Label: ABALONE CRYSTALDOUBLE EX AMPOULE- arbutin, adenosine liquid

  • 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 10, 2017

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  • ACTIVE INGREDIENT

    Arbutin, Adenosine

  • INACTIVE INGREDIENT

    Water, Glycerin, Butylene Glycol, Etc.

  • PURPOSE

    Skin Protectant - Anti-Wrinkle & Whitening

  • KEEP OUT OF REACH OF CHILDREN

    keep out or reach of the children


  • INDICATIONS & USAGE

    Take 1EA of ampoule on the palm entirely

    Mixing well with fingertips and gently tapping along the skin texture for absorption

    Even if you do not apply emulsion or cream, you can feel the moistness until next morning

    *1EA of crystal Double-EX Ampoule is a throwaway product

  • WARNINGS

    1. Do not use in the following cases(Eczema and scalp wounds)
    2.Side Effects
    1)Due to the use of this druf if rash, irritation, itching and symptopms of hypersnesitivity occur dicontinue use and consult your phamacisr or doctor
    3.General Precautions
    1)If in contact with the eyes, wash out thoroughty with water If the symptoms are servere, seek medical advice immediately
    2)This product is for exeternal use only. Do not use for internal use
    4.Storage and handling precautions
    1)If possible, avoid direct sunlight and store in cool and area of low humidity
    2)In order to maintain the quality of the product and avoid misuse
    3)Avoid placing the product near fire and store out in reach of children

  • DOSAGE & ADMINISTRATION

    for external use only

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    ABALONE CRYSTALDOUBLE EX AMPOULE 
    arbutin, adenosine liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60611-0006
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARBUTIN (UNII: C5INA23HXF) (ARBUTIN - UNII:C5INA23HXF) ARBUTIN2.2 g  in 100 mL
    ADENOSINE (UNII: K72T3FS567) (ADENOSINE - UNII:K72T3FS567) ADENOSINE0.044 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60611-0006-114 in 1 PACKAGE03/10/2017
    10.8 mL in 1 SYRINGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other03/10/2017
    Labeler - C&BCOSMETIC Co.,Ltd. (689909208)
    Registrant - C&BCOSMETIC Co.,Ltd. (689909208)
    Establishment
    NameAddressID/FEIBusiness Operations
    C&BCOSMETIC Co.,Ltd.689909208manufacture(60611-0006) , label(60611-0006) , pack(60611-0006)