Label: ACTIVE HYDROGEN PROFESSIONAL- 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 May 11, 2018

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  • Warnings

    • For external use only

    • use only as directed

    • do not bandage or use with heating pad or medicated patch

    • avoid contact with eyes and mucous membranes

    • do not apply to open wounds or damaged, broken or irritated skin

    • a slight burningmay occur upon application with disappearing

  • Purpose 

    External analgesic

  • Uses

    Reduces and stops the inflammatory process, eliminates pain, reduces swelling, speeds up
    recovery process after injuries, neutralizes excretion of lactic acid in the muscles

  • Dosage and Administration

    adults and children over 12 years:
    • apply a thin layer to the target - the sore spot
    • massage into painful area until thoroughly absorbed into skin

    • repeat the process several (4 to 5) times • wipe over with wet hand to remove any sense of tension

    • repeat the process minimum 3 times per days Children 12 years or younger: ask a doctor

  • Keep out of reach of children

    Keep out of reach of children

    If swallowed get medical help or contact a Poison Control Center right away

  • Stop use and ask doctor if

    • condition worsens
    • redness is present

    • irritation develops
    • symptoms persist for more then 7 days or clear up and occur again within a few days

  • Active ingridients

    Menthol 1.2 % 

  • Inactive Ingridients

    Aqua, Ascorbic Acid, Boric, Acid, Carboxy Methyl Cellulose, Magnesium Oxide, Potassium Sorbate, Glycerol.

  • Product Label

    product label

  • INGREDIENTS AND APPEARANCE
    ACTIVE HYDROGEN PROFESSIONAL 
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72316-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL12 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    AQUA REGIA (UNII: X3TT5X989E)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    BORIC ACID (UNII: R57ZHV85D4)  
    CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)  
    MAGNESIUM OXIDE (UNII: 3A3U0GI71G)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    GLYCEROL (1-(12-HYDROXYSTEARATE)) (UNII: X84XWP4TOC)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72316-001-01100 mL in 1 TUBE; Type 0: Not a Combination Product05/11/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34805/11/2018
    Labeler - EXECUTIVE PRO SOLUTIONS DOO (506157273)
    Establishment
    NameAddressID/FEIBusiness Operations
    8.0 IDEAL BALANCE D.O.O. BEOGRAD506132408manufacture(72316-001)
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