FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
Innovation Specialties Inc
Effective date
2024-07-10
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:15:09

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure11 sections

Dosage and administration

• Spread on both hands.

Storage and handling

• store at 20°C (68° to 77° F).  • may discolor fabrics.

Label contents#

Full prescribing information#

Active ingredients

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.Children must be supervised in use of this product.

Use

INDICATIONS & USAGE SECTION

To help clean hands

Warnings

WARNINGS SECTION

For external use only.

Flammable. Keep away from fire or flame.

Do not apply around eyes.

When using this product,avoid contact with eyes. In case of contact flush eyes with water.

Stop use and ask a doctorif redness or irritation develop & persist for more than 72 hrs.

Directions

DOSAGE & ADMINISTRATION SECTION

• Spread on both hands.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

Other Information

STORAGE AND HANDLING SECTION

• store at 20°C (68° to 77° F).  • may discolor fabrics.

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

Sanitizer-1Sanitizer-1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581660ethanol 62 % Topical GelPSN4
581660ethanol 0.62 ML/ML Topical GelSCD4
581660ethanol 62 % Topical GelSY4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76138-114-132024-01-30C16284748780-11030e365-525b-111a-e063-dadaa90a10e2Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76138-114-13Hand Sanitizer30 mL in 1 BOTTLEGEL304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76138-114HAND SANITIZER (ETHYL ALCOHOL) GEL [INNOVATION SPECIALTIES INC]4Current NDC, Legacy NDC, 1 package rows20240712_b2eee632-5a1d-4df5-99c8-8ceb3d644c94.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
76138-11476138-114-13

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hand SanitizerETHYL ALCOHOLInnovation Specialties Incb2eee632-5a1d-4df5-99c8-8ceb3d644c942024-07-10WarningsExact identifier
ndc (package): 76138-114-13
ndc (product): 76138-114
ndc11 (package): 76138011413
spl id: 1cee8656-3017-15b2-e063-6394a90a1e1d
spl set id: b2eee632-5a1d-4df5-99c8-8ceb3d644c94

Reported adverse events (FAERS/openFDA)#

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