Label: JUVEHEAL W AMPOULE- niacinamide liquid

  • NDC Code(s): 81689-030-01, 81689-030-02
  • Packager: J MEDICAL Inter 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 June 21, 2021

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

  • ACTIVE INGREDIENT

    Niacinamide 2.0%

  • INACTIVE INGREDIENTS

    Oryza Sativa (Rice) Bran Water, Water, Glycereth-26, Hydroxyethyl Urea, 1,2-Hexanediol, Bis-PEG-18 Methyl Ether Dimethyl Silane, Arbutin, Glycerin, Cucumis Sativus (Cucumber) Fruit Extract, Hippophae Rhamnoides Fruit Extract, Melaleuca Alternifolia (Tea Tree) Leaf Extract, Camellia Sinensis Leaf Extract, Glycine Soja (Soybean) Seed Extract, Nigella Sativa Seed Extract, Oryza Sativa (Rice) Extract, Ribes Nigrum (Black Currant) Fruit Extract, Rubus Fruticosus (Blackberry) Fruit Extract, Salvia Hispanica Seed Extract, Sesamum Indicum (Sesame) Seed Extract, Vaccinium Angustifolium (Blueberry) Fruit Extract, Butylene Glycol, Olive Oil Glycereth-8 Esters, Polyglyceryl-10 Laurate, Hydroxy Ethyl Cellulose, Glutathione, Helianthus Annuus (Sunflower) Seed Oil, Lavandula Hybrida Oil, Lavandula Angustifolia (Lavender) Oil, Carbomer, Arginine, Caprylyl Glycol, Chlorphenesin, Propanediol, Ethylhexylglycerin, Disodium EDTA

  • PURPOSE

    Skin Brightening

  • WARNINGS

    1. For external use only
    2. Keep out of reach of children
    3. If sympoms such as redness, swelling, itching or irritation occur by being exposed to direct sunlight during or after using cosmetics, consult a doctor.
    4. Not to be applied over wound
    5. Test the product by placing a small amount on the inside of your elbow and waiting 24 hours to see any skin reactions.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. 

  • Uses

    ■ Helps brighten skin tone
    ■ Helps improve skin elasticity

  • Directions

    1. Open he bottle while tearing off palstic cap.
    2. Apply the solution after cleansing th face depending on purpose of use.
    3. Apply it on skin for reparing and soothing.

  • Other information

    Storage of handling precautions.
    1) Avoid direct sunlight
    2) Keep it cool
    3) Avoid steam

  • QUESTIONS

    ■ http://juveheal.co.kr/products.php
    ■ Tel. +82 2 578 7728

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    JUVEHEAL W AMPOULE 
    niacinamide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81689-030
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Niacinamide (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) Niacinamide2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    RICE BRAN, DEFATTED (UNII: H6597RO5A2)  
    Water (UNII: 059QF0KO0R)  
    Glycereth-26 (UNII: NNE56F2N14)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81689-030-025 in 1 CARTON03/01/2021
    1NDC:81689-030-015 mL in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other03/01/2021
    Labeler - J MEDICAL Inter Co., Ltd. (694065206)
    Registrant - J MEDICAL Inter Co., Ltd. (694065206)
    Establishment
    NameAddressID/FEIBusiness Operations
    J MEDICAL Inter Co., Ltd.695439825manufacture(81689-030)