MedPath

Hand sanitizer

77975-016

Approved
Approval ID

358cb0c6-a07f-120e-e063-6294a90a167e

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 20, 2025

Manufacturers
FDA

Guangzhou Tingcai Cosmetic Co., Ltd.

DUNS: 529562889

Products 1

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

Hand sanitizer spray

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code77975-016
Application Number505G(a)(3)
Product Classification
M
Marketing Category
C200263
G
Generic Name
Hand sanitizer spray
Product Specifications
Route of AdministrationTOPICAL
Effective DateMay 20, 2025
FDA Product Classification

INGREDIENTS (8)

WATERInactive
Code: 059QF0KO0R
Classification: IACT
CLOVEInactive
Code: K48IKT5321
Classification: IACT
ALOE VERA LEAF OILInactive
Code: JQ7YW886UQ
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
RED 33Inactive
Code: 9DBA0SBB0L
Classification: IACT
YELLOW 6Inactive
Code: H77VEI93A8
Classification: IACT
ALPHA-TOCOPHEROL ACETATEInactive
Code: 9E8X80D2L0
Classification: IACT
ALCOHOLActive
Quantity: 70 g in 100 mL
Code: 3K9958V90M
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 5/20/2025

Package Label - Principal Display Panel

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INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 5/20/2025

Use

■Hand sanitizer to decrease bacteria on the skin

■Recommended for repeated use.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 5/20/2025

Directions

■Spray enough product in your palm to thoroughly cover your hands.

■Rub hands together briskly 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: 5/20/2025

Other information

■Protect the product in this container from excessive heat and direct sun.
■Store below 104°F (40°C)

■ May discolor certain fabrics.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 5/20/2025

Inactive ingredients

Water, Fragrance, Aloe Barbadensis Leaf Water, Glycerin, TocopheryI Acetate, Yellow 6 (CI 15985), Red 33(CI 17200)

RECENT MAJOR CHANGES SECTION

LOINC: 43683-2Updated: 5/20/2025

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 5/20/2025

Stop use and ask a doctor if rritation and rash occurs. These may be signs of serious
condition.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 5/20/2025

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control
Center right away.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 5/20/2025

Active Ingredient(s)

ETHYL ALCOHOL 70%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 5/20/2025

Purpose

Antiseptic

WARNINGS SECTION

LOINC: 34071-1Updated: 5/20/2025

Warnings

For external use only.
Flammable, keep away from fire or flame.

OTC - DO NOT USE SECTION

LOINC: 50570-1Updated: 5/20/2025

Do not use

Do not use on open skin wounds.

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 5/20/2025

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes,
rinse eyes thoroughly with water. Avoid contact with broken skin.

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Hand sanitizer - FDA Drug Approval Details