HAND SANITIZER- alcohol liquid

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by GUANGDONG HAOSHUN ODIS TECHNOLOGY COMPANY LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Information

This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations.

Active ingredient & Purpose

Antiseptic, Hand Sanitizer

• Actove ingredient: Purpose
• Alcohol 75% v/v ...............: Antiseptic

Use

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 or flame.

Do not use

• in 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 occurs. These may be signs of a serious condition.

Keep out of reach of children.

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

Directions

• place 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 15-30C (59-86F)
• avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

glycerin, chlorhexidine gluconate, purified water USP

Package Label - Principal Display Panel

180 mL NDC: 74895-104-01

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74895-104
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	75 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)	0.5 mL  in 100 mL
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)	2.5 mL  in 100 mL
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74895-104-01	180 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/05/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/05/2020

Labeler - GUANGDONG HAOSHUN ODIS TECHNOLOGY COMPANY LIMITED (547109432)