DISINFECTANT ALCOHOL liquid

DISINFECTANT ALCOHOL by

Drug Labeling and Warnings

DISINFECTANT ALCOHOL 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. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (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 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, DISINFECTANT ALCOHOL

Use

fist aid to help prevent prevent the risk of infection in minor cuts, scrapes, and burms.

Warnings

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 OF REACH OF CHILDREN

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

Directions

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

Other information

• store at room temperature
• does not contain, nor is intended as a substitute for grain or ethyl alcohol

Inactive ingredients

glycerin, hydrogen peroxide, purified water USP

Package Label - Principal Display Panel

NDC: 55449-005

INGREDIENTS AND APPEARANCE

DISINFECTANT ALCOHOL 
disinfectant alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55449-005
Route of Administration	EXTRACORPOREAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55449-005-01	3800 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
2	NDC: 55449-005-02	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
3	NDC: 55449-005-03	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/30/2020

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

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

Establishment
Name	Address	ID/FEI	Business Operations
Jiangsu Doer biotechnology Co., Ltd		554529820	manufacture(55449-005)