FDA.reportPublic FDA data

Smart Care WATERMELON HAND SANITIZER

Manufacturer
Ashtel Studios Inc.
Effective date
2024-08-07
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:18:26

Label at a glance#

ProductSmart Care WATERMELON HAND SANITIZER
Active ingredientALCOHOL
Label structure10 sections

Indications and uses

Decreases bacteria on skin

Dosage and administration

• Adults and children 6 years and older    Apply the spray to your hands and rub them together until dry. Recommended for repeated use. • Children under 6 years of age    Supervision recommended when using this product.

Storage and handling

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

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

Flammability. 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
   Apply the spray to your hands and rub them together until dry. Recommended for repeated use.
• Children under 6 years of age
   Supervision recommended when using this product.

Other Information

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Gel, Aminomethyl Propanol, Denatonium Benzoate, Fragrance, Glycerin, 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% OF GERMS*

MADE IN CHINA

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

*Effective at killing 99.9% Escherichia coli, Staphylococcus aureus.

Smart Care® SMARTCAREUS.COM
COMMENTS? / QUESTIONS? / COMMENTAIRES?
1-909-434-0911 INTERNATIONAL

PATENTS, COPYRIGHTS AND TRADEMARKS GRANTED OR PENDING WORLDWIDE

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

WatermelonSanitizer-097WatermelonSanitizer-097

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
70108-097-01Smart Care WATERMELON HAND SANITIZER40 mL in 1 BOTTLE, SPRAYSPRAY401
70108-097-01Smart Care WATERMELON HAND SANITIZER1 in 1 POUCHSPRAY11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70108-097SMART CARE WATERMELON HAND SANITIZER (ETHYL ALCOHOL) SPRAY [ASHTEL STUDIOS INC.]1Current NDC, 2 package rows20240901_dc2c772b-4bd4-4a5f-b89d-ad2ca36574e0.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70108-09770108-097-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 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
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 WATERMELON HAND SANITIZERETHYL ALCOHOLAshtel Studios Inc.dc2c772b-4bd4-4a5f-b89d-ad2ca36574e02024-08-07WarningsExact identifier
ndc (package): 70108-097-01
ndc (product): 70108-097
ndc11 (package): 70108009701
spl id: f94b4730-97a2-4214-9990-61658d48ce7e
spl set id: dc2c772b-4bd4-4a5f-b89d-ad2ca36574e0

Reported adverse events (FAERS/openFDA)#

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