190d7d61-5ea9-6670-e063-6294a90a4535

SPL v2
SPL
SPL Set ID 190d7d61-5ea9-6670-e063-6294a90a4535
Route
topical
Published
Effective Date 2024-05-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
benzalkonium (0.13 g)
Inactive Ingredients
caprylyl glycol peg-8 dimethicone alcohol phenoxyethanol dihydroxypropyl peg-5 linoleammonium chloride edetate disodium aloe vera leaf water potassium sorbate citric acid monohydrate

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2023-12-01

Purpose

Antibacterial

Description

Benzalkonium Chloride 0.13%


Medication Information

Warnings

For external use only

Purpose

Antibacterial

Directions

• apply to hands • 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 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.

Description

Benzalkonium Chloride 0.13%

Principal Display Panel

Wet

Ones

BIG

&

STRONG

ANTIBACTERIAL HAND WIPE

KILLS 99.99% OF COMMON BACTERIA

REMOVES FROM HANDS

• OIL • GRIME • GREASE

• GLUE • DIRT • PAINT

FRESH SCENT

PULL UP HERE

50% LARGE

EXTRA THICK

28

wipes

DO NOT FLUSH

Use

decreases bacteria on skin

Do Not Use

if you are allergic to any of the ingredients

Active Ingredient

Benzalkonium Chloride 0.13%

Questions Or Comments?

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

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

Warnings

For external use only

Purpose

Antibacterial

Directions

• apply to hands • 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 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.

Principal Display Panel

Wet

Ones

BIG

&

STRONG

ANTIBACTERIAL HAND WIPE

KILLS 99.99% OF COMMON BACTERIA

REMOVES FROM HANDS

• OIL • GRIME • GREASE

• GLUE • DIRT • PAINT

FRESH SCENT

PULL UP HERE

50% LARGE

EXTRA THICK

28

wipes

DO NOT FLUSH

Use

decreases bacteria on skin

Do Not Use (Do not use)

if you are allergic to any of the ingredients

Active Ingredient

Benzalkonium Chloride 0.13%

Questions Or Comments? (Questions or Comments?)

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

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 If (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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