Orajel Cold Sore Touch Free - Single Dose

Orajel Cold Sore Touch Free - Single Dose is an FDA-registered drug product whose active ingredient is BENZALKONIUM CHLORIDE, BENZOCAINE. It is labelled by Church & Dwight Co., Inc. taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 10237-798, application M017, label effective 20260513. It is one of 2 FDA drug label records sharing the active ingredient BENZALKONIUM CHLORIDE, BENZOCAINE. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing BENZALKONIUM CHLORIDE, BENZOCAINE are most often described in connection with: treat cold, sores fever. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses to treat cold sores/fever blisters

Directions •slide-off to remove the protective blue paper cover and slide it on the other end - opposite the white applicator tip •squeeze the vial firmly on the arrow shown on the blue paper cap until you hear it snap •hold with the white applicator tip down to allow the medication to saturate the tip •to minimize pain during application gently touch the site of the cold sore with the saturated applicator tip •Once the area is numb, rub the site of the cold sore and the surrounding area. Rub firmly to allow the treatment to deeply penetrate the skin •to treat most cold sores, multiple treatments may be required •discard after use •for best result ensure that lip area is free of lip preparations, lotions, ointments, residual beverages, or cosmetics, including lipstick Adults and children 2 years of age and older Do not use more than 3 times per day Children between 2 and 12 years of age Ask a doctor before use. Should be supervised in the use of this product Children under 2 years of age Do not use

Warnings For external use only. Flammable, keep away from fire or flame. Methemoglobinemia warning: Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops: ​•pale, gray, or blue colored skin (cyanosis) •headache •rapid heart rate •shortness of breath •dizziness or lightheadedness •fatigue or lack of energy​ 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 •if you are allergic to any ingredient in this product •more than 3 times per day •longer than 1 week unless directed by a physician •for teething •in children under 2 years of age Stop use and ask a dentist or physician if •condition persists or worsens •symptoms persist for more than 7 days Ask a physician if •used to treat deep or puncture wounds, animal bites or serious burns •you are pregnant or nursing a baby When using this product you may feel a brief stinging when you apply it. The sting should go away in a short time. Keep out of reach of children. In case of overdose, or allergic reaction, get medical help or contact a Poison Control Center right away

FDA lists 2 drug label records with BENZALKONIUM CHLORIDE, BENZOCAINE as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

2 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

What is Orajel Cold Sore Touch Free - Single Dose used for?
Uses to treat cold sores/fever blisters

Who makes Orajel Cold Sore Touch Free - Single Dose?
Church & Dwight Co., Inc. is the labeler of record for Orajel Cold Sore Touch Free - Single Dose. 2 FDA label records share the active ingredient BENZALKONIUM CHLORIDE, BENZOCAINE, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Orajel Cold Sore Touch Free - Single Dose come in?
administered by topical. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Orajel Cold Sore Touch Free - Single Dose prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing BENZALKONIUM CHLORIDE, BENZOCAINE?
Yes. 2 FDA drug label records list BENZALKONIUM CHLORIDE, BENZOCAINE as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Orajel Cold Sore Touch Free - Single Dose been recalled?
2 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.