Benzyl Alcohol Topical
Benzyl alcohol topical is a numbing medicine applied to the mouth or lips that temporarily relieves pain from cold sores, fever blisters, canker sores, mouth sores and gum irritation.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
How we combine label and product data →
Patient information guide — a plain-language walkthrough of Benzyl Alcohol Topical, written from its FDA label.
What Benzyl Alcohol Topical is used for
▾
Benzyl alcohol topical temporarily relieves pain from several kinds of mouth and lip problems.
- Cold sores and fever blisters
- Canker sores
- Mouth sores
- Gum irritation
Benzyl Alcohol Topical dosage
▾
This product is applied to the skin or mouth sore, not swallowed. Dry the area, then apply with a cotton swab or clean finger.
- Use up to 4 times daily.
- Let it dry for 30 to 60 seconds.
- Adults and children 2 years and older may use it. Children under 12 need adult supervision.
- Children under 2: do not use unless a physician or dentist advises it.
Follow your prescriber and the label.
Dosing details from the FDA-approved label
From the Benzyl Alcohol Topical prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Adults and children 2 years and older
- Dry affected area
- Apply with cotton swab or clean finger up to 4 times daily
- Allow to dry 30-60 seconds
- Children under 12 years
- Adult supervision should be given in the use of this product
- Adult supervision required
- Children under 2 years
- Do not use, consult a physician or dentist
Read the label’s full dosing text
Directions adults and children 2 years and older dry affected area. Apply with cotton swab or clean finger up to 4 times daily. Allow to dry 30-60 seconds. children under 12 years adult supervision should be given in the use of this product children under 2 years do not use, consult a physician or dentist
Read the full Dosage and Administration section on DailyMed →
Benzyl Alcohol Topical side effects
▾
Specific common side effects are not listed. Stop use and get medical advice if you notice any of these.
- Swelling, rash or fever
- Irritation, pain or redness that continues or gets worse
- Your condition getting worse
If the product is swallowed, get medical help or call poison control right away.
Benzyl Alcohol Topical warnings and precautions
▾
- Flammable: keep away from fire or flame.
- Apply only to the affected area and do not exceed the recommended dosage.
- Avoid contact with the eyes.
- Do not use for more than 7 days unless a physician or dentist directs you to.
- Stop use and ask a physician if symptoms do not improve in 7 days, or clear up and return within a few days.
- Keep out of reach of children.
Before taking Benzyl Alcohol Topical
▾
- Children under 2 years: do not use without consulting a physician or dentist.
- Children under 12 years: an adult should supervise use.
- Anyone whose sore has lasted beyond 7 days or keeps returning should check in with a physician or dentist.
Benzyl Alcohol Topical overdose
▾
If this product is swallowed, get medical help or contact a poison control center immediately.
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Benzyl Alcohol Topical: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Benzyl Alcohol Topical — the kind of thing our pharmacy team would talk through with you at the counter.
What is this used for?
▾
How do I apply it?
▾
Can my child use it?
▾
How long can I use it?
▾
When should I stop and call someone?
▾
Any safety tips?
▾
Is Benzyl Alcohol Topical available over the counter?
▾
When was Benzyl Alcohol Topical first available?
▾
Who makes Benzyl Alcohol Topical?
▾
Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Benzyl Alcohol Topical on HelloPharmacist
Benzyl Alcohol Topical forms and strengths (how it comes)
Benzyl Alcohol Topical is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Topical cream, ointment or gel
How this form is used
- Zilactin is used to temporarily relieve pain from cold sores, fever blisters, canker sores, mouth sores and gum irritation.
- Zilactin: dry the affected area, then apply with a cotton swab or clean finger up to 4 times daily.
- Zilactin: allow it to dry for 30 to 60 seconds.
- Zilactin: children under 12 need adult supervision, and children under 2 should not use it without asking a physician or dentist.
Benzyl Alcohol Topical on the U.S. market: products, makers and brands
How Benzyl Alcohol Topical appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
3 companies list 3 Benzyl Alcohol Topical product records with the FDA, mostly as topical cream, ointment or gel; the earliest marketing or approval year on record is 2025. Brand names on the directory include Ulesfia, Zilactin-L Cold Sore Liquid, Zilactin Cold Sore and 2 more; the rest are generics.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
Compare Benzyl Alcohol Topical products
A representative set of FDA-listed product records for Benzyl Alcohol Topical — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Topical cream, ointment or gel | ||||
| 0.1 g/g | Topical | Applied Laboratories, Inc. | OTC MONOGRAPH NOT FINAL | View NDC → |
| 0.1 g/g | Topical | Ascent Consumer Products, Inc | OTC MONOGRAPH DRUG | View NDC → |
| 0.1 g/g | Topical | Blairex Laboratories, Inc. | OTC MONOGRAPH NOT FINAL | View NDC → |
Showing 3 of 3 products — FDA National Drug Code Directory. See every product, package size and price: browse all 3 Benzyl Alcohol Topical NDCs →
Benzyl Alcohol Topical side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Benzyl Alcohol Topical — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Benzyl Alcohol Topical in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Benzyl Alcohol Topical FDA approval history
How Benzyl Alcohol Topical went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Benzyl Alcohol Topical recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list no Benzyl Alcohol recalls since July 2021.
✅No Benzyl Alcohol recalls on record since July 2021Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 1426 3 dose forms · 3 strengths
-
Dose form (SCDF) Oral Gel RxCUI 581455In current FDA listingsClinical drug / strength (SCD) 0.1 ML/MLRxCUI 581456 -
Dose form (SCDF) Topical Lotion RxCUI 376822In current FDA listingsClinical drug / strength (SCD) 0.05 ML/MLRxCUI 1356671 -
Dose form (SCDF) Topical Solution RxCUI 376940No current FDA listingClinical drug / strength (SCD) 100 MG/MLRxCUI 795484
Look up RxCUI 1426 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
Benzyl Alcohol Topical supply and shortage status
Whether Benzyl Alcohol Topical is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
Benzyl Alcohol Topical brand names
Benzyl Alcohol Topical is sold under 5 brand names in the FDA directory — Ulesfia, Zilactin-L Cold Sore Liquid, Zilactin Cold Sore, Zilactin and others. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Benzyl Alcohol Topical: manufacturers and labelers
3 companies list Benzyl Alcohol Topical products with the FDA. By number of product records, the largest are Applied Laboratories, Inc., Ascent Consumer Products, Inc, Blairex Laboratories, Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Benzyl Alcohol Topical drug class (RxNorm)
Benzyl Alcohol Topical belongs to the Pediculicide class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
Sources for this Benzyl Alcohol Topical page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Ascent Consumer Products, Inc is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →