FDA.reportPublic FDA data

D HAND SANITIZER GEL

Manufacturer
SODI PINTURAS, S.A. DE C.V.
Effective date
2020-08-04
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:32:58

Label at a glance#

Productd Hand
Active ingredientALCOHOL
Label structure10 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. Directions Place enough product on hands to cover all surfaces. Rub hands together until dry.

Dosage and administration

Directions Place enough product on hands to cover all surfaces. Rub hands together until dry. When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Active ingredient Ethyl Alcohol 70% v/v

PURPOSE

OTC - PURPOSE SECTION

Purpose Antmicrobial

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.

Directions

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

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

Directions

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

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

WARNINGS AND PRECAUTIONS

WARNINGS AND PRECAUTIONS SECTION

Store below 110°F (43°C)

Children under 6 years of age should be supervised when using.

WARNINGS

WARNINGS SECTION

Warnings

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

STOP USE

OTC - STOP USE SECTION

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

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.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Water (Aqua), Glycerin, Carbomer, Triethanolamine

PACKAGE LABELS

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LABEL 60 mLLABEL 60 mLLABEL 125 mLLABEL 125 mLLABEL 250 mLLABEL 250 mLLABEL 500 mLLABEL 500 mLLABEL 1000 mLLABEL 1000 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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79050-0030-12022-01-28C16284748780-1d6a99b39-cbb3-a426-e053-dadaa90af4c2D HAND SANITIZER GEL
79050-0030-22022-01-28C16284748780-1d6a99b39-cbb3-a426-e053-dadaa90af4c2D HAND SANITIZER GEL
79050-0030-32022-01-28C16284748780-1d6a99b39-cbb3-a426-e053-dadaa90af4c2D HAND SANITIZER GEL
79050-0030-42022-01-28C16284748780-1d6a99b39-cbb3-a426-e053-dadaa90af4c2D HAND SANITIZER GEL
79050-0030-52022-01-28C16284748780-1d6a99b39-cbb3-a426-e053-dadaa90af4c2D HAND SANITIZER GEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79050-0030-1d Hand60 mL in 1 BOTTLEGEL601
79050-0030-2d Hand125 mL in 1 BOTTLEGEL1251
79050-0030-3d Hand250 mL in 1 BOTTLEGEL2501
79050-0030-4d Hand500 mL in 1 BOTTLEGEL5001
79050-0030-5d Hand1000 mL in 1 BOTTLEGEL10001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79050-0030D HAND (ALCOHOL) GEL [SODI PINTURAS, S.A. DE C.V.]1Legacy NDC, 5 package rows20201105_ac16f9f6-572d-24ec-e053-2a95a90ad1cc.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
79050-003079050-0030-1, 79050-0030-2, 79050-0030-3, 79050-0030-4, 79050-0030-5

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
ALCOHOL3K9958V90MACTIB
TRIETHANOLAMINE CAPROYL GLUTAMATE0F2FO57253IACT
CARBOMER 9404Q93RCW27EIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT

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
ac16f9f6-572e-24ec-e053-2a95a90ad1ccac16f9f6-572d-24ec-e053-2a95a90ad1cc2020-08-04WarningsExact identifier
spl id: ac16f9f6-572e-24ec-e053-2a95a90ad1cc
spl set id: ac16f9f6-572d-24ec-e053-2a95a90ad1cc

Reported adverse events (FAERS/openFDA)#

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