Hand Sanitizer Antiseptic Gel

Manufacturer
HART Health | Safetec of America, Inc
Effective date
2024-01-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:07:57

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure10 sections

Indications and uses

For hanwashing to decrease bacteria on 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 with adult supervision

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Ethyl alcohol 62%

Purpose

OTC - PURPOSE SECTION

Antiseptic handwash

Uses

INDICATIONS & USAGE SECTION

For hanwashing to decrease bacteria on 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 with adult supervision

Inactive ingrediends

INACTIVE INGREDIENT SECTION

acrylates/C10-30 alkyl acrylate crosspolymer, aloe barbadensis leaf juice, fragrance, PEG-60 almond glycerides, propylene glycol, purified water, triisopropanolamine

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

5399HandSanitizerv21f.jpg5399HandSanitizerv21f.jpg

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50332-0040HAND SANITIZER (ANTISEPTIC GEL) GEL [HART HEALTH]1Current NDC20240126_f07daf29-d0db-4cf8-8baf-d175c2b2ef50.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50332-004050332-0040-1, 50332-0040-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 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
Hand SanitizerANTISEPTIC GELHART Healthf07daf29-d0db-4cf8-8baf-d175c2b2ef502024-01-25WarningsExact identifier
ndc (package): 50332-0040-1
ndc (package): 50332-0040-2
ndc (product): 50332-0040
ndc11 (package): 50332004001
ndc11 (package): 50332004002
spl id: c17bf898-5cdc-4285-8c5f-6709a279135b
spl set id: f07daf29-d0db-4cf8-8baf-d175c2b2ef50

Reported adverse events (FAERS/openFDA)#

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