Benzalkonium Chloride/Benzocaine

Benzalkonium chloride/benzocaine is an over-the-counter (OTC) product used to treat cold sores.

Benzalkonium chloride/benzocaine is available under the following different brand names: Orajel Single Dose.

Dosages of Benzalkonium Chloride/Benzocaine:

Dosage Forms and Strengths

Topical Solution (Touch-Free Applicator)

• 0.13%/5%

Dosage Considerations – Should be Given as Follows:

Cold Sores

Orajel Single Dose: Apply single dose topically to cold sore (see administration)

Administration

Orajel Single Dose

Adults and children 2 years and older

• Clean lip area using only warm water or alcohol of any lip preparations, lotions, ointments, residual beverages, or cosmetics, including lipstick
• Follow directions on the applicator to allow the medication to saturate the tip
• 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, 1 treatment is typically enough, if symptoms go away and then return, apply another dose for the second cold sore
• Do not exceed 3 or more applications/day
• Discard after use

Side effects of benzalkonium chloride/benzocaine include:

• Temporary stinging at the application site

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Benzalkonium chloride/benzocaine has no listed severe interactions with other drugs.
• Benzalkonium chloride/benzocaine has no listed serious interactions with other drugs.
• Benzalkonium chloride/benzocaine has no listed moderate interactions with other drugs.
• Benzalkonium chloride/benzocaine has no listed mild interactions with other drugs.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. Check with your physician if you have health questions or concerns.

Warnings

• This medication contains benzalkonium chloride/benzocaine. Do not take Orajel Single Dose if you are allergic to benzalkonium chloride/benzocaine or any ingredients contained in this drug.
• Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

Contraindications

• Hypersensitivity

Effects of Drug Abuse

• No information available

Short-Term Effects

• See "What Are Side Effects Associated with Using Benzalkonium Chloride/Benzocaine?”

Long-Term Effects

• See "What Are Side Effects Associated with Using Benzalkonium Chloride/Benzocaine?”

Cautions

• For external use only
• Flammable, keep away from fire or flame
• Stop and contact dentist or physician if symptoms persist more than 7 days
• Ingredients in toothpaste, soft drinks, and some fruit juices can deactivate active ingredient

Pregnancy and Lactation

• Use benzalkonium chloride/benzocaine with caution during pregnancy if the benefits outweigh the risks. Animal studies show risk and human studies are not available or neither animal nor human studies were done.
• It is unknown whether benzalkonium chloride/benzocaine is distributed in breast milk.
• Pregnant or breastfeeding patients should seek the advice of a health professional before using over-the-counter (OTC) drugs.