MELAMIX SKIN LIGHTENER AND BLENDING- hydroquinone cream 
ZO Skin Health, Inc.

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.

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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.

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.

Principal Display Panel 80 g Bottle Carton
MELAMIX SKIN LIGHTENER AND BLENDING 
hydroquinone cream
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:42851-033
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE) HYDROQUINONE0.04 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
GLYCERIN (UNII: PDC6A3C0OX)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
AMINOPROPYL DIHYDROGEN PHOSPHATE (UNII: D5J0Q2CM4V)  
CURDLAN (UNII: 6930DL209R)  
SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
GLYCOLIC ACID (UNII: 0WT12SX38S)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CAULOSIDE D (UNII: 4N5Z068GAZ)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42851-033-801 in 1 CARTON07/01/201407/01/2021
180 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC:42851-033-321 in 1 CARTON07/01/201407/01/2021
232 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other07/01/201407/01/2021
Labeler - ZO Skin Health, Inc. (826468527)
Establishment
NameAddressID/FEIBusiness Operations
G.S. COSMECEUTICAL USA, INC.017014734manufacture(42851-033)

Revised: 12/2022
 
ZO Skin Health, Inc.