MELAMIX Skin Lightener and Blending

Manufacturer
ZO Skin Health, Inc. | Sanitor Coporation
Effective date
2014-04-08
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 01:35:47

Label at a glance#

ProductMELAMIX Skin Lightener and Blending
Active ingredientHydroquinone
Label structure9 sections

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.)

Storage and handling

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

Label contents#

Full prescribing information#

DESCRIPTION SECTION

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

INDICATIONS & USAGE SECTION

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

DOSAGE & ADMINISTRATION SECTION

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

WARNINGS SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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.

OTC - WHEN USING SECTION

For external use only. Avoid contact with the eyes.

OTC - STOP USE SECTION

Some users may experience a mild skin irritation. If skin irritation becomes severe, stop use and consult a physician.

OTC - DO NOT USE SECTION

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

SPL UNCLASSIFIED SECTION

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

STORAGE AND HANDLING SECTION

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

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Hydroquinone 4%

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

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.

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 80 g Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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
PRINCIPAL DISPLAY PANEL - 80 g Bottle Carton

FDA-Initiated Inactive NDC Indexing#

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
HydroquinoneACTIVE INGREDIENTXV74C1N1AE2
HydroquinoneACTIVE MOIETYXV74C1N1AE2
.Alpha.-Tocopherol AcetateINACTIVE INGREDIENT9E8X80D2L02
Ascorbic AcidINACTIVE INGREDIENTPQ6CK8PD0R2
Butylated HydroxytolueneINACTIVE INGREDIENT1P9D0Z171K2
CAULOSIDE DINACTIVE INGREDIENT4N5Z068GAZ2
Cetyl AlcoholINACTIVE INGREDIENT936JST6JCN2
Edetate DisodiumINACTIVE INGREDIENT7FLD91C86K2
Ethylhexyl PalmitateINACTIVE INGREDIENT28659933092
GlycerinINACTIVE INGREDIENTPDC6A3C0OX2
Glycolic AcidINACTIVE INGREDIENT0WT12SX38S2
MethylparabenINACTIVE INGREDIENTA2I8C7HI9T2
Phenyl TrimethiconeINACTIVE INGREDIENTDR0K5NOJ4R2
PropylparabenINACTIVE INGREDIENTZ8IX2SC1OH2
Sodium Lauryl SulfateINACTIVE INGREDIENT368GB5141J2
Sodium MetabisulfiteINACTIVE INGREDIENT4VON5FNS3C2
WaterINACTIVE INGREDIENT059QF0KO0R2

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
42851-03142851-031-80, 42851-031-32

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Source Document#

Source XML · Source PDF

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 8 · 464 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
MethylparabenMETHYLPARABENA2I8C7HI9TINJECTION, SOLUTION / INTRAMUSCULAR45 mgExact identifier — unii candidate
79 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TSPRAY / TOPICAL0.2 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSYRUP / ORAL16734 mgExact identifier — unii candidate
75 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KLIQUID / ORAL0.5 mg/1mlExact identifier — unii candidate
77 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TSUSPENSION, EXTENDED RELEASE / ORAL40 mgExact identifier — unii candidate
79 equally ranked IID candidates
PropylparabenPROPYLPARABENZ8IX2SC1OHINJECTION / INTRALESIONAL0.02 %w/vExact identifier — unii candidate
68 equally ranked IID candidates
Sodium MetabisulfiteSODIUM METABISULFITE4VON5FNS3CINJECTION / INTRACARDIAC0.09 %w/vExact identifier — unii candidate
43 equally ranked IID candidates
Sodium Lauryl SulfateSODIUM LAURYL SULFATE368GB5141JTABLET, DELAYED RELEASE / ORAL199 mgExact identifier — unii candidate
42 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION, SOLUTION / INTRAVENOUS15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
Cetyl AlcoholCETYL ALCOHOL936JST6JCNSUSPENSION / AURICULAR (OTIC)1 %w/vExact identifier — unii candidate
20 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TTABLET, CHEWABLE / ORAL1.28 mgExact identifier — unii candidate
79 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TCONCENTRATE / ORAL12 mgExact identifier — unii candidate
79 equally ranked IID candidates
Butylated HydroxytolueneBUTYLATED HYDROXYTOLUENE1P9D0Z171KTABLET / SUBLINGUAL0.13 mgExact identifier — unii candidate
32 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KDROPS / OPHTHALMIC0.05 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KELIXIR / ORAL1.3 mg/5mlExact identifier — unii candidate
77 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS225 mgExact identifier — unii candidate
75 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KCONCENTRATE / ORAL20 mgExact identifier — unii candidate
77 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KINJECTION, SOLUTION / INTRAMUSCULAR4 mgExact identifier — unii candidate
77 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KCREAM, AUGMENTED / TOPICAL2 mgExact identifier — unii candidate
77 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION, EMULSION / INTRAVENOUS24100 mgExact identifier — unii candidate
75 equally ranked IID candidates
PropylparabenPROPYLPARABENZ8IX2SC1OHSOLUTION, CONCENTRATE / ORAL0.2 mg/1mlExact identifier — unii candidate
68 equally ranked IID candidates
PropylparabenPROPYLPARABENZ8IX2SC1OHCONCENTRATE / ORAL2.5 mg/5mlExact identifier — unii candidate
68 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KSYSTEM / TOPICAL126 mgExact identifier — unii candidate
77 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSPONGE / TOPICAL2 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXCREAM / TOPICAL1720 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXPASTE, DENTIFRICE / DENTAL18 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
PropylparabenPROPYLPARABENZ8IX2SC1OHENEMA / RECTAL0.02 %w/wExact identifier — unii candidate
68 equally ranked IID candidates
PropylparabenPROPYLPARABENZ8IX2SC1OHINJECTION / SUBCUTANEOUS2 mgExact identifier — unii candidate
68 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSUPPOSITORY / RECTAL440 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXTABLET, COATED / ORAL1 mgExact identifier — unii candidate
75 equally ranked IID candidates
Ascorbic AcidASCORBIC ACIDPQ6CK8PD0RAEROSOL, SPRAY / RESPIRATORY (INHALATION)0.11 %w/wExact identifier — unii candidate
25 equally ranked IID candidates
PropylparabenPROPYLPARABENZ8IX2SC1OHPOWDER, FOR SUSPENSION / ORAL8 mgExact identifier — unii candidate
68 equally ranked IID candidates
PropylparabenPROPYLPARABENZ8IX2SC1OHPASTE, DENTIFRICE / DENTALNAExact identifier — unii candidate
68 equally ranked IID candidates
Cetyl AlcoholCETYL ALCOHOL936JST6JCNCREAM / TOPICAL1280 mgExact identifier — unii candidate
20 equally ranked IID candidates
Cetyl AlcoholCETYL ALCOHOL936JST6JCNEMULSION / TOPICALNAExact identifier — unii candidate
20 equally ranked IID candidates
PropylparabenPROPYLPARABENZ8IX2SC1OHSOLUTION / OPHTHALMIC0.02 %w/wExact identifier — unii candidate
68 equally ranked IID candidates
Butylated HydroxytolueneBUTYLATED HYDROXYTOLUENE1P9D0Z171KSOLUTION, CONCENTRATE / ORAL0.1 mg/1mlExact identifier — unii candidate
32 equally ranked IID candidates
PropylparabenPROPYLPARABENZ8IX2SC1OHSPRAY / TOPICAL0.8 %w/wExact identifier — unii candidate
68 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXOINTMENT / TOPICALNAExact identifier — unii candidate
75 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TSOLUTION / RESPIRATORY (INHALATION)0.03 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
Sodium MetabisulfiteSODIUM METABISULFITE4VON5FNS3CINJECTION, SOLUTION / SUBMUCOSAL5 %w/vExact identifier — unii candidate
43 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION / INTRADERMAL1.6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
Sodium MetabisulfiteSODIUM METABISULFITE4VON5FNS3CINJECTION / SUBCUTANEOUS43 mgExact identifier — unii candidate
43 equally ranked IID candidates
Sodium Lauryl SulfateSODIUM LAURYL SULFATE368GB5141JTABLET, CHEWABLE / ORAL6 mgExact identifier — unii candidate
42 equally ranked IID candidates
Cetyl AlcoholCETYL ALCOHOL936JST6JCNLOTION / TOPICAL1140 mgExact identifier — unii candidate
20 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TSOLUTION / INTRAMUSCULAR0.13 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KTABLET, ORALLY DISINTEGRATING / ORAL3 mgExact identifier — unii candidate
77 equally ranked IID candidates
Ascorbic AcidASCORBIC ACIDPQ6CK8PD0RSUSPENSION / ORAL520 mgExact identifier — unii candidate
25 equally ranked IID candidates
Sodium MetabisulfiteSODIUM METABISULFITE4VON5FNS3CINJECTION / INTRAVENOUS27.5 %w/vExact identifier — unii candidate
43 equally ranked IID candidates
Ascorbic AcidASCORBIC ACIDPQ6CK8PD0RINJECTION, SOLUTION / INTRAVENOUS4 mgExact identifier — unii candidate
25 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TSUSPENSION / RECTAL1808 mgExact identifier — unii candidate
79 equally ranked IID candidates
PropylparabenPROPYLPARABENZ8IX2SC1OHINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS0.8 mgExact identifier — unii candidate
68 equally ranked IID candidates
PropylparabenPROPYLPARABENZ8IX2SC1OHGEL / TOPICAL4 mgExact identifier — unii candidate
68 equally ranked IID candidates
Sodium Lauryl SulfateSODIUM LAURYL SULFATE368GB5141JDROPS / ORALNAExact identifier — unii candidate
42 equally ranked IID candidates
PropylparabenPROPYLPARABENZ8IX2SC1OHCAPSULE / ORAL1 mgExact identifier — unii candidate
68 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TTABLET, EXTENDED RELEASE / ORAL0.17 mgExact identifier — unii candidate
79 equally ranked IID candidates
Sodium MetabisulfiteSODIUM METABISULFITE4VON5FNS3CINJECTION, SOLUTION / SUBCUTANEOUS79 mgExact identifier — unii candidate
43 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TOINTMENT / TOPICAL29 mgExact identifier — unii candidate
79 equally ranked IID candidates
Ascorbic AcidASCORBIC ACIDPQ6CK8PD0RSUPPOSITORY / RECTAL3 mgExact identifier — unii candidate
25 equally ranked IID candidates
PropylparabenPROPYLPARABENZ8IX2SC1OHOINTMENT / TOPICAL0.2 %w/wExact identifier — unii candidate
68 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
efe40d11-412b-61ba-e053-2a95a90adcde84b81ea2-d349-4f5c-84a6-63bfc478571d2022-12-15WarningsExact identifier
spl set id: 84b81ea2-d349-4f5c-84a6-63bfc478571d

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.