NDC 71080-0005 Lebody Fit Cool Body Massager

Ilex Paraguariensis Leaf

NDC Product Code 71080-0005

NDC 71080-0005-2

Package Description: 1 TUBE in 1 PACKAGE > 130 mL in 1 TUBE (71080-0005-1)

NDC Product Information

Lebody Fit Cool Body Massager with NDC 71080-0005 is a a human over the counter drug product labeled by Gtg Wellness Co., Ltd.. The generic name of Lebody Fit Cool Body Massager is ilex paraguariensis leaf. The product's dosage form is cream and is administered via topical form.

Labeler Name: Gtg Wellness Co., Ltd.

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Lebody Fit Cool Body Massager Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • ILEX PARAGUARIENSIS LEAF .13 g/130mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • WATER (UNII: 059QF0KO0R)
  • ALCOHOL (UNII: 3K9958V90M)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Gtg Wellness Co., Ltd.
Labeler Code: 71080
Marketing Category: UNAPPROVED DRUG OTHER - What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 01-02-2018 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Lebody Fit Cool Body Massager Product Label Images

Lebody Fit Cool Body Massager Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

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.

* Please review the disclaimer below.