FDA.reportPublic FDA data

HAND SANITIZER GEL

Manufacturer
JOSE ALBERTO PURECO CANO
Effective date
2020-06-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:18:00

Label at a glance#

ProductHAND SANITIZER
Active ingredientALCOHOL
Label structure11 sections

Indications and uses

Use[s] Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Dosage and administration

Directions Place enough product on hands to cover all surfaces. Rub hands together until dry.

Label contents#

Full prescribing information#

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

Directions

Place enough product on hands to cover all surfaces. Rub hands together until dry.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Inactive ingredients Water (Aqua), Glycerin, Carbomer, Triethanolamine

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

Use[s]

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

KEEP OUT OF REACH OF CHILDREN

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.

PURPOSE

OTC - PURPOSE SECTION

Purpose Antmicrobial

WARNINGS AND PRECAUTIONS

WARNINGS AND PRECAUTIONS SECTION

Store below 110°F (43°C)

Avoid freezing and excessive heat above 40C (104F)

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

in children less than 2 months of age
on open skin wounds

WARNINGS

WARNINGS SECTION

Warnings

For external use only. Flammable. Keep away from heat or flame

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Active ingredient Ethyl Alcohol 70% v/v

STOP USE AND ASK A DOCTOR

OTC - ASK DOCTOR SECTION

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

STOP USE AND ASK A DOCTOR

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

PACKAGE LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LABEL 250 mlLABEL 250 mlLABEL 500 mLLABEL 500 mLLABEL 1000 mLLABEL 1000 mLLABEL 4000 mL FINALLABEL 4000 mL FINAL

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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79048-0010-22022-01-28C16284748780-1d6a99b39-c31c-a426-e053-dadaa90af4c2HAND SANITIZER GEL
79048-0010-32022-01-28C16284748780-1d6a99b39-c31c-a426-e053-dadaa90af4c2HAND SANITIZER GEL
79048-0010-42022-01-28C16284748780-1d6a99b39-c31c-a426-e053-dadaa90af4c2HAND SANITIZER GEL
79048-0010-52022-01-28C16284748780-1d6a99b39-c31c-a426-e053-dadaa90af4c2HAND SANITIZER GEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79048-0010-2HAND SANITIZER250 mL in 1 BOTTLEGEL2501
79048-0010-3HAND SANITIZER500 mL in 1 BOTTLEGEL5001
79048-0010-4HAND SANITIZER1000 mL in 1 BOTTLEGEL10001
79048-0010-5HAND SANITIZER4000 mL in 1 BOTTLEGEL40001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79048-0010HAND SANITIZER (ALCOHOL) GEL [JOSE ALBERTO PURECO CANO]1Legacy NDC, 4 package rows20200617_a8401f2e-b13e-b250-e053-2a95a90a5e55.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
79048-001079048-0010-2, 79048-0010-3, 79048-0010-4, 79048-0010-5

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
GLYCERINPDC6A3C0OXIACT
TRIETHANOLAMINE CAPROYL GLUTAMATE0F2FO57253IACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
CARBOMER 9404Q93RCW27EIACT

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
a8401f2e-b13f-b250-e053-2a95a90a5e55a8401f2e-b13e-b250-e053-2a95a90a5e552020-06-16WarningsExact identifier
spl id: a8401f2e-b13f-b250-e053-2a95a90a5e55
spl set id: a8401f2e-b13e-b250-e053-2a95a90a5e55

Reported adverse events (FAERS/openFDA)#

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