STEREZE TM Antiseptic Presaturated Wipes

STEREZE Antiseptic Presaturated Wipes by

Drug Labeling and Warnings

STEREZE 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 ANTISEPTIC PRESATURATED WIPES- isopropyl 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 Antiseptic Presaturated Wipes

Drug Facts

Active ingredient

Isopropyl alcohol 75% v/v

Purpose

Antiseptic

Uses

  • hand wipes 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

                                        keep out of eyes, ears and mouth

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

  • cut along the dotted line in the oval (.....) on top of the bag
  • pull the first wipe up from the CENTER of the roll and place the roll WITH THE BAG into the dispenser
  • feed the first wipe through the hole in the lid of the dispenser and place the lid back on
  • wet hands thoroughly with product and allow to dry without wiping
  • additional fresh wipes will dispense as you pull and tear off sheets
  • supervise children under 6 years of age when using this product to avoid swallowing
  • to start roll, remove the lid and detach the foil seal
  • pull the first sheet up from the center of the roll then twist the sheet and feed it through the opening in the lid
  • replace the lid on the tub and pull the first sheet through the lid

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

With Non-Sterile Solution

PREMIUM WIPES

Carefully read drug facts table on rear panel.

Made in USA

STRONG, TEAR RESISTANT WIPES

UNIQUE SELF-CLOSING LID WILL KEEP UNUSED WIPES CLEAN, WELL SATURATED AND READY TO USE

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

Image

STEREZE ANTISEPTIC PRESATURATED WIPES 
isopropyl alcohol cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 81141-004
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL75 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 81141-004-10100 in 1 POUCH12/22/202012/31/2021
13.93 mL in 1 PACKAGE; Type 0: Not a Combination Product
2NDC: 81141-004-80800 in 1 POUCH12/22/202012/31/2021
22.78 mL in 1 PACKAGE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A12/22/202012/31/2021
Labeler - Microcare LLC (144922879)
Establishment
NameAddressID/FEIBusiness Operations
Microcare LLC144922879manufacture(81141-004)

Revised: 11/2021
 

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