MedPath

WET ONES

Approved
Approval ID

225275f3-58aa-36d6-e063-6394a90adc13

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 17, 2025

Manufacturers
FDA

Edgewell Personal Care Brands LLC

DUNS: 151179769

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

BENZALKONIUM CHLORIDE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code63354-774
Application Number505G(a)(3)
Product Classification
M
Marketing Category
C200263
G
Generic Name
BENZALKONIUM CHLORIDE
Product Specifications
Route of AdministrationTOPICAL
Effective DateSeptember 17, 2025
FDA Product Classification

INGREDIENTS (11)

WATERInactive
Code: 059QF0KO0R
Classification: IACT
CAPRYLYL GLYCOLInactive
Code: 00YIU5438U
Classification: IACT
PEG-8 DIMETHICONEInactive
Code: GIA7T764OD
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
PHENOXYETHANOLInactive
Code: HIE492ZZ3T
Classification: IACT
BENZALKONIUM CHLORIDEActive
Quantity: 0.13 g in 1 1
Code: F5UM2KM3W7
Classification: ACTIB
DIHYDROXYPROPYL PEG-5 LINOLEAMMONIUM CHLORIDEInactive
Code: 0Y0NQR2GH1
Classification: IACT
POTASSIUM SORBATEInactive
Code: 1VPU26JZZ4
Classification: IACT
ALOE VERA LEAFInactive
Code: ZY81Z83H0X
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/17/2024

Principal Display Panel

Wet

Ones

ANTIBACTERIAL

HAND WIPE

Fresh Scent

Tough On Dirt

Gentle on Skin

KILLS 99.99% OF COMMON BACTERIA

WET LOCK SEAL

Keeps Wipes Moist

LIFT HERE

pouch lid

8H Moisturization

20

wipes

Do Not Flush

pouch

TEAR HERE

Wet

Ones

ANTIBACTERIAL

HAND WIPE

Fresh Scent

Tough On Dirt

Gentle on Skin

KILLS 99.99% OF COMMON BACTERIA**

**Kills 99.99% of the strains

listed in the FDA Consumer

Antiseptic Rub rule.

1 WIPE

packette

TEAR HERE

Wet

Ones

ANTIBACTERIAL

HAND WIPE

Fresh Scent

Tough On Dirt

Gentle on Skin

KILLS 99.99% OF COMMON BACTERIA**

**Kills 99.99% of the strains

listed in the FDA Consumer

Antiseptic Rub rule.

1 WIPE

actual size

Pocket Size

Singles

Perfect for

on-the-go

8 hour moisturization

No sticky residue

Dermatologist and

pediatrician tested

24 INDIVIDUALLY

WRAPPED WIPES

carton

Wet

Ones

ANTIBACTERIAL

HAND WIPE

Fresh Scent

Tough On Dirt

Gentle on Skin

KILLS 99.99% OF COMMON BACTERIA

8 Hour Moisturization

Do Not Flush

40

wipes

canister

7 - 20ct. TRAVEL PACKS
140 TOTAL WIPES
Wet
Ones
ANTIBACTERIAL
HAND WIPE
7 Travel
Packs
Kills 99.99% of Germs*

Carton

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 9/17/2024

Use

decreases bacteria on skin

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 9/17/2024

Active Ingredient

Benzalkonium Chloride 0.13%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 9/17/2024

Purpose

Antimicrobial Agent

WARNINGS SECTION

LOINC: 34071-1Updated: 9/17/2024

Warnings

For external use only

Do not use

if you are allergic to any of the ingredients

When using this product

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

Stop use and ask a doctor

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

Keep out of reach of children.

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

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 9/17/2024

Directions

adults and children 2 years and over** |**Rub on hands for 30 seconds and allow skin to dry without wiping.

children under 2 years** |**ask a doctor before use

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 9/17/2024

Inactive Ingredients

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.

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 9/17/2024

Questions or Comments?

Call 1-866-WET-111S; (1-866-938-1117), M-F

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