HAND SANITIZER- alcohol liquid
Star Union Spirits

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Star Union Spirits

Alcohol Antiseptic 80%
Topical Solution
Antiseptic Hand Sanitizer
Non-sterile Solution
NOT FOR HUMAN CONSUMPTION
Produced in accordance with World Health Organization
(WHO) Guidelines.
These guidelines do not currently permit the use of a thickening agent.

NOT FOR RE-SALE

Bottled

Batch#

Active Ingredient(s)

Alcohol 80% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

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

Do not use

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

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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

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

3.78 L NDC: 74260-001-01

See attached SUS-Gallon-Label 4-2-2020.jpg for Package Label and Drug Facts

Label Image

HAND SANITIZER
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:74260-001
Route of Administration	TOPICAL

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

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:74260-001-01	3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/30/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	03/30/2020	11/20/2021

Labeler - Star Union Spirits (116377204)

Registrant - Star Union Spirits (116377204)

Name	Address	ID/FEI	Business Operations
Establishment
Star Union Spirits		116377204	manufacture(74260-001)

Revised: 11/2021

Document Id: d0715606-59cf-26e1-e053-2a95a90a088b

Set id: a256329e-386f-2a01-e053-2a95a90a18d7

Version: 8

Effective Time: 20211110

Star Union Spirits