FDA.reportPublic FDA data

STERAL ANTISEPTIC SANITIZING WIPE

Manufacturer
STERAL PRODUCTS LIMITED
Effective date
2021-07-07
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:41:47

Label at a glance#

ProductSTERAL ANTISEPTIC SANITIZING WIPE
Active ingredientBENZALKONIUM CHLORIDE
Label structure10 sections

Indications and uses

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

Dosage and administration

• 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

Storage and handling

• store between 15-30°C (59-86°F)

Label contents#

Full prescribing information#

Active Ingredient 

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium chloride 0.075% w/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

• 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

STORAGE AND HANDLING SECTION

• store between 15-30°C (59-86°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions?

OTC - QUESTIONS SECTION

+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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Hand sanitizerHand sanitizer

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2565423benzalkonium chloride 0.75 MG/ML Medicated PadSCD1
2565423benzalkonium chloride 0.075 % Medicated PadSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
bb6d6c68-649d-4e6d-a1f6-603d969c8f68Product name120160303

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
82045-050-012023-01-30C16284748780-1f386c649-a683-0266-e053-dadaa90a7c1aBENZALKONIUM CHLORIDE ANTISEPTIC SANITIZING WIPE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82045-050-01STERAL ANTISEPTIC SANITIZING WIPE1 in 1 PACKETCLOTH11
82045-050-01STERAL ANTISEPTIC SANITIZING WIPE2.9 mL in 1 PACKAGECLOTH2.91

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82045-050STERAL ANTISEPTIC SANITIZING WIPE (BENZALKONIUM CHLORIDE) CLOTH [STERAL PRODUCTS LIMITED]1Legacy NDC, 2 package rows20210805_23a53fc5-7436-443d-b668-a41f1ae7103e.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82045-05082045-050-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
CHLORHEXIDINE GLUCONATEMOR84MUD8EIACT
DIDECYLDIMONIUM CHLORIDEJXN40O9Y9BIACT
ALCOHOL3K9958V90MIACT
LAURAMINE OXIDE4F6FC4MI8WIACT
CHLOROCRESOL36W53O7109IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
b6d6d9f8-0568-438f-91ca-501c461b97c323a53fc5-7436-443d-b668-a41f1ae7103e2021-07-07WarningsExact identifier
spl id: b6d6d9f8-0568-438f-91ca-501c461b97c3
spl set id: 23a53fc5-7436-443d-b668-a41f1ae7103e

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.