Label: VITAMIN C 15%- L- ASCORBIC ACID solution

  • NDC Code(s): 84785-0053-1, 84785-0053-2
  • Packager: Gazebo Wellness SKIN LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 18, 2024

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  • DOSAGE & ADMINISTRATION

    Directions: Perform a patch test before using. Apply 3-5 drops once daily followed by moisturizer. For external use only.

  • WARNINGS

    Directions: Perform a patch test before using. Apply 3-5 drops once daily followed by moisturizer. For external use only.

  • INACTIVE INGREDIENT

    Inactive ingredients: Potassium Sorbate, Citric Acid.

  • ACTIVE INGREDIENT

    Active ingredients: L-Ascorbic Acid, Hyaluronic Acid (Botanical).

  • PURPOSE

    high potency VITAMIN C 15% (I-ascorbic acid)
    Intense Antioxidant Protection Complexion Correction & Age Control
    Distributed By:
    Skin Beauty Solutions Elk Grove CA 95759
    1 oz/30 ml

  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of children section

  • INDICATIONS & USAGE

    Perform a patch test before using. Apply 3-5 drops once daily followed by moisturizer. For external use only.

  • PRINCIPAL DISPLAY PANEL

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

  • INGREDIENTS AND APPEARANCE
    VITAMIN C 15% (L- ASCORBIC ACID) 
    vitamin c 15% (l- ascorbic acid) solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84785-0053
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID0.3 mg  in 30 mL
    HYALURONIC ACID (UNII: S270N0TRQY) (HYALURONIC ACID - UNII:S270N0TRQY) HYALURONIC ACID0.3 mg  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84785-0053-130 mL in 1 BOTTLE; Type 0: Not a Combination Product10/01/2024
    2NDC:84785-0053-260 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(84785-0053)
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