Label: LEBODY FIT HOT BODY MASSAGER- ilex paraguariensis leaf cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated February 8, 2018

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

  • ACTIVE INGREDIENT

    Active ingredients: ILEX PARAGUARIENSIS LEAF EXTRACT 0.3%

  • INACTIVE INGREDIENT

    Inactive ingredients: Water, Cetyl Ethylhexanoate, Alcohol, Polysorbate 60, Butylene Glycol, Cetearyl Alcohol, Chenopodium Quinoa Seed Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Cimicifuga Racemosa Root Extract, Polygonum Multiflorum Root Extract, Sesamum Indicum (Sesame) Seed Extract, Phellinus Linteus Extract, Angelica Gigas Root Extract, Morus Alba Bark Extract, Paeonia Lactiflora Root Extract, Sophora Flavescens Root Extract, Scutellaria Baicalensis Root Extract, Punica Granatum Fruit Extract, Ficus Carica (Fig) Fruit Extract, Morus Alba Fruit Extract, Ginkgo Biloba Nut Extract, Glycerin, 1,2-Hexanediol, Sorbitan Sesquioleate, Beeswax, Sorbitan Stearate, Vanillyl Butyl Ether, Ethylhexylglycerin, Carbomer, Tromethamine, Menthol, Squalane, Panthenol, Glyceryl Stearate, Menthyl Lactate, PEG-100 Stearate, Adenosine, Disodium EDTA, Dipotassium Glycyrrhizate, Sodium Hyaluronate, Pantolactone, Lavandula Angustifolia (Lavender) Oil, Rosmarinus Officinalis (Rosemary) Leaf Oil

  • PURPOSE

    Purpose: Skin Conditioning

  • WARNINGS

    Warnings: 1) When you have symptoms such as red spots, swelling, itching or side effect during use of the cosmetic or after exposing direct sunlight, you should consult a specialist. 2) Do not use in wounded areas. 3) Precautions for storage and handling. A) Keep out the reaching of children. B) Keep away from the direct sunlight.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

  • Uses

    Uses:

    Thermal sensation: It makes massage effect with heat sensation.

    Moisturizing Care: Provides soothing and moisturizing for tired skin.

  • Directions

    Directions:

    1.Turn the part of the applicator on to squeeze the contents. 2.Apply the appropriate amount of the contents to the parts (arm, abdomen, buttocks, things, etc.) that need care. 3.Make massage like a circle or straight direction using a massage ball to penetrate cream.

    *After use, turn off the applicator to the right side and lock it. You do not need a shower separately.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    LEBODY FIT HOT BODY MASSAGER 
    ilex paraguariensis leaf cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71080-0006
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F) (ILEX PARAGUARIENSIS LEAF - UNII:1Q953B4O4F) ILEX PARAGUARIENSIS LEAF0.39 g  in 130 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Cetyl Ethylhexanoate (UNII: 134647WMX4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71080-0006-21 in 1 PACKAGE01/02/2018
    1NDC:71080-0006-1130 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other01/02/2018
    Labeler - GTG Wellness Co., Ltd. (689458057)
    Registrant - GTG Wellness Co., Ltd. (689458057)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hansol Bio Co.,Ltd694046931manufacture(71080-0006)