FDA.reportPublic FDA data

Instant Hand Sanitizer

Manufacturer
Henry Schein, Inc. | Safetec of America, Inc.
Effective date
2025-01-10
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:52:23

Label at a glance#

ProductInstant Hand Sanitizer
Active ingredientALCOHOL
Label structure8 sections

Indications and uses

for handwashing to decrease bacteria on skin without soap and water

Dosage and administration

place a small amount and rub over both hands & wrists until dry allow to dry without wiping children under 6 should be supervised while using this product

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 - WHEN USING SECTION

When using this productdo not get into eyes. If contact occurs, rinse eyes thoroughly with water

Stop use and ask doctor if

OTC - STOP USE SECTION

  • irritation and redness develops and persists for more than 72 hours

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 a small amount and rub over both hands & wrists until dry
  • allow to dry without wiping
  • children under 6 should be supervised while using this product

Inactive Ingredients

INACTIVE INGREDIENT SECTION

aloe vera, carbomer, fragrance, purified water, triethanolamine

Distributed by HENRY SCHEIN, INC.Melville, NY 11747 USA
Made in U.S.A.

PRINCIPAL DISPLAY PANEL – 27.05 fl. oz. Box Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Henry Schein

112-5991

Maxiclens

Instant Hand Sanitizer

NDC 0404-5991-01

27.05 FL. OZ. (800 ML)

PRINCIPAL DISPLAY PANEL – 27.05 fl. oz. Box Label
PRINCIPAL DISPLAY PANEL – 27.05 fl. oz. Box Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
616762ethanol 66.5 % Topical GelPSN5
616762ethanol 0.665 ML/ML Topical GelSCD5
616762ethanol 66.5 % Topical GelSY5

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0404-5991-01Instant Hand Sanitizer800 mL in 1 BOXGEL8005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0404-5991INSTANT HAND SANITIZER (ALCOHOL) GEL [HENRY SCHEIN, INC.]5Current NDC, Legacy NDC, 1 package rows20250112_e80feb63-2c51-4164-806d-778e39e620e8.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
alcoholACTIVE INGREDIENT3K9958V90M1
alcoholACTIVE MOIETY3K9958V90M1
aloeINACTIVE INGREDIENTV5VD430YW91
trolamineINACTIVE INGREDIENT9O3K93S3TK1
waterINACTIVE INGREDIENT059QF0KO0R1

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
0404-59910404-5991-01

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
WATER059QF0KO0RIACT
TROLAMINE9O3K93S3TKIACT
ALCOHOL3K9958V90MACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 2 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
trolamineTROLAMINE9O3K93S3TKGEL / TOPICAL6 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKGEL / TOPICAL6 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates

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
Instant Hand SanitizerALCOHOLHenry Schein, Inc.e80feb63-2c51-4164-806d-778e39e620e82025-01-10WarningsExact identifier
ndc (package): 0404-5991-01
ndc (product): 0404-5991
ndc11 (package): 00404599101
spl id: 2b5c3dc6-90bc-abe9-e063-6294a90af76e
spl set id: e80feb63-2c51-4164-806d-778e39e620e8

Reported adverse events (FAERS/openFDA)#

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