HAND SANITIZER- alcohol gel

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Guangzhou Danting Bath&Body Care Industry Co. Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients[s]

Alcohol 75% v/v

Purpose

Antiseptic

Use[s]:

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

Warnings

For external use only. Flammable. Keep away from heat and flame.

Do not use 

• On children less than 2 months of age
• On open skin wounds

When using this product:

Keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor:

If irritation or rash or occur. These may be signs of a serious condition.

Keep out of reach of children:

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

Directions

• Put enough product on hands to cover all surfaces. Rub hands together until dry.
• Supervise children under 6 years of age when using this product to avoid swallowing.

Other Information

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

Inactive ingredients

Deionized water, Glycerin, Fragrance, Benzalkonium chloride, Hydroxyethyl cellulose

Package Labeling

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75376-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.75 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75376-002-00	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/15/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	05/15/2020

Labeler - Guangzhou Danting Bath&Body Care Industry Co. Ltd. (545337886)

Establishment
Name	Address	ID/FEI	Business Operations
Guangzhou Danting Bath&Body Care Industry Co. Ltd.		545337886	manufacture(75376-002)