Label: LEBODY FIT COOL BODY MASSAGER- ilex paraguariensis leaf cream
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Contains inactivated NDC Code(s)
NDC Code(s): 71080-0005-1, 71080-0005-2 - 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.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
Inactive ingredients: Water, PEG-8, Alcohol, 1,2-Hexanediol, PEG-60 Hydrogenated Castor Oil, Erythritol, 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, Chenopodium Quinoa Seed Extract, Ficus Carica (Fig) Fruit Extract, Punica Granatum Fruit Extract, Morus Alba Fruit Extract, Ginkgo Biloba Nut Extract, Sodium Hyaluronate, Methyl Diisopropyl Propionamide, Menthol, Ammonium Acryloyldimethyltaurate/VP Copolymer, Carbomer, Tromethamine, Eucalyptus Globulus Leaf Oil, Citrus Limon (Lemon) Peel Oil, Cymbopogon Schoenanthus Oil, Sodium Guaiazulene Sulfonate, Adenosine, Ethylhexylglycerin, Butylene Glycol
- 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 COOL BODY MASSAGER
ilex paraguariensis leaf creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71080-0005 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 0.13 g in 130 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Alcohol (UNII: 3K9958V90M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71080-0005-2 1 in 1 PACKAGE 01/02/2018 1 NDC:71080-0005-1 130 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(71080-0005)