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
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- DOSAGE & ADMINISTRATION
- WARNINGS
- INACTIVE INGREDIENT
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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
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- PURPOSE
- PRINCIPAL DISPLAY PANEL
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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 solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:84785-0011 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIMETHYL SULFONE (UNII: 9H4PO4Z4FT) (DIMETHYL SULFONE - UNII:9H4PO4Z4FT) DIMETHYL SULFONE 0.6 mg in 60 mL ANISE (UNII: 21C2F5E8RE) (ANISE - UNII:21C2F5E8RE) ANISE 0.6 mg in 60 mL HORSERADISH (UNII: 8DS6G120HJ) (HORSERADISH - UNII:8DS6G120HJ) HORSERADISH 0.6 mg in 60 mL LICORICE (UNII: 61ZBX54883) (LICORICE - UNII:61ZBX54883) LICORICE 0.6 mg in 60 mL FENNEL (UNII: 557II4LLC3) (FENNEL - UNII:557II4LLC3) FENNEL 0.6 mg in 60 mL AMERICAN GINSENG (UNII: 8W75VCV53Q) (AMERICAN GINSENG - UNII:8W75VCV53Q) AMERICAN GINSENG 0.6 mg in 60 mL KOJIC ACID (UNII: 6K23F1TT52) (KOJIC ACID - UNII:6K23F1TT52) KOJIC ACID 0.6 mg in 60 mL WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34) WITCH HAZEL 0.6 mg in 60 mL JOJOBA OIL (UNII: 724GKU717M) (JOJOBA OIL - UNII:724GKU717M) JOJOBA OIL 0.6 mg in 60 mL HYALURONIC ACID (UNII: S270N0TRQY) (HYALURONIC ACID - UNII:S270N0TRQY) HYALURONIC ACID 0.6 mCi in 60 mL SCHISANDRA CHINENSIS SEED (UNII: MO9DK65G18) (SCHISANDRA CHINENSIS SEED - UNII:MO9DK65G18) SCHISANDRA CHINENSIS SEED 0.6 mg in 60 mL SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 0.6 mg in 60 mL DANDELION HONEY (UNII: Z9305QFA72) (DANDELION HONEY - UNII:Z9305QFA72) DANDELION HONEY 0.6 mg in 60 mL ALOE VERA LEAF (UNII: ZY81Z83H0X) (ALOE VERA LEAF - UNII:ZY81Z83H0X) ALOE VERA LEAF 0.6 mg in 60 mL LEMON BALM OIL (UNII: MJ76269K9S) (LEMON BALM OIL - UNII:MJ76269K9S) LEMON BALM OIL 0.6 mg in 60 mL GLYCOLIC ACID (UNII: 0WT12SX38S) (GLYCOLIC ACID - UNII:0WT12SX38S) GLYCOLIC ACID 0.6 mg in 60 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:84785-0011-1 60 mL in 1 BOTTLE; Type 0: Not a Combination Product 10/01/2024 2 NDC:84785-0011-2 120 mL in 1 BOTTLE; Type 0: Not a Combination Product 10/01/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M016 10/01/2024 Labeler - Gazebo Wellness SKIN LLC (119609953) Registrant - Gazebo Wellness SKIN LLC (119609953) Establishment Name Address ID/FEI Business Operations Gazebo Wellness SKIN LLC 119609953 manufacture(84785-0011)