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.)
MELAMIX Skin Lightener and Blending
- Manufacturer
- ZO Skin Health, Inc. | G.S. COSMECEUTICAL USA, INC.
- Effective date
- 2014-10-06
- Label type
- HUMAN PRESCRIPTION DRUG LABEL
- Version
- 1
- Source
- legacy-cache
- Hydrated at
- 2026-08-02 01:34:56
Label at a glance#
ProductMELAMIX Skin Lightener and Blending
Active ingredientHYDROQUINONE
Label structure7 sections
Storage and handling
Store at controlled room temperature: 15°-30°C (59°-86°F), away from direct sunlight.
Label contents#
Full prescribing information#
INDICATIONS & USAGE SECTION
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.
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 42851-033-32 | 2023-02-10 | C162847 | 48780-1 | 9d75b9d0-bd43-f424-e053-dadaa90a57ce | MELAMIX™ Skin Lightener & Blending Crème |
| 42851-033-80 | 2023-02-10 | C162847 | 48780-1 | 9d75b9d0-bd43-f424-e053-dadaa90a57ce | MELAMIX™ Skin Lightener & Blending Crème |
| 42851-033-32 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-bd43-f424-e053-dadaa90a57ce | MELAMIX™ Skin Lightener & Blending Crème |
| 42851-033-80 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-bd43-f424-e053-dadaa90a57ce | MELAMIX™ Skin Lightener & Blending Crème |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| HYDROQUINONE | ACTIVE INGREDIENT | XV74C1N1AE | 1 | |
| HYDROQUINONE | ACTIVE MOIETY | XV74C1N1AE | 1 | |
| .ALPHA.-TOCOPHEROL ACETATE | INACTIVE INGREDIENT | 9E8X80D2L0 | 1 | |
| AMINOPROPYL DIHYDROGEN PHOSPHATE | INACTIVE INGREDIENT | D5J0Q2CM4V | 1 | |
| ASCORBIC ACID | INACTIVE INGREDIENT | PQ6CK8PD0R | 1 | |
| ASCORBYL PALMITATE | INACTIVE INGREDIENT | QN83US2B0N | 1 | |
| CAPRYLYL GLYCOL | INACTIVE INGREDIENT | 00YIU5438U | 1 | |
| CAULOSIDE D | INACTIVE INGREDIENT | 4N5Z068GAZ | 1 | |
| CETYL ALCOHOL | INACTIVE INGREDIENT | 936JST6JCN | 1 | |
| CHLORPHENESIN | INACTIVE INGREDIENT | I670DAL4SZ | 1 | |
| CURDLAN | INACTIVE INGREDIENT | 6930DL209R | 1 | |
| EDETATE DISODIUM | INACTIVE INGREDIENT | 7FLD91C86K | 1 | |
| ETHYLHEXYL PALMITATE | INACTIVE INGREDIENT | 2865993309 | 1 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 1 | |
| GLYCOLIC ACID | INACTIVE INGREDIENT | 0WT12SX38S | 1 | |
| LAURYL GLUCOSIDE | INACTIVE INGREDIENT | 76LN7P7UCU | 1 | |
| MALTODEXTRIN | INACTIVE INGREDIENT | 7CVR7L4A2D | 1 | |
| PHENOXYETHANOL | INACTIVE INGREDIENT | HIE492ZZ3T | 1 | |
| PHENYL TRIMETHICONE | INACTIVE INGREDIENT | DR0K5NOJ4R | 1 | |
| SODIUM METABISULFITE | INACTIVE INGREDIENT | 4VON5FNS3C | 1 | |
| STEARYL ALCOHOL | INACTIVE INGREDIENT | 2KR89I4H1Y | 1 | |
| SUNFLOWER OIL | INACTIVE INGREDIENT | 3W1JG795YI | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Products#
Every source-derived product name is available through these pages.
- MELAMIX Skin Lightener and Blending
- HYDROQUINONE
- 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
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 42851-033 | 42851-033-80, 42851-033-32 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
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.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SOLUTION/ DROPS / OPHTHALMIC | 0.13 %w/v | ||
| SODIUM METABISULFITE | SODIUM METABISULFITE | 4VON5FNS3C | INJECTION, EMULSION / INTRAVENOUS | 0.03 %w/v | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | SUSPENSION / OPHTHALMIC | 0.5 %w/v | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | OINTMENT / TOPICAL | 7 %w/w | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | TABLET, EFFERVESCENT / ORAL | 32 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | TABLET, CHEWABLE / ORAL | 1 mg | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | TABLET / ORAL | NA | ||
| ASCORBYL PALMITATE | ASCORBYL PALMITATE | QN83US2B0N | TABLET / ORAL | 7.14 mg | ||
| ASCORBIC ACID | ASCORBIC ACID | PQ6CK8PD0R | INJECTION, SOLUTION / INTRAVENOUS | 4 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | LIQUID / INTRAVENOUS | 0.03 %w/v | ||
| SODIUM METABISULFITE | SODIUM METABISULFITE | 4VON5FNS3C | INJECTION, SOLUTION, CONCENTRATE / INTRAMUSCULAR | 0.15 %w/v | ||
| ASCORBYL PALMITATE | ASCORBYL PALMITATE | QN83US2B0N | SYSTEM / TOPICAL | 0.04 mg | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | AEROSOL, FOAM / RECTAL | 17 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SYSTEM / TOPICAL | 18144 mg | ||
| MALTODEXTRIN | MALTODEXTRIN | 7CVR7L4A2D | SOLUTION / ORAL | 1451 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CREAM / TOPICAL | 1720 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | POWDER, FOR SUSPENSION / ORAL | 285 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | LOTION / TOPICAL | 3990 mg | ||
| SODIUM METABISULFITE | SODIUM METABISULFITE | 4VON5FNS3C | SUSPENSION/ DROPS / OPHTHALMIC | 0.1 %w/w | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | ELIXIR / ORAL | 1.3 mg/5ml | ||
| SODIUM METABISULFITE | SODIUM METABISULFITE | 4VON5FNS3C | SUSPENSION, EXTENDED RELEASE / ORAL | 100 mg | ||
| ASCORBIC ACID | ASCORBIC ACID | PQ6CK8PD0R | TABLET, FILM COATED / ORAL | 20 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | GEL / VAGINAL | 5 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | TABLET, EXTENDED RELEASE / ORAL | 10 mg | ||
| SODIUM METABISULFITE | SODIUM METABISULFITE | 4VON5FNS3C | INJECTION / SUBCUTANEOUS | 43 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUPPOSITORY / RECTAL | 440 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SYSTEM / TOPICAL | 126 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | JELLY / TOPICAL | NA | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET / ORAL | 42 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 19 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SOLUTION / OPHTHALMIC | 4 mg | ||
| MALTODEXTRIN | MALTODEXTRIN | 7CVR7L4A2D | TABLET, EFFERVESCENT / ORAL | 14404 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | AEROSOL / TOPICAL | 3 %w/w | ||
| SODIUM METABISULFITE | SODIUM METABISULFITE | 4VON5FNS3C | INJECTION / PERINEURAL | 0.05 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CAPSULE, COATED / ORAL | 14.21 mg | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | CREAM / TOPICAL | 1280 mg | ||
| ASCORBIC ACID | ASCORBIC ACID | PQ6CK8PD0R | POWDER, FOR SOLUTION / ORAL | 560 mg | ||
| SODIUM METABISULFITE | SODIUM METABISULFITE | 4VON5FNS3C | INJECTION, SOLUTION / SUBMUCOSAL | 5 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUPPOSITORY / VAGINAL | 227.9 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SOLUTION / TOPICAL | 1 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SUSPENSION/ DROPS / OPHTHALMIC | 1 mg | ||
| SODIUM METABISULFITE | SODIUM METABISULFITE | 4VON5FNS3C | INJECTION, SOLUTION / INFILTRATION | 0.05 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION / ORAL | 26208 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | GEL / OPHTHALMIC | 396 mg | ||
| ASCORBIC ACID | ASCORBIC ACID | PQ6CK8PD0R | SOLUTION / RESPIRATORY (INHALATION) | 0.04 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SHAMPOO / TOPICAL | 5 %w/w | ||
| MALTODEXTRIN | MALTODEXTRIN | 7CVR7L4A2D | SUSPENSION / ORAL | 6040 mg | ||
| ASCORBIC ACID | ASCORBIC ACID | PQ6CK8PD0R | INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS | 2 mg | ||
| SODIUM METABISULFITE | SODIUM METABISULFITE | 4VON5FNS3C | SYSTEM / TOPICAL | 0.5 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | INJECTION / INTRA-ARTICULAR | 0.05 %w/v | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | TABLET, COATED / ORAL | 0.25 mg | ||
| STEARYL ALCOHOL | STEARYL ALCOHOL | 2KR89I4H1Y | AEROSOL, FOAM / TOPICAL | 37 mg | ||
| ASCORBIC ACID | ASCORBIC ACID | PQ6CK8PD0R | CAPSULE, EXTENDED RELEASE / ORAL | 17 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | GEL / TOPICAL | 24 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | EMULSION / OPHTHALMIC | 3 mg | ||
| PHENOXYETHANOL | PHENOXYETHANOL | HIE492ZZ3T | LOTION / TOPICAL | 1 %w/w | ||
| STEARYL ALCOHOL | STEARYL ALCOHOL | 2KR89I4H1Y | LOTION / TOPICAL | 1140 mg | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | SUSPENSION / TOPICAL | 2.01 %w/w | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS | 0.4 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SUSPENSION/ DROPS / AURICULAR (OTIC) | 0.01 %w/v |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| efd1049f-6166-6ce2-e053-2995a90a89fd | 9f3a6a77-7e19-43fe-922a-76ed5f25c3f1 | 2022-12-14 | Warnings | 9f3a6a77-7e19-43fe-922a-76ed5f25c3f1 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.