Label: LEBODY FIT BODY MASSAGER- ilex paraguariensis leaf cream
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Contains inactivated NDC Code(s)
NDC Code(s): 71080-0002-1, 71080-0002-2 - Packager: GTG Wellness Co., Ltd.
- 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.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
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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
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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
- Uses
- Directions
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
LEBODY FIT BODY MASSAGER
ilex paraguariensis leaf creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71080-0002 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F) (ILEX PARAGUARIENSIS LEAF - UNII:1Q953B4O4F) ILEX PARAGUARIENSIS LEAF 3.0 g in 150 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Cetyl Ethylhexanoate (UNII: 134647WMX4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71080-0002-2 1 in 1 PACKAGE 10/01/2017 1 NDC:71080-0002-1 150 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 10/01/2017 Labeler - GTG Wellness Co., Ltd. (689458057) Registrant - GTG Wellness Co., Ltd. (689458057) Establishment Name Address ID/FEI Business Operations Hansol Bio Co.,Ltd 694046931 manufacture(71080-0002)