FDA.reportPublic FDA data

Smart Care

Manufacturer
Ashtel Studios, Inc.
Effective date
2026-04-17
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:55:16

Label at a glance#

ProductSmart Care APPLE HAND SANITIZER
Active ingredientALCOHOL
Label structure10 sections

Indications and uses

Decreases bacteria on skin.

Dosage and administration

• Adults and children 6 years and older   Spray onto hands and rub them together until dry. Recommended for repeated use. • Children under 6 years of age   Should be supervised when using this product.

Storage and handling

• Store between 15-30°C (59-86°F) • Avoid freezing and excessive heat above 40°C (104°F)

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

Decreases bacteria on skin.

Warnings

WARNINGS SECTION

For external use only

Flammable, keep away from fire or flame.

Do not use
• If you are allergic to any of the ingredients.

When using this product • Do not get into eyes. If contact occurs, rinse thoroughly with water.

Stop use and ask a doctor • If irritation or rash develops and continues for more than 72 hours.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, call Poison Help at 1-800-222-1222 or go to PoisonHelp.org.

Directions

DOSAGE & ADMINISTRATION SECTION

• Adults and children 6 years and older
  Spray onto hands and rub them together until dry. Recommended for repeated use.

• Children under 6 years of age
  Should be supervised when using this product.

Other information

STORAGE AND HANDLING SECTION

• Store between 15-30°C (59-86°F)
• Avoid freezing and excessive heat above 40°C (104°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Gel, Aminomethyl Propanol, Denatonium Benzoate, Fragrance, Glycerin, PEG-40 Hydrogenated Castor Oil, Red 4, Red 33, Tocopheryl Acetate, Water

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free 1-877-274-8358

SPL UNCLASSIFIED SECTION

SCENTED & POCKET-FRIENDLY

KILLS UP TO 99.9%* OF GERMS

*Effective at killing 99.9% Escherichia coli, Staphylococcus aureus under laboratory settings

MADE IN CHINA

DISTRIBUTED BY:
ASHTEL STUDIOS, INC. • ONTARIO, CALIFORNIA 91761

Smart Care® SMARTCAREUS.COM
1-909-434-0911 INTERNATIONAL

COPYRIGHTS AND TRADEMARKS GRANTED OR PENDING WORLDWIDE

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SCAPPLEHANDSANITIZERSCAPPLEHANDSANITIZER

SCAPPLEHANDSANITIZERSCAPPLEHANDSANITIZER

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1041849ethanol 70 % Topical SprayPSN2
1041849ethanol 0.7 ML/ML Topical SpraySCD2
1041849ethanol 70 % Topical SpraySY2

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130810147884735GTIN-13: 0810147884735
EAN-13: 0810147884735
GTIN-12: 810147884735
UPC-A: 810147884735
GTIN storage (14 digits): 00810147884735		70108126-10.jpg
BarcodeEAN-130810216261108GTIN-13: 0810216261108
EAN-13: 0810216261108
GTIN-12: 810216261108
UPC-A: 810216261108
GTIN storage (14 digits): 00810216261108		70108126-9.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70108-126-01Smart Care APPLE HAND SANITIZER40 mL in 1 BOTTLE, SPRAYSPRAY402
70108-126-01Smart Care APPLE HAND SANITIZER1 in 1 POUCHSPRAY12
70108-126-02Smart Care APPLE HAND SANITIZER44.4 mL in 1 BOTTLE, SPRAYSPRAY44.42

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70108-12670108-126-01, 70108-126-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S)8Z5ZAL5H3VIACT
ALOE VERA LEAFZY81Z83H0XIACT
AMINOMETHYLPROPANOLLU49E6626QIACT
DENATONIUM BENZOATE4YK5Z54AT2IACT
GLYCERINPDC6A3C0OXIACT
POLYOXYL 40 HYDROGENATED CASTOR OIL7YC686GQ8FIACT
FD&C RED NO. 4X3W0AM1JLXIACT
D&C RED NO. 339DBA0SBB0LIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
WATER059QF0KO0RIACT

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
Smart Care APPLE HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.3a377d37-28c3-4cd6-8633-8b13464a28ef2026-04-17WarningsExact identifier
ndc (package): 70108-126-01
ndc (package): 70108-126-02
ndc (product): 70108-126
ndc11 (package): 70108012602
ndc11 (package): 70108012601
spl id: 06623af3-576d-4648-8be8-4f20241ecf8d
spl set id: 3a377d37-28c3-4cd6-8633-8b13464a28ef

Reported adverse events (FAERS/openFDA)#

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