INSTANT HAND SANITIZER liquid

INSTANT HAND SANITIZER by

Drug Labeling and Warnings

INSTANT HAND SANITIZER by is a Otc medication manufactured, distributed, or labeled by Dongyang Medical & Hygienic Articles 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, Hand Sanitizer

Use

• to decrease bacteria on the skin that could cause disease.
• recommended for repeated use.

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

When using this product:

• keep out of eyes. In case of contact with eyes, flush thoroughly with water.

• avoid contact with broken skin
• do not inhale or ingest.

STOP USE

Stop use and ask a doctor:

• if irritation or redness develops.
• condition persists for more than 72 hours.

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

• 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

Inactive ingredients

purified water,Propylene Glycol,Glycerin, CARBOMER, AMINOMETHYL PROPANOL

Package Label - Principal Display Panel

100 mL NDC: 81276-004-01

INGREDIENTS AND APPEARANCE

INSTANT HAND SANITIZER 
instant hand sanitizer liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81276-004
Route of Administration	TOPICAL

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
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code	DureSafety
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81276-004-01	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/06/2020

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

Labeler - Dongyang Medical & Hygienic Articles Co., Ltd. (530310429)

Registrant - Dongyang Medical & Hygienic Articles Co., Ltd. (530310429)

Establishment
Name	Address	ID/FEI	Business Operations
Dongyang Medical & Hygienic Articles Co., Ltd.		530310429	manufacture(81276-004)