STERAL ANTISEPTIC SANITIZING WIPE- benzalkonium chloride cloth

STERAL ANTISEPTIC SANITIZING WIPE by

Drug Labeling and Warnings

STERAL ANTISEPTIC SANITIZING WIPE by is a Otc medication manufactured, distributed, or labeled by STERAL PRODUCTS LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient 

Benzalkonium chloride 0.075% w/v

Purpose

Antiseptic

Uses

hand sanitizing wipe to decrease bacteria on skin for use when soap and water are not available

Warnings

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 persist for more than 72 hours there are symptoms of serious allergic reactions.
Contains chlorhexidine digluconate.

If pregnant or breast-feeding, ask a health professional before use.

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 discard after use do not dispose of wipes in flush toilet

Other information

store between 15-30°C (59-86°F)

Inactive ingredients

Chlorhexidine Digluconate, Didecyldimethylammonium Chloride, Ethyl Alcohol, Lauramine Oxide, p-Chloro-m-Cresol, Propylene Glycol, Water (Aqua)

Questions?

+1-XXX-XXX-XXXX
You may also report serious side effects to this phone number. Mon - Fri 9:00 AM - 5:00 PM

SPL UNCLASSIFIED SECTION

1 Wipe

Size 7.87 in x 5.91 in (200 mm x 150 mm)

Manufactured by: Steral Products Ltd
Unit 1 Easter Court, Warrington,
United Kingdom, WA5 7ZB

(MADE IN UK)

Lot No.:
Expiry Date:

info@steral.com

Packaging

INGREDIENTS AND APPEARANCE

STERAL ANTISEPTIC SANITIZING WIPE 
benzalkonium chloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82045-050
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.75 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)
DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B)
ALCOHOL (UNII: 3K9958V90M)
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)
CHLOROCRESOL (UNII: 36W53O7109)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82045-050-01	1 in 1 PACKET	07/12/2021
1		2.9 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	07/12/2021

Labeler - STERAL PRODUCTS LIMITED (227818160)

Establishment
Name	Address	ID/FEI	Business Operations
STERAL PRODUCTS LIMITED		227818160	manufacture(82045-050)