol Acetate

  • DOSAGE & ADMINISTRATION

    Distributed By:

    Save-A-Lot Food Stores, Ltd.

    100 Corporate Office Dr.

    Earth City, MO 63045

    Product of Korea

  • PRINCIPAL DISPLAY PANEL

    image of carton label

  • INGREDIENTS AND APPEARANCE
    BEING WELL EXTRA STRENGTH MENTHOL HEAT  
    menthol patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46994-851
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL750 mg
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    GELATIN (UNII: 2G86QN327L)  
    KAOLIN (UNII: 24H4NWX5CO)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    WATER (UNII: 059QF0KO0R)  
    POLYVINYL ALCOHOL (UNII: 532B59J990)  
    TARTARIC ACID (UNII: W4888I119H)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:46994-851-021 in 1 CARTON
    12 in 1 POUCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34806/30/2013
    Labeler - SAVE-A-LOT FOOD STORES, LTD. (095484572)
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