MedPath
FDA Approval

Smart Care HAND SANITIZER SWEET CITRUS

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Ashtel Studios, Inc.
DUNS: 148689180
Effective Date
April 16, 2025
Labeling Type
HUMAN OTC DRUG LABEL
Ethanol(70 mL in 100 mL)

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Smart Care HAND SANITIZER SWEET CITRUS

Product Details

NDC Product Code
70108-144
Application Number
505G(a)(3)
Marketing Category
OTC Monograph Drug (C200263)
Route of Administration
TOPICAL
Effective Date
April 16, 2025
EthanolActive
Code: 3K9958V90MClass: ACTIBQuantity: 70 mL in 100 mL
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S)Inactive
Code: 8Z5ZAL5H3VClass: IACT
ALOE VERA LEAFInactive
Code: ZY81Z83H0XClass: IACT
AMINOMETHYLPROPANOLInactive
Code: LU49E6626QClass: IACT
DENATONIUM BENZOATEInactive
Code: 4YK5Z54AT2Class: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
POLYOXYL 40 HYDROGENATED CASTOR OILInactive
Code: 7YC686GQ8FClass: IACT
FD&C RED NO. 4Inactive
Code: X3W0AM1JLXClass: IACT
.ALPHA.-TOCOPHEROL ACETATEInactive
Code: 9E8X80D2L0Class: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
FD&C YELLOW NO. 5Inactive
Code: I753WB2F1MClass: IACT

Drug Labeling Information

Complete FDA-approved labeling information including indications, dosage, warnings, contraindications, and other essential prescribing details.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Packaging

SWEETCITRUSSANITIZER-1


INDICATIONS & USAGE SECTION

Uses

Decreases bacteria on skin.

DOSAGE & ADMINISTRATION SECTION

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.


WARNINGS SECTION

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.


STORAGE AND HANDLING SECTION

Other information

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


OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Ethyl Alcohol 70% v/v

OTC - PURPOSE SECTION

Purpose

Antiseptic

OTC - QUESTIONS SECTION

Questions or comments?

Call toll free1-877-274-8358


SPL UNCLASSIFIED SECTION

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

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

COPYRIGHTS AND TRADEMARKS GRANTED OR PENDING WORLDWIDE

DISTRIBUTED BY**ASHTEL STUDIOS, INC.**
ONTARIO CALIFORNIA 91761

INACTIVE INGREDIENT SECTION

Inactive ingredients

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


© Copyright 2025. All Rights Reserved by MedPath