Label: A.M- 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 April 24, 2021

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  • ACTIVE INGREDIENT

    Niacinamide, Adenosine

  • INACTIVE INGREDIENT

    Water, Butylene Glycol, Butylene Glycol Dicaprylate/Dicaprate, Caprylic/Capric Triglyceride, Beeswax, Niacinamide, Behenyl Alcohol, Coco-Caprylate/Caprate, Cetearyl Alcohol, Stearyl Alcohol, CetearylOlivate, Betaine, Glyceryl Caprylate, Glyceryl Stearate, Trehalose, SorbitanOlivate, Sodium Acrylate/Sodium AcryloyldimethylTaurate Copolymer, Arachidyl Alcohol, Arginine, Carbomer, Polyisobutene, Chlorphenesin, Cetearyl Glucoside, Xanthan Gum, Hydrogenated Olive Oil Unsaponifiables, Adenosine, Caprylyl/Capryl Glucoside, Sorbitan Oleate, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Lavandula Hybrida Oil, Citrus Aurantium Dulcis (Orange) Peel Oil, Cupressus Sempervirens Leaf/Nut/Stem Oil , Juniperus Virginiana Oil, Citrus Paradisi (Grapefruit) Peel Oil, Glucose, Bisabolol, Tranexamic Acid, 1,2-Hexanediol, Centella Asiatica Extract, Polygonum Cuspidatum Root Extract, ScutellariaBaicalensis Root Extract , Camellia Sinensis Leaf Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Chamomilla Recutita (Matricaria) Flower Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Bambusa Vulgaris Extract, Citrus Aurantifolia (Lime) Fruit Extract, Melissa Officinalis Leaf Extract, Opuntia Ficus-Indica Stem Extract, Rosmarinus Officinalis (Rosemary) Extract, Ethylhexylglycerin, NelumbiumSpeciosum Flower Extract, Pearl Extract

  • PURPOSE

    anti wrinkle, whitening

  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of the children

  • INDICATIONS & USAGE

    Take an appropriate amount of this product and spread it evenly on the skin.

  • WARNINGS

    If there are any abnormal symptoms or side effects such as red spots, swelling, or itching due to direct sunlight during or after using cosmetics. 2. Avoid using areas with wounds. 3. Precautions for storage and handling. 3.1) Keep out reach of children. 3.2) Keep it out of direct sunlight.

  • DOSAGE & ADMINISTRATION

    for external use only

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    A.M 
    niacinamide, adenosine cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74997-0008
    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
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74997-0008-150 mL in 1 TUBE; Type 0: Not a Combination Product04/25/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other04/25/2021
    Labeler - J&J COMPANY (688995236)
    Registrant - J&J COMPANY (688995236)
    Establishment
    NameAddressID/FEIBusiness Operations
    J&J COMPANY688995236manufacture(74997-0008) , label(74997-0008) , pack(74997-0008)