FDA.reportPublic FDA data

Mysalon hand sanitizer

Manufacturer
AEROSOL IBERICA SA
Effective date
2020-06-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:25:45

Label at a glance#

ProductMysalon hand sanitizer
Active ingredientALCOHOL
Label structure9 sections

Dosage and administration

Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age when using this product to avoid swallowing.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Alcohol 80% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

Hand Sanitizer to help reduce bacteria that potentilly can cause disease. For use when soap and water are not available.

Warnings

WARNINGS SECTION

For external use only. Flammable. Keep away from heat or flame.

Do not use 

OTC - DO NOT USE SECTION

  • in children less than 2 months of age.
  • on open skin wounds.

When using this product

OTC - WHEN USING SECTION

keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor 

OTC - STOP USE SECTION

if irritation or rash occurs. These may be signs of a serious conditions.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

SPL UNCLASSIFIED SECTION

  • Store between 14-30°C (59-86°F).
  • Avoid freezing and excessive heat above 40°C (104°F).

Inactive ingredients:

INACTIVE INGREDIENT SECTION

glycerin, hydrogen peroxide, purified water USP.

Package Labeling:4000mL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BottleBottle

Package Labeling: 160mL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

160160

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78537-000-012022-01-28C16284748780-1d6a99b39-7499-a426-e053-dadaa90af4c2Mysalon hand sanitizer
78537-000-022022-01-28C16284748780-1d6a99b39-7499-a426-e053-dadaa90af4c2Mysalon hand sanitizer

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78537-000MYSALON HAND SANITIZER (ALCOHOL) SOLUTION [AEROSOL IBERICA SA]1Legacy NDC20200616_a82542f6-2691-17d3-e053-2a95a90a22b3.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78537-00078537-000-02, 78537-000-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
HYDROGEN PEROXIDEBBX060AN9VIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB

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
a82542f6-2692-17d3-e053-2a95a90a22b3a82542f6-2691-17d3-e053-2a95a90a22b32020-06-15WarningsExact identifier
spl id: a82542f6-2692-17d3-e053-2a95a90a22b3
spl set id: a82542f6-2691-17d3-e053-2a95a90a22b3

Reported adverse events (FAERS/openFDA)#

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