Label: INCELLDERM DERMATOLOGY FIRST PACKAGE- niacinamide, adenosine kit

  • 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 August 20, 2020

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENTS

    Niacinamide 2.0%
    Adenosine 0.04%

  • INACTIVE INGREDIENTS

    [INCELLDERM DERMATOLOGY BOOSTER]

    Centella Asiatica Leaf Water, Mineral Water, Hamamelis Virginiana (Witch Hazel) Extract, Propanediol, Methyl Gluceth-20, Lysine, Histidine, Arginine, Aspartic Acid, Threonine, Serine, Glutamic Acid, Proline, Glycine, Alanine, Valine, Methionine, lsoleucine, Leucine, Tyrosine, Phenylalanine, Cysteine, Rubus Idaeus (Raspberry) Fruit Extract, Rubus Fruticosus (Blackberry) Fruit Extract, Vaccinium Angustifolium (Blueberry) Fruit Extract, Vaccinium Macrocarpon (Cranberry) Fruit Extract, Euterpe Oleracea Fruit Extract, Cichorium Intybus (Chicory) Root Extract, Artemisia Capillaris Extract, Olea Europaea (Olive) Fruit Extract, Madecassoside, Palmitoyl Pentapeptide-4, Bacillus Ferment, Butylene Glycol, Sodium Hyaluronate, Ethylhexylglycerin, Sodium Polystyrene Sulfonate, Sclerotium Gum, Panax Ginseng Callus Culture Extract, Nelumbo Nucifera Callus Culture Extract, Solanum Lycopersicum (Tomato) Callus Culture Extract, Neofinetia Falcata Callus Culture Extract, Oryza Sativa (Rice) Callus Culture Extract, Ipomoea Hederacea Callus Culture Extract, Panthenol, Acetyl Hexapeptide-8, Ascorbic Acid , Tocopherol, Helianthus Annuus (Sunflower) Seed Oil, Dimethyl Sulfone, Morinda Citrifolia Extract, rh-Oligopeptide-1, sh-Polypeptide-1, sh-Polypeptide-3, Disodium EDTA, Camellia Japonica Seed Oil, Macadamia Ternifolia Seed Oil, Argania Spinosa Kernel Oil, Limnanthes Alba (Meadowfoam) Seed Oil, Sparassis Crispa Extract, 1,2-Hexanediol, Octyldodecanol, Ceramide NP, Caprylyl Glycol, Hydroxydecyl Ubiquinone, Glycine Soja (Soybean) Sterols, Caprylic/Capric Triglyceride

    [INCELLDERM DERMATOLOGY SERUM]

    Centella Asiatica Leaf Water, Mineral Water, Propanediol, Polyglycerin-3, Rubus Idaeus (Raspberry) Fruit Extract, Rubus Fruticosus (Blackberry) Fruit Extract, Vaccinium Angustifolium (Blueberry) Fruit Extract, Vaccinium Macrocarpon (Cranberry) Fruit Extract, Euterpe Oleracea Fruit Extract, Lysine, Histidine, Arginine, Aspartic Acid, Threonine, Serine, Glutamic Acid, Proline, Glycine, Alanine, Valine, Methionine, lsoleucine, Leucine, Tyrosine, Phenylalanine, Cysteine, Artemisia Capillaris Extract, Olea Europaea (Olive) Fruit Extract, Panax Ginseng Callus Culture Extract, Nelumbo Nucifera Callus Culture Extract, Solanum Lycopersicum (Tomato) Callus Culture Extract, Neofinetia Falcata Callus Culture Extract, Oryza Sativa (Rice) Callus Culture Extract, Ipomoea Hederacea Callus Culture Extract, Madecassoside, Aminobutyric Acid, Palmitoyl Pentapeptide-4, Panthenol, Cichorium Intybus (Chicory) Root Extract , Acetyl Hexapeptide-8, Ascorbic Acid, Tocopherol, Helianthus Annuus (Sunflower) Seed Oil, Dimethyl Sulfone, Morinda Citrifolia Extract, rh-Oligopeptide-1, sh-Polypeptide-1, sh-Polypeptide-3, Hydroxyethylcellulose, Xanthan Gum, Disodium EDTA, Camellia Japonica Seed Oil, Macadamia Ternifolia Seed Oil, Argania Spinosa Kernel Oil, Limnanthes Alba (Meadowfoam) Seed Oil, Sparassis Crispa Extract, Octyldodecanol, Ceramide NP, Caprylyl Glycol, Hydroxydecyl Ubiquinone, Glycine Soja (Soybean) Sterols, Caprylic/Capric Triglyceride, 1,2-Hexanediol, Butylene Glycol

  • PURPOSE

    Skin Brightening
    Anti-wrinkle

  • WARNINGS

    1. Consult a physician if red spots, swollenness, itchiness, or any other abnormal symptoms or side effects develops on the applied area during or after use or under direct sunlight.
    2. Do not use on wound, etc.
    3. Precautions for handling and storage
    a) Keep out of the reach of children
    b) Avoid direct sunlight

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

  • Uses

    Helps to brighten the skin.
    Helps to improve wrinkles in the skin.

  • Directions

    Take an appropriate amount and spread it evenly over the skin.

  • QUESTIONS

    http://www.incellderm.com

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of box

  • INGREDIENTS AND APPEARANCE
    INCELLDERM DERMATOLOGY FIRST PACKAGE 
    niacinamide, adenosine kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72650-080
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72650-080-011 in 1 BOX; Type 0: Not a Combination Product08/01/2020
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE, SPRAY 120 mL
    Part 21 BOTTLE 45 mL
    Part 1 of 2
    INCELLDERM DERMATOLOGY BOOSTER 
    niacinamide, adenosine spray
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Niacinamide (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) Niacinamide2.4 g  in 120 mL
    Adenosine (UNII: K72T3FS567) (ADENOSINE - UNII:K72T3FS567) Adenosine0.048 g  in 120 mL
    Inactive Ingredients
    Ingredient NameStrength
    CENTELLA ASIATICA LEAF (UNII: 6810070TYD)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1120 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other08/01/2020
    Part 2 of 2
    INCELLDERM DERMATOLOGY SERUM 
    niacinamide, adenosine liquid
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Niacinamide (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) Niacinamide0.9 g  in 45 mL
    Adenosine (UNII: K72T3FS567) (ADENOSINE - UNII:K72T3FS567) Adenosine0.018 g  in 45 mL
    Inactive Ingredients
    Ingredient NameStrength
    CENTELLA ASIATICA LEAF (UNII: 6810070TYD)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    145 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other08/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other08/01/2020
    Labeler - Riman Co., Ltd. (694893735)
    Registrant - Riman Co., Ltd. (694893735)
    Establishment
    NameAddressID/FEIBusiness Operations
    HANSOLBIOTECH694455165manufacture(72650-080)