FDA.reportPublic FDA data

Smart Care Hand Sanitizer 2 oz

Manufacturer
Ashtel Studios, Inc
Effective date
2020-04-10
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:06:32

Label at a glance#

ProductSmart Care Hand Sanitizer 2 oz
Active ingredientALCOHOL
Label structure9 sections

Dosage and administration

Place enough product in palm to cover hands and rub hands together briskly until dry.  Children under 6, use only under adult supervision. Not recommended for infants.

Storage and handling

▪ Do not store above 100°F (38°C). ▪ May discolor some fabrics. ▪ Harmful to wood finishes and plastics.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 62%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

To help reduce bacteria and germs on the skin.

WARNING

WARNINGS SECTION

  • Flammable. Keep away from fire or flame. For external use only
  • Stop use and ask a doctor if irritation or redness develops and persists.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental digestion, seek professional assistance or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Place enough product in palm to cover hands and rub hands together briskly until dry. 
  • Children under 6, use only under adult supervision.
  • Not recommended for infants.

Other Information

STORAGE AND HANDLING SECTION

▪ Do not store above 100°F (38°C).

▪ May discolor some fabrics.

▪ Harmful to wood finishes and plastics.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

WATER (AQUA), ISOPROPYL ALCOHOL, GLYCERIN, CARBOMER, AMINOMETHYL PROPANOL, PARFUM, PROPYLENE GLYCOL, ISOPROPYL MYRISTATE, ALOE BARBADENSIS LEAF JUICE, TOCOPHERYL ACETATE, FD&C YELLOW NO. 5 (TARTRAZINE), FD&C BLUE NO. 1

SPL UNCLASSIFIED SECTION

KILLS UP TO 99.99% OF MOST COMMON GERMS

Aloe Vera & Vitamin E

FAST & EFFECTIVE

DESIGNED IN U.S.A. • MADE IN CHINA

QUESTIONS OR COMMENTS?

1-877-274-8358 Toll Free in USA. • 1-909-434-0911 International

COPYRIGHTS AND TRADEMARKS GRANTED OR PENDING WORLDWIDE

DISTRIBUTED BY ASHTEL STUDIOS INC. ONTARIO, CALIFORNIA 91761

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
70108-037-012024-01-30C16284748780-11030e365-599c-111a-e063-dadaa90a10e2Smart Care Hand SANITIZER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70108-037-01Smart Care Hand Sanitizer 2 oz59 mL in 1 BOTTLEGEL591

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70108-037SMART CARE HAND SANITIZER 2 OZ (ETHYL ALCOHOL) GEL [ASHTEL STUDIOS, INC]1Legacy NDC, 1 package rows20200416_f570fbfd-918f-4097-8f84-a63fdc043a7c.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70108-03770108-037-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
ISOPROPYL ALCOHOLND2M416302IACT
GLYCERINPDC6A3C0OXIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
AMINOMETHYLPROPANOLLU49E6626QIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
ALOE VERA LEAFZY81Z83H0XIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
FD&C YELLOW NO. 5I753WB2F1MIACT
FD&C BLUE NO. 1H3R47K3TBDIACT

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
67fd3d02-cddc-4565-8d25-2b82ed265774f570fbfd-918f-4097-8f84-a63fdc043a7c2020-04-10WarningsExact identifier
spl id: 67fd3d02-cddc-4565-8d25-2b82ed265774
spl set id: f570fbfd-918f-4097-8f84-a63fdc043a7c

Reported adverse events (FAERS/openFDA)#

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