FDA.reportPublic FDA data

Allsan Plus Hand Sanitizer

Manufacturer
Distribuidora y Comercializadora AGBHAL, S.A. de C.V.
Effective date
2020-08-18
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:25:09

Label at a glance#

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Allsan + Plus hand sanitizer

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 80% 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, carbomer, triethanolamine, purified water USP

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1000 mL NDC: 79104-000-01

1000 ML1000 ML

3800 mL NDC: 79104-000-02

3800 ML3800 ML

125 mL NDC: 79104-000-03

125 ML125 ML

325 mL NDC: 79104-000-04

325ML325ML

500 mL NDC: 79104-000-05

500 ML500 ML

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79104-001-012022-01-28C16284748780-1d6a99b39-e00c-a426-e053-dadaa90af4c2Allsan + Plus Hand Sanitizer
79104-001-022022-01-28C16284748780-1d6a99b39-e00c-a426-e053-dadaa90af4c2Allsan + Plus Hand Sanitizer
79104-001-032022-01-28C16284748780-1d6a99b39-e00c-a426-e053-dadaa90af4c2Allsan + Plus Hand Sanitizer
79104-001-042022-01-28C16284748780-1d6a99b39-e00c-a426-e053-dadaa90af4c2Allsan + Plus Hand Sanitizer
79104-001-052022-01-28C16284748780-1d6a99b39-e00c-a426-e053-dadaa90af4c2Allsan + Plus Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79104-001-01Allsan Plus Hand Sanitizer1000 mL in 1 BOTTLEGEL10001
79104-001-02Allsan Plus Hand Sanitizer3800 mL in 1 BOTTLEGEL38001
79104-001-03Allsan Plus Hand Sanitizer125 mL in 1 BOTTLEGEL1251
79104-001-04Allsan Plus Hand Sanitizer325 mL in 1 BOTTLEGEL3251
79104-001-05Allsan Plus Hand Sanitizer500 mL in 1 BOTTLEGEL5001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79104-001ALLSAN PLUS HAND SANITIZER (ALCOHOL) GEL [DISTRIBUIDORA Y COMERCIALIZADORA AGBHAL, S.A. DE C.V.]1Legacy NDC, 5 package rows20200819_ad32085a-87cf-f6a7-e053-2a95a90a6237.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
79104-00179104-001-01, 79104-001-02, 79104-001-03, 79104-001-04, 79104-001-05

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
TRIETHANOLAMINE LAURYL SULFATEE8458C1KAAIACT
GLYCERINPDC6A3C0OXIACT
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)809Y72KV36IACT
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
ad32085a-87ce-f6a7-e053-2a95a90a6237ad32085a-87cf-f6a7-e053-2a95a90a62372020-08-18WarningsExact identifier
spl id: ad32085a-87ce-f6a7-e053-2a95a90a6237
spl set id: ad32085a-87cf-f6a7-e053-2a95a90a6237

Reported adverse events (FAERS/openFDA)#

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