FDA.reportPublic FDA data

Smart Care Hand Sanitizer 16.9 oz

Manufacturer
Yozzi Co.,ltd
Effective date
2020-04-23
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:07:58

Label at a glance#

ProductSmart Care Hand Sanitizer 16.9 oz
Active ingredientALCOHOL
Label structure8 sections

Indications and uses

For external use only: hands

Dosage and administration

Put a thumbnail size amount in your palm and rub your hands together briskly until dry. Children under 6 years of age should be supervised when using SMART CARE ® HAND SANITIZER.  

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 62%

Purposes

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

For external use only: hands

Directions:

DOSAGE & ADMINISTRATION SECTION

Put a thumbnail size amount in your palm and rub your hands together briskly until dry. Children under 6 years of age should be supervised when using SMART CARE® HAND SANITIZER.  

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Aloe Barbadensis Leaf Extract, Carbomer, Fragrance, Glycerin, Propylene Glycol, Tocopheryl Acetate (Vitamin E), Triethanolamine 

Warnings:

WARNINGS SECTION

For external use only: hands

Flammable. Keep away from fire or flame.

When using this product

▪ Keep out of eyes.

▪ In case of contact with eyes, flush thoroughly with water.

▪ Avoid contact with broken skin.

▪ Do not inhale or ingest.

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.

SPL UNCLASSIFIED SECTION

KILLS UP TO 99.99% OF MOST COMMON GERMS

Aloe Vera & Vitamin E

FAST & EFFECTIVE

Keep bottle of Hand Sanitizer in:

  • Kitchen
  • Medical Offices
  • Nurseries
  • Automobile
  • Bathrooms
  • Workplace

DESIGNED IN U.S.A.

MADE IN CHINA

WWW.SMARTCAREUS.COM

QUESTIONS OR COMMENTS?

1-877-274-8358 TOLL FREE IN U.S.A.

1-909-434-0911 INTERNATIONAL

PATENTS, COPYRIGHTS AND TRADEMARKS GRANTED OR PENDING WORLDWIDE

DISTRIBUTED BY ASHTEL STUDIOS INC. ONTARIO, CALIFORNIA 91761

EXP: 04/2022

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PackagingPackaging

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581660ethanol 62 % Topical GelPSN1
581660ethanol 0.62 ML/ML Topical GelSCD1
581660ethanol 62 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72285-003-012022-01-28C16284748780-1d6a99b39-8969-a426-e053-dadaa90af4c2Smart Care ® Hand SANITIZER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72285-003-01Smart Care Hand Sanitizer 16.9 oz500 mL in 1 BOTTLEGEL5001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72285-003SMART CARE HAND SANITIZER 16.9 OZ (ETHYL ALCOHOL) GEL [YOZZI CO.,LTD]1Legacy NDC, 1 package rows20200426_932fb103-343d-434e-bfb1-e5a6b08b3e9d.zip

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
72285-00372285-003-01

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
WATER059QF0KO0RIACT
ALOE VERA LEAFZY81Z83H0XIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
TROLAMINE9O3K93S3TKIACT

Source Document#

Source XML · Source PDF

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
2f78a161-800c-4ea2-87e0-91228655ad94932fb103-343d-434e-bfb1-e5a6b08b3e9d2020-04-23WarningsExact identifier
spl id: 2f78a161-800c-4ea2-87e0-91228655ad94
spl set id: 932fb103-343d-434e-bfb1-e5a6b08b3e9d

Reported adverse events (FAERS/openFDA)#

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