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

Hydro White Pro Strength Kojic and Alpha Arbutin Skin Lightening Serum by

Drug Labeling and Warnings

Hydro White Pro Strength Kojic and Alpha Arbutin Skin Lightening Serum by is a Otc medication manufactured, distributed, or labeled by Gazebo Wellness SKIN LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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 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)