FDA.reportPublic FDA data

Renew Antibacterial Hand Wipes

Manufacturer
Kairon Corp.
Effective date
2020-06-22
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:23:23

Label at a glance#

ProductRenew Antibacterial Hand Wipes
Active ingredientBENZALKONIUM CHLORIDE
Label structure12 sections

Dosage and administration

Adults and children 6 years and older: wet hands thoroughly with product and allow to dry. Children under 6 years: should be supervised when using this product.

Storage and handling

Store at room temperature and out of direct sunlight. To dispose: place in wastebasket after use. Do not flush.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

helps decrease bacteria on the skin

Warnings

WARNINGS SECTION

Flammable. Keep away from fire or flame. For external use only

OTC - WHEN USING SECTION

When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

OTC - STOP USE SECTION

Stop use and ask a doctor if if irritation or rash appears and lasts.

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.

Do not use

OTC - DO NOT USE SECTION

on children under 2 months of age or on open skin wounds

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 6 years and older: wet hands thoroughly with product and allow to dry.
  • Children under 6 years: should be supervised when using this product.

Other information

STORAGE AND HANDLING SECTION

  • Store at room temperature and out of direct sunlight. To dispose: place in wastebasket after use. Do not flush.

Inactive ingredients

INACTIVE INGREDIENT SECTION

aqua, alcohol, glycerin, phenoxyethanol, parfum (fragrance), disodium EDTA, aloe barbadensis leaf juice, tocopheryl acetate, citric acid

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package Design ImagePackage Design Image15 PRE-MOISTENED WIPES

NDC: 78899 -001-01

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78899-001-012022-01-28C16284748780-1d6a99b39-f704-a426-e053-dadaa90af4c2Renew Antibacterial Hand Wipes

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78899-001-01Renew Antibacterial Hand Wipes100 g in 1 PACKAGECLOTH1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78899-001RENEW ANTIBACTERIAL HAND WIPES (BENZALKONIUM CHLORIDE) CLOTH [KAIRON CORP.]1Legacy NDC, 1 package rows20200801_a8b1dfd9-3e76-5410-e053-2a95a90a0c07.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78899-00178899-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
PHENOXYETHANOLHIE492ZZ3TIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
.ALPHA.-TOCOPHEROL ACETATE, D-A7E6112E4NIACT
ALOE VERA LEAFZY81Z83H0XIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT

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
a798aba9-5ad4-3734-e053-2a95a90a8ff4a8b1dfd9-3e76-5410-e053-2a95a90a0c072020-06-22WarningsExact identifier
spl id: a798aba9-5ad4-3734-e053-2a95a90a8ff4
spl set id: a8b1dfd9-3e76-5410-e053-2a95a90a0c07

Reported adverse events (FAERS/openFDA)#

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