FDA.reportPublic FDA data

5253 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 00:15:08

Label at a glance#

Product5253 hand sanitizer
Active ingredientALCOHOL
Label structure10 sections

Indications and uses

Hand sanitizer to help decrease bacteria on the skin.

Dosage and administration

Spread on both hands, rub in, let dry.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 62%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

Hand sanitizer to help decrease bacteria on the skin.

Warnings

WARNINGS SECTION

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

When using this productAvoid contact with eyes. In case of contact flush eyes with water.

Stop use and ask a doctorIf redness or irritation develop and persist 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

Spread on both hands, rub in, let dry.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

Questions?

OTC - QUESTIONS SECTION

Call ​1-855-755 5346

NPN # 80062390

SPL UNCLASSIFIED SECTION

Made in China For Innovation Line Culver City, CA 90230

Citrus Scent

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

5253 hand sanitizer5253 hand sanitizer

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
76138-117-022024-01-30C16284748780-11030e365-1c9a-111a-e063-dadaa90a10e25253 hand sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76138-117-025253 hand sanitizer15 mL in 1 BOTTLEGEL153

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76138-1175253 HAND SANITIZER (ETHYL ALCOHOL) GEL [INNOVATION SPECIALTIES]3Current NDC, Legacy NDC, 1 package rows20240712_3ef15fec-bb7a-424a-a361-88a8f9503b5f.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
76138-11776138-117-02

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
5253 hand sanitizerETHYL ALCOHOLInnovation Specialties3ef15fec-bb7a-424a-a361-88a8f9503b5f2024-07-10WarningsExact identifier
ndc (package): 76138-117-02
ndc (product): 76138-117
ndc11 (package): 76138011702
spl id: 1cee56d0-ef03-0c14-e063-6394a90a380f
spl set id: 3ef15fec-bb7a-424a-a361-88a8f9503b5f

Reported adverse events (FAERS/openFDA)#

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