FDA.reportPublic FDA data

Personal Performance Hand Sanitizer

Manufacturer
Autotrol Corporation
Effective date
2020-08-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:37:39

Label at a glance#

ProductPersonal Performance Hand Sanitizer
Active ingredientALCOHOL
Label structure12 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70% v/v

OTC - PURPOSE SECTION

Antiseptic

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

Flammable. Keep away from heat or flame

For external use only.

INSTRUCTIONS FOR USE SECTION

place enough product in your palm to thoroughly cover your hands
rub hands together briskly until dry
children under 6 years of age should be supervised when using this product

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.

OTHER SAFETY INFORMATION

Store between 15-30C (59-86F)Avoid freezing and excessive heat above 40C (104F)

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.

OTC - WHEN USING SECTION

When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

OTC - STOP USE SECTION

Stop use and ask a physician if skin irritation or rash develops.

INACTIVE INGREDIENT SECTION

Water, Glycerin, Carbomer, Aloe, Tocopheryl Acetate

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

3785 mL NDC: 79097-020-28 1 Gallon Label1 Gallon Label

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
79097-030-012022-07-29C16284748780-1e4f33bdf-b070-d8a0-e053-dadaa90a6e4eHand Sanitizer
79097-030-022022-07-29C16284748780-1e4f33bdf-b070-d8a0-e053-dadaa90a6e4eHand Sanitizer
79097-030-032022-07-29C16284748780-1e4f33bdf-b070-d8a0-e053-dadaa90a6e4eHand Sanitizer
79097-030-042022-07-29C16284748780-1e4f33bdf-b070-d8a0-e053-dadaa90a6e4eHand Sanitizer
79097-030-082022-07-29C16284748780-1e4f33bdf-b070-d8a0-e053-dadaa90a6e4eHand Sanitizer
79097-030-122022-07-29C16284748780-1e4f33bdf-b070-d8a0-e053-dadaa90a6e4eHand Sanitizer
79097-030-162022-07-29C16284748780-1e4f33bdf-b070-d8a0-e053-dadaa90a6e4eHand Sanitizer
79097-030-282022-07-29C16284748780-1e4f33bdf-b070-d8a0-e053-dadaa90a6e4eHand Sanitizer
79097-030-752022-07-29C16284748780-1e4f33bdf-b070-d8a0-e053-dadaa90a6e4eHand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79097-030-01Personal Performance Hand Sanitizer50 mL in 1 BOTTLE, PLASTICGEL501
79097-030-02Personal Performance Hand Sanitizer59 mL in 1 BOTTLE, PLASTICGEL591
79097-030-03Personal Performance Hand Sanitizer100 mL in 1 BOTTLE, PLASTICGEL1001
79097-030-04Personal Performance Hand Sanitizer118 mL in 1 BOTTLE, PLASTICGEL1181
79097-030-08Personal Performance Hand Sanitizer237 mL in 1 BOTTLE, PLASTICGEL2371
79097-030-12Personal Performance Hand Sanitizer355 mL in 1 BOTTLE, PLASTICGEL3551
79097-030-16Personal Performance Hand Sanitizer473 mL in 1 BOTTLE, PLASTICGEL4731
79097-030-28Personal Performance Hand Sanitizer3785 mL in 1 BOTTLE, PLASTICGEL37851
79097-030-75Personal Performance Hand Sanitizer1000000 mL in 1 TANKGEL10000001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79097-030PERSONAL PERFORMANCE HAND SANITIZER (ALCOHOL) GEL [AUTOTROL CORPORATION]1Legacy NDC, 9 package rows20210203_b0f162fe-3bac-cc3c-e053-2995a90a271f.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79097-03079097-030-01, 79097-030-02, 79097-030-03, 79097-030-04, 79097-030-08, 79097-030-12, 79097-030-16, 79097-030-28, 79097-030-75

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOEV5VD430YW9IACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE ANX76LV5T8JIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
.ALPHA.-TOCOPHEROL ACETATE, DL-WR1WPI7EW8IACT
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
b0f19c03-599a-7650-e053-2a95a90ac312b0f162fe-3bac-cc3c-e053-2995a90a271f2020-08-01WarningsExact identifier
spl id: b0f19c03-599a-7650-e053-2a95a90ac312
spl set id: b0f162fe-3bac-cc3c-e053-2995a90a271f

Reported adverse events (FAERS/openFDA)#

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