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Melamix Skin Lightener Cream

Generic Name: hydroquinone
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.

MELAMIX™
Skin Lightener &
Blending Crème

Melamix™ contains 4% Hydroquinone, which is used for the treatment of pigmentation problems. It helps to even color tone by inhibiting melanin production.

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

Melamix Skin Lightener 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. Contains Sodium Metabisulfite, a sulfite that may cause serious allergic-type reactions including anaphylactic symptoms (e.g. hives, itching), and life threatening or less severe asthmatic episodes in certain susceptible persons. 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.

SUNBURN ALERT

This product contains an alpha hydroxy acid (AHA) that may increase your skin's sensitivity to the sun and particularly the possibility of sunburn. Use a sunscreen, wear protective clothing, and limit sun exposure while using this product and for a week afterwards.

STORAGE

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

ACTIVE INGREDIENT

Hydroquinone 4%

INACTIVE INGREDIENTS

Water (Aqua), Cetyl Alcohol, Glycerin, Ethylhexyl Palmitate, Lauryl Glucoside, Stearyl Alcohol, Helianthus Annuus Seed Oil, Maltodextrin, Phenyl Trimethicone, Tocopheryl Acetate, Ascorbic Acid, Phenoxyethanol, Aminopropyl Dihydrogen Phosphate, Beta-Glucan, Sodium Metabisulfite, Glycolic Acid, Brassica Oleracea Italica Extract, Ascorbyl Palmitate, Chlorphenesin, Disodium EDTA, Caprylyl Glycol, Stachys Officinalis Extract, Saponins.

DIST BY
ZO Skin Health, Inc. Irvine, CA 92618

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

MADE IN USA 080500

zomedical.com

PRINCIPAL DISPLAY PANEL 80 g Bottle Carton

ZO®MEDICAL
BY ZEIN OBAGI, MD

NDC 42851-033-80

MELAMIX™
Skin Lightener &
Blending Crème

Hydroquinone USP, 4%

RX ONLY

Net Wt. 80 g / 2.8 Oz.

MELAMIX SKIN LIGHTENER AND BLENDING 
hydroquinone cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:42851-033
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
WATER  
CETYL ALCOHOL  
GLYCERIN  
ETHYLHEXYL PALMITATE  
LAURYL GLUCOSIDE  
STEARYL ALCOHOL  
SUNFLOWER OIL  
MALTODEXTRIN  
PHENYL TRIMETHICONE  
.ALPHA.-TOCOPHEROL ACETATE  
ASCORBIC ACID  
PHENOXYETHANOL  
AMINOPROPYL DIHYDROGEN PHOSPHATE  
CURDLAN  
SODIUM METABISULFITE  
GLYCOLIC ACID  
ASCORBYL PALMITATE  
CHLORPHENESIN  
EDETATE DISODIUM  
CAPRYLYL GLYCOL  
CAULOSIDE D  
Packaging
# Item Code Package Description
1 NDC:42851-033-80 1 BOTTLE, PLASTIC in 1 CARTON
1 80 g in 1 BOTTLE, PLASTIC
2 NDC:42851-033-32 1 BOTTLE, PLASTIC in 1 CARTON
2 32 g in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 07/01/2014
Labeler - ZO Skin Health, Inc. (826468527)
Establishment
Name Address ID/FEI Operations
G.S. COSMECEUTICAL USA, INC. 017014734 MANUFACTURE(42851-033)
Revised: 10/2014
 
ZO Skin Health, Inc.



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