Wet Ones Antibacterial Hand Wipes Ocean Breeze: Package Insert and Label Information

WET ONES ANTIBACTERIAL HAND WIPES OCEAN BREEZE- benzalkonium chloride swab
Edgewell Personal Care Brands LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Benzalkonium Chloride 0.11%

Purpose

Antibacterial

Use

to decrease bacteria on skin

Warnings

For external use only

Do not use

if you are allergic to any of the ingredients

if irritation and redness develop

When using this product

Keep out of eyes. In case of contact with eyes, flush thoroughly with water

Stop use and ask a doctor

if condition persists for more than 72 hours.

Keep out of reach of children

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

Directions

Adults and children 3 years and over: rub hands thoroughly with product and allow skin to dry without wiping

Children under 3 years: ask a doctor before use.

Inactive ingredients

Water, Ethyl Alcohol, Propylene Glycol, Phenoxyethanol, Lauryl Glucoside, Iodopropynyl Butylcarbamate, Tetrasodium EDTA, 2-Bromo-2-Nitropropane-1,3-DIol, Citric Acid, Fragrance, Aloe Barbadensis Leaf Extract, Chamomilla, Recutita (Matricaria) Flower Extract

Questions or Comments?

Call 1-866-WET-111S

(1-866-938-1117)-M-F

Principal Display Panel

Wet

Ones

ANTIBACTERIAL HAND WIPES

Ocean Breeze

Touch of Aloe

Wet

Ones

ANTIBACTERIAL

HAND WIPES

Ocean Breeze

Touch of Aloe

ANTIBACTERIAL

25

wipes

Soft Texture

50

wipes

WET ONES ANTIBACTERIAL HAND WIPES OCEAN BREEZE benzalkonium chloride swab

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63354-906 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE 0.11 g in 100 g

Inactive Ingredients Ingredient Name Strength SODIUM HYDROXIDE WATER IODOPROPYNYL BUTYLCARBAMATE CHAMOMILE ALCOHOL CITRIC ACID MONOHYDRATE POLYETHYLENE GLYCOL, UNSPECIFIED BRONOPOL SODIUM BENZOATE EDETATE SODIUM ALOE VERA LEAF LAURYL GLUCOSIDE PHENOXYETHANOL PROPYLENE GLYCOL ANHYDROUS CITRIC ACID POTASSIUM SORBATE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:63354-906-25 25 g in 1 POUCH None 2 NDC:63354-906-50 50 g in 1 POUCH None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 07/26/2022

Labeler — Edgewell Personal Care Brands LLC (151179769)

Establishment
Name	Address	ID/FEI	Operations
AHC Ltd		413138557	manufacture (63354-906)

Revised: 07/2022 Edgewell Personal Care Brands LLC