FDA.reportPublic FDA data

MELANO OUT MASK CREAM

Manufacturer
MESO SYSTEM S.A.
Effective date
2016-12-18
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 Mask
Active ingredientGLYCERIN, ALLANTOIN, MINERAL OIL
Label structure10 sections

Indications and uses

Mask formulated to attenuate and eliminate coetanous spots of melanic origin located at epidemic levels.

Dosage and administration

Clean the skin thoroughly before applying the mask Covered the entire skin with a thin layer Single use

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

  • Mask formulated to attenuate and eliminate coetanous spots of melanic origin located at epidemic levels.

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 mask
  • Covered the entire skin with a thin layer
  • Single use

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

Glycerin 2%....................................Skin Protectant

Mineral Oil 2%................................Skin Protectant

Allantoin 2%...................................Skin Protectant

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Urea, Apricot Kernel Oil Peg-6 Esters, Isohexadecane, Lactic Acid, Azelaic Acid, Cetearyl Alcohol, Sodium Lactate, Arbutin, Propylene Glycol, Glycyrrhiza Glabra Root, Sodium Acrylate, Acryloyldimethyltaurate Copolymer, Polysorbate 80, Glycyrrhetinic Acid, Phytic Acid, Ascorbic Acid, Kojic Acid, Sodium Lauryl Sulfate, Sodium Cetearyl Sulfate, Serine, Tea-lactate, Sodium Chloride, Citric Acid, Phenoxyethanol, Salicylic Acid, Sorbitol, Ethylhexylglycerin

BoxBox

INDICATIONS & USAGE SECTION

  • Mask formulated to attenuate and eliminate coetanous spots of melanic origin located at epidemic levels.

MELANO OUT MASK CREAM

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CylinderCylinder

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
6c6fc281-9445-2e9e-1c29-a09ddbc4299cProduct name220200213
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
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
70663-010-022020-01-31C16284748780-19d75b9d0-9d6c-f424-e053-dadaa90a57ceMELANO OUT MASK CREAM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70663-010-01Melano Out Mask15 mL in 1 CYLINDERCREAM151
70663-010-02Melano Out Mask15 in 1 BOXCREAM151

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70663-010MELANO OUT MASK (GLYCERIN, MINERAL OIL, ALLANTOIN) CREAM [MESO SYSTEM S.A.]1Legacy NDC, 2 package rows20161223_43ec9a62-83f5-722d-e054-00144ff8d46c.zip

Products#

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

DailyMed product names page 1 of 1 · 33 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70663-01070663-010-01, 70663-010-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 31 matching rows.

Name, UNII, Kind table
NameUNIIKind
SORBITOL506T60A25RIACT
GLYCERINPDC6A3C0OXACTIB
ALLANTOIN344S277G0ZACTIB
ISOHEXADECANE918X1OUF1EIACT
WATER059QF0KO0RIACT
LACTIC ACID33X04XA5ATIACT
PHENOXYETHANOLHIE492ZZ3TIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
APRICOT KERNEL OIL PEG-6 ESTERSDRG3KJZ1TJIACT
UREA HYDROCHLORIDERCE1061F6AIACT
AZELAIC ACIDF2VW3D43YTIACT
MINERAL OILT5L8T28FGPACTIB
ISOSTEARYL ALCOHOLQ613OCQ44YIACT
SODIUM LACTATETU7HW0W0QTIACT
ARBUTINC5INA23HXFIACT
PROPANEDIOL5965N8W85TIACT
GLYCYRRHIZA GLABRA2788Z9758HIACT
SODIUM ACRYLATE7C98FKB43HIACT
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW)1DXE3F3OZXIACT
POLYSORBATE 806OZP39ZG8HIACT
ENOXOLONEP540XA09DRIACT
FYTIC ACID7IGF0S7R8IIACT
ASCORBIC ACIDPQ6CK8PD0RIACT
KOJIC ACID6K23F1TT52IACT
SODIUM LAURYL SULFATE368GB5141JIACT
SODIUM CETOSTEARYL SULFATE7ZBS06BH4BIACT
SERINE452VLY9402IACT
TRIETHANOLAMINE LACTATE064C51N81OIACT
SODIUM CHLORIDE451W47IQ8XIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
SALICYLIC ACIDO414PZ4LPZIACT

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
43ec9a62-83f6-722d-e054-00144ff8d46c43ec9a62-83f5-722d-e054-00144ff8d46c2016-12-18WarningsExact identifier
spl id: 43ec9a62-83f6-722d-e054-00144ff8d46c
spl set id: 43ec9a62-83f5-722d-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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