Smart Care WATERMELON HAND SANITIZER — v4

Smart Care WATERMELON HAND SANITIZER

6 Views

Version

v4

Effective date

September 24, 2025

Original packager

Yes

Sections captured

12

Identifiers

Document ID
6af54cc7-5c88-4700-b94f-bf353f486c9b
Set ID
dd40b8d2-7b6e-4bfc-8a52-a852c3ffe45b
Application numbers
505G(a)(3)
Product NDCs
70108-109
Package NDCs
70108-109-01, 70108-109-02
Original packager NDCs
—

Names & Manufacturers

Brand names
Smart Care WATERMELON HAND SANITIZER
Generic names
ETHYL ALCOHOL
Manufacturer names
Ashtel Studios Inc.
Product types
HUMAN OTC DRUG

Substances & Pharmacology

Substance names
ALCOHOL
Routes
TOPICAL
Pharmacologic class (PE)
—
Pharmacologic class (EPC)
—
Pharmacologic class (CS)
—
Mechanism of action
—

Other identifiers

NUI
—
RxCUI
1041849
UNII
3K9958V90M
UPC
0810147883530

Structured Label Sections

Active Ingredient (1)

Sequence 1

Active ingredient Ethyl Alcohol 70% v/v
Dosage And Administration (1)

Sequence 1

Directions • 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.
Inactive Ingredient (1)

Sequence 1

Inactive ingredients Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Gel, Aminomethyl Propanol, Denatonium Benzoate, Fragrance, Glycerin, Red 33, Tocopheryl Acetate, Water
Indications And Usage (1)

Sequence 1

Uses Decreases bacteria on skin.
Keep Out Of Reach Of Children (1)

Sequence 1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.
Package Label Principal Display Panel (1)

Sequence 1

Packaging WatermelonHandSanitizer
Purpose (1)

Sequence 1

Purpose Antiseptic
Questions (1)

Sequence 1

Questions or comments? Call toll free 1-877-274-8358
Spl Product Data Elements (1)

Sequence 1

Smart Care WATERMELON HAND SANITIZER Ethyl Alcohol ALCOHOL ALCOHOL ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S) ALOE VERA LEAF AMINOMETHYLPROPANOL DENATONIUM BENZOATE GLYCERIN D&C RED NO. 33 .ALPHA.-TOCOPHEROL ACETATE WATER
Spl Unclassified Section (2)

Sequence 1

Drug Facts

Sequence 2

SCENTED & POCKET-FRIENDLY KILLS UP TO 99.9% OF GERMS* A refreshing combination of juicy watermelon and crisp summer air. Indulge your senses and whisk away stress with each delicate spritz of our invigorating hand sanitizer. Every airy mist ensures clean and nourished skin, providing a refreshing experience with each use. The smell of crisp, juicy watermelon transports you to sun-soaked summer days. Fight germs and nourish your skin with an aloe-infused formula. Notes: Tea Leaves, Honeysuckle, Vetiver *Effective at killing 99.9% Escherichia coli, Staphylococcus aureus ​under laboratory settings Smart Care ® 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
Storage And Handling (1)

Sequence 1

Other information • Store between 15-30°C (59-86°F) • Avoid freezing and excessive heat above 40°C (104°F)
Warnings (1)

Sequence 1

Warnings: 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. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

OpenFDA raw payload

{'application_number': ['505G(a)(3)'],
 'brand_name': ['Smart Care WATERMELON HAND SANITIZER'],
 'generic_name': ['ETHYL ALCOHOL'],
 'is_original_packager': [True],
 'manufacturer_name': ['Ashtel Studios Inc.'],
 'package_ndc': ['70108-109-01', '70108-109-02'],
 'product_ndc': ['70108-109'],
 'product_type': ['HUMAN OTC DRUG'],
 'route': ['TOPICAL'],
 'rxcui': ['1041849'],
 'spl_id': ['6af54cc7-5c88-4700-b94f-bf353f486c9b'],
 'spl_set_id': ['dd40b8d2-7b6e-4bfc-8a52-a852c3ffe45b'],
 'substance_name': ['ALCOHOL'],
 'unii': ['3K9958V90M'],
 'upc': ['0810147883530']}