ANTISEPTIC HAND SANITIZER

Manufacturer
Innovation Specialties Inc
Effective date
2024-07-10
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:15:09

Label at a glance#

ProductANTISEPTIC HAND SANITIZER
Active ingredientALCOHOL
Label structure11 sections

Dosage and administration

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

Storage and handling

Store at room temperature 15 0 to 30 0 C (59 0 to 86 0 F)

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 children.If swallowed, get medical help or contact a Poison Control Center right away. 

Use

INDICATIONS & USAGE SECTION

For handwashing to decrease bacteria on the skin.

Warnings

WARNINGS SECTION

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

Do not usein the eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor ifirritation and redness develop and persist for more than 72 hours.

Directions

DOSAGE & ADMINISTRATION SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

STORAGE AND HANDLING SECTION

Store at room temperature 15 0to 30 0C (59 0to 86 0F)

Questions?

OTC - QUESTIONS SECTION

HOTLINE # 1-855-755-5346

SPL UNCLASSIFIED SECTION

Made in China for Innovation Line Culver City, CA 90230

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

sanitizer-6sanitizer-6

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581660ethanol 62 % Topical GelPSN6
581660ethanol 0.62 ML/ML Topical GelSCD6
581660ethanol 62 % Topical GelSY6

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76138-113-032024-01-30C16284748780-11030e364-fc76-111a-e063-dadaa90a10e2ANTISEPTIC HAND SANITIZER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76138-113-03ANTISEPTIC HAND SANITIZER30 mL in 1 BOTTLEGEL306

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76138-113ANTISEPTIC HAND SANITIZER (ETHYL ALCOHOL) GEL [INNOVATION SPECIALTIES INC]6Current NDC, Legacy NDC, 1 package rows20240712_89af8a07-49cd-4b51-9ca7-016f849d7b70.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
76138-11376138-113-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

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 · 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 (product): 76138-113
ANTISEPTIC HAND SANITIZERETHYL ALCOHOLInnovation Specialties Inc89af8a07-49cd-4b51-9ca7-016f849d7b702024-07-10WarningsExact identifier
ndc (package): 76138-113-03
ndc (product): 76138-113
ndc11 (package): 76138011303
spl id: 1cee56d0-eef5-0c14-e063-6394a90a380f
spl set id: 89af8a07-49cd-4b51-9ca7-016f849d7b70
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.