UNBLEMISH - 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.

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Rodan + Fields Unblemish Toner

Active ingredient Hydroquinone 2%

Purpose:  Skin lightener

Uses For the gradual fading of dark spots and discolorations in the skin following acne.

Warnings

For external use only.

When Using this product

Avoid contact with eyes.

Some users of this product may experience a mild skin irritation.  If skin irritation becomes severe, stop use and consult a physician.

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

If pregnant or nursing, consult a physician before use.

Keep out of reach of children.

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

Directions

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.


Adults:  apply a small amount as a thin layer on affected area once or twice dsily, 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 noticable when used on very dark skin.


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

Other Information

You may report a serious adverse reaction to Rodan + Fields, Attn: Product Development, 111 Maiden Lane, Suite 400, San Francisco, CA 94108

Inactive Ingredients Water, Ethoxydiglycol, Hamamelis Virginiana (Whitch Hazel) Water, Methylpropanediol, Polysorbate 20, Salicylic Acid, Zinc Phenosulfonate, Peg-12, Dimethicone, Glycerin, Arctostaphylos Uva Ursi Leaf Extract, Foeniculum Vulgare (Fennel) Seed Extract, Caprylic/Capric Triglyceride, Sea Whip Extract, Arnica Montana Flower Extract, Citrus Medica Limonum (Lemon) Peel Extract, Magnesium Ascorbyl Phosphate, Kojic Acid, Butylene Glycol, Propylene Glycol, Citric Acid, Sodium Hydroxide, Yellow 5, Yellow6, Fragrance, DMDM Hydatoin, Sodium Sulfite, Sodium Metabisulfite.

QUESTIONS OR COMMENTS   1-888-995-5656

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UNBLEMISH  
hydroquinone liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14222-1900
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE) HYDROQUINONE2.0 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
ARCTOSTAPHYLOS UVA-URSI LEAF (UNII: 3M5V3D1X36)  
FENNEL SEED (UNII: G3QC02NIE6)  
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
SALICYLIC ACID (UNII: O414PZ4LPZ)  
METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
HAMAMELIS VIRGINIANA LEAF WATER (UNII: 8FP93ED6H2)  
ZINC PHENOLSULFONATE (UNII: 4O71YT5YB5)  
KOJIC ACID (UNII: 6K23F1TT52)  
PSEUDOPTEROGORGIA ELISABETHAE (UNII: UDY3H1OUX5)  
PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
LEMON (UNII: 24RS0A988O)  
SODIUM SULFITE (UNII: VTK01UQK3G)  
SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:14222-1900-21 in 1 CARTON10/01/201106/21/2016
1NDC:14222-1900-1125 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart358A10/01/201106/21/2016
Labeler - Rodan + Fields LLC (051659584)

Revised: 6/2016
 
Rodan + Fields LLC