HAND SANITIZER- alcohol liquid

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by SynCardia Systems, LLC. 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.

World Health Organization (WHO) recommended Handrub Formulation

Active Ingredient(s)

Alcohol 80% v/v. Purpose: Antiseptic

Purpose

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. Avoid contact with eyes, ears and mouth.

Keep out of reach of children.

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

Stop use and ask a doctor if irritation or rash occurs.

Do not use

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

Keep out of reach of children

Keep out of reach of children

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.

Storage

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

Inactive ingredients

distilled water, glycerin, hydrogen peroxide

Package Label - Principal Display Panel

3.78L NDC: 74681-541-01

946.353ml NDC: 74681-541-02

118.294ml NDC: 74681-541-04

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74681-541
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	80 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)	1.45 mL  in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V)	0.125 mL  in 100 mL
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74681-541-01	3785.41 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/06/2020
2	NDC: 74681-541-02	946.353 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	04/17/2020
3	NDC: 74681-541-04	118.294 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	04/17/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/06/2020

Labeler - SynCardia Systems, LLC (080414145)

Registrant - SynCardia Systems, LLC (080414145)

Establishment
Name	Address	ID/FEI	Business Operations
SynCardia Systems, LLC		080414145	manufacture(74681-541)