SKIN LIGHTENING RODAN FIELDS- hydroquinone liquid 
Rodan & Fields, LLC.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Rodan and Fields Reverse 2 Skin Toner

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



image of box


for external use only

Rodan and Fields

Reverse

Dermatologist developed skin lightening toner

125 mL/ 4.2 Fl. Oz.



image of bottle



SKIN LIGHTENING  RODAN FIELDS
hydroquinone liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14222-1615
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE) HYDROQUINONE2 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:14222-1615-21 in 1 BOX
1NDC:14222-1615-1125 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart358A06/06/2011
Labeler - Rodan & Fields, LLC. (051659584)
Registrant - Cosmetic Enterprises Ltd (017701475)
Establishment
NameAddressID/FEIBusiness Operations
Cosmetic Enterprises Ltd017701475manufacture

Revised: 1/2012
Document Id: c6954fc7-c178-41e7-895d-5b71f8f9b657
Set id: 7a5faa65-5132-4e36-8c11-fbb91bb8b275
Version: 4
Effective Time: 20120124
 
Rodan & Fields, LLC.