Label: LEBODY FIT HOT BODY MASSAGER- ilex paraguariensis leaf cream
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Contains inactivated NDC Code(s)
NDC Code(s): 71080-0006-1, 71080-0006-2 - 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 February 8, 2018
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
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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
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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
- Uses
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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
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INGREDIENTS AND APPEARANCE
LEBODY FIT HOT BODY MASSAGER
ilex paraguariensis leaf creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71080-0006 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 0.39 g in 130 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:71080-0006-2 1 in 1 PACKAGE 01/02/2018 1 NDC:71080-0006-1 130 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 01/02/2018 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(71080-0006)