FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
Tempo Industries, Inc.
Effective date
2025-01-08
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:51:32

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure10 sections

Indications and uses

For Hand Sanitizing

Dosage and administration

Wet hands thoroughly with product and allow to dry without wiping. For children under 6 age use only under adult supervision. Not recommended for infants

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 62%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses:

INDICATIONS & USAGE SECTION

For Hand Sanitizing

Warnings:

WARNINGS SECTION

For external use only-hands.

Flammable. Keep away from heat and flame.

When using this product

OTC - WHEN USING SECTION

  • Keep out of eyes. In case of contact with eyes, flush thoroughly with water
  • Avoid contact with broken skin.
  • Do not inhale or ingest.

Stop use and ask a doctor

OTC - STOP USE SECTION

If skin irritation develops

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions:

DOSAGE & ADMINISTRATION SECTION

  • Wet hands thoroughly with product and allow to dry without wiping.
  • For children under 6 age use only under adult supervision.
  • Not recommended for infants

Other Information:

SPL UNCLASSIFIED SECTION

  • Do not store above 105°F. 
  • May discolor some fabrics.
  • Harmful to wood finishes and plastics

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Carbomer, Fragrance, Glycerin, Propylene Glycol, Tocopheryl Acetate, Triethanolamine, Water.

Package Labeling:30ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

30 ml30 ml30 ml30 ml

Package Labeling:53ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle53mlBottle53ml

Package Labeling:60ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle60mlBottle60ml

Package Labeling:15ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle15mlABottle15mlABottle15mlBBottle15mlB

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581660ethanol 62 % Topical GelPSN3
581660ethanol 0.62 ML/ML Topical GelSCD3
581660ethanol 62 % Topical GelSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80524-000-152023-12-15C16284748780-1d6a99b39-c890-a426-e053-dadaa90af4c2Hand Sanitizer
80524-000-302023-12-15C16284748780-1d6a99b39-c890-a426-e053-dadaa90af4c2Hand Sanitizer
80524-000-532023-12-15C16284748780-1d6a99b39-c890-a426-e053-dadaa90af4c2Hand Sanitizer
80524-000-602023-12-15C16284748780-1d6a99b39-c890-a426-e053-dadaa90af4c2Hand Sanitizer
80524-000-152022-01-28C16284748780-1d6a99b39-c890-a426-e053-dadaa90af4c2Hand Sanitizer
80524-000-302022-01-28C16284748780-1d6a99b39-c890-a426-e053-dadaa90af4c2Hand Sanitizer
80524-000-532022-01-28C16284748780-1d6a99b39-c890-a426-e053-dadaa90af4c2Hand Sanitizer
80524-000-602022-01-28C16284748780-1d6a99b39-c890-a426-e053-dadaa90af4c2Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80524-000-15Hand Sanitizer15 mL in 1 BOTTLEGEL153
80524-000-30Hand Sanitizer30 mL in 1 BOTTLEGEL303
80524-000-53Hand Sanitizer53 mL in 1 BOTTLEGEL533
80524-000-60Hand Sanitizer60 mL in 1 BOTTLEGEL603

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80524-000HAND SANITIZER (ALCOHOL) GEL [TEMPO INDUSTRIES, INC.]3Current NDC, Legacy NDC, 4 package rows20250110_af9a0d53-0d4a-6dc7-e053-2a95a90acc1c.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80524-00080524-000-30, 80524-000-53, 80524-000-60, 80524-000-15

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
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
Hand SanitizerALCOHOLTempo Industries, Inc.af9a0d53-0d4a-6dc7-e053-2a95a90acc1c2025-01-08WarningsExact identifier
ndc (package): 80524-000-15
ndc (package): 80524-000-53
ndc (package): 80524-000-30
ndc (package): 80524-000-60
ndc (product): 80524-000
ndc11 (package): 80524000030
ndc11 (package): 80524000053
ndc11 (package): 80524000015
ndc11 (package): 80524000060
spl id: 2b320ea1-a8da-6421-e063-6294a90a9b1c
spl set id: af9a0d53-0d4a-6dc7-e053-2a95a90acc1c

Reported adverse events (FAERS/openFDA)#

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