FDA.reportPublic FDA data

Hand Sanitizer wth Aloe, 5 Gallon 18,500g

Manufacturer
Owen Biosciences, Inc.
Effective date
2026-05-06
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:56:19

Label at a glance#

ProductHand Sanitizer with Aloe
Active ingredientALCOHOL
Label structure2 sections

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients Purpose
Ethyl Alcohol 65% v/v....................Antimicrobial

Use

OTC - PURPOSE SECTION

■ Hand sanitizer to help reduce bacteria on the skin

Use

INDICATIONS & USAGE SECTION

■ Hand sanitizer to help reduce bacteria on the skin

Warnings

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

■ For external use only.
■ When using this product avoid use in or near the
eyes. In case of contact, rinse eyes thoroughly with
water.
■ Stop use and ask a doctor if irritation or rash occurs.
■ Keep out of reach of children. If swallowed, get
medical help or contact Poison Control.

■ Flammable. Keep away from fire and flame.

warnings

WARNINGS SECTION

■ For external use only.
■ When using this product avoid use in or near the
eyes. In case of contact, rinse eyes thoroughly with
water.
■ Stop use and ask a doctor if irritation or rash occurs.
■ Keep out of reach of children. If swallowed, get
medical help or contact Poison Control.

■ Flammable. Keep away from fire and flame.

Directions

DOSAGE & ADMINISTRATION SECTION

■ Apply product generously in palm using enough to
cover hands. Rub hands together until dry. Children
under 6 years of age should be supervised when using
this product.

Other information

OTHER SAFETY INFORMATION

■ Protect the product in this container from excessive
heat and direct sun. Store below 110ºF(43ºC).
■ May discolor some fabrics or surfaces

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Hydroxyethylcellulose,
Glycerin, Menthol, Cocoyl Argininamide, Safflower Acids,
Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, Coconut
Acids, Eucalyptus Globulus Leaf Oil, Caprylyl Glycol,
Fragrance, 1,2-Hexanediol, Disodium EDTA-Copper

image.jpg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
902574ethanol 65 % Topical GelPSN6
902574ethanol 0.65 ML/ML Topical GelSCD6
902574ethyl alcohol 65 % Topical GelSY6

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59958-500-032026-01-29C16284748780-149896155-ae55-586f-e063-e6dba90add90Hand Sanitizer wth Aloe, 5 Gallon 18,500g

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59958-500-03Hand Sanitizer with Aloe18500 g in 1 BOTTLE, PUMPGEL185006

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59958-50059958-500-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hand Sanitizer with Aloe65% ETHYL ALCOHOLOwen Biosciences, Inc.fb93b4f6-9eaf-4c35-a110-1f526ca7c3732026-05-06WarningsExact identifier
ndc (product): 59958-500
Hand Sanitizer with Aloe65% ETHYL ALCOHOLOwen Biosciences, Inc.57f60d9e-954d-413d-ab3b-e4b800d072bf2026-05-06WarningsExact identifier
ndc (package): 59958-500-03
ndc (product): 59958-500
ndc11 (package): 59958050003
spl id: 512ae0ca-7731-d98f-e063-6394a90ae67e
spl set id: 57f60d9e-954d-413d-ab3b-e4b800d072bf

Reported adverse events (FAERS/openFDA)#

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