LEBODY FIT COOL BODY MASSAGER- ilex paraguariensis leaf cream

LEBODY FIT COOL BODY MASSAGER by

Drug Labeling and Warnings

LEBODY FIT COOL BODY MASSAGER by is a Otc medication manufactured, distributed, or labeled by GTG Wellness Co., Ltd., Hansol Bio Co.,Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

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

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)