Hand Sanitizer

Manufacturer
SentryPPE, Inc.
Effective date
2020-05-28
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:15:12

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure12 sections

Storage and handling

Other Information: Store between 15-30℃(59-86℉) Avoid freezing and excessive heat above 40℃(104℉) May discolor certain fabrics or surfaces.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient
Ethyl Alcohol 62% v/v

OTC - PURPOSE SECTION

Purpose
Antiseptic

INDICATIONS & USAGE SECTION

Uses:

Hand sanitizer to help reduce bacteria that potentially can cause disease.

For use when soap and water not available.

WARNINGS SECTION

Warnings:

For external use only. Flammable. Keep away from heat or flame.

OTC - DO NOT USE SECTION

Do not use:

On children less than 2 months of age

On open skin wounds

OTC - WHEN USING SECTION

When using this product, keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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 way.

DOSAGE & ADMINISTRATION SECTION

Directions

Place enough product on hands to cover all surfaces. Rub hands together until dry.

Supervise Children under 6 years of age when using this product to avoid swallowing.

STORAGE AND HANDLING SECTION

Other Information:

Store between 15-30℃(59-86℉)

Avoid freezing and excessive heat above 40℃(104℉)

May discolor certain fabrics or surfaces.

INACTIVE INGREDIENT SECTION

Inactive Ingredients

Water, Aloe Barbadensis Leaf Juice, Maltodextrin,Glycerin, Propylene Glycol, Acrylates/C1O-30 Alkyl Acrylate Crosspolymer, Triethanoamine, Fragrance, Tocopheryl Acetate.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of bottle labelimage of bottle label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581660ethanol 62 % Topical GelPSN1
581660ethanol 0.62 ML/ML Topical GelSCD1
581660ethanol 62 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78398-008-012025-01-30C16284748780-12cef2736-6d9e-d83d-e063-dadaa90ab31fa6c009a3-9c74-2769-e053-2995a90a316c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78398-008-01Hand Sanitizer236 mL in 1 BOTTLE, PUMPGEL2361

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78398-008HAND SANITIZER (ETHYL ALCOHOL) GEL [SENTRYPPE, INC.]1Legacy NDC, 1 package rows20200529_a6c009a3-9c74-2769-e053-2995a90a316c.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78398-00878398-008-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

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
a6c043ce-83ca-46c8-e053-2995a90a11e5a6c009a3-9c74-2769-e053-2995a90a316c2020-05-28WarningsExact identifier
spl id: a6c043ce-83ca-46c8-e053-2995a90a11e5
spl set id: a6c009a3-9c74-2769-e053-2995a90a316c

Reported adverse events (FAERS/openFDA)#

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