Label: LEBODY FIT BODY MASSAGER PLUS- 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 December 10, 2018

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, Glycerin, Polysorbate 60, Cetearyl Alcohol, Butylene Glycol, Ilex Paraguariensis Leaf Extract, Chenopodium Quinoa Seed Extract, Aloe Barbadensis Leaf Extract, Hamamelis Virginiana (Witch Hazel) Water, Salvia Officinalis (Sage) Leaf Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Sesamum Indicum (Sesame) Seed Extract, Angelica Gigas Root Extract, Morus Alba Bark Extract, Phellinus Linteus Extract, Paeonia Lactiflora Root Extract, Polygonum Multiflorum Root Extract, Scutellaria Baicalensis Root Extract, Sophora Flavescens Root Extract, Cimicifuga Racemosa Root Extract, Juniperus Communis Fruit Extract, Mentha Piperita (Peppermint) Leaf Extract, Viscum Album (Mistletoe) Extract, Arctium Majus Root Extract, Melissa Officinalis Leaf Extract, Saponaria Officinalis Root Extract, Hypericum Perforatum Extract, Panthenol, Squalane, Sodium Hyaluronate, Citrus Aurantium Amara (Bitter Orange) FlowerExtract, Coffea Arabica (Coffee) Seed Extract, Glycine, Serine, Glutamic Acid, Aspartic Acid, Leucine, Alanine, Lysine, Arginine, Tyrosine, Phenylalanine, Valine, Threonine, Proline, Isoleucine, Histidine, Cysteine, Ficus Carica (Fig) Fruit Extract, Punica Granatum Fruit Extract, Morus Alba Fruit Extract, Ginkgo Biloba Nut Extract, Pyrus Malus (Apple) Fruit Water, Mentha Piperita (Peppermint) Oil, Dimethicone, Sorbitan Sesquioleate, Sorbitan Stearate, Beeswax, Ethylhexylglycerin, Phenoxyethanol, Glyceryl Stearate, PEG-100 Stearate, Tromethamine, 1,2-Hexanediol, Disodium EDTA, Dipotassium Glycyrrhizate, Pantolactone, Methionine, Carbomer, Polyglutamic Acid, Menthol, Fragrance

  • 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 Storage and Handling.
    A. 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:

    It provides nutrition and moisture to your skin effectively.

  • 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  PLUS
    ilex paraguariensis leaf cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71080-0007
    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:71080-0007-21 in 1 CARTON11/01/2018
    1NDC:71080-0007-1150 mL in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other11/01/2018
    Labeler - GTG Wellness Co., Ltd. (689458057)
    Registrant - GTG Wellness Co., Ltd. (689458057)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hansol Bio Co.,Ltd694046931manufacture(71080-0007)