FDA.reportPublic FDA data

HAND SANITIZER

Manufacturer
Total Resources International Inc.
Effective date
2022-12-06
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-05-31 23:52:19

Label at a glance#

ProductHAND SANITIZER 08
Active ingredientALCOHOL
Label structure12 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient Purpose

Ethyl Alcohol 66.5% v/v....................Antiseptic

OTC - PURPOSE SECTION

Use: For handwashing to decrease bacteria on skin without soap and water.

WARNINGS SECTION

Warnings For external use only

Flammable, keep away from fire or flame

OTC - DO NOT USE SECTION

Do not use •in the eyes if happens, rinse thoroughly with water.

OTC - STOP USE SECTION

Stop use, ask a doctor if irritation develops and persists for 72 hours.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, seek medical help or contact a Poison Control Center immediately.

INDICATIONS & USAGE SECTION

Directions wet hands and wrists thoroughly with product and allow to dry without wiping supervise children while using this product

OTHER SAFETY INFORMATION

Other Information store at room temperature 59°- 86°F ( 15°- 30°C )

INACTIVE INGREDIENT SECTION

Inactive ingredient aloe vera*, carbomer*, D&C green #5*, D&C yellow #10*, fragrance *, triethanolamine*, water* may contain

OTC - QUESTIONS SECTION

Questions? Call 1-888-771-7824

DOSAGE & ADMINISTRATION SECTION

For External Use Only

HAND SANITIZER

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Hand SanitizerHand Sanitizer

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55550-108-082024-01-30C16284748780-11030e365-50de-111a-e063-dadaa90a10e2Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55550-108-08HAND SANITIZER081.5 mL in 1 POUCHPATCH1.56

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55550-108HAND SANITIZER 08 (ETHYL ALCOHOL) PATCH [TOTAL RESOURCES INTERNATIONAL INC.]6Legacy NDC, 1 package rows20221208_bbf69bef-8519-493d-e053-2a95a90a6547.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
55550-10855550-108-08

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
ALOEV5VD430YW9IACT
TROLAMINE9O3K93S3TKIACT
WATER059QF0KO0RIACT
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
ef2cda8f-157f-4f93-e053-2a95a90aebb5bbf69bef-8519-493d-e053-2a95a90a65472022-12-06WarningsExact identifier
spl id: ef2cda8f-157f-4f93-e053-2a95a90aebb5
spl set id: bbf69bef-8519-493d-e053-2a95a90a6547

Reported adverse events (FAERS/openFDA)#

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