FDA.reportPublic FDA data

Hand Sanitizer Gel - 65% Alcohol

Manufacturer
Juarez Torres Adrian de Jesus
Effective date
2020-06-02
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-05-31 23:15:51

Label at a glance#

ProductHand Sanitizer Gel - 65% Alcohol
Active ingredientALCOHOL
Label structure12 sections

Dosage and administration

Place enough product in your palm to thoroughly cover your hands and rub hands together until dry. Children under 6 years should be supervised when using this product.

Storage and handling

Store at a temperature below 110°F (43°C) May discolor certain fabrics or surfaces

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Hand Sanitizer Gel - 65% Alcohol

Drug Facts

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 65% v/v.

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

Hand sanitizer to help reduce bacteria on the skin.

Warnings

WARNINGS SECTION

Flammable. Keep away from source of heat, fire or flame.

For external use only.

When using this product

OTC - WHEN USING SECTION

When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or redness develops and lasts.

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Place enough product in your palm to thoroughly cover your hands and rub hands together until dry.
  • Children under 6 years should be supervised when using this product.

Storage

STORAGE AND HANDLING SECTION

  • Store at a temperature below 110°F (43°C)
  • May discolor certain fabrics or surfaces

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Carbomer, Sodium Bicarbonate

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

8.5 fl. oz. NDC: 78650-100-25

Made in Mexico

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
902574ethanol 65 % Topical GelPSN6
902574ethanol 0.65 ML/ML Topical GelSCD6
902574ethyl alcohol 65 % Topical GelSY6

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78650-100-252022-01-28C16284748780-1d6a99b39-a8b7-a426-e053-dadaa90af4c2Hand Sanitizer Gel - 65% Alcohol

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78650-100-25Hand Sanitizer Gel - 65% Alcohol250 mL in 1 BOTTLEGEL2506

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78650-100HAND SANITIZER GEL - 65% ALCOHOL (ALCOHOL) GEL [JUAREZ TORRES ADRIAN DE JESUS]6Legacy NDC, 1 package rows20200603_a71f8e42-aafe-ddf9-e053-2a95a90a94a6.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78650-10078650-100-25

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
SODIUM BICARBONATE8MDF5V39QOIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT

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
a71f847d-fea9-fe29-e053-2995a90a7b20a71f8e42-aafe-ddf9-e053-2a95a90a94a62020-06-02WarningsExact identifier
spl id: a71f847d-fea9-fe29-e053-2995a90a7b20
spl set id: a71f8e42-aafe-ddf9-e053-2a95a90a94a6

Reported adverse events (FAERS/openFDA)#

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