Label: LEBODY LAB RENEWAL DUAL EFFECT BTX COLLAGEN SERUM- niacinamide, adenosine liquid

  • NDC Code(s): 71080-0012-1, 71080-0012-2
  • 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 March 22, 2019

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active ingredients: Niacinamide 2%, Adenosine 0.04%

  • INACTIVE INGREDIENT

    Inactive ingredients:

    Water, Glycerin, Glyceryl Glucoside, Propanediol, Polyglycerin-3, 1,2-Hexanediol, Butylene Glycol, Ammonium Acryloyldimethyltaurate/VP Copolymer, Carbomer, Glycereth-25 PCA Isostearate, Tromethamine, Salicornia Herbacea Extract, Phragmites Communis Extract, Disodium EDTA, Bacillus Ferment, Portulaca Oleracea Extract, Glycine, Glutamic Acid, Serine, Sclerotium Gum, Aspartic Acid, Leucine, Alanine, Lysine, Arginine, Tyrosine, Phenylalanine, Valine, Threonine, Proline, Isoleucine, Histidine, Methionine, Cysteine, Caprylyl Glycol, Hydrolyzed Collagen, Acetyl Hexapeptide-8

  • PURPOSE

    Purpose: Skin Brightening, Anti wrinkle

  • WARNINGS

    Cautions:
    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

    Uses:

    ■ It makes improvement in skin tone evenness and level of brightness.

  • Directions

    Directions:

    Apply the LEBODY LAB RENEWAL DUAL EFFECT BTX COLLAGEN SERUM to the back of your hand with the included applicator, then apply it to the area you want to use and rub lightly.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    LEBODY LAB RENEWAL DUAL EFFECT BTX COLLAGEN SERUM 
    niacinamide, adenosine liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71080-0012
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Niacinamide (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) Niacinamide0.6 g  in 30 mL
    Adenosine (UNII: K72T3FS567) (ADENOSINE - UNII:K72T3FS567) Adenosine0.012 g  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Glycerin (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71080-0012-21 in 1 CARTON03/01/2019
    1NDC:71080-0012-130 mL in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other03/01/2019
    Labeler - GTG Wellness Co., Ltd. (689458057)
    Registrant - GTG Wellness Co., Ltd. (689458057)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hansol Bio Co.,Ltd694046931manufacture(71080-0012)