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Smart Care Barbie Coastal Breeze Scent HAND SANITIZER

Smart Care Barbie Coastal Breeze Scent HAND SANITIZER

Approved
Approval ID

4a2c95de-f858-40b6-b7b6-155318ff9d87

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Jun 16, 2025

Manufacturers
FDA

Ashtel Studios, Inc.

DUNS: 148689180

Products 1

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

Ethyl Alcohol

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code70108-184
Application Number505G(a)(3)
Product Classification
M
Marketing Category
C200263
G
Generic Name
Ethyl Alcohol
Product Specifications
Route of AdministrationTOPICAL
Effective DateJune 16, 2025
FDA Product Classification

INGREDIENTS (11)

ALCOHOLActive
Quantity: 70 mL in 100 mL
Code: 3K9958V90M
Classification: ACTIB
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S)Inactive
Code: 8Z5ZAL5H3V
Classification: IACT
ALOE VERA LEAFInactive
Code: ZY81Z83H0X
Classification: IACT
AMINOMETHYLPROPANOLInactive
Code: LU49E6626Q
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
DENATONIUM BENZOATEInactive
Code: 4YK5Z54AT2
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
POLYOXYL 40 HYDROGENATED CASTOR OILInactive
Code: 7YC686GQ8F
Classification: IACT
D&C RED NO. 33Inactive
Code: 9DBA0SBB0L
Classification: IACT
.ALPHA.-TOCOPHEROL ACETATEInactive
Code: 9E8X80D2L0
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 6/20/2025

Packaging

SCBarbieCoastalBreezeScent-3

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 6/16/2025

Uses

Decreases bacteria on skin.

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 6/20/2025

MATTEL

KILLS UP TO 99.9% OF GERMS*

MIST + SILICONE CASE

SCENTED & POCKET**-FRIENDLY**

SmartCare**®**** SMARTCAREUS.COM**
1-909-434-0911 INTERNATIONAL

COPYRIGHTS AND TRADEMARKS GRANTED OR PENDING WORLDWIDE

DISTRIBUTED BY ASHTEL STUDIOS INC.
ONTARIO, CALIFORNIA 91761

barbie.com

BARBIE™ and associated trademarks and trade dress are owned by, and used under license from, Mattel.
©2025 Mattel.

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

MADE IN CHINA

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 6/16/2025

Active ingredient

Ethyl Alcohol 70% v/v

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 6/16/2025

Purpose

Antiseptic

WARNINGS SECTION

LOINC: 34071-1Updated: 6/18/2025

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 continuous for more than 72 hours.

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

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 6/16/2025

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.

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 6/18/2025

Other information

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

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 6/16/2025

Inactive ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Gel, Aminomethyl Propanol, Blue 1, Denatonium Benzoate, Fragrance, Glycerin, PEG-40 Hydrogenated Castor Oil, Red 33, Tocopheryl Acetate, Water

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 6/16/2025

Questions or comments?

Call toll free** 1-877-274-8358**

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Smart Care Barbie Coastal Breeze Scent HAND SANITIZER - FDA Drug Approval Details