Label: ACTIVE HYDROGEN PROFESSIONAL GEL- 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 March 13, 2019

If you are a consumer or patient please visit this version.

  • Warnings

    • For external use only
    • When using this product

    • 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 burning may occur upon application with disappearing effect in short period of time

  • Purpose 

    Topical 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

    If preganant 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

  • 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 ingredient

    Menthol 1.2 % 

  • Inactive Ingredients

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

  • Product Label

    product label

  • INGREDIENTS AND APPEARANCE
    ACTIVE HYDROGEN PROFESSIONAL GEL 
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72901-001
    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:72901-001-01100 mL in 1 TUBE; Type 0: Not a Combination Product03/13/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/13/2019
    Labeler - 8.0 IDEAL BALANCE D.O.O. BEOGRAD (506132408)
    Establishment
    NameAddressID/FEIBusiness Operations
    8.0 IDEAL BALANCE D.O.O. BEOGRAD506132408manufacture(72901-001)