FDA.reportPublic FDA data

Aeroclean Hand Sanitizer

Manufacturer
Aerobal, S.A. de C.V.
Effective date
2020-11-30
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:34:36

Label at a glance#

ProductAeroclean Hand Sanitizer
Active ingredientALCOHOL
Label structure12 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.

Storage and handling

Store between 15-30C (59-86F) Avoid freezing and excessive heat above 40C (104F)

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 70% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

Hand Sanitizer to help reduce bacteria that potentially 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

OTC - WHEN USING SECTION

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. 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

STORAGE AND HANDLING SECTION

  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Glycerin, Rapidgel EZ1

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

60 mL NDC: 61962-0010-1

60 mL NDC: 61962-001-01 Front60 mL NDC: 61962-001-01 Front60 mL NDC: 61962-001-01 Back60 mL NDC: 61962-001-01 Back

180 mL NDC: 61962-0010-2

180 mL NDC: 61962-001-02180 mL NDC: 61962-001-02

300 mL NDC: 61962-0010-3

300 mL NDC: 61962-001-03 Front300 mL NDC: 61962-001-03 Front300 mL NDC: 61962-001-03 Back300 mL NDC: 61962-001-03 Back

500 mL NDC: 61962-001-04500 mL NDC: 61962-001-04

4000 mL NDC: 61962-0010-5

4000 mL NDC: 61962-001-05 Front4000 mL NDC: 61962-001-05 Front4000 mL NDC: 61962-001-05 Back4000 mL NDC: 61962-001-05 Back

5000 mL NDC: 61962-0010-6

5000 mL NDC: 61962-001-06 Front5000 mL NDC: 61962-001-06 Front5000 mL NDC: 61962-001-06 Back5000 mL NDC: 61962-001-06 Back

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN2
581662ethanol 0.7 ML/ML Topical GelSCD2
581662ethanol 70 % Topical GelSY2
581662ethyl alcohol 70 % Topical GelSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61962-0010-12022-01-28C16284748780-1d6a99b39-99b5-a426-e053-dadaa90af4c2Aeroclean Alcohol 70% NDC 61962-0010
61962-0010-22022-01-28C16284748780-1d6a99b39-99b5-a426-e053-dadaa90af4c2Aeroclean Alcohol 70% NDC 61962-0010
61962-0010-32022-01-28C16284748780-1d6a99b39-99b5-a426-e053-dadaa90af4c2Aeroclean Alcohol 70% NDC 61962-0010
61962-0010-42022-01-28C16284748780-1d6a99b39-99b5-a426-e053-dadaa90af4c2Aeroclean Alcohol 70% NDC 61962-0010
61962-0010-52022-01-28C16284748780-1d6a99b39-99b5-a426-e053-dadaa90af4c2Aeroclean Alcohol 70% NDC 61962-0010
61962-0010-62022-01-28C16284748780-1d6a99b39-99b5-a426-e053-dadaa90af4c2Aeroclean Alcohol 70% NDC 61962-0010

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61962-0010-1Aeroclean Hand Sanitizer60 mL in 1 BOTTLEGEL602
61962-0010-2Aeroclean Hand Sanitizer180 mL in 1 BOTTLEGEL1802
61962-0010-3Aeroclean Hand Sanitizer300 mL in 1 BOTTLEGEL3002
61962-0010-4Aeroclean Hand Sanitizer500 mL in 1 BOTTLEGEL5002
61962-0010-5Aeroclean Hand Sanitizer4000 mL in 1 BOTTLEGEL40002
61962-0010-6Aeroclean Hand Sanitizer5000 mL in 1 BOTTLEGEL50002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61962-0010AEROCLEAN HAND SANITIZER (ALCOHOL) GEL [AEROBAL, S.A. DE C.V.]2Legacy NDC, 6 package rows20201204_b48b00af-cc95-0684-e053-2995a90a8e9b.zip

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61962-001061962-0010-1, 61962-0010-2, 61962-0010-3, 61962-0010-4, 61962-0010-5, 61962-0010-6

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
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
b554803a-08a4-4e02-e053-2a95a90a1185b48b00af-cc95-0684-e053-2995a90a8e9b2020-11-30WarningsExact identifier
spl id: b554803a-08a4-4e02-e053-2a95a90a1185
spl set id: b48b00af-cc95-0684-e053-2995a90a8e9b

Reported adverse events (FAERS/openFDA)#

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