SKIN LIGHTENING RODAN FIELDS- hydroquinone liquid

Skin Lightening by

Drug Labeling and Warnings

Skin Lightening by is a Otc medication manufactured, distributed, or labeled by Rodan & Fields, LLC., Cosmetic Enterprises Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Hydroquinone 2%

Skin Lightening

Keep out of reach of children

if swallowed, get medical help or contact a poison control center immediately.

avoid contact with eyes.

some user of this product may experience a mild skin irritation. if skin irritation becomes severe , stop use and consult a physician.

do not use if pregnant or nursing.

do not use on children under 12 years of age unless directed by a physician.

apply evenly to the entire face with a fresh gauze pad, avoiding the eye area. do not rinse off, allow to dry. use once daily and increase to twice daily as tolerated.

Adult: apply a small amount as a think layer in affected area once or twice daily, or use as directed by a physician . if no improvement is seen after three months of treatment, use of this product should be discontinued . lightening effect of this product may not be noticeable when used on very dark skin.

children under 12 years of age: do not use unless directed by a physician.

Water (aqua), Ethoxydiglycol, Hamamelis Virgiana ( Witch Hazel) Water, Methylpropanediol, Alcohol Denat, Polysorbate 20, Butylene Glycol, Aminopropyl Ascorbyl Phosphate, Foeniculum Vulgare ( Fennel) Seed Extract, Magnesium Ascorbyl Phosphate, Arctostaphylos Uva Ursi (leaf) Extract, PEG-12, Dimethicone, Arnica Montana Flower Extract, Zinc Phenolsulfonate, Kojic Acid, Citrus Medica Limonum ( Lemon) Peel Extract, Sodium Salicylate, Citric Acid, Sodium Sulfite, Sodium Metabisulfite, DMDM Hydantoin, Fragrance, Yellow 5, Yellow 6

for external use only

PRINCIPAL DISPLAY PANEL

Rodan and Fields

Reverse

Dermatologist developed skin lightening toner

125 mL/ 4.2 Fl. Oz.

INGREDIENTS AND APPEARANCE

SKIN LIGHTENING  RODAN FIELDS
hydroquinone liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14222-1615
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE)	HYDROQUINONE	2 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
WITCH HAZEL (UNII: 101I4J0U34)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
FENNEL SEED (UNII: G3QC02NIE6)
MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)
ARCTOSTAPHYLOS UVA-URSI LEAF (UNII: 3M5V3D1X36)
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)
DIMETHICONE (UNII: 92RU3N3Y1O)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
ZINC PHENOLSULFONATE (UNII: 4O71YT5YB5)
KOJIC ACID (UNII: 6K23F1TT52)
LEMON PEEL (UNII: 72O054U628)
SODIUM SALICYLATE (UNII: WIQ1H85SYP)
SODIUM SULFITE (UNII: VTK01UQK3G)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
DMDM HYDANTOIN (UNII: BYR0546TOW)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14222-1615-2	1 in 1 BOX
1	NDC: 14222-1615-1	125 mL in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part358A	06/06/2011

Labeler - Rodan & Fields, LLC. (051659584)

Registrant - Cosmetic Enterprises Ltd (017701475)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmetic Enterprises Ltd		017701475	manufacture