FDA.reportPublic FDA data

5259 HAND SANITIZER

Manufacturer
Innovation Specialties
Effective date
2024-07-10
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:15:07

Label at a glance#

Product5259 HAND SANITIZER
Active ingredientALCOHOL
Label structure10 sections

Storage and handling

Store at room temperature 15° to 30°C (59° to 86°F).

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Ethyl alcohol 62%

OTC - PURPOSE SECTION

Purpose

Antiseptic

INDICATIONS & USAGE SECTION

For handwashing to decrease bacteria on the skin.

WARNINGS SECTION

Warnings:Flammable, keep away from fire or flame. For external use only.

Stop use and ask a doctor ifirritation and redness develop 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.

DOSAGE & ADMINISTRATION SECTION

Wet hands thoroughly with product, briskly rub hands together until dry. Supervise children in the use of this product.

INACTIVE INGREDIENT SECTION

Inactive ingredients:Carbomer, Fragrance, Glycerin, Propylene Glycol, Tocopheryl Acetate, Triethanolamine, Water.

STORAGE AND HANDLING SECTION

Store at room temperature 15° to 30°C (59° to 86°F).

OTC - QUESTIONS SECTION

Questions?Call 1-855-755 5346

NPN# 80062390   Citrus Scent

SPL UNCLASSIFIED SECTION

Made in China for Innovation Line Culver City, CA 90230

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

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
76138-120-042024-01-30C16284748780-11030e365-36ec-111a-e063-dadaa90a10e25259 HAND SANITIZER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76138-120-045259 HAND SANITIZER40 mL in 1 BOTTLEGEL403

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76138-1205259 HAND SANITIZER (ETHYL ALCOHOL) GEL [INNOVATION SPECIALTIES]3Current NDC, Legacy NDC, 1 package rows20240712_3923fe13-0e57-406a-afb9-3e9cef263dab.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
76138-12076138-120-04

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 · Source PDF

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
5259 HAND SANITIZERETHYL ALCOHOLInnovation Specialties3923fe13-0e57-406a-afb9-3e9cef263dab2024-07-10WarningsExact identifier
ndc (package): 76138-120-04
ndc (product): 76138-120
ndc11 (package): 76138012004
spl id: 1cee8d76-1f8e-14b4-e063-6294a90afc0e
spl set id: 3923fe13-0e57-406a-afb9-3e9cef263dab

Reported adverse events (FAERS/openFDA)#

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