FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
Magaña Muela, Jesús | Mario Hidalgo
Effective date
2020-05-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:14:10

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure17 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

Ethyl Alcohol 75% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

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. Isopropyl Alcohol (75%, 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.

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

Distillet water, glycerin, carbomer 940, Trolamine

Package Label - Principal Display Panel

PATIENT COUNSELING INFORMATION

Label 3785 mL GelLabel 3785 mL Gel3785 mL NDC 77934-123-11

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label 125 mL GelLabel 125 mL Gel125 mL NDC 77934-123-07

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label 250 mL GelLabel 250 mL Gel250 mL NDC 77934-123-08

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label 946 mL GelLabel 946 mL Gel946 mL NDC 77934-123-09

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label 1893 mL GelLabel 1893 mL Gel1893 mL NDC 777934-123-10

Pachage Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label 20000 mL GelLabel 20000 mL Gel20000 mL NDC 77934-123-13

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1305100ethanol 75 % Topical GelPSN1
1305100ethanol 0.75 ML/ML Topical GelSCD1
1305100ethanol 75 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77934-123-072022-01-28C16284748780-1d6a99b39-72f7-a426-e053-dadaa90af4c2Hand Sanitizer
77934-123-082022-01-28C16284748780-1d6a99b39-72f7-a426-e053-dadaa90af4c2Hand Sanitizer
77934-123-092022-01-28C16284748780-1d6a99b39-72f7-a426-e053-dadaa90af4c2Hand Sanitizer
77934-123-102022-01-28C16284748780-1d6a99b39-72f7-a426-e053-dadaa90af4c2Hand Sanitizer
77934-123-112022-01-28C16284748780-1d6a99b39-72f7-a426-e053-dadaa90af4c2Hand Sanitizer
77934-123-132022-01-28C16284748780-1d6a99b39-72f7-a426-e053-dadaa90af4c2Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77934-123-07Hand Sanitizer125 mL in 1 BOTTLE, PLASTICGEL1251
77934-123-08Hand Sanitizer250 mL in 1 BOTTLE, PLASTICGEL2501
77934-123-09Hand Sanitizer946 mL in 1 BOTTLE, PLASTICGEL9461
77934-123-10Hand Sanitizer1893 mL in 1 BOTTLE, PLASTICGEL18931
77934-123-11Hand Sanitizer3785 mL in 1 BOTTLE, PLASTICGEL37851
77934-123-13Hand Sanitizer20000 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULKGEL200001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77934-123HAND SANITIZER (ALCOHOL) GEL [MAGAÑA MUELA, JESÚS]1Legacy NDC, 6 package rows20200522_a5cca49b-7f60-1f54-e053-2a95a90aff53.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
77934-12377934-123-07, 77934-123-08, 77934-123-09, 77934-123-10, 77934-123-11, 77934-123-13

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBOMER 9404Q93RCW27EIACT
TROLAMINE9O3K93S3TKIACT
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
a5cca49b-7f52-1f54-e053-2a95a90aff53a5cca49b-7f60-1f54-e053-2a95a90aff532020-05-16WarningsExact identifier
spl id: a5cca49b-7f52-1f54-e053-2a95a90aff53
spl set id: a5cca49b-7f60-1f54-e053-2a95a90aff53

Reported adverse events (FAERS/openFDA)#

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