University of Miami Hand Sanitizer Spray - 80% Alcohol

University of Miami Hand Sanitizer by

Drug Labeling and Warnings

University of Miami Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Kira Labs Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

UNIVERSITY OF MIAMI HAND SANITIZER- alcohol spray 
Kira Labs Inc

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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University of Miami Hand Sanitizer Spray - 80% Alcohol

Drug Facts

Active ingredient

Alcohol 80% v/v

Purpose

Antiseptic

Use(s)

• Hand Sanitizer to help reduce bacteria that potentially can cause disease.
• For use when soap & water are not available.

Warnings

For external use only. Flammable. Keep away from fire 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 immediately.

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° - 30°C (59° - 86°F)

Avoid freezing and excessive heat above 40°C (104°F)

Inactive ingredients

glycerin, hydrogen peroxide, purified water USP

Package Labeling:

UNIVERSITY OF MIAMI HAND SANITIZER 
alcohol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77816-504
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.8 mL  in 1 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77816-504-02	240 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2020	06/30/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	05/01/2020	06/30/2022

Labeler - Kira Labs Inc (132579397)

Revised: 7/2021

Document Id: c6eee693-4a11-67f2-e053-2995a90a0c37

34390-5

Set id: afeba6dc-11d7-2cd2-e053-2a95a90adf48

Version: 2

Effective Time: 20210712