FDA.reportPublic FDA data

SureSafe ANTIBACTERIAL WIPES

Manufacturer
QUANZHOU AIWINA HYGIENE PRODUCTS CO.,LTD
Effective date
2021-02-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:38:37

Label at a glance#

ProductSureSafe ANTIBACTERIAL WIPES
Active ingredientBENZALKONIUM CHLORIDE
Label structure10 sections

Indications and uses

For hand washing to decrease bacteria on the skin. Recommended for repeat use.

Dosage and administration

Adults and Children over 2 years: Thoroughly clean hands or affected area and discard in waste. Do not flush. Allow to dry without wiping.

Storage and handling

Store at room temperature

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.10%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses:

INDICATIONS & USAGE SECTION

For hand washing to decrease bacteria on the skin. Recommended for repeat use.

Directions:

DOSAGE & ADMINISTRATION SECTION

Adults and Children over 2 years:
Thoroughly clean hands or affected area and discard in waste. Do not flush. Allow to dry without wiping.

Cautions and Warnings:

WARNINGS SECTION

For external use only. Keep out of reach of eyes. If contact occurs, rinse thoroughly with water. Do not use if you are allergic to any of the ingredients. Discontinue use if irritation or redness develops and if condition persists for more than 72 hours consult a physician. 

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children unless under adult supervision. If swallowed, get medical help or contact a Poison Control Center immediately.

Other Information:

STORAGE AND HANDLING SECTION

Store at room temperature

Inactive ingredients:

INACTIVE INGREDIENT SECTION

Water, Citric Acid, Glycerol, Propanediol, Aloe Vera Extract, Hexadecyl Pyridinium Chloride, Iodopropynyl butylcarbamate

Questions:

OTC - QUESTIONS SECTION

1-800-215-2516

SPL UNCLASSIFIED SECTION

KILLS 99.9% OF GERMS AND BACTERIA

√ Alcohol - Free

√ Safe on Hands

Designed in USA | Made In China

Distributed By:

EDC Holdings INC

www.SureSafeSupplies.com

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PackagingPackaging

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1038856benzalkonium Cl 0.1 % Medicated PadPSN1
1038856benzalkonium chloride 1 MG/ML Medicated PadSCD1
1038856benzalkonium chloride 0.1 % Medicated WipesSY1
1038856benzalkonium chloride 0.1 % Topical SwabSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80671-003-802023-01-30C16284748780-1f386c649-c381-0266-e053-dadaa90a7c1aSureSafe ANTIBACTERIAL WIPES

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80671-003-80SureSafe ANTIBACTERIAL WIPES1 in 1 PAILCLOTH11
80671-003-80SureSafe ANTIBACTERIAL WIPES800 in 1 BAGCLOTH8001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80671-003SURESAFE ANTIBACTERIAL WIPES (BENZALKONIUM CHLORIDE) CLOTH [QUANZHOU AIWINA HYGIENE PRODUCTS CO.,LTD]1Legacy NDC, 2 package rows20210228_9312e70b-c826-42c4-9bf0-0703925b27e3.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
80671-00380671-003-80

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
WATER059QF0KO0RIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
GLYCERINPDC6A3C0OXIACT
PROPANEDIOL5965N8W85TIACT
ALOE VERA LEAFZY81Z83H0XIACT
CETYLPYRIDINIUM CHLORIDE ANHYDROUS6BR7T22E2SIACT
IODOPROPYNYL BUTYLCARBAMATE603P14DHEBIACT

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
20f85c6f-4aa1-427a-b08b-33d084fa8a4a9312e70b-c826-42c4-9bf0-0703925b27e32021-02-12WarningsExact identifier
spl id: 20f85c6f-4aa1-427a-b08b-33d084fa8a4a
spl set id: 9312e70b-c826-42c4-9bf0-0703925b27e3

Reported adverse events (FAERS/openFDA)#

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