Label: CELLADIX SKIN BARRIER RECOVERY 131 CREAM- 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 March 9, 2023

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  • Active Ingredients

    Niacinamide 2.0%
    Adenosine 0.04%

  • Purposes

    Niacinamide 2.0% ------ Skin protectant
    Adenosine 0.04%------ Astringent

  • Uses

    For skin barrier repair, perfect for oily skin.

  • Warnings

    Do not use it on open wounds and sensitive skin.

  • Warnings

    Keep out of reach of children.

  • Warnings

    Stop use and ask a doctor If there are any abnormal symptoms or side effects such as red spots, swelling, or itching during or immediately after use.

  • Warnings

  • Warnings

    For external use only.

  • Directions

    Take an appropriate amount of the cream and gently spread it over the face for absorption

  • Inactive Ingredients

    Water, Butylene Glycol, Glycerin, 1,2-Hexanediol, Dipropylene Glycol, Cetearyl Alcohol, Sodium Polyacryloyldimethyl Taurate, Carbomer, Arginine, Hydrogenated Lecithin,

    Allantoin, Zea Mays (Corn) Starch, Microcrystalline Cellulose, Mannitol, Centella Asiatica Extract, Ficus Carica (Fig) Fruit Extract, Ethylhexylglycerin, Ceramide NP, Phytosterols,

    Disodium EDTA, Palmitic Acid, Stearic Acid, Myristic Acid, Hyaluronic Acid, Pentylene Glycol, Dioscorea Japonica Root Extract, Laminaria Japonica Extract, Viola Mandshurica Flower Extract,

    Ulmus Davidiana Root Extract, Aloe Barbadensis Leaf Extract, Caprylyl Glycol, Lactobacillus Ferment

  • Label

    Celladix Skin Barrier Recovery 131 Cream

  • INGREDIENTS AND APPEARANCE
    CELLADIX SKIN BARRIER RECOVERY 131 CREAM 
    niacinamide, adenosine cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83490-602
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE2 g  in 100 mL
    ADENOSINE (UNII: K72T3FS567) (ADENOSINE - UNII:K72T3FS567) ADENOSINE0.04 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PALMITIC ACID (UNII: 2V16EO95H1)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    ALLANTOIN (UNII: 344S277G0Z)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    MANNITOL (UNII: 3OWL53L36A)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    FIG (UNII: TGD87RII2U)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    DIOSCOREA JAPONICA ROOT (UNII: I43FCF3356)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ARGININE (UNII: 94ZLA3W45F)  
    VIOLA MANDSHURICA FLOWER (UNII: 46MR945M6X)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    CERAMIDE NP (UNII: 4370DF050B)  
    MYRISTIC ACID (UNII: 0I3V7S25AW)  
    HYALURONIC ACID (UNII: S270N0TRQY)  
    LAMINARIA JAPONICA (UNII: WE98HW412B)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CENTELLA ASIATICA TRITERPENOIDS (UNII: 4YS74Q4G4J)  
    ULMUS DAVIDIANA ROOT (UNII: URQ79U8261)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83490-602-0180 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/24/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other05/24/2023
    Labeler - 2359 US INC (118974080)
    Registrant - 2359 US INC (118974080)
    Establishment
    NameAddressID/FEIBusiness Operations
    isamogu Inc.695695834manufacture(83490-602)