STEREZE TM Antiseptic Hand Sanitizer Gel

STEREZE Antiseptic Hand Sanitizer by

Drug Labeling and Warnings

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

Drug Details [pdf]

STEREZE ANTISEPTIC HAND SANITIZER- isopropyl alcohol gel 
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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STEREZE TM Antiseptic Hand Sanitizer Gel

Drug Facts

Active ingredient

Isopropyl alcohol 75% v/v

Purpose

Antiseptic

Uses

• hand sanitizer to decrease bacteria on the skin
• recommended for repeated use
• 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. 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

• wet hands thoroughly with product and allow to dry without wiping
• 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

Acrylate polymer, glycerin, hydrogen peroxide, polyethylene glycol, 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

Carefully read drug facts table on rear panel.

Made in USA

Manufactured by: MicroCare, LLC
595 John Downey Dr., New Britain, CT 06051
www.MicroCare.com

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

Packaging

STEREZE ANTISEPTIC HAND SANITIZER 
isopropyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81141-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	75 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
RAPIDGEL EZ1 (UNII: 33JH4A7R2K)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81141-002-08	237 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	12/22/2020	12/31/2021

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(81141-002)

Revised: 11/2021

Document Id: cd9271b8-6acc-4e75-811b-a0c116b4b34b

34390-5

Set id: e16d6076-5208-4924-be66-4a06a0a7ba3b

Version: 2

Effective Time: 20211111