BRUCKE A.C.C. CURE AMPOULE (ADENOSINE, NIACINAMIDE) GEL [NATURE4 CO., LTD.]

BRUCKE A.C.C. CURE AMPOULE (ADENOSINE, NIACINAMIDE) GEL [NATURE4 CO., LTD.]
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NDC 71380-0004-1
Set ID 4f9a9d09-10f4-1c74-e054-00144ff88e88
Category HUMAN OTC DRUG LABEL
Packager Nature4 co., Ltd.
Generic Name
Product Class Adenosine Receptor Agonist
Product Number
Application Number
  • ACTIVE INGREDIENT

    Adenosine, Niacinamide

  • INACTIVE INGREDIENT

    Water, Glycerin, Butylene Glycol, etc.

  • PURPOSE

    Skin Protectant - Anti-Wrinkle, Whitening

  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of the children

  • INDICATIONS & USAGE

    Apply 1-2 drops to facial area and take an appropriate amount over the entire face.

    Then apply other cream or lotion.

  • WARNINGS

    1. If the following symptoms occur after product use, stop using the product immediately and consult a dermatologist (continuous use can exacerbate the symptoms).

    1) Occurrence of red spots, swelling, itchiness, and other skin irritation

    2) If the symptoms above occur after the application area is exposed to direct sunlight

    2. Do not use on open wounds, eczema, and other skin irritations

    3. Precaution for Storage and Handling

    1) Close the lid after use

    2) Keep out of reach of infants and children

    3) Do not to store in a place with high/low temperature and exposed to direct sunlight

    4. Use as avoiding eye areas.

  • DOSAGE & ADMINISTRATION

    for external use only


  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    BRUCKE A.C.C. CURE AMPOULE 
    adenosine, niacinamide gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71380-0004
    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
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71380-0004-130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product05/15/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other05/15/2017
    Labeler - Nature4 co., Ltd. (694208420)
    Registrant - Nature4 co., Ltd. (694208420)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nature4 co., Ltd.694208420manufacture(71380-0004) , label(71380-0004) , pack(71380-0004)

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