Label: HYDRA EXTRA CONCENTRATESERUM- niacinamide, adenosine liquid

  • Category: HUMAN OTC DRUG LABEL

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 February 13, 2017

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • ACTIVE INGREDIENT

    Niacinamide, Adenosine

  • INACTIVE INGREDIENT

    Water, Glycerin, Butylene Glycol, Crithmum Maritimum Callus Culture Filtrate, etc.

  • PURPOSE

    Helps brighten the skin and reduce skin wrinkles.

  • KEEP OUT OF REACH OF CHILDREN

    keep out or reach of the children


  • INDICATIONS & USAGE

    Take an adequate amount of this product and evenly spread on the skin.

  • WARNINGS

    1. Discontinue use, if any of the following abnormal symptoms
    occur after using the product. If you continue to use the
    product, your symptoms can get worse. Please consult a
    dermatologist.
    1) If symptoms such as red spots, swelling, itching or irritation appear while
    using the product
    2) If the above symptoms appear when the skin is exposed to direct sunlight
    after using the product
    2. Do not use on wounds, and areas affected by eczema and
    dermatitis
    3. Precautions for storage and handling
    1) Always recap after use.
    2) Keep out of reach of infants and children.
    3) Do not store at high or low temperatures, and in direct sunlight.
    4. Avoid contact with the eyes.
    - If you are very sensitive to a sticking plaster or a wet compress, use with
    caution or discontinue use
    - Limited to Whitening Concentrate Treatment Mask products.
    - Fine grains can be felt due to CELTOSOME™ Crithmum Maritimum ST (Limited
    to Hydra Extra Concentrate products.)
    5. The SPF of this product was measured according to the
    method of Cosmmedics Europe and its PA according to the
    method of the Japan Cosmetic Industry Association (JCIA).
    (Limited to Protective Base Sunscreen products for dry skin)
    6. The SPF of this product was measured according to the
    International SPF Test Method and its PA according to the
    method of the Japan Cosmetic Industry Association (JCIA).
    (Limited to Protective Base Sunscreen products for oily skin)
    7. The SPF and PA of this product were measured according
    to the methods proposed by the Regulations of Functional
    Cosmetic Evaluation. (Limited to BB cream.)
    8. Do not use on children under the age of 3 because this
    product contains salicylic acids and salts.
    (Limited to Purifying Sebum Relief Spot products.)
    If this product causes any abnormal symptoms,
    you can exchange it or be compensated for damages in
    accordance with the consumer dispute settlement regulation
    notified by the Fair Trade Commission.
    This product was made by COSMAX
    which has been approved to comply with
    CGMP (Current Good Manufacturing Practice) regulations.

  • DOSAGE & ADMINISTRATION

    for external use only

  • PRINCIPAL DISPLAY PANEL

    1

  • INGREDIENTS AND APPEARANCE
    HYDRA EXTRA CONCENTRATESERUM 
    niacinamide, adenosine liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71217-0004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ADENOSINE (UNII: K72T3FS567) (ADENOSINE - UNII:K72T3FS567) ADENOSINE0.04 g  in 100 mL
    NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71217-0004-130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product02/08/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other02/08/2017
    Labeler - In This Morning (694519423)
    Registrant - In This Morning (694519423)
    Establishment
    NameAddressID/FEIBusiness Operations
    In This Morning694519423label(71217-0004) , pack(71217-0004) , manufacture(71217-0004)