Label: BOTA C RESET- niacinamide, adenosine 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 November 26, 2021

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  • ACTIVE INGREDIENTS

    Niacinamide 2%
    Adenosine 0.04%

  • INACTIVE INGREDIENTS

    Centella Asiatica Leaf Water, Water, Butylene Glycol, 1,2-Hexanediol, Caprylic/Capric Triglyceride, Macadamia Ternifolia Seed Oil, Glycerin,
    Cetearyl Alcohol, Butylene Glycol Dicaprylate / Dicaprate, Propanediol, Octyldodecanol, Stearyl Alcohol, Centella Asiatica Extract, Beeswax, Panthenol, Carbomer, Glyceryl Stearate, Tromethamine, Cetearyl Olivate, Citrus Aurantifolia (lime) Fruit Extract, Sorbitan Olivate, Alcohol, Camellia Japonica Seed Oil, Argania Spinosa Kernel Oil, Limnanthes Alba (Meadowfoam) Seed Oil, Hydrogenated Jojoba Oil, Helianthus Annuus (Sunflower) Seed Oil, Chamomilla Recutita (Matricaria) Flower Extract, Hydrogenated Lecithin, Ubiquinone, Disodium EDTA, Ceramide NP, Sodium Hyaluronate

  • PURPOSE

    Skin Brightening
    Anti wrinkle

  • Uses

    ■ Helps brighten skin tone and improve wrinkles to disappear.
    ■ Hydrates and calms skin.

  • WARNINGS

    For external use only
    Avoid contact with eyes.
    Discontinue use if signs of irritation or rashes appear.
    Replace the cap after use.
    Keep out of reach of children

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

  • Directions

    ■ After using the BOTA C Ascorbic Acid Ampoule, apply an appropriate amount and gently pat into skin.
    ■ Increase the effects of vitamin C by frequently reapplying the BOTA C Reset Cream.

  • Other Information

    ■ Do not store this product in an inappropriate place such as high or low temperatures or under direct sun light

  • Questions

    ■ www.botac-care.com

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    BOTA C RESET 
    niacinamide, adenosine cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82399-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Niacinamide (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) Niacinamide1.0 g  in 50 mL
    Adenosine (UNII: K72T3FS567) (ADENOSINE - UNII:K72T3FS567) Adenosine0.02 g  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    CENTELLA ASIATICA LEAF (UNII: 6810070TYD)  
    Water (UNII: 059QF0KO0R)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82399-010-021 in 1 CARTON11/01/2021
    1NDC:82399-010-0150 mL in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other11/01/2021
    Labeler - JB.MONSTER PTY LTD (746985518)
    Registrant - JB.MONSTER PTY LTD (746985518)
    Establishment
    NameAddressID/FEIBusiness Operations
    D & H INTERNATIONAL PTY LTD743492571manufacture(82399-010)