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Smart Care Sweet Pea HAND SANITIZER

Smart Care

Approved
Approval ID

a67aef1b-c0b2-4626-b89b-58a6b56efe1c

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Apr 10, 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 Code70108-120
Application Number505G(a)(3)
Product Classification
M
Marketing Category
C200263
G
Generic Name
Ethyl Alcohol
Product Specifications
Route of AdministrationTOPICAL
Effective DateApril 10, 2025
FDA Product Classification

INGREDIENTS (12)

GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
POLYOXYL 40 HYDROGENATED CASTOR OILInactive
Code: 7YC686GQ8F
Classification: IACT
FD&C RED NO. 4Inactive
Code: X3W0AM1JLX
Classification: IACT
D&C RED NO. 33Inactive
Code: 9DBA0SBB0L
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ALCOHOLActive
Quantity: 70 mL in 100 mL
Code: 3K9958V90M
Classification: ACTIB
AMINOMETHYLPROPANOLInactive
Code: LU49E6626Q
Classification: IACT
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S)Inactive
Code: 8Z5ZAL5H3V
Classification: IACT
ALOE VERA LEAFInactive
Code: ZY81Z83H0X
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
DENATONIUM BENZOATEInactive
Code: 4YK5Z54AT2
Classification: IACT
.ALPHA.-TOCOPHEROL ACETATEInactive
Code: 9E8X80D2L0
Classification: IACT

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Smart Care Sweet Pea HAND SANITIZER - FDA Drug Approval Details