FDA.reportPublic FDA data

Hand Sanitizer Antiseptic Gel

Manufacturer
HART Health
Effective date
2025-12-02
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:19:25

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure11 sections

Indications and uses

For hanwashing to help decrease bacteria on the skin. Recommended for repeated use.

Dosage and administration

wet hands thoroughly with product and allow to dry without wiping for children under 6 years of age; use only under adult supervision

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 62% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic handwash

Uses

INDICATIONS & USAGE SECTION

For hanwashing to help decrease bacteria on the skin. Recommended for repeated use.

Warnings

WARNINGS SECTION

For external use only

Flammable, keep away from heat and flame

When using this product

OTC - WHEN USING SECTION

  • do not use in the eyes
  • in case of contact, rinse eyes throughly with water

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • irritation and redness develop
  • condition persists for more than 72 hours

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away. 1-800-222-1222

Directions

DOSAGE & ADMINISTRATION SECTION

  • wet hands thoroughly with product and allow to dry without wiping
  • for children under 6 years of age; use only under adult supervision

OTHER SAFETY INFORMATION

  • Store at 59° to 86°F (15-30°C)

Inactive ingrediends

INACTIVE INGREDIENT SECTION

acrylates/C10-30 alkyl acrylate crosspolymer, aloe barbadensis leaf juice, aminomethyl propanol, denatonium benzoate, fragrance, glycerin, propylene glycol, tocopheryl acetate, water.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HB 5399-25 Hand Sani box 25 ct v 25c -Final_smallJpeg.jpgHB 5399-25 Hand Sani box 25 ct v 25c -Final_smallJpeg.jpgHB 5399-25 Hand Sani box 25 ct v 25c -Final_smallJpeg.jpgHB 5399-25 Hand Sani box 25 ct v 25c -Final_smallJpeg.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581660ethanol 62 % Topical GelPSN2
581660ethanol 0.62 ML/ML Topical GelSCD2
581660ethanol 62 % Topical GelSY2

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
50332-009450332-0094-6, 50332-0094-2, 50332-0094-9

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
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S)8Z5ZAL5H3VIACT
ALOE BARBADENSIS LEAF JUICERUE8E6T4NBIACT
AMINOMETHYL PROPANOLLU49E6626QIACT
DENATONIUM BENZOATE4YK5Z54AT2IACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT

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 SanitizerANTISEPTIC GELHART Health87fcd27f-e4bf-4ae9-ad2e-b9b11ac554cc2025-12-02WarningsExact identifier
ndc (package): 50332-0094-9
ndc (package): 50332-0094-6
ndc (package): 50332-0094-2
ndc (product): 50332-0094
ndc11 (package): 50332009402
ndc11 (package): 50332009406
ndc11 (package): 50332009409
spl id: 26dc1681-b8bf-412e-982d-f6ada1520dd0
spl set id: 87fcd27f-e4bf-4ae9-ad2e-b9b11ac554cc

Reported adverse events (FAERS/openFDA)#

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