SPL v4
SPL
SPL Set ID 225275f3-58aa-36d6-e063-6394a90adc13
Route
TOPICAL
Published
Effective Date 2024-09-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.13 g)
Inactive Ingredients
Water Caprylyl Glycol Peg-8 Dimethicone Edetate Disodium Citric Acid Monohydrate Phenoxyethanol Dihydroxypropyl Peg-5 Linoleammonium Chloride Potassium Sorbate Aloe Vera Leaf Alcohol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-09-17

Description

Benzalkonium Chloride 0.13%

Purpose

Antimicrobial Agent


Medication Information

Purpose

Antimicrobial Agent

Description

Benzalkonium Chloride 0.13%

Use

decreases bacteria on skin

Warnings

For external use only

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

Do Not Use

if you are allergic to any of the ingredients

Active Ingredient

Benzalkonium Chloride 0.13%

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.

Questions Or Comments?

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

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

8H Moisturization

20

wipes

Do Not Flush

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

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

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

7 - 20ct. TRAVEL PACKS

140 TOTAL WIPES

Wet

Ones

ANTIBACTERIAL

HAND WIPE

7 Travel

Packs

Kills 99.99% of Germs*

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.


Structured Label Content

Use

decreases bacteria on skin

Purpose

Antimicrobial Agent

Warnings

For external use only

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

Do Not Use (Do not use)

if you are allergic to any of the ingredients

Active Ingredient

Benzalkonium Chloride 0.13%

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.

Questions Or Comments? (Questions or Comments?)

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

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

8H Moisturization

20

wipes

Do Not Flush

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

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

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

7 - 20ct. TRAVEL PACKS

140 TOTAL WIPES

Wet

Ones

ANTIBACTERIAL

HAND WIPE

7 Travel

Packs

Kills 99.99% of Germs*

When Using This Product (When using this product)

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

Stop Use and Ask A Doctor (Stop use and ask a doctor)

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

Keep Out of Reach of Children. (Keep out of reach of children.)

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


Advanced Ingredient Data


Raw Label Data

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