FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
DZA Brands LLC | Apollo Health and Beauty Care Inc.
Effective date
2017-04-28
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:49:41

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure8 sections

Indications and uses

to help reduce bacteria on the skin

Dosage and administration

apply a small amount in your palm and rub hands together briskly until dry. Children under 6 should be supervised when using this product.

Storage and handling

do not store above 110°F (43°C)

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 65%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

  • to help reduce bacteria on the skin

Warnings

WARNINGS SECTION

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

When using this product

OTC - WHEN USING SECTION

  • avoid contact with eyes.
  • if contact occurs, rinse with water.
Stop using and ask a doctor

OTC - STOP USE SECTION

  • if irritation or redness develops and lasts.
Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • In case of accidental ingestion, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • apply a small amount in your palm and rub hands together briskly until dry. Children under 6 should be supervised when using this product.

Other information

STORAGE AND HANDLING SECTION

do not store above 110°F (43°C)

Questions/comments?

OTC - QUESTIONS SECTION

1-866-322-2439

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), Isopropyl Alcohol, Glycerin, Isopropyl Myristate, Aloe Barbadensis Leaf Juice, Tocopheryl Actate, Carbomer, Aminomethyl Propanol, Fragrance (Parfum).

Label Copy

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of the labelImage of the label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
902574ethanol 65 % Topical GelPSN1
902574ethanol 0.65 ML/ML Topical GelSCD1
902574ethyl alcohol 65 % Topical GelSY1

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130725439935876GTIN-13: 0725439935876
EAN-13: 0725439935876
GTIN-12: 725439935876
UPC-A: 725439935876
GTIN storage (14 digits): 00725439935876		17088L.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55316-253-032020-01-31C16284748780-19d75b9d0-af51-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55316-253-03Hand Sanitizer59 mL in 1 BOTTLE, PLASTICGEL591

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55316-253HAND SANITIZER (ETHYL ALCOHOL) GEL [DZA BRANDS LLC]1Legacy NDC, 1 package rows20170428_56bebada-75e8-4d6c-a7f8-2139b07b09f4.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55316-25355316-253-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
ISOPROPYL ALCOHOLND2M416302IACT
GLYCERINPDC6A3C0OXIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
ALOE VERA LEAFZY81Z83H0XIACT
.ALPHA.-TOCOPHEROL ACETATE, DL-WR1WPI7EW8IACT
AMINOMETHYLPROPANOLLU49E6626QIACT

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
8efc98b7-2016-4a0f-ac8e-3c46194fe61e56bebada-75e8-4d6c-a7f8-2139b07b09f42017-04-28WarningsExact identifier
spl id: 8efc98b7-2016-4a0f-ac8e-3c46194fe61e
spl set id: 56bebada-75e8-4d6c-a7f8-2139b07b09f4

Reported adverse events (FAERS/openFDA)#

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