Hand Sanitizer Non-Sterile Solution

Hand Sanitizer Non Sterile by

Drug Labeling and Warnings

Hand Sanitizer Non Sterile by is a Otc medication manufactured, distributed, or labeled by PERSE BEAUTY INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HAND SANITIZER NON STERILE- alcohol solution 
PERSE BEAUTY 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.

----------

Hand Sanitizer Non-Sterile Solution

Drug Facts

Active ingredient[s]

Alcohol 80%v/v

Purpose

Antiseptic

Use[s]

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. 

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 Labeling:

HAND SANITIZER NON STERILE 
alcohol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80031-000
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: 80031-000-01	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/22/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	06/22/2020

Labeler - PERSE BEAUTY INC (080898563)

Revised: 9/2020

Document Id: aef7843a-8948-cfc1-e053-2a95a90ab045

34390-5

Set id: aef78707-3bbd-5628-e053-2a95a90a9140

Version: 1

Effective Time: 20200910