Dex Antibacterial Wipes

Manufacturer
Fuson LLC
Effective date
2020-07-04
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:25:04

Label at a glance#

ProductDex Antibacterial Wipes
Active ingredientBENZALKONIUM CHLORIDE
Label structure13 sections

Indications and uses

Indications and Usage section was added Dosage and Administration section was added

Dosage and administration

Provides practical cleaning without need of water and soap. Used for hand cleaning. Open the adhesive label and pick up a wipe. Gently wipe your hands with antibacterial wipe. No rinsing required.

Storage and handling

Do not ingest the product internally. Store in a cool, dry place. Store away from oxidizing agents and food.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride .13% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Antibacterial Wet Hand Wipes

Use

INDICATIONS & USAGE SECTION

Antibacterial wet wipes helps reduce bacteria (organisms).Effective on bacterias :Staphylococcus aureus ATCC 6538,Pseudomonas aeruginosa ATCC 15442,Enterococcus hirae ATCC 10541,Escherichia coli ATCC 10536. Use only on hands and away from eyes.

Warnings

WARNINGS SECTION

Keep away from children and direct sunlight. Children should not use this product without an adult supervision. For external use only. In case of poisoning, call the National Toxitation Information Center. Avoid contact with eyes. This product consists of nonwoven fabric (solid) impregnated with a flammable liquid solution that has an estimated flashpoint of approximately 120 degrees fahrenheit; keep away from heat, sparks, open flames, and hot surfaces. Do not smoke near this product or while using. Keep container tightly closed when not in use.

Do Not Use

OTC - DO NOT USE SECTION

Do not use if allergic to any of its ingredients. Do not use near eyes. Consult a doctor before use if pregnant, breastfeeding, have sensitive skin, or are under the age of 12. Do not buy opened and/or damaged products.

When Using

OTC - WHEN USING SECTION

In case of inhaling: If you feel uncomfortable get some fresh air. In case of skin Irritation: Occurs stop using the wipes immediately and wash the affected area with water and soap for at least 15 minutes. People with sensitive skin, pregnant women, breastfeeding women and children under the age of 12 should consult a doctor/pharmacist before using the product. Seek for medical advice if necessary. In case of contact with eyes: If you are wearing contact lenses, remove them immediately. Rince your eyes with plenty of clean water. In case of swallowing: Call your local Toxication Center and get medical help.

Stop Using

OTC - STOP USE SECTION

Stop use if rednedd or irritation occurs and persists for longer than 48 hours and contact a healthcare professional.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep away from children. Children should not use this product without adult supervision.

Directions

DOSAGE & ADMINISTRATION SECTION

Provides practical cleaning without need of water and soap. Used for hand cleaning. Open the adhesive label and pick up a wipe. Gently wipe your hands with antibacterial wipe. No rinsing required.

Other Information

STORAGE AND HANDLING SECTION

Do not ingest the product internally. Store in a cool, dry place. Store away from oxidizing agents and food.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aqua, Parfum, C12-15 Pareth-12, Glycerin, Polysorbate 20, Propylene Glycol, Tetrasodium EDTA, Piroctone Olamine, Tocopheryl Acetate, Panthenol, Citric Acid

Indications and Usage; Dosage and Administration

RECENT MAJOR CHANGES SECTION

Indications and Usage section was added

Dosage and Administration section was added

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display PanelPrincipal Display Panel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1038558benzalkonium chloride 0.13 % Medicated PadPSN1
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCD1
1038558benzalkonium chloride 0.13 % Topical ClothSY1
1038558benzalkonium chloride 0.13 % Topical SwabSY1
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSY1
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSY1
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78141-800-022022-01-28C16284748780-1d6a99b39-c799-a426-e053-dadaa90af4c2a99db394-2ba8-6561-e053-2995a90a0b48

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78141-800-02Dex Antibacterial Wipes100 g in 1 POUCHCLOTH1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78141-800DEX ANTIBACTERIAL WIPES (BENZALKONIUM CHLORIDE) CLOTH [FUSON LLC]1Legacy NDC, 1 package rows20200819_a99db394-2ba8-6561-e053-2995a90a0b48.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78141-80078141-800-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

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
ad264bb3-f8bc-efe6-e053-2a95a90a09d9a99db394-2ba8-6561-e053-2995a90a0b482020-07-04WarningsExact identifier
spl id: ad264bb3-f8bc-efe6-e053-2a95a90a09d9
spl set id: a99db394-2ba8-6561-e053-2995a90a0b48

Reported adverse events (FAERS/openFDA)#

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