FDA.reportPublic FDA data

First Aid Only Instant Hand Sanitizer

Manufacturer
Acme United Corporation
Effective date
2024-11-26
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:39:27

Label at a glance#

ProductFirst Aid Only Instant Hand Sanitizer
Active ingredientALCOHOL
Label structure9 sections

Indications and uses

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

Dosage and administration

wet hands & wrists thoroughly with product and allow to dry without wiping

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 66.5%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

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

.

Warnings

WARNINGS SECTION

For External use only.

Flammable.keep away from fire or flame.

OTC - DO NOT USE SECTION

Do not use in eyes. If this happens, rinse thoroughly with water.

OTC - STOP USE SECTION

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

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 & wrists thoroughly with product and allow to dry without wiping

Inactive ingredients

INACTIVE INGREDIENT SECTION

aloe vera, carbomer, D&C green #5, D&C yellow #10, fragrance, purified water, triethanolamine

OTC - QUESTIONS SECTION

Questions 1.800.835.2263

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Box LabelBox LabelBox Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
616762ethanol 66.5 % Topical GelPSN3
616762ethanol 0.665 ML/ML Topical GelSCD3
616762ethanol 66.5 % Topical GelSY3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0924-0450-00First Aid Only Instant Hand Sanitizer0.034 L in 1 POUCHGEL0.0343
0924-0450-01First Aid Only Instant Hand Sanitizer10 in 1 BOXGEL103
0924-0450-01First Aid Only Instant Hand Sanitizer0.034 L in 1 POUCHGEL0.0343
0924-0450-02First Aid Only Instant Hand Sanitizer0.034 L in 1 POUCHGEL0.0343
0924-0450-02First Aid Only Instant Hand Sanitizer20 in 1 BOXGEL203

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0924-0450FIRST AID ONLY INSTANT HAND SANITIZER (ALCOHOL) GEL [ACME UNITED CORPORATION]3Current NDC, Legacy NDC, 5 package rows20241127_c94e8db3-2db7-fce4-e053-2a95a90a62d9.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0924-04500924-0450-00, 0924-0450-01, 0924-0450-02
61010-1112

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
D&C GREEN NO. 58J6RDU8L9XIACT
D&C YELLOW NO. 1035SW5USQ3GIACT
ALOEV5VD430YW9IACT
WATER059QF0KO0RIACT
TROLAMINE9O3K93S3TKIACT
ALCOHOL3K9958V90MACTIB
FRAGRANCE 135765EM498GW35IACT
CARBOMER 9804Q93RCW27EIACT

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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Instant Hand SanitizerALCOHOLSafetec of America, Inc.c3f0556d-f967-4f19-922c-57a2bf1848922026-01-16WarningsExact identifier
ndc (product): 61010-1112
Instant Hand SanitizerALCOHOLSafetec of America3b5b46d0-308a-4649-8384-246da3a18ba12026-01-16WarningsExact identifier
ndc (product): 61010-1112
Instant Hand SanitizerALCOHOLSafetec of Americabf69cc74-ebe9-40c3-a95a-a489492cc6932026-01-16WarningsExact identifier
ndc (product): 61010-1112
First Aid Only Instant Hand SanitizerALCOHOLAcme United Corporationc94e8db3-2db7-fce4-e053-2a95a90a62d92024-11-26WarningsExact identifier
ndc (package): 0924-0450-02
ndc (package): 0924-0450-00
ndc (package): 0924-0450-01
ndc (product): 0924-0450
ndc11 (package): 00924045001
ndc11 (package): 00924045002
ndc11 (package): 00924045000
spl id: 27d77dd5-c4b4-d75c-e063-6394a90ab50f
spl set id: c94e8db3-2db7-fce4-e053-2a95a90a62d9

Reported adverse events (FAERS/openFDA)#

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