FDA.reportPublic FDA data

Hand Sanitizer Gel

Manufacturer
JE INDUSTRIAS QUIMICAS SA DE CV
Effective date
2020-10-05
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:31:02

Label at a glance#

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

  1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (70%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  2. Glycerol (1.45% v/v).
  3. Hydrogen peroxide (0.125% v/v).
  4. Sterile distilled water or boiled cold water.

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Liquid BackLiquid BackAlcohol 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

glycerin, hydrogen peroxide, purified water USP

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

liquid frontliquid front125 mL NDC: 75107-801-01

250 mL NDC: 75107-801-02

500 mL NDC: 75107-801-03

1000 mL NDC: 75107-801-04

3780 mL NDC: 75107-801-05

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
582753ethanol 70 % Topical SolutionPSN2
582753ethanol 0.7 ML/ML Topical SolutionSCD2
582753ethanol 70 % Topical SolutionSY2
582753ethyl alcohol 70 % Topical SolutionSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
75107-801-012022-01-28C16284748780-1d6a99b39-fc54-a426-e053-dadaa90af4c2Hand Sanitaizer LIQUID
75107-801-022022-01-28C16284748780-1d6a99b39-fc54-a426-e053-dadaa90af4c2Hand Sanitaizer LIQUID
75107-801-032022-01-28C16284748780-1d6a99b39-fc54-a426-e053-dadaa90af4c2Hand Sanitaizer LIQUID
75107-801-042022-01-28C16284748780-1d6a99b39-fc54-a426-e053-dadaa90af4c2Hand Sanitaizer LIQUID
75107-801-052022-01-28C16284748780-1d6a99b39-fc54-a426-e053-dadaa90af4c2Hand Sanitaizer LIQUID

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75107-801-01Sanetto125 mL in 1 BOTTLELIQUID1252
75107-801-02Sanetto250 mL in 1 BOTTLELIQUID2502
75107-801-03Sanetto500 mL in 1 BOTTLELIQUID5002
75107-801-04Sanetto1000 mL in 1 BOTTLELIQUID10002
75107-801-05Sanetto3780 mL in 1 BOTTLELIQUID37802

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75107-801SANETTO (ALCOHOL) LIQUID [JE INDUSTRIAS QUIMICAS SA DE CV]2Legacy NDC, 5 package rows20201006_a5f50da8-aa1c-5652-e053-2a95a90a557b.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
75107-80175107-801-01, 75107-801-02, 75107-801-03, 75107-801-04, 75107-801-05

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 · Source PDF

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
b0ea9994-2ce7-141a-e053-2a95a90a9f7ca5f50da8-aa1c-5652-e053-2a95a90a557b2020-10-05WarningsExact identifier
spl id: b0ea9994-2ce7-141a-e053-2a95a90a9f7c
spl set id: a5f50da8-aa1c-5652-e053-2a95a90a557b

Reported adverse events (FAERS/openFDA)#

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