FDA.reportPublic FDA data

Health Smart Hand Sanitizer ORIGINAL

Manufacturer
International Wholesale Inc
Effective date
2023-10-23
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 21:23:30

Label at a glance#

ProductHealth Smart Hand Sanitizer ORIGINAL
Active ingredientALCOHOL
Label structure8 sections

Indications and uses

help reduce bacteria on the skin that could cause disease recommended for repeated use

Dosage and administration

Place enough product in your palm to thoroughly cover your hands Rub hands together briskly until dry Children under 6 years of age should be supervised when using this product.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 62%

Purpose

OTC - PURPOSE SECTION

Antimicrobial

Uses

INDICATIONS & USAGE SECTION

  • help reduce bacteria on the skin that could cause disease
  • recommended for repeated use

Warnings

WARNINGS SECTION

For exeternal use only.Flammable. Keep away from fire or flame.

When using this product:

OTC - WHEN USING SECTION

do not use in or near the eyes. In case of eye contact, flush eyes thoroughly with water.

Stop use and ask a doctor if:

OTC - STOP USE SECTION

irritation and redness develops and lasts 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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Place enough product in your palm to thoroughly cover your hands
  • Rub hands together briskly until dry
  • Children under 6 years of age should be supervised when using this product.

Other Information:

SPL UNCLASSIFIED SECTION

  • Store below 110°F(43°C)
  • may discolor certain fabrics or surfaces

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Water, Aloe Barbadensis Gel, Carbomer, Fragrance, Glycerin, Triethanolamine, Tocopheryl Acetate

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

Package Labeling:60ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BottleBottle

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52862-612HEALTH SMART HAND SANITIZER ORIGINAL (ALCOHOL) GEL [INTERNATIONAL WHOLESALE INC]4Legacy NDC20231024_f854fc11-7f1a-4592-ab66-d4e2dac70d5b.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
52862-61252862-612-53, 52862-612-60

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ALOE VERA LEAFZY81Z83H0XIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
GLYCERINPDC6A3C0OXIACT
TROLAMINE9O3K93S3TKIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
3edb19bb-32ad-7d84-e063-6394a90a11a0f854fc11-7f1a-4592-ab66-d4e2dac70d5b2025-09-15WarningsExact identifier
spl set id: f854fc11-7f1a-4592-ab66-d4e2dac70d5b

Reported adverse events (FAERS/openFDA)#

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