FDA.reportPublic FDA data

Melano Out Cream

Manufacturer
MESO SYSTEM S.A.
Effective date
2016-12-17
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:48:14

Label at a glance#

ProductMelano Out Cream
Active ingredientALLANTOIN, GLYCERIN
Label structure10 sections

Indications and uses

Cream formulated to atenuate and eliminate the coetaneus spot of melanic origin located at the epidermic level

Dosage and administration

Clean the skin thoroughly before applying the cream. Cover the entire affected area with a thin layer. First week apply three times daily (morning-afternoon-night). Second week apply two times daily (morning-night). Third week apply once a day for one year. During summer it is recommended the application of the cream after sun exposure. If bothersome dryness or peeling occurs, reduce application to once a day or e...

Label contents#

Full prescribing information#

Warnings

OTC - ASK DOCTOR SECTION

Stop use and ask a Doctor if rash occurs

WARNINGS

WARNINGS SECTION

  • For external use only.
  • Do no use on damaged or broken skin
  • Stop use and ask a doctor if rash occurs
  • Avoid the product from entering your eyes
  • Children under 6 months Ask a Doctor

USES

OTC - PURPOSE SECTION

  • Cream formulated to atenuate and eliminate the coetaneus spot of melanic origin located at the epidermic level

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • Keep out of the reach of chuldren.
  • In case of overdose get medical help or Contact a Poison Control Center right away.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • Clean the skin thoroughly before applying the cream.
  • Cover the entire affected area with a thin layer. First week apply three times daily (morning-afternoon-night). Second week apply two times daily (morning-night). Third week apply once a day for one year.
  • During summer it is recommended the application of the cream after sun exposure. If bothersome dryness or peeling occurs, reduce application to once a day or every other day

QUESTIONS OR COMMENTS ?

OTC - QUESTIONS SECTION

  • +35 1227347125 M-F: 9:00 am to 5:00 pm

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients Purpose

Allantoin 0.01%................................Skin Protectant

Glycerin 0.25%.................................Skin Protectant

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Azelaic Acid, Mineral Oil, Ethylhexyl Methoxycinnamate, Cetearyl Alcohol, Salicylic Acid, Kojic Acid,,Arbutin, Phenoxyethanol, Glycyrrhetinic Acid, Citric Acid, Lactic Acid, Phytic Acid, Sodium Cetearyl Sulfate, Sodium Lauryl Sulfate, Ascorbic Acid, Sodium, Lactate, Serine, Sorbitol, Tea-lactate, Urea, Ethylhexylglycerin, Sodium Chloride

BoxBox

INDICATIONS & USAGE SECTION

  • Cream formulated to atenuate and eliminate the coetaneus spot of melanic origin located at the epidermic level

Melano Out Cream

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Melano Out Cream

Skin Protecting

CreamCream

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
GLYCERIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
6c6fc281-9445-2e9e-1c29-a09ddbc4299cProduct name220200213
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
2a856070-cbe7-4f85-be0f-09885ff91196Product name120150806
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70663-007-022020-01-31C16284748780-19d75b9d0-1945-f424-e053-dadaa90a57ceMelano Out Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70663-007-01Melano Out Cream30 mL in 1 CONTAINERCREAM301
70663-007-02Melano Out Cream30 in 1 BOXCREAM301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70663-007MELANO OUT CREAM (ALLANTOIN, GLYCERIN) CREAM [MESO SYSTEM S.A.]1Legacy NDC, 2 package rows20161223_43e51c3c-adc5-3f98-e054-00144ff88e88.zip

Products#

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

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70663-00770663-007-01, 70663-007-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Name, UNII, Kind table
NameUNIIKind
SALICYLIC ACIDO414PZ4LPZIACT
ALLANTOIN344S277G0ZACTIB
ETHYLHEXYL METHOXYCRYLENES3KFG6Q5X8IACT
WATER059QF0KO0RIACT
AZELAIC ACIDF2VW3D43YTIACT
PHENOXYETHANOLHIE492ZZ3TIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
MINERAL OILT5L8T28FGPIACT
CETYL ALCOHOL936JST6JCNIACT
KOJIC ACID6K23F1TT52IACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
LACTIC ACID33X04XA5ATIACT
SODIUM LACTATETU7HW0W0QTIACT
SORBITOL, L-01Q0586BG1IACT
TRIETHANOLAMINE LACTATE064C51N81OIACT
ARBUTINC5INA23HXFIACT
ALLANTOIN GLYCYRRHETINIC ACIDH6FL381368IACT
FYTIC ACID7IGF0S7R8IIACT
SODIUM CETOSTEARYL SULFATE7ZBS06BH4BIACT
SODIUM LAURYL SULFATE368GB5141JIACT
ASCORBIC ACIDPQ6CK8PD0RIACT
GLYCERINPDC6A3C0OXACTIB
SERINE452VLY9402IACT
HYDROXYETHYL UREAMBQ7DDQ7ARIACT
SODIUM CHLORIDE451W47IQ8XIACT

Source Document#

Source XML

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
43e51c3c-adc6-3f98-e054-00144ff88e8843e51c3c-adc5-3f98-e054-00144ff88e882016-12-17WarningsExact identifier
spl id: 43e51c3c-adc6-3f98-e054-00144ff88e88
spl set id: 43e51c3c-adc5-3f98-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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