FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
IVM Especialidades Quimicas, S.A. de C.V.
Effective date
2025-01-02
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:50:42

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure13 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 15-30°C (59-86 °F) Avoid freezing and excessive heat above 40°C (104°F)

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic.

Use

INDICATIONS & USAGE SECTION

Hand Sanitizer to help reduce bacteria tt potentially can cause disease. For use when water and soap 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 if

OTC - STOP USE SECTION

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

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

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION


distilled water, glycerin, hydrogen peroxide, polyacrylic acid, triethanolamine.

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL



1000 mL NDC: 80711-002-01

Hand Sanitizer_70_1000Hand Sanitizer_70_1000

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL



5000 ml NDC:80711-002-02


Hand Sanitizer_70_5000Hand Sanitizer_70_5000

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80711-002-012025-07-29C16284748780-1f386c649-dcbe-0266-e053-dadaa90a7c1aHand Sanitizer Alcohol 80%
80711-002-022025-07-29C16284748780-1f386c649-dcbe-0266-e053-dadaa90a7c1aHand Sanitizer Alcohol 80%
80711-002-012023-02-14C16284748780-1f386c649-dcbe-0266-e053-dadaa90a7c1aHand Sanitizer Alcohol 80%
80711-002-022023-02-14C16284748780-1f386c649-dcbe-0266-e053-dadaa90a7c1aHand Sanitizer Alcohol 80%
80711-002-012023-01-30C16284748780-1f386c649-dcbe-0266-e053-dadaa90a7c1aHand Sanitizer Alcohol 80%
80711-002-022023-01-30C16284748780-1f386c649-dcbe-0266-e053-dadaa90a7c1aHand Sanitizer Alcohol 80%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80711-002-01Hand Sanitizer1000 mL in 1 BOTTLEGEL10004
80711-002-02Hand Sanitizer5000 mL in 1 BOTTLEGEL50004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80711-002HAND SANITIZER (ALCOHOL) GEL [IVM ESPECIALIDADES QUIMICAS, S.A. DE C.V.]4Legacy NDC, 2 package rows20250105_c1c38e32-49ed-7cec-e053-2995a90a7c98.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80711-00280711-002-01, 80711-002-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
HYDROGEN PEROXIDEBBX060AN9VIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
TROLAMINE9O3K93S3TKIACT

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
2abef236-090b-f3fc-e063-6294a90a97b2c1c38e32-49ed-7cec-e053-2995a90a7c982025-01-02WarningsExact identifier
spl id: 2abef236-090b-f3fc-e063-6294a90a97b2
spl set id: c1c38e32-49ed-7cec-e053-2995a90a7c98

Reported adverse events (FAERS/openFDA)#

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