Label: NIACINAMIDE B3 SERUM solution

  • NDC Code(s): 84785-0006-1, 84785-0006-2
  • Packager: Gazebo Wellness SKIN LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 16, 2024

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

  • DOSAGE & ADMINISTRATION

    Niacinamide 83 Serum helps to protect the skin's immune function as well as improve signs of sun damage, dryness and roughness.

  • WARNINGS

    Directions: Apply a small amount twice daily to the affected area. Make sure skin is clean and dry. Gently massage until completely absorbed.

  • INACTIVE INGREDIENT

    Inactive ingredients: Glycerin, Emulsifying Wax NF, Phenoxyethanol, Xanthan Gum, Tetrasodium EDTA.

  • ACTIVE INGREDIENT

    Active ingredients: Aloe Vera Leaf Juice, Niacinamide (Vitamin B3), Avocado Oil, Vitamin E, Organic Neem Seed Oil, Rosemary Leaf Extract, Hyaluronic Acid.

  • INDICATIONS & USAGE

    Apply a small amount twice daily to the affected area. Make sure skin is clean and dry. Gently massage until completely absorbed.

  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of children

  • PURPOSE

    natural + organic Niacinamide B3 facial serum
    Niacinamide 83 Reduces Water Loss in the Skin and Retains Fatty Acid Levels for a Younger, Plumper and Firmer Skin.

    Distributed By: Skin Beauty Solutions Elk Grove CA 95759

  • PRINCIPAL DISPLAY PANEL

    Content of labeling
    Content of labeling 60 mlContent of labeling 30 ml

  • INGREDIENTS AND APPEARANCE
    NIACINAMIDE B3 SERUM 
    niacinamide b3 serum solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84785-0006
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X) (ALOE VERA LEAF - UNII:ZY81Z83H0X) ALOE VERA LEAF0.3 mg  in 30 mL
    ROSEMARY (UNII: IJ67X351P9) (ROSEMARY - UNII:IJ67X351P9) ROSEMARY0.3 mg  in 30 mL
    HYALURONIC ACID (UNII: S270N0TRQY) (HYALURONIC ACID - UNII:S270N0TRQY) HYALURONIC ACID0.3 mg  in 30 mL
    NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE0.3 mg  in 30 mL
    AVOCADO OIL (UNII: 6VNO72PFC1) (AVOCADO OIL - UNII:6VNO72PFC1) AVOCADO OIL0.3 mg  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    TETRASODIUM EDETATE DIHYDRATE (UNII: 3JGX4KKZ4A)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    VITAMIN E POLYETHYLENE GLYCOL SUCCINATE (UNII: O03S90U1F2)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84785-0006-130 mL in 1 BOTTLE; Type 0: Not a Combination Product10/01/2024
    2NDC:84785-0006-260 mL in 1 BOTTLE; Type 0: Not a Combination Product10/01/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01610/01/2024
    Labeler - Gazebo Wellness SKIN LLC (119609953)
    Registrant - Gazebo Wellness SKIN LLC (119609953)
    Establishment
    NameAddressID/FEIBusiness Operations
    Gazebo Wellness SKIN LLC119609953manufacture(84785-0006)