Label: BIOTOC REGEN PEEL- adenosine gel

  • 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 September 3, 2017

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  • ACTIVE INGREDIENT

    Adenosine

  • INACTIVE INGREDIENT

    Water, Glycerin

  • PURPOSE

    Anti-Wrinkle

  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of the children

  • INDICATIONS & USAGE

    Apply an appropriate amount of BIOTOC Regen Peel to pores and wrinkles especially around the lips and under the eyes.

    Then massage roundly with your fingertips pressure for 2 or 3 minutes, and press firmly with your fingers.

    Apply BIOTOC Serum and Cream thickly after using BIOTOC Regen Peel.

    It is effective to use mask pack together.

    For the best results, apply BIOTOC Regen Peel twice a week and BIOTOC Regen Ampoule, Serum, and Cream every morning and evening.

  • 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
    BIOTOC REGEN PEEL 
    adenosine gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71638-0004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ADENOSINE (UNII: K72T3FS567) (ADENOSINE - UNII:K72T3FS567) ADENOSINE0.04 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71638-0004-113.5 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product09/04/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other09/04/2017
    Labeler - Dermafirm INC. (690171603)
    Registrant - Dermafirm INC. (690171603)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dermafirm INC.690171603label(71638-0004) , pack(71638-0004) , manufacture(71638-0004)