Hand Sanitizer

Manufacturer
Articulos Medicos Brooks, S.A. de C.V.
Effective date
2020-06-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:18:57

Label at a glance#

ProductHand 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, carbomer, glycerin and triethanolamine.

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PDP 60 mL NDC: 79078-002-01 PDP 60 mlPDP 60 ml

PI 60 mL NDC: 79078-002-01 PI 60 mlPI 60 ml

PDP 236.58 mL NDC: 79078-002-02 PDP 236.58 mlPDP 236.58 ml

PI 236.58 mL NDC: 79078-002-02 PI 236.58 mlPI 236.58 ml

PDP 250 mL NDC: 79078-002-03 PDP 250 mlPDP 250 ml

PI 250 mL NDC: 79078-002-03 PI 250 mlPI 250 ml

PDP 473.1 mL NDC: 79078-002-04 PDP 473.1 mlPDP 473.1 mlPDP 500 mL NDC: 79078-002-05 PDP 500 mlPDP 500 ml PDP 1000 mL NDC: 79078-002-06 PDP 1000 mlPDP 1000 mlPDP 3785 mL NDC: 79078-002-07 PDP 3785 mlPDP 3785 mlPDP 5000 mL NDC: 79078-002-08 PDP 5000 mlPDP 5000 mlPDP 200000 mL NDC: 79078-002-09 PDP 200000 mlPDP 200000 ml

PDP 1000000 mL NDC: 79078-002-10 1000000 ml1000000 ml

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN1
581662ethanol 0.7 ML/ML Topical GelSCD1
581662ethanol 70 % Topical GelSY1
581662ethyl alcohol 70 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79078-002-01Hand Sanitizer60 mL in 1 BOTTLEGEL601
79078-002-02Hand Sanitizer236.58 mL in 1 BOTTLEGEL236.581
79078-002-03Hand Sanitizer250 mL in 1 BOTTLEGEL2501
79078-002-04Hand Sanitizer473.1 mL in 1 BOTTLEGEL473.11
79078-002-05Hand Sanitizer500 mL in 1 BOTTLEGEL5001
79078-002-06Hand Sanitizer1000 mL in 1 BOTTLEGEL10001
79078-002-07Hand Sanitizer3785 mL in 1 BOTTLEGEL37851
79078-002-08Hand Sanitizer5000 mL in 1 BOTTLEGEL50001
79078-002-09Hand Sanitizer200000 mL in 1 CONTAINERGEL2000001
79078-002-10Hand Sanitizer1000000 mL in 1 CONTAINERGEL10000001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79078-002HAND SANITIZER (ALCOHOL) GEL [ARTICULOS MEDICOS BROOKS, S.A. DE C.V.]1Legacy NDC, 10 package rows20200625_a8d98511-f389-76c3-e053-2a95a90a9bd3.zip

Products#

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

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

NDC Codes#

Ingredients#

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

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

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
a8d98511-f37b-76c3-e053-2a95a90a9bd3a8d98511-f389-76c3-e053-2a95a90a9bd32020-06-24WarningsExact identifier
spl id: a8d98511-f37b-76c3-e053-2a95a90a9bd3
spl set id: a8d98511-f389-76c3-e053-2a95a90a9bd3

Reported adverse events (FAERS/openFDA)#

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