Label: HYDRO WHITE PRO STRENGTH KOJIC AND ALPHA ARBUTIN SKIN LIGHTENING SERUM solution

  • NDC Code(s): 84785-0011-1, 84785-0011-2
  • Packager: Gazebo Wellness SKIN LLC
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated December 16, 2024

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • DOSAGE & ADMINISTRATION

    Apply a small amount twice daily to the problem area or as directed by a physician. Make sure the skin is clean and dry. Gently massage until completely absorbed.

  • WARNINGS

    Directions: Apply a small amount twice daily to the problem area or as directed by a physician. Make sure the skin is clean and dry. Gently massage until completely absorbed.

  • INACTIVE INGREDIENT

    Inactive ingredients: Aqua (Water), Glycerin (Kosher Vegetable), Hydroxyethyl Ethylcellulose, Carrageenan, Ethylhexylglycerin, Sodium Benzoate, Potassium Sorbate.

  • ACTIVE INGREDIENT

    Active ingredients: Witch Hazel, Plant-Based Hyaluronic Acid, Organic Aloe Vera, MSM, Organic Reishi/Kojic Acid Extract, Glycolic Acid, Salicylic Acid Extract, Organic Anise Extract, Horseradish Extract, Licorice Root Extract, Schisandra Extract, Lemon Balm Extract, Fennel Extract, Ginseng Extract, Melissa Essential Oil, Jojoba Oil, Vitamin E, Gotu Kola Extract, Horsetail Extract, Wild Geranium Extract, Dandelion Extract.

  • INDICATIONS & USAGE

    Directions: Apply a small amount twice daily to the problem area or as directed by a physician. Make sure the skin is clean and dry. Gently massage until completely absorbed.

  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of children

  • PURPOSE

    SKINBEAUTY
    SOLUTIONS-
    Pro Strength Treatment
    Skin Light
    Fade & Remove Dark Spots, Melasma, Acne Scars, & More
    Formulated with Hyaluronic, Glycolic Acid, Kojic Acid & Licorice Root

    Distributed By:
    Skin Beauty Solutions Elk Grove CA 95759

  • PRINCIPAL DISPLAY PANEL

    Content of labeling

    Content of labeling 60 ml

  • INGREDIENTS AND APPEARANCE
    HYDRO WHITE PRO STRENGTH KOJIC AND ALPHA ARBUTIN SKIN LIGHTENING SERUM 
    hydro white pro strength kojic and alpha arbutin skin lightening serum solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84785-0011
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT) (DIMETHYL SULFONE - UNII:9H4PO4Z4FT) DIMETHYL SULFONE0.6 mg  in 60 mL
    ANISE (UNII: 21C2F5E8RE) (ANISE - UNII:21C2F5E8RE) ANISE0.6 mg  in 60 mL
    HORSERADISH (UNII: 8DS6G120HJ) (HORSERADISH - UNII:8DS6G120HJ) HORSERADISH0.6 mg  in 60 mL
    LICORICE (UNII: 61ZBX54883) (LICORICE - UNII:61ZBX54883) LICORICE0.6 mg  in 60 mL
    FENNEL (UNII: 557II4LLC3) (FENNEL - UNII:557II4LLC3) FENNEL0.6 mg  in 60 mL
    AMERICAN GINSENG (UNII: 8W75VCV53Q) (AMERICAN GINSENG - UNII:8W75VCV53Q) AMERICAN GINSENG0.6 mg  in 60 mL
    KOJIC ACID (UNII: 6K23F1TT52) (KOJIC ACID - UNII:6K23F1TT52) KOJIC ACID0.6 mg  in 60 mL
    WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34) WITCH HAZEL0.6 mg  in 60 mL
    JOJOBA OIL (UNII: 724GKU717M) (JOJOBA OIL - UNII:724GKU717M) JOJOBA OIL0.6 mg  in 60 mL
    HYALURONIC ACID (UNII: S270N0TRQY) (HYALURONIC ACID - UNII:S270N0TRQY) HYALURONIC ACID0.6 mCi  in 60 mL
    SCHISANDRA CHINENSIS SEED (UNII: MO9DK65G18) (SCHISANDRA CHINENSIS SEED - UNII:MO9DK65G18) SCHISANDRA CHINENSIS SEED0.6 mg  in 60 mL
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID0.6 mg  in 60 mL
    DANDELION HONEY (UNII: Z9305QFA72) (DANDELION HONEY - UNII:Z9305QFA72) DANDELION HONEY0.6 mg  in 60 mL
    ALOE VERA LEAF (UNII: ZY81Z83H0X) (ALOE VERA LEAF - UNII:ZY81Z83H0X) ALOE VERA LEAF0.6 mg  in 60 mL
    LEMON BALM OIL (UNII: MJ76269K9S) (LEMON BALM OIL - UNII:MJ76269K9S) LEMON BALM OIL0.6 mg  in 60 mL
    GLYCOLIC ACID (UNII: 0WT12SX38S) (GLYCOLIC ACID - UNII:0WT12SX38S) GLYCOLIC ACID0.6 mg  in 60 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARRAGEENAN (UNII: 5C69YCD2YJ)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROXYETHYL ETHYLCELLULOSE (UNII: ZDN57Z154K)  
    VITAMIN E POLYETHYLENE GLYCOL SUCCINATE (UNII: O03S90U1F2)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84785-0011-160 mL in 1 BOTTLE; Type 0: Not a Combination Product10/01/2024
    2NDC:84785-0011-2120 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(84785-0011)