Wet Wipes: Package Insert and Label Information

WET WIPES- benzethonium chloride cloth
Rejoice International

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.

Active Ingredient Purpose

Benzethonium Chloride 0.3% …………… Antibacterial

Uses

decrease bacteria on skin

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

XtraCare Wet Wipes

Antibacterial Hand Wipes

Fresh Scent

Kills 99.9% of germs

Pull up here

Resealable

32 Thick Moist Wipes

14.6 cm x 19 cm

XtraCare Antibacterial Hand Wipes kill 99.9% of germs, helping prevent the spread of bacteria, and they remove dirt, providing a better clean-up after hand sanitizers. They are ideal for quick clean-ups after contact with germs, sticky foods, greasy dirt and everyday messes.

XtraCare Antibacterial Hand Wipes are formulated to be tough on dirt and germs, yet gentle on skin. Help keep your family healthy and clean anytime and anywhere, when soap and water are not available.

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.

Directions

adults and children 2 years and over

• apply to hands
• allow to dry without wiping

children under 2 years

• ask a doctor before use

Inactive Ingredients

water, ethyl alcohol, propylene glycol, PEG-40 hydrogenated castor oil, fragrance, disodium EDTA, aloe barbadensis leaf juice, methylparaben, propylparaben.

WET WIPES benzethonium chloride cloth

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57337-067 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZETHONIUM CHLORIDE (BENZETHONIUM) BENZETHONIUM CHLORIDE 0.3 g

Inactive Ingredients Ingredient Name Strength WATER ALCOHOL PROPYLENE GLYCOL POLYOXYL 40 HYDROGENATED CASTOR OIL EDETATE DISODIUM ALOE VERA LEAF METHYLPARABEN PROPYLPARABEN

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:57337-067-01 32 CLOTH in 1 PACKAGE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 12/08/2014

Labeler — Rejoice International (078741245)

Establishment
Name	Address	ID/FEI	Operations
China Ningbo Shangge Cosmetic Technology Corp		529287434	manufacture (57337-067)

Revised: 09/2019 Rejoice International