Smart Care HAND SANITIZER PASSION FRUIT

Basic Information

Product Name

FDA Product Code

70108-145

Regulatory Information

NDC Product Code

70108-145

Application Number

505G(a)(3)

Marketing Category

C200263

Effective Date

April 17, 2025

Territorial Authority

USA

FDA Title

Smart CareHAND SANITIZER

Labeling Type

HUMAN OTC DRUG LABEL

Version Number

Active Ingredients

ALCOHOL

Quantity: 70 mL in 100 mL

Code: 3K9958V90M

Class Code: ACTIB

Inactive Ingredients

ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S)

Code: 8Z5ZAL5H3V

Class Code: IACT

ALOE VERA LEAF

Code: ZY81Z83H0X

Class Code: IACT

AMINOMETHYLPROPANOL

Code: LU49E6626Q

Class Code: IACT

DENATONIUM BENZOATE

Code: 4YK5Z54AT2

Class Code: IACT

GLYCERIN

Code: PDC6A3C0OX

Class Code: IACT

POLYOXYL 40 HYDROGENATED CASTOR OIL

Code: 7YC686GQ8F

Class Code: IACT

FD&C RED NO. 4

Code: X3W0AM1JLX

Class Code: IACT

.ALPHA.-TOCOPHEROL ACETATE

Code: 9E8X80D2L0

Class Code: IACT

WATER

Code: 059QF0KO0R

Class Code: IACT

FD&C YELLOW NO. 5

Code: I753WB2F1M

Class Code: IACT

Active Moieties

ALCOHOL

Code: 3K9958V90M

Basic Information

Regulatory Information

Company Information

Active Ingredients

Inactive Ingredients

ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S)

ALOE VERA LEAF

AMINOMETHYLPROPANOL

DENATONIUM BENZOATE

GLYCERIN

POLYOXYL 40 HYDROGENATED CASTOR OIL

FD&C RED NO. 4

.ALPHA.-TOCOPHEROL ACETATE

WATER

FD&C YELLOW NO. 5

Active Moieties

ALCOHOL