FDA.reportPublic FDA data

Smart Care ® TRANSFORMERS HAND SANITIZER SPRAY

Manufacturer
Ashtel Studios, Inc.
Effective date
2025-05-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:02:08

Label at a glance#

ProductSmart Care TRANSFORMERS HAND SANITIZER
Active ingredientALCOHOL
Label structure10 sections

Indications and uses

Decreases bacteria on skin.

Dosage and administration

• Adults and children 6 years and olde r 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, get medical help or contact a Poison Control Center immediately.

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, Tocopheryl Acetate, Water

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free 1-877-274-8358

SPL UNCLASSIFIED SECTION

MORE THAN MEETS THE EYE

KILLS 99.9% OF GERMS*

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

TRANSFORMERS and all related characters are trademarks of Hasbro and are used with permission. ©2025 Hasbro. All Rights Reserved. Licensed by Hasbro.

DESIGNED IN U.S.A.
MANUFACTURED IN CHINA

SmartCare®
WWW.SMARTCAREUS.COM

1-909-434-0911 INTERNATIONAL

PATENTS, COPYRIGHTS AND TRADEMARKS GRANTED OR PENDING WORLDWIDE

DISTRIBUTED BY ASHTEL STUDIOS INC.
ONTARIO, CALIFORNIA 91761

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SCTransformers-3SCTransformers-3

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1041849ethanol 70 % Topical SprayPSN1
1041849ethanol 0.7 ML/ML Topical SpraySCD1
1041849ethanol 70 % Topical SpraySY1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70108-163-01Smart Care TRANSFORMERS HAND SANITIZER28 mL in 1 BOTTLE, SPRAYSPRAY281

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
70108-16370108-163-01

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
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S)8Z5ZAL5H3VIACT
ALOE VERA LEAFZY81Z83H0XIACT
AMINOMETHYLPROPANOLLU49E6626QIACT
DENATONIUM BENZOATE4YK5Z54AT2IACT
GLYCERINPDC6A3C0OXIACT
.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 TRANSFORMERS HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.d0a63ec5-c795-442f-8fdb-bbad8ba3e9c12025-05-29WarningsExact identifier
ndc (package): 70108-163-01
ndc (product): 70108-163
ndc11 (package): 70108016301
spl id: 9f9bc16e-fed9-4a55-b88e-94ddd60d0cd9
spl set id: d0a63ec5-c795-442f-8fdb-bbad8ba3e9c1

Reported adverse events (FAERS/openFDA)#

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