FDA.reportPublic FDA data

Personal CARE

Manufacturer
Delta Brands & Products, LLC
Effective date
2018-05-07
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:55:27

Label at a glance#

ProductPersonal CARE Wipes
Active ingredientBENZALKONIUM CHLORIDE
Label structure11 sections

Indications and uses

decreases bacteria on the skin

Dosage and administration

adults and children 2 years and over ■ apply to hands ■ allow to dry without wiping. children under 2 years ask a doctor before use.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.1%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

decreases bacteria on the skin

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

if you are allergic to any of the ingredients

When using this product

OTC - WHEN USING SECTION


do not get into eyes. If contact occurs, rinse thoroughly with water.

Stop use and ask a doctor if

OTC - STOP USE SECTION

irritation or rash develops and continues for more than 72 hours

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children 2 years and over ■ apply to hands

■ allow to dry without wiping.

children under 2 years ask a doctor before use.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

water, propylene glycol, cocamidopropyl betaine, PEG-7 glyceryl cocoate, fragrance, benzyl alcohol, methylchloroisothiazolinine, methylisothiazolinone, PEG-40 hydrogenated castor oil, tetrasodium EDTA, cetrimonium chloride, citric acid, tocopherol acetate

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package LabelPackage Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1038856benzalkonium Cl 0.1 % Medicated PadPSN2
1038856benzalkonium chloride 1 MG/ML Medicated PadSCD2
1038856benzalkonium chloride 0.1 % Medicated WipesSY2
1038856benzalkonium chloride 0.1 % Topical SwabSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72133-431-302020-01-31C16284748780-19d75b9d1-015c-f424-e053-dadaa90a57ceDrug Facts
72133-431-402020-01-31C16284748780-19d75b9d1-015c-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72133-431-30Personal CAREWipes30 in 1 PACKAGECLOTH302
72133-431-40Personal CAREWipes40 in 1 PACKAGECLOTH402

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72133-431PERSONAL CARE WIPES (BENZALKONIUM CHLORIDE) CLOTH [DELTA BRANDS & PRODUCTS, LLC]2Legacy NDC, 2 package rows20180508_6920a18d-73f7-aeb8-e053-2991aa0ad79e.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
72133-43172133-431-30, 72133-431-40

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
PEG-7 GLYCERYL COCOATEVNX7251543IACT
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
EDETATE SODIUMMP1J8420LUIACT
CETRIMONIUM CHLORIDEUC9PE95IBPIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
BENZYL ALCOHOLLKG8494WBHIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
POLYOXYL 40 HYDROGENATED CASTOR OIL7YC686GQ8FIACT

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
6ba3c9fa-0202-aef6-e053-2991aa0a551d6920a18d-73f7-aeb8-e053-2991aa0ad79e2018-05-07WarningsExact identifier
spl id: 6ba3c9fa-0202-aef6-e053-2991aa0a551d
spl set id: 6920a18d-73f7-aeb8-e053-2991aa0ad79e

Reported adverse events (FAERS/openFDA)#

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