Label: HUITOMI SLIMMING SPORTS- menthol gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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, 2014

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

  • ACTIVE INGREDIENT

    menthol


  • INACTIVE INGREDIENT

    ■Purified water ■Polysolvate 80 ■Ethanol ■1,3-Butylene glycol ■Polyacrylate crosspolymer-6 ■Camellia sinensis leaf extract ■Morus alba fruit extract ■Prunus persica (peach) kernel extract ■Biota orientalis leaf extract ■Bisabolol ■PEG-60 hydrogenated castor oil ■Methyl paraben ■Bupleurum Chinensis root extract ■Prunus mume fruit extract ■Salicornia herbacea extract ■Laminaria japonica extract ■Sphacelaria scoparia extract ■Phenoxy ethanol ■Propyl paraben ■Flavor



  • PURPOSE

    reduce body fat and abdominal fat
    reduce cellulite
    anti-wrinkle
    anti-imflammatory
    analgesic
    pain relief
    moisture


  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of children


  • INDICATIONS & USAGE

    This product is only used to manage your site, such as fat or forearm and thigh and can be applied to all parts of the body except the face and chest, but use the small sensitive area.
    Squeeze the required amount of gel in the palm when applied to the skin after 2 or 3 minutes and cool or warm feeling occurs; we recommend you so sweaty moderate exercise to the body as possible. After applying the gel is also recommended to use the sauna or electric massager aids such as hula hoops.
    If using this product on part that use a lot of muscle or joint before or after exercise prevent arthralgia and myalgia or restore tired muscle and joint rapidly



  • WARNINGS

    For external use only, drinking ban
    keep in a cool place


  • DOSAGE & ADMINISTRATION

    for external use only

  • PRINCIPAL DISPLAY PANEL

    package label
  • INGREDIENTS AND APPEARANCE
    HUITOMI SLIMMING SPORTS 
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69388-4001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.3 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    LANTHANUM CHLORIDE (UNII: 04M8624OXV)  
    ADENOSINE (UNII: K72T3FS567)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69388-4001-1500 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34111/01/2014
    Labeler - Lancell Bio Co., Ltd. (689062337)
    Registrant - Lancell Bio Co., Ltd. (689062337)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lancell Bio Co., Ltd.689062337manufacture(69388-4001)