Label: CLAPIEL HYALON SERUM- hyaluronate sodium, niacinamide cream

  • 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 July 24, 2015

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  • ACTIVE INGREDIENT

    Active Ingredient: Sodium Hyaluronate 35%, Niacinamide 2.0%

  • INACTIVE INGREDIENT

    Inactive Ingredients: Water, Glycerin, Butylene Glycol, 1,2-Hexanediol, Centella Asiatica Extract, Undaria Pinnatifida Extract, Sodium Polygamma-Glutamate, Boerhavia Diffusa Root Extract, Hydrolyzed Myrtus Communis Leaf Extract, Pichia Anomala Extract, Yeast Extract, Myrothamnus Flabellifolia Callus Culture Extract, Pentylene Glycol, Lactuca Indica Extract, Corydalis Ochotensis Extract, Draba Nemorasa Extract, Chenopodium Album Flower Extract, Lactobacillus/Soybean Ferment Extract, Salix Alba Bark Extract, Cinnamomum Cassia Bark Extract, Origanum Bulgare Leaf Extract, Chamaecyparis Obtusa Leaf Extract, Portulaca Oleracea Extract, Panthenol, Carbomer, Arginine, Adenosine, Disodium EDTA

  • PURPOSE

    Purpose: Skin Protectant

  • WARNINGS

    Warnings: 1. In case of having following symptoms after using this, you’re advised to stop using it immediately. If you keep using it, the symptoms will get worse and need to consult a dermatologist. 1) In case of having problems such as red rash, swollenness, itching, stimulation during usage. 2) In case of having the same symptoms above on the part you put this product on by direct sunlight. 2. You are banned to use it on the part where you have a scar, eczema, or dermatitis. 3. In case of getting it into your eyes, you have to wash it immediately.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of babies and children

  • INDICATIONS & USAGE

    Indications & Usage: Apply a desired amount evenly over entire face.

  • DOSAGE & ADMINISTRATION

    Dosage & Administration: Take an adequate amount of this product

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    CLAPIEL HYALON SERUM 
    hyaluronate sodium, niacinamide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69977-020
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE0.6 mg  in 30 mL
    HYALURONATE SODIUM (UNII: YSE9PPT4TH) (HYALURONIC ACID - UNII:S270N0TRQY) HYALURONATE SODIUM10.5 mg  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Glycerin (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69977-020-0130 mL in 1 CARTON; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other05/01/2015
    Labeler - AUS KOREA CO., LTD. (689515251)
    Registrant - AUS KOREA CO., LTD. (689515251)
    Establishment
    NameAddressID/FEIBusiness Operations
    AUS KOREA CO., LTD.689515251manufacture(69977-020)