FDA.reportPublic FDA data

Wet Ones Antibacterial Hand Wipes Tropical Splash

Manufacturer
Edgewell Personal Care Brands LLC
Effective date
2022-01-13
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:17:15

Label at a glance#

ProductWet Ones Antibacterial Hand Wipes Tropical Splash
Active ingredientBENZALKONIUM CHLORIDE
Label structure7 sections

Dosage and administration

adults and childre 2 years and over • apply to hands • allow skin 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 0.13%

Purpose

OTC - PURPOSE SECTION

Antimicrobial Agent

Use

INDICATIONS & USAGE SECTION

decreases bacteria on 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

OTC - STOP USE SECTION

if irritation or rash develops and continues for more than 72 hour

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 childre 2 years and over • apply to hands • allow skin to dry without wiping

children under 2 years ask a doctor before use

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Alcohol Denat., Phenoxyethanol, PEG-8 Dimethicone. Caprylyl Glycol, Dihydroxypropyl PEG-5 Linoleammonium Chloride, Potassium Sorbate, Disodium EDTA, Citric Acid, Fragrance, Aloe Barbadensis Leaf Juice

PDP

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Wet

Ones®

ANTIBACTERIAL

HAND WIPES

Tropical Splash

Kills 99.99% of Germs

Hypoallergenic Paraben Free

Fresh, Clean Feel

America's #1 Hand Wipe*

63354-989-4063354-989-40

63354-989-15-163354-989-15-1

63354-989-15-263354-989-15-2

63354-989-15-363354-989-15-3

63354-989-24-163354-989-24-1

63354-989-24-263354-989-24-2

63354-989-24-363354-989-24-3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63354-989-152025-03-27C16284748780-12cef2736-7c29-d83d-e063-dadaa90ab31f9351b508-9828-8d02-e053-2a95a90a3770
63354-989-242025-03-27C16284748780-12cef2736-7c29-d83d-e063-dadaa90ab31f9351b508-9828-8d02-e053-2a95a90a3770
63354-989-402025-03-27C16284748780-12cef2736-7c29-d83d-e063-dadaa90ab31f9351b508-9828-8d02-e053-2a95a90a3770
63354-989-152025-01-30C16284748780-12cef2736-7c29-d83d-e063-dadaa90ab31f9351b508-9828-8d02-e053-2a95a90a3770
63354-989-242025-01-30C16284748780-12cef2736-7c29-d83d-e063-dadaa90ab31f9351b508-9828-8d02-e053-2a95a90a3770
63354-989-402025-01-30C16284748780-12cef2736-7c29-d83d-e063-dadaa90ab31f9351b508-9828-8d02-e053-2a95a90a3770

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63354-98963354-989-15, 63354-989-24, 63354-989-40

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
POTASSIUM SORBATE1VPU26JZZ4IACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
ALCOHOL3K9958V90MIACT
PHENOXYETHANOLHIE492ZZ3TIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
PEG-8 DIMETHICONEGIA7T764ODIACT
CAPRYLYL GLYCOL00YIU5438UIACT
DIHYDROXYPROPYL PEG-5 LINOLEAMMONIUM CHLORIDE0Y0NQR2GH1IACT
ALOE VERA LEAFZY81Z83H0XIACT
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
d579f41e-bf00-240b-e053-2995a90a8ef89351b508-9828-8d02-e053-2a95a90a37702022-01-13WarningsExact identifier
spl id: d579f41e-bf00-240b-e053-2995a90a8ef8
spl set id: 9351b508-9828-8d02-e053-2a95a90a3770

Reported adverse events (FAERS/openFDA)#

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