OTC Medication Information: LEBODY FIT COOL BODY MASSAGER

LEBODY FIT COOL BODY MASSAGER- ilex paraguariensis leaf cream
GTG Wellness Co., Ltd.

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.

ACTIVE INGREDIENT

Active ingredients: ILEX PARAGUARIENSIS LEAF EXTRACT 0.1%

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

Purpose: Skin Conditioning

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

KEEP OUT OF REACH OF CHILDREN

Uses

Uses:

Cooling Sensation: it makes massage effect with cooling sensation.

Moisturizing Care: Provides soothing and moisturizing for tired skin.

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

LEBODY FIT COOL BODY MASSAGER ilex paraguariensis leaf cream

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71080-0005 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ILEX PARAGUARIENSIS LEAF (ILEX PARAGUARIENSIS LEAF) ILEX PARAGUARIENSIS LEAF 0.13 g in 130 mL

Inactive Ingredients Ingredient Name Strength Water Alcohol

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:71080-0005-2 1 TUBE in 1 PACKAGE contains a TUBE (71080-0005-1) 1 NDC:71080-0005-1 130 mL in 1 TUBE This package is contained within the PACKAGE (71080-0005-2)

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	Operations
Hansol Bio Co.,Ltd		694046931	manufacture (71080-0005)

Revised: 02/2018 GTG Wellness Co., Ltd.