MELAMIX SKIN LIGHTENER AND BLENDING- hydroquinone cream

MELAMIX Skin Lightener and Blending by

Drug Labeling and Warnings

MELAMIX Skin Lightener and Blending by is a Prescription medication manufactured, distributed, or labeled by ZO Skin Health, Inc., G.S. COSMECEUTICAL USA, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

INDICATIONS & USAGE

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.

SPL UNCLASSIFIED SECTION

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.

INGREDIENTS AND APPEARANCE

MELAMIX SKIN LIGHTENER AND BLENDING 
hydroquinone cream

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 42851-033
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE)	HYDROQUINONE	0.04 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42851-033-80	1 in 1 CARTON
1		80 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC: 42851-033-32	1 in 1 CARTON
2		32 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

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	Business Operations
G.S. COSMECEUTICAL USA, INC.		017014734	MANUFACTURE(42851-033)