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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

BENZETHONIUM: 27 Adverse Event Reports & Safety Profile

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27
Total FAERS Reports
1 (3.7%)
Deaths Reported
2
Hospitalizations
27
As Primary/Secondary Suspect
2
Life-Threatening
1
Disabilities
Innovative Biodefense
Manufacturer

Active Ingredient: BENZETHONIUM CHLORIDE · Route: TOPICAL · Manufacturer: Innovative Biodefense · HUMAN OTC DRUG · FDA Label: Available

First Report: 20141214 · Latest Report: 20250108

What Are the Most Common BENZETHONIUM Side Effects?

#1 Most Reported
Application site pain
5 reports (18.5%)
#2 Most Reported
Application site erythema
5 reports (18.5%)
#3 Most Reported
Burning sensation
4 reports (14.8%)

All BENZETHONIUM Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Application site erythema 5 18.5% 0 0
Application site pain 5 18.5% 0 0

Who Reports BENZETHONIUM Side Effects? Age & Gender Data

Gender: 73.1% female, 26.9% male. Average age: 45.8 years. Most reports from: US. View detailed demographics →

Is BENZETHONIUM Getting Safer? Reports by Year

YearReportsDeathsHosp.
2014 1 0 0
2016 1 0 0
2017 1 0 0
2018 3 0 0
2019 1 0 0
2020 2 0 1
2021 4 0 0
2022 1 0 0
2024 1 0 0
2025 1 0 0

View full timeline →

Official FDA Label for BENZETHONIUM

Official prescribing information from the FDA-approved drug label.

FDA Approved Uses (Indications)

XtraCare Wet Wipes Antibacterial Hand Wipes Sensitive Skin 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.

Dosage & Administration

DIRECTIONS SPRAY CA-REZZ LONG TERM CARE WASH WHERE URINE, FECES OR EMESIS HAS SOILED SKIN PAD LINENS AND CLOTHING. REMOVE BULK OF FECES OR EMESIS. SPRAY ADDITIONAL CA-REZZ LONG TERM CARE WASH ON WARM WET CLOTH. CLEANSE SKIN OF ALL REMAINING RESIDUE. PAT DRY. NOTE: IF AREA NEEDING CARE IS SIZEABLE AND FECAL OR EMESIS MATERIAL MASSIVE, RINSING IS ADVISED. ADD ONE CAPFUL OF CA-REZZ LONG TERM CARE WASH TO THE REGULAR LAUNDRY TO ELIMINATE RESIDUAL ODORS.

Warnings

Warnings For external use only Flammable do not use near heat, flame, or fire or while smoking Allergy alert: do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics. Do not use in the eyes over large areas of the body When using this product avoid contact with eyes. Do not spray in the face or mouth. use only as directed intentional misuse by deliberately concentrating or inhaling the contents can be harmful or fatal do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120°F. Ask a doctor before use if you have deep or puncture wounds animal bites serious burns Stop use and ask a doctor if condition worsens or symptoms persist for more than 7 days symptoms clear up and occur again within a few days itching, rash or irritation develops Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Active Ingredient

Active Ingredient/Purpose Benzethonium Chloride - 0.1%............Antiseptic Thymol - 0.1%..................................Antiseptic Uses Helps protect skin and supports healing of minor cuts, scrapes, burns and wounds, including pressure sores, diabetic ulcers, cracked skin and lips. Topical antiseptic to help decrease the risk of skin infections.

Inactive Ingredients

Allantoin, Aloe Barbadensis (Aloe Vera)

Leaf

Juice†, Caprylyl/Capryl Glucoside, Cetyl Hydroxyethylcellulose, Citric Acid, Citrus Aurantium Dulcis Fruit Extract, Cocamidopropyl Betaine, Cocamidopropyl Hydroxysultaine, Decyl Glucoside, Disodium 2-Sulfolaurate, Fragrance/Parfum, Leuconostoc /Radish Root Ferment Filtrate, Lycium Chinensis Fruit Extract, Niacinamide, Olea Europaea Fruit Extract, Opuntia Ficus-Indica Fruit Extract, Panthenol, Potassium Sorbate, Propanediol, Sodium Citrate, Sodium Lauryl Sulfoacetate, Sodium Methyl 2-Sulfolaurate, Tetrasodium Glutamate Diacetate, Water/Aqua, Zinc PCA. † Certified Organic Ingredient - Mayacert Certifier