Label: GLYCOLIC 35 / LACTIC 45 COMBO PEEL solution

  • NDC Code(s): 84785-0018-1, 84785-0018-2, 84785-0018-3, 84785-0018-4, view more
    84785-0018-5, 84785-0018-6
  • Packager: Gazebo Wellness SKIN LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 16, 2024

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  • DOSAGE & ADMINISTRATION

    AHA PEELS work by loosening and gently sloughing off the damaged. unattractive skin cells, while working on the deeper layers of skin to accelerate the skin's natural production of collagen and elastin.

  • WARNINGS

    DIRECTIONS: Apply the peel to the treatment area. Let stand on skin for 2-10 minutes depending on skin tolerance. Remove peel with copious amount of water. Follow with moisturizer. Note: A stinging sensation may occur. Flakiness may occur for 3-5 days after performing peel. When using this product avoid unnecessary sun exposure and use sunscreen. For external use only.

  • INACTIVE INGREDIENT

    Inactive ingredient: Deionized Water.

  • INDICATIONS & USAGE

    DIRECTIONS: Apply the peel to the treatment area. Let stand on skin for 2-10 minutes depending on skin tolerance. Remove peel with copious amount of water. Follow with moisturizer. Note: A stinging sensation may occur. Flakiness may occur for 3-5 days after performing peel. When using this product avoid unnecessary sun exposure and use sunscreen. For external use only.

  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of children

  • PURPOSE

    Glycolic Acid 35%
    Lactic Acid
    45%
    Clears Acne & Scars Removes Dead Skin Cells
    Smoothes Fine lines & Wrinkles

    Distributed By:
    Skin Beauty Solutions Elk Grove CA 95759

  • ACTIVE INGREDIENT

    Active ingredients: MD Grade Glycolic Acid, Lactic Acid.

  • PRINCIPAL DISPLAY PANEL

    Content of labeling

    Content of labeling 15 mlContent of labeling Content of labeling 30 mlContent of labeling 60 ml

  • INGREDIENTS AND APPEARANCE
    GLYCOLIC 35 / LACTIC 45 COMBO PEEL 
    glycolic 35 / lactic 45 combo peel solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84785-0018
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LACTIC ACID (UNII: 33X04XA5AT) (LACTIC ACID - UNII:33X04XA5AT) LACTIC ACID0.3 mg  in 30 mL
    GLYCOLIC ACID (UNII: 0WT12SX38S) (GLYCOLIC ACID - UNII:0WT12SX38S) GLYCOLIC ACID0.3 mg  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84785-0018-115 mL in 1 BOTTLE; Type 0: Not a Combination Product10/01/2024
    2NDC:84785-0018-230 mL in 1 BOTTLE; Type 0: Not a Combination Product10/01/2024
    3NDC:84785-0018-360 mL in 1 BOTTLE; Type 0: Not a Combination Product10/01/2024
    4NDC:84785-0018-4120 mL in 1 BOTTLE; Type 0: Not a Combination Product10/01/2024
    5NDC:84785-0018-5240 mL in 1 BOTTLE; Type 0: Not a Combination Product10/01/2024
    6NDC:84785-0018-6480 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(84785-0018)
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