FDA.reportPublic FDA data

Hand Sanitizer with Aloe

Manufacturer
Owen Biosciences, Inc.
Effective date
2024-11-05
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 20:50:22

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

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59958-500HAND SANITIZER WITH ALOE (65% ETHYL ALCOHOL) GEL [OWEN BIOSCIENCES, INC.]4Current NDC, Legacy NDC20241107_cdaf6db9-c7df-41bc-a74c-0111694dbe9d.zip

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
59958-50059958-500-05

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
512ace31-89fd-c627-e063-6294a90af7eccdaf6db9-c7df-41bc-a74c-0111694dbe9d2026-05-06WarningsExact identifier
spl set id: cdaf6db9-c7df-41bc-a74c-0111694dbe9d
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 (product): 59958-500

Reported adverse events (FAERS/openFDA)#

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