HAND SANITIZER- 75% alcohol liquid

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Jiangsu Doer biotechnology Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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:

1. Isopropyl Alcohol (75%, v/v) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
2. Glycerol (1.45% v/v).
3. Hydrogen peroxide (0.125% v/v).
4. Sterile distilled water or boiled cold water.

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Active Ingredient(s)

Alcohol 75% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

USE: for disinfection, sterilization. relief of prockly heat. insect bites, hygenic purposes and general antiseptic.

Warnings

For external use only. if taken internally serious gasric disturbances will result.

Flammable. Keep away from heat or flame. Use only in a well-ventilated area; fumes may be toxic.

Do not use

• in children less than 2 months of age
• on open skin wounds

WHEN USING

do not get into eyes.

do not apply over large areas of the body.

do not use longer than one week unless directed by a doctor

STOP USE

Stop use and ask a doctor if condition persists or gets worse. Keep out reach of children.

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.

Directions

Directions:

• clean affected area.
• apply small amount of this product on the area 1-3 times dailly.
• if bandaged let dry first.
• may be covered with a sterile bandage.

Other information

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

Inactive ingredients

glycerin, hydrogen peroxide, purified water USP

Package Label - Principal Display Panel

500 ml NDC: 55449-075-01

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
75% alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55449-075
Route of Administration	EXTRACORPOREAL

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)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55449-075-01	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/29/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	10/29/2021

Labeler - Jiangsu Doer biotechnology Co., Ltd (554529820)

Establishment
Name	Address	ID/FEI	Business Operations
Jiangsu Doer biotechnology Co., Ltd		554529820	manufacture(55449-075)