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 and Blending Crème

Melamin™ 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), Glycolic Acid, Glycerin, Cetyl Alcohol, Ethylhexyl Palmitate, Ascorbic Acid, Sodium Lauryl Sulfate, Phenyl Trimethicone, Saponins, Tocopheryl Acetate, Methylparaben, Propylparaben, Sodium Metabisulfite, BHT, Disodium EDTA.

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

PRINCIPAL DISPLAY PANEL - 80 g Bottle Carton

ZO®MEDICAL
BY ZEIN OBAGI, MD

NDC 42851-031-80

08rx

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:42851-031
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
Ascorbic Acid (UNII: PQ6CK8PD0R)  
Butylated Hydroxytoluene (UNII: 1P9D0Z171K)  
Cetyl Alcohol (UNII: 936JST6JCN)  
Edetate Disodium (UNII: 7FLD91C86K)  
Ethylhexyl Palmitate (UNII: 2865993309)  
Glycerin (UNII: PDC6A3C0OX)  
Glycolic Acid (UNII: 0WT12SX38S)  
Methylparaben (UNII: A2I8C7HI9T)  
Phenyl Trimethicone (UNII: DR0K5NOJ4R)  
Propylparaben (UNII: Z8IX2SC1OH)  
Water (UNII: 059QF0KO0R)  
CAULOSIDE D (UNII: 4N5Z068GAZ)  
Sodium Lauryl Sulfate (UNII: 368GB5141J)  
Sodium Metabisulfite (UNII: 4VON5FNS3C)  
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42851-031-801 in 1 CARTON
180 g in 1 BOTTLE, PLASTIC
2NDC:42851-031-321 in 1 CARTON
232 g in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER01/01/2012
Labeler - ZO Skin Health, Inc. (826468527)
Establishment
NameAddressID/FEIBusiness Operations
Sanitor Coporation797472792MANUFACTURE(42851-031)

Revised: 4/2014
Document Id: cd0910a6-6a79-437e-bc91-00e7f13cc61a
Set id: 84b81ea2-d349-4f5c-84a6-63bfc478571d
Version: 2
Effective Time: 20140408
 
ZO Skin Health, Inc.