BENZYL ALCOHOL: 54 Adverse Event Reports & Safety Profile
Boost Your Natural Energy & Metabolism
Mitolyn — 6 exotic plants to unlock your body's fat-burning power. 90-day guarantee.
Drug Class: Pediculicide [EPC] · Route: TOPICAL · Manufacturer: CVS Pharmacy Inc. · FDA Application: 022129 · HUMAN OTC DRUG · FDA Label: Available
First Report: 20040312 · Latest Report: 20250430
What Are the Most Common BENZYL ALCOHOL Side Effects?
All BENZYL ALCOHOL Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Drug administered to patient of inappropriate age | 16 | 29.6% | 15 | 0 |
| Toxicity to various agents | 16 | 29.6% | 15 | 0 |
| Metabolic acidosis | 11 | 20.4% | 10 | 0 |
| Drug ineffective | 8 | 14.8% | 0 | 1 |
| Drug abuse | 5 | 9.3% | 1 | 2 |
| Gasping syndrome | 5 | 9.3% | 5 | 0 |
Who Reports BENZYL ALCOHOL Side Effects? Age & Gender Data
Gender: 75.0% female, 25.0% male. Average age: 38.2 years. Most reports from: US. View detailed demographics →
Is BENZYL ALCOHOL Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2004 | 1 | 0 | 0 |
| 2014 | 1 | 0 | 0 |
| 2017 | 3 | 0 | 1 |
| 2020 | 1 | 1 | 0 |
| 2021 | 1 | 0 | 0 |
| 2022 | 2 | 1 | 0 |
| 2023 | 1 | 0 | 1 |
| 2024 | 6 | 0 | 2 |
| 2025 | 1 | 0 | 0 |
What Is BENZYL ALCOHOL Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 22 |
| Catheter management | 13 |
Other Drugs in Same Class: Pediculicide [EPC]
Official FDA Label for BENZYL ALCOHOL
Official prescribing information from the FDA-approved drug label.
FDA Approved Uses (Indications)
Use Temporarily relieves pain and itching associated with insect bites, minor burns, sunburn, minor cuts, scrapes, minor skin irritations, hives and rashes due to poison ivy, poison oak, or poison sumac
Dosage & Administration
Directions
- remove imprinted safety seal from bottle cap
- to remove child-resistant cap, squeeze smooth sides of cap while turning. Reclose tightly. Ready to use, no mixing needed. Adults and children 2 years of age or over: Swish one-half capful (2 teaspoons = 10mL) around the mouth over the affected area for at least 1 minute and then spit out. Use up to 4 times daily after meals and at bedtime or as directed by a dentist or healthcare provider Children under 12 years of age: Should be supervised in the use of this product Children under 2 years of age: Consult a dentist or healthcare provider Other Information
- cap tightly
- keep away from heat or direct sunlight
- do not use if safety seal is broken or missing
Warnings
Warnings For external use only Flammable: Keep away from fire or flame -Do not use near heat or flame or while smoking. -avoid long term storage above 40 degree Celcius. -do not puncture or incinerate. COntents under pressure -do not store at temperatures above 49 degree Celcius Do not use on large areas of the body or cut or wounds or damaged skin on puncture wounds for more than one week without consulting a doctor When using this product use only as directed avoid contact with the eyes, mucous membranes or rashes avoid spraying on face avoid inhalation of spray do not bandage or apply local heat such as heating pads or a medicated patch to area of use do not use at the same time as other topical analgesics Stop use and ask a doctor if skin reactions occur, such as rash, itching, redness, irritaion, pain, swelling and blistering conditions worsen symptoms persist for more than 7 days symptoms clear up and occur again within a few days If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Active Ingredient
Active ingredients......................................Purpose Benzyl alcohol 10%......................................Topical analgesic Pramoxine hydrochloride 1%.......................Topical analgesic
Inactive Ingredients
Inactive ingredients bentonite, benzethonium chloride, camphor, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, hydroxyethylcellulose, lanolin alcohol, lanolin oil, magnesium aluminum silicate, menthol, petrolatum, polyethylene glycol, polyglyceryl-3 diisostearate, polysorbate 60, propylene glycol, purified water, PVP, red 33, sorbitan stearate, squalane, yellow 5, yellow 6