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Melamin-C Skin Bleaching Cream

Generic Name: hydroquinone, vitamin C
Dosage Form: cream

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Melamin-C™ Skin Bleaching and Correcting Crème contains 4% hydroquinone and 20% vitamin C for optimal melanin inhibition to correct the most severe and advanced forms of hyperpigmentation. A potent level of 20% vitamin C accelerates the exfoliation of existing skin surface pigmentation to create a more uniform skin tone. Added antioxidants and skin soothers help calm and soothe irritated skin, making this maximally potent, water-free formula highly tolerable.

Indicated for the gradual bleaching of moderate to severe forms of hyperpigmented skin conditions such as chloasma, melasma, freckles, senile lentigines, and other unwanted areas of hyperpigmentation

Melamin-C Skin Bleaching Cream Dosage and Administration

Apply 2 pumps (1 g) to affected areas twice a day or as directed by a physician. Always use sunscreen protection. (See enclosed package insert for full prescribing information.)

Warnings

Keep out of reach of children. For external use only. Avoid contact with the eyes. Some users 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 swallowed, get medical help or contact a Poison Control Center right away.

STORAGE

Store at controlled room temperature: 15°-30°C (59°-86°F), away from direct sunlight.

ACTIVE INGREDIENT

Hydroquinone 4%

INACTIVE INGREDIENTS

Dimethicone, Ascorbic Acid, Caprylyl Methicone, Dimethicone Crosspolymer, Ethoxydiglycol, Cetyl PEG/PPG-10/1 Dimethicone, Squalane, Helianthus Annuus (Sunflower) Seed Oil, Plukenetia Volubilis Seed Oil, Oleyl Alcohol, Tocopheryl Acetate, Retinyl Palmitate, Caprylic/Capric Triglyceride, Ascorbyl Palmitate, PEG-12 Allyl Ether, Rosmarinus Officinalis (Rosemary) Leaf Extract, Zanthoxylum Bungeanum Fruit Extract, Tocopherol.

DIST BY
ZO Skin Health, Inc. Irvine, CA 92618
MADE IN USA 082000

zomedical.com

"ZO" is a registered trademark of ZO Skin Health, Inc.

PRINCIPAL DISPLAY PANEL - 85 g Bottle Carton

ZO®MEDICAL
BY ZEIN OBAGI MD

NDC 42851-034-85

MELAMIN-C™
Skin Bleaching &
Correcting Crème
with 20% Vitamin C

Hydroquinone USP, 4%

RX ONLY

Net Wt. 85 g / 2.99 Oz.

ZO MEDICAL MELAMIN-C SKIN BLEACHING AND CORRECTING WITH VITAMIN C HYDROQUINONE 
hydroquinone cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:42851-034
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROQUINONE (HYDROQUINONE) HYDROQUINONE 0.04 g  in 1 g
Inactive Ingredients
Ingredient Name Strength
DIMETHICONE  
ASCORBIC ACID  
CAPRYLYL TRISILOXANE  
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE)  
DIETHYLENE GLYCOL MONOETHYL ETHER  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 3)  
SQUALANE  
SUNFLOWER OIL  
PLUKENETIA VOLUBILIS SEED OIL  
OLEYL ALCOHOL  
.ALPHA.-TOCOPHEROL ACETATE  
VITAMIN A PALMITATE  
MEDIUM-CHAIN TRIGLYCERIDES  
ASCORBYL PALMITATE  
OLETH-12  
ROSEMARY  
ZANTHOXYLUM BUNGEANUM FRUIT  
TOCOPHEROL  
Packaging
# Item Code Package Description
1 NDC:42851-034-85 1 BOTTLE, PLASTIC in 1 CARTON
1 85 g in 1 BOTTLE, PLASTIC
2 NDC:42851-034-34 1 BOTTLE, PLASTIC in 1 CARTON
2 34 g in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 06/01/2016
Labeler - ZO Skin Health, Inc. (826468527)
Establishment
Name Address ID/FEI Operations
G.S. COSMECEUTICAL USA, INC. 017014734 MANUFACTURE(42851-034)
Revised: 04/2016
 
ZO Skin Health, Inc.



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