OTC Medication Information: LEBODY FIT BODY MASSAGER

LEBODY FIT BODY MASSAGER- coconut oil 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

Cocos Nucifera (Coconut) Oil 0.5%

INACTIVE INGREDIENTS

Water, Cyclopentasiloxane, Cetyl Ethylhexanoate, Ethylhexyl Palmitate, Butylene Glycol, Polysorbate 60, Pentylene Glycol, Stearyl Alcohol, Cetyl Alcohol, Sorbitan Stearate, Glyceryl Stearate, PEG-100 Stearate, Sorbitan Sesquioleate, Dimethicone, Glycerin, Beeswax, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Menthol, Tromethamine, Carbomer, Menthyl Lactate, Dipotassium Glycyrrhizate, Disodium EDTA, Ethylhexylglycerin, Sorbitan Isostearate, Myristyl Alcohol, Lauryl Alcohol, Chenopodium Quinoa Seed Extract, Ilex Paraguariensis Leaf Extract, Scutellaria Baicalensis Root Extract, Polygonum Multiflorum Root Extract, Angelica Gigas Root Extract, Phellinus Linteus Extract, Paeonia Lactiflora Root Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Pyrus Malus (Apple) Fruit Extract, Morus Alba Bark Extract, Cimicifuga Racemosa Root Extract, Sophora Flavescens Root Extract, Sesamum Indicum (Sesame) Seed Extract, Phenoxyethanol, Coptis Japonica Extract, Cnidium Officinale Rhizome Extract, Angelica Gigas Root Extract, Pearl Extract, Bletilla Striata Root Extract, Kalopanax Pictus Bark Extract, Artemisia Princeps Leaf Extract, Atractylodes Japonica Root Extract, Borago Officinalis Extract, Dictamnus Dasycarpus Root Extract, Corchorus Olitorius Leaf Extract, Paeonia Suffruticosa Root Extract, Daucus Carota Sativa (Carrot) Root Extract, Vigna Radiata Seed Extract, Angelica Dahurica Root Extract, Nardostachys Chinensis Root Extract, Kaempferia Galanga Root Extract, 1,2-Hexanediol, Fragrance

PURPOSE

Skin Conditioning

WARNINGS

1. In case of using cosmetics or after use, please consult a specialist if there is any abnormal symptom or side effect such as red spot, swelling or itching in direct sunlight. 2. Do not use on wounded areas.
3. Precautions for storage and handling a. Keep out of reach of children. b. Avoid direct sunlight.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

Uses

■ Helps moisturize and beautify dry and rough body skin

Directions

■ Apply LEBODY Fit Body Massager Cream gently on dry skin except for face as daily body massager cream.

Questions

■ gtgwellness.co.kr | +82-2-3462-5400

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton
(click image for full-size original)

LEBODY FIT BODY MASSAGER
coconut cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:71080-0030
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
COCONUT OIL (COCONUT OIL) COCONUT OIL 0.5 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
Water
CYCLOMETHICONE 5
Cetyl Ethylhexanoate
Ethylhexyl Palmitate
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71080-0030-2 1 CONTAINER in 1 CARTON contains a CONTAINER (71080-0030-1)
1 NDC:71080-0030-1 80 mL in 1 CONTAINER This package is contained within the CARTON (71080-0030-2)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 03/01/2023
Labeler — GTG WELLNESS CO., LTD. (689458057)
Registrant — GTG WELLNESS CO., LTD. (689458057)
Establishment
Name Address ID/FEI Operations
YUYU LnP Inc 694752447 manufacture (71080-0030)

Revised: 03/2023 GTG WELLNESS CO., LTD.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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