FDA.reportPublic FDA data

Smart Care Hand Sanitizer 2 oz

Manufacturer
Ashtel Studios, Inc
Effective date
2020-04-23
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:08:43

Label at a glance#

ProductSmart Care Hand Sanitizer 2 oz
Active ingredientALCOHOL
Label structure10 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. 

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

• Keep out of reach of children. • 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), GLYCERIN, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, AMINOMETHYLPROPANOL, TOCOPHERYL ACETATE, ALOE BARBADENSIS LEAF JUICE, MALTODEXTRIN, POTASSIUM SORBATE, SODIUM BENZOATE, CI 42090, CI 19140

QUESTIONS OR COMMENTS?

OTC - QUESTIONS SECTION

1-877-274-8358 Toll Free in USA

1-909-434-0911 International

SPL UNCLASSIFIED SECTION

KILLS UP TO 99.9% OF MOST COMMON GERMS 

Aloe Vera & Vitamin E 

FAST & EFFECTIVE

COPYRIGHTS AND TRADEMARKS GRANTED OR PENDING WORLDWIDE

DISTRIBUTED BY ASHTEL STUDIOS INC. ONTARIO, CALIFORNIA 91761

DESIGNED IN U.S.A. • MADE IN CHINA

Packaging 

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Hsntzr51Hsntzr51

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
70108-051-012022-01-28C16284748780-1d6a99b39-a4a4-a426-e053-dadaa90af4c2Smart Care ® Hand SANITIZER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70108-051-01Smart Care Hand Sanitizer 2 oz59 mL in 1 BOTTLEGEL591

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70108-051SMART CARE HAND SANITIZER 2 OZ (ETHYL ALCOHOL) GEL [ASHTEL STUDIOS, INC]1Legacy NDC, 1 package rows20200429_bc09e23f-7824-4db5-bd16-35a5070ff20b.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
70108-05170108-051-01

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
GLYCERINPDC6A3C0OXIACT
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
AMINOMETHYLPROPANOLLU49E6626QIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
ALOE VERA LEAFZY81Z83H0XIACT
MALTODEXTRIN7CVR7L4A2DIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
SODIUM BENZOATEOJ245FE5EUIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C YELLOW NO. 5I753WB2F1MIACT

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
6d8bdc0d-87f4-4ff8-a369-18c6300c7290bc09e23f-7824-4db5-bd16-35a5070ff20b2020-04-23WarningsExact identifier
spl id: 6d8bdc0d-87f4-4ff8-a369-18c6300c7290
spl set id: bc09e23f-7824-4db5-bd16-35a5070ff20b

Reported adverse events (FAERS/openFDA)#

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