FDA.reportPublic FDA data

Smart Care PASSION PARADISE HAND SANITIZER

Manufacturer
Ashtel Studios Inc.
Effective date
2026-01-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:34:43

Label at a glance#

ProductSmart Care PASSION PARADISE 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, Tocopheryl Acetate, Water, Yellow 5

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*

SmartCare®
SMARTCAREUS.COM

1-909-434-0911 INTERNATIONAL

PATENTS, COPYRIGHTS AND TRADEMARKS GRANTED OR PENDING WORLDWIDE

DISTRIBUTED BY ASHTEL STUDIOS INC. ONTARIO, CALIFORNIA 91761

MADE IN CHINA

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

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Smart Care PASSION PARADISE HSSmart Care PASSION PARADISE HS

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130810147889990GTIN-13: 0810147889990
EAN-13: 0810147889990
GTIN-12: 810147889990
UPC-A: 810147889990
GTIN storage (14 digits): 00810147889990		70108297-2.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70108-297-01Smart Care PASSION PARADISE HAND SANITIZER40 mL in 1 BOTTLE, SPRAYSPRAY401
70108-297-01Smart Care PASSION PARADISE HAND SANITIZER1 in 1 POUCHSPRAY11

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
70108-29770108-297-01

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
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
WATER059QF0KO0RIACT
FD&C YELLOW NO. 5I753WB2F1MIACT

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 PASSION PARADISE HAND SANITIZERETHYL ALCOHOLAshtel Studios Inc.f6819964-c426-427b-bdff-40cfb1a758c42026-01-16WarningsExact identifier
ndc (package): 70108-297-01
ndc (product): 70108-297
ndc11 (package): 70108029701
spl id: 4e0acd6a-d10c-4725-87c6-57bb2b46940b
spl set id: f6819964-c426-427b-bdff-40cfb1a758c4

Reported adverse events (FAERS/openFDA)#

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