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MISTIFY HAND SANITIZER PEACH

MISTIFY HAND SANITIZER PEACH

Approved
Approval ID

3b104177-be18-8b50-e063-6394a90a3b39

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Jul 29, 2025

Manufacturers
FDA

Kingkey MBC Life Technology Group Co.,Ltd

DUNS: 545349263

Products 1

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

Alcohol antiseptic

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code73928-099
Application NumberM003
Product Classification
M
Marketing Category
C200263
G
Generic Name
Alcohol antiseptic
Product Specifications
Route of AdministrationTOPICAL
Effective DateJuly 29, 2025
FDA Product Classification

INGREDIENTS (5)

FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
ALCOHOLActive
Quantity: 62 mL in 100 mL
Code: 3K9958V90M
Classification: ACTIB
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 1/1/2025

label

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 2/1/2025

Users

Hand Sanitizer to help reduce bacteria that potentially can cause disease.

For use when soap and water are not available.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 2/1/2025

Active ingredient

Alcohol 62% ------------------------------- Antibacterial

OTC - PURPOSE SECTION

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

Purpose

Uses

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available

WARNINGS SECTION

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

Warnings

Flammable. Keep away from fire or flame.

For external use only.

Do not use it

near eye area. In case of contact, rinse eyes thoroughly with water.

Stop use and****ask a doctor if irritation or rash appears and lasts.

Keep out of reach of children.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 1/1/2025

Directions

■ Apply into hand and thoroughly spreadon both hands, rub until dry.

■ Supervise children under 6 years of age when using this product to avoid swallowing

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 2/1/2025

Inactives ingredient

Water
GLYCERIN
FRAGRANCE
FD&C Yellow No.6(CI 15985)
FD&C Red No.40(CI 16035)

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 2/1/2025

Other information

■ Store between 15 - 30°C ( 59 - 86°F )

■ Avoid freezing and excessive heat above 40°C (104°F )

Questions or comments?

call toll free 212-68906008

RECENT MAJOR CHANGES SECTION

LOINC: 43683-2Updated: 6/13/2024

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MISTIFY HAND SANITIZER PEACH - FDA Drug Approval Details