INSTANT HAND SANITIZER- alcohol gel

Instant Hand Sanitizer by

Drug Labeling and Warnings

Instant Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by ZHEJIANG SHUNAN INDUSTRY&TRADE CO.,LTD, ZHEJIANG SHUNAN INDUSTRY & TRADE 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 75% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

to decrease bacteria on the skin, only when water is not available.

Warnings

• Flammable. Keep away from fire and flame.
• For external use only.

Do not use

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

WHEN USING

When using this product . Do not get into eyes. If contact occurs, rinse eyes thoroughly with water. May discolor some fabrics.

STOP USE

Stop use and ask a doctor if

• Irritation or redness develop
• Keep out of reach of children
• If swallowed. get medical help or contact a Poison Control Center right away.

KEEP OUT OF REACH OF CHILDREN

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

Directions

• wet hands thoroughly with product and allow to dry without wiping.

Other information

• Store below 105℉

Inactive ingredients

Water,Carbomer, Triethanolamine, Glycerol

Package Label - Principal Display Panel

59.1 mL in 1 Bottle NDC: 75556-591-01

INGREDIENTS AND APPEARANCE

INSTANT HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75556-591
Route of Administration	EXTRACORPOREAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	44.325 mL  in 59.1 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
TROLAMINE (UNII: 9O3K93S3TK)

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75556-591-01	59.1 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/20/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/20/2020

Labeler - ZHEJIANG SHUNAN INDUSTRY&TRADE CO.,LTD (528198838)

Registrant - ZHEJIANG SHUNAN INDUSTRY&TRADE CO.,LTD (528198838)

Establishment
Name	Address	ID/FEI	Business Operations
ZHEJIANG SHUNAN INDUSTRY & TRADE CO., LTD		528198838	manufacture(75556-591)