STEREZE TM Antiseptic Presaturated Wipes

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
replace the lid on the tub and pull the first sheet through the lid
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

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

SAVE THE TUB!
Save money & reduce waste with Stereze Antiseptic Presaturated Wipe refill packs (STHS100RW/ STHS800RW)
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 PRESATURATED WIPES
isopropyl alcohol cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81141-003
Route of Administration	TOPICAL

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

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 81141-003-10	100 in 1 CANISTER	12/22/2020	12/31/2021
1		3.93 mL in 1 PACKAGE; Type 0: Not a Combination Product
2	NDC: 81141-003-80	800 in 1 PAIL	12/22/2020	12/31/2021
2		2.78 mL in 1 PACKAGE; Type 0: Not a Combination Product

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

Labeler - Microcare LLC (144922879)

Name	Address	ID/FEI	Business Operations
Establishment
Microcare LLC		144922879	manufacture(81141-003)

Revised: 11/2021

Document Id: 8f48f114-1359-4735-9061-4ffca931af9b

Set id: a2c0cac8-a2a3-4832-a1e8-8ee6949c8474

Version: 2

Effective Time: 20211111