FDA.reportPublic FDA data

ANTI-BACTERIAL WET WIPES

Manufacturer
Dalian Daxin Nonwoven Technology Co., Ltd.
Effective date
2022-01-14
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:46:59

Label at a glance#

ProductANTI-BACTERIAL WET WIPES
Active ingredientBENZALKONIUM CHLORIDE
Label structure8 sections

Dosage and administration

Wipe liberally over the hands & body, rub into skin until dry, Recommended for single use.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13%

Purpose

OTC - PURPOSE SECTION

Antiseptic/Hand & Skin Sanitizer

USE

INDICATIONS & USAGE SECTION

Sanitizing Hand Wipes to help decrease bacteria on the skin.
Recommended for single use.

WARNINGS SECTION

Do not freeze. For external use only, Store at room temperature.
Do not use in ears, eyes or mouth.
Avoid contact with the eyes. In case of contact, flush eyes with water.
Stop use and ask a doctor if redness or irritation develop and persist
for more than 72 hours,

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

●Keep out of reach of children.
●Children should be supervised when using this product.
If swallowed, get medical help or contact Poison Control Centre
immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

Wipe liberally over the hands & body, rub into skin until dry,
Recommended for single use.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), Glycerol, Propanediol,
Aloe Vera Extract, Amino acid moisturizer,
Hexadecylpyridinium Chloride,Chlorphenesin,
Vitamin E, Dodecyl polyglucoside, Citric acid,
Sodium citrate.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1038558benzalkonium chloride 0.13 % Medicated PadPSN3
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCD3
1038558benzalkonium chloride 0.13 % Topical ClothSY3
1038558benzalkonium chloride 0.13 % Topical SwabSY3
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSY3
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSY3
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSY3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d1c9d1af-bddd-448d-86f7-69052b7d5b47Product name120220627

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78028-004-012024-01-30C16284748780-11030e365-4b90-111a-e063-dadaa90a10e278028-004 ANTI-BACTERIAL WET WIPES 0.13% BENZALKONIUM CHLORIDE
78028-004-022024-01-30C16284748780-11030e365-4b90-111a-e063-dadaa90a10e278028-004 ANTI-BACTERIAL WET WIPES 0.13% BENZALKONIUM CHLORIDE
78028-004-032024-01-30C16284748780-11030e365-4b90-111a-e063-dadaa90a10e278028-004 ANTI-BACTERIAL WET WIPES 0.13% BENZALKONIUM CHLORIDE
78028-004-042024-01-30C16284748780-11030e365-4b90-111a-e063-dadaa90a10e278028-004 ANTI-BACTERIAL WET WIPES 0.13% BENZALKONIUM CHLORIDE
78028-004-052024-01-30C16284748780-11030e365-4b90-111a-e063-dadaa90a10e278028-004 ANTI-BACTERIAL WET WIPES 0.13% BENZALKONIUM CHLORIDE
78028-004-062024-01-30C16284748780-11030e365-4b90-111a-e063-dadaa90a10e278028-004 ANTI-BACTERIAL WET WIPES 0.13% BENZALKONIUM CHLORIDE
78028-004-072024-01-30C16284748780-11030e365-4b90-111a-e063-dadaa90a10e278028-004 ANTI-BACTERIAL WET WIPES 0.13% BENZALKONIUM CHLORIDE
78028-004-082024-01-30C16284748780-11030e365-4b90-111a-e063-dadaa90a10e278028-004 ANTI-BACTERIAL WET WIPES 0.13% BENZALKONIUM CHLORIDE
78028-004-092024-01-30C16284748780-11030e365-4b90-111a-e063-dadaa90a10e278028-004 ANTI-BACTERIAL WET WIPES 0.13% BENZALKONIUM CHLORIDE
78028-004-102024-01-30C16284748780-11030e365-4b90-111a-e063-dadaa90a10e278028-004 ANTI-BACTERIAL WET WIPES 0.13% BENZALKONIUM CHLORIDE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78028-004-01ANTI-BACTERIAL WET WIPES6.5 g in 1 NOT APPLICABLECLOTH6.53
78028-004-01ANTI-BACTERIAL WET WIPES50 in 1 PAILCLOTH503
78028-004-02ANTI-BACTERIAL WET WIPES6.5 g in 1 NOT APPLICABLECLOTH6.53
78028-004-02ANTI-BACTERIAL WET WIPES70 in 1 PAILCLOTH703
78028-004-03ANTI-BACTERIAL WET WIPES80 in 1 PAILCLOTH803
78028-004-03ANTI-BACTERIAL WET WIPES6.5 g in 1 NOT APPLICABLECLOTH6.53
78028-004-04ANTI-BACTERIAL WET WIPES100 in 1 PAILCLOTH1003
78028-004-04ANTI-BACTERIAL WET WIPES6.5 g in 1 NOT APPLICABLECLOTH6.53
78028-004-05ANTI-BACTERIAL WET WIPES6.5 g in 1 NOT APPLICABLECLOTH6.53
78028-004-05ANTI-BACTERIAL WET WIPES30 in 1 BAGCLOTH303
78028-004-06ANTI-BACTERIAL WET WIPES6.5 g in 1 NOT APPLICABLECLOTH6.53
78028-004-06ANTI-BACTERIAL WET WIPES40 in 1 BAGCLOTH403
78028-004-07ANTI-BACTERIAL WET WIPES6.5 g in 1 NOT APPLICABLECLOTH6.53
78028-004-07ANTI-BACTERIAL WET WIPES50 in 1 BAGCLOTH503
78028-004-08ANTI-BACTERIAL WET WIPES6.5 g in 1 NOT APPLICABLECLOTH6.53
78028-004-08ANTI-BACTERIAL WET WIPES60 in 1 BAGCLOTH603
78028-004-09ANTI-BACTERIAL WET WIPES80 in 1 BAGCLOTH803
78028-004-09ANTI-BACTERIAL WET WIPES6.5 g in 1 NOT APPLICABLECLOTH6.53
78028-004-10ANTI-BACTERIAL WET WIPES150 in 1 PAILCLOTH1503
78028-004-10ANTI-BACTERIAL WET WIPES6.5 g in 1 NOT APPLICABLECLOTH6.53

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78028-004ANTI-BACTERIAL WET WIPES (BENZALKONIUM CHLORIDE) CLOTH [DALIAN DAXIN NONWOVEN TECHNOLOGY CO., LTD.]3Legacy NDC, 20 package rows20220115_ab2def5c-5033-902a-e053-2a95a90af986.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78028-00478028-004-01, 78028-004-02, 78028-004-03, 78028-004-04, 78028-004-05, 78028-004-06, 78028-004-07, 78028-004-08, 78028-004-09, 78028-004-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM CITRATE1Q73Q2JULRIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
GLYCERINPDC6A3C0OXIACT
ALOE VERA LEAFZY81Z83H0XIACT
POLY(LAURYLGLUCOSIDE)-7VB00RDE21RIACT
PROPANEDIOL5965N8W85TIACT
BETAINE3SCV180C9WIACT
CETYLPYRIDINIUM CHLORIDE ANHYDROUS6BR7T22E2SIACT
CHLORPHENESINI670DAL4SZIACT
WATER059QF0KO0RIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT

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
d5983e19-5987-2a64-e053-2a95a90a4333ab2def5c-5033-902a-e053-2a95a90af9862022-01-14WarningsExact identifier
spl id: d5983e19-5987-2a64-e053-2a95a90a4333
spl set id: ab2def5c-5033-902a-e053-2a95a90af986

Reported adverse events (FAERS/openFDA)#

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