Label: LEBODY FIT 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 November 23, 2017

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

  • ACTIVE INGREDIENT

    Active ingredients: ILEX PARAGUARIENSIS LEAF EXTRACT 2.0%

  • INACTIVE INGREDIENT

    Inactive ingredients:

    Water, Cetyl Ethylhexanoate, Cyclopentasiloxane, Ethylhexyl Palmitate, Butylene Glycol, Cocos Nucifera (Coconut) Oil, Polysorbate 60, Cetyl Alcohol, Panthenol, Pentylene Glycol, Glycerin, Beeswax, Dimethicone, Sorbitan Stearate, Phenoxyethanol, Sorbitan Sesquioleate, Glyceryl Stearate, PEG-100 Stearate, Carbomer, Caprylyl Glycol, Tromethamine, Fragrance, Propanediol, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Squalane, Pyrus Malus (Apple) Fruit Water, Dipotassium Glycyrrhizate, Caffeine, Chenopodium Quinoa Seed Extract, Aloe Barbadensis Leaf Extract, Angelica Gigas Root Extract, Cimicifuga Racemosa Root Extract, Disodium EDTA, Glycyrrhiza Glabra (Licorice) Root Extract, Morus Alba Bark Extract, Paeonia Lactiflora Root Extract, Phellinus Linteus Extract, Polygonum Multiflorum Root Extract, Scutellaria Baicalensis Root Extract, Sesamum Indicum (Sesame) Seed Extract, Sophora Flavescens Root Extract, Sorbitan Isostearate, Sodium Hyaluronate, Mentha Piperita (Peppermint) Oil, Ficus Carica (Fig) Fruit Extract, Ginkgo Biloba Nut Extract, Morus Alba Fruit Extract, Punica Granatum Fruit Extract, Arctium Majus Root Extract, Hamamelis Virginiana (Witch Hazel) Water, Hypericum Perforatum Extract, Juniperus Communis Fruit Extract, Melissa Officinalis Extract, Mentha Piperita (Peppermint) Extract, Menthol, Salvia Officinalis (Sage) Water, Saponaria Officinalis Leaf/Root Extract, Viscum Album (Mistletoe) Extract, Polyglutamic Acid

  • PURPOSE

    Purpose: Skin Conditioning

  • WARNINGS

    Caution:

    1. If you experience the following abnormalities during use, stop using the cosmetics. If you keep using the product, your symptoms may grow worse and you may need to consult a dermatologist.

    A. Abnormalities including red spots, swelling, itchiness, and irritation.

    B. If you experience the aforementioned abnormalities after the applied area is exposed to direct sunlight.

    2. Do not use on area with scars, eczema, or other skin inflammations.

    3. Caution during

    A. Storage and Handing.Store out of reach of children.

    B. Store away from direct sunlight.

  • KEEP OUT OF REACH OF CHILDREN

    Store out of reach of children.

  • Uses

    Uses:

    Le Body Fit Massager cream makes your skin smooth, and deeply moisturized.

  • Directions

    Directions: Apply LEBODY FIT Body massager Cream whenever needed, except for face and bust, and massage lightly.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    LEBODY FIT  BODY MASSAGER
    ilex paraguariensis leaf cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71080-0002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F) (ILEX PARAGUARIENSIS LEAF - UNII:1Q953B4O4F) ILEX PARAGUARIENSIS LEAF3.0 g  in 150 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Cetyl Ethylhexanoate (UNII: 134647WMX4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71080-0002-21 in 1 PACKAGE10/01/2017
    1NDC:71080-0002-1150 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other10/01/2017
    Labeler - GTG Wellness Co., Ltd. (689458057)
    Registrant - GTG Wellness Co., Ltd. (689458057)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hansol Bio Co.,Ltd694046931manufacture(71080-0002)