FDA.reportPublic FDA data

Antiseptic Hand Sanitizer

Manufacturer
Innovation Specialties Inc
Effective date
2024-07-10
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 00:15:09

Label at a glance#

ProductAntiseptic Hand Sanitizer
Active ingredientALCOHOL
Label structure10 sections

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of childrenIf swallowed get medical help or contact a Poison Control Center right away.

Use

INDICATIONS & USAGE SECTION

To help clean hands

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.

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

Call1-855-755-5346

SPL UNCLASSIFIED SECTION

Made in China for Innovation Line Culver City, CA 90230

Citrus Scent

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

sanitzer-5sanitzer-5

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581660ethanol 62 % Topical GelPSN7
581660ethanol 0.62 ML/ML Topical GelSCD7
581660ethanol 62 % Topical GelSY7

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76138-113-012024-01-30C16284748780-11030e365-4ed9-111a-e063-dadaa90a10e2Antiseptic Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76138-113-01Antiseptic Hand Sanitizer59 mL in 1 BOTTLEGEL597

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76138-113ANTISEPTIC HAND SANITIZER (ETHYL ALCOHOL) GEL [INNOVATION SPECIALTIES INC]7Current NDC, Legacy NDC, 1 package rows20240712_b80b88e1-e35c-47de-89ee-314d6054f4ce.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
76138-11376138-113-01

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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Antiseptic Hand SanitizerETHYL ALCOHOLInnovation Specialties Incb80b88e1-e35c-47de-89ee-314d6054f4ce2024-07-10WarningsExact identifier
ndc (package): 76138-113-01
ndc (product): 76138-113
ndc11 (package): 76138011301
spl id: 1cee2804-1509-7fdb-e063-6294a90a1b89
spl set id: b80b88e1-e35c-47de-89ee-314d6054f4ce
ANTISEPTIC HAND SANITIZERETHYL ALCOHOLInnovation Specialties Inc89af8a07-49cd-4b51-9ca7-016f849d7b702024-07-10WarningsExact identifier
ndc (product): 76138-113
Antiseptic Hand SanitizerETHYL ALCOHOLInnovation Specialties Inc10a9ea3c-f2a5-4b10-a9a0-12b95cb0f90a2024-07-10WarningsExact identifier
ndc (product): 76138-113
Antiseptic Hand SanitizerETHYL ALCOHOLInnovation Specialties Inc5849d19f-5761-4500-9596-e705b78f14ae2024-07-10WarningsExact identifier
ndc (product): 76138-113

Reported adverse events (FAERS/openFDA)#

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