STEREZE TM Hand Sanitizer Antiseptic Presaturated Wipes

STEREZE Hand Sanitizer Antiseptic Presaturated Wipes by

Drug Labeling and Warnings

STEREZE Hand Sanitizer Antiseptic Presaturated Wipes by is a Otc medication manufactured, distributed, or labeled by Microcare LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

STEREZE HAND SANITIZER ANTISEPTIC PRESATURATED WIPES- ethyl alcohol cloth 
Microcare LLC

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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STEREZETM Hand Sanitizer Antiseptic Presaturated Wipes

Drug Facts

Active ingredient

Ethyl alcohol 80% v/v

Purpose

Antiseptic

Uses

hand wipes to decrease bacteria on the skin  for use when soap and water are not available

Warnings

Flammable, keep away from fire/flame
For external use only

Do not use  in children less than 2 months of age  on open skin wounds

When using this product do not get into eyes, ears and mouth. In case of contact, rinse eyes thoroughly with water

Stop use and ask a doctor if  irritation and redness develop  condition persists for more than 72 hours

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

Directions

Unfold a clean wipe and thoroughly wet hands  allow skin to air dry  discard used wipe  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

Questions? +1-860-827-0626

You may also report serious side effects to this phone number. Mon-Fri 9:00 AM - 5:00 PM

Non-Sterile Solution

Made in USA

MicroCare.com

Manufactured by: MicroCare, LLC

595 John Downey Dr., New Britain, CT 06051

Stereze™ is a trademark or registered trademark of MicroCare, LLC.

Packaging

STEREZE HAND SANITIZER ANTISEPTIC PRESATURATED WIPES 
ethyl alcohol cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81141-005
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)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81141-005-50	50 in 1 BOX	12/22/2020	12/31/2021
1	NDC: 81141-005-01	1 in 1 PACKET
1		2.6 mL in 1 PACKAGE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	12/22/2020	12/31/2021

Labeler - Microcare LLC (144922879)

Establishment
Name	Address	ID/FEI	Business Operations
Microcare LLC		144922879	manufacture(81141-005)

Revised: 11/2021

Document Id: ce8eced8-9ed4-474b-8bca-d2a62fe7b0cd

34390-5

Set id: c4deb9c4-9de4-4387-a270-fded8b6a7d1b

Version: 2

Effective Time: 20211111