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What is the only OTC FDA approved drug for cold sores?: The Efficacy of Docosanol

4 min read

An estimated one-in-five Americans are affected by cold sores annually. For those seeking an effective over-the-counter solution, it is important to know what is the only OTC FDA approved drug for cold sores and how it is proven to shorten healing time.

Quick Summary

Docosanol, the active ingredient in Abreva, is the only FDA-approved over-the-counter medication for cold sores. It functions by inhibiting the herpes virus's ability to infect healthy skin cells, which helps to shorten healing time and reduce symptoms when applied early.

Key Points

  • Docosanol is the only FDA-Approved OTC Drug: Docosanol (brand name Abreva) is the sole over-the-counter medication with FDA approval to shorten the healing time of cold sores.

  • Inhibits Viral Spread: It works by blocking the herpes simplex virus from entering healthy cells, thereby stopping the viral replication cycle and shortening the duration of the outbreak.

  • Start Early for Best Results: For maximum efficacy, treatment with docosanol must begin at the first sign of a cold sore, such as tingling, burning, or itching.

  • Clinically Proven Effectiveness: Clinical trials have shown that docosanol can shorten the median healing time by approximately 18 hours compared to a placebo.

  • Symptom Relief vs. Healing: Unlike many other OTC products that only provide pain relief or drying effects, docosanol actively targets the virus to speed up healing.

  • Proper Application Protocol: It should be applied five times daily until the cold sore is healed, for a maximum of 10 days, with clean hands.

In This Article

The Quest for Cold Sore Relief

Cold sores, also known as fever blisters or herpes labialis, are caused by the herpes simplex virus type 1 (HSV-1). After the initial infection, the virus remains dormant in nerve cells and can be reactivated by triggers like stress, sunlight, or a weakened immune system, leading to a recurrent outbreak. These blisters are not only painful but also highly contagious.

Many over-the-counter (OTC) products promise relief, but not all are created equal. While many can soothe symptoms, only one has received Food and Drug Administration (FDA) approval specifically for its ability to shorten healing time: docosanol.

Understanding Docosanol: The FDA-Approved Solution

What Is Docosanol?

Docosanol is the active ingredient in the widely known brand Abreva, as well as several generic versions. It is a topical cream designed to treat cold sores on the face or lips. The FDA's approval of docosanol is based on its demonstrated efficacy in clinical trials for shortening the healing process and the duration of associated symptoms.

How Docosanol Works

Unlike some topical remedies that simply numb pain, docosanol's mechanism of action is unique and addresses the viral cause of the cold sore. It works by inhibiting the herpes simplex virus from entering and infecting healthy skin cells. By blocking the virus's ability to fuse with the cell membrane, docosanol helps contain the viral spread and allows the healing process to begin sooner. This effectively shortens the cold sore's duration and reduces associated symptoms like tingling, pain, burning, and itching. It is important to note that docosanol does not kill the virus; instead, it prevents its proliferation.

Proper Application for Maximum Efficacy

For docosanol to be most effective, timing is crucial. The treatment should be initiated as soon as the first sign of a cold sore, known as the prodromal stage, appears. This is typically a tingling, itching, or burning sensation in the affected area. Starting treatment early ensures that the cream can interfere with the virus's replication cycle before the blisters fully form. Waiting until the sore has fully erupted diminishes the drug's effectiveness.

How to Apply Docosanol

  • Wash your hands thoroughly before and after application to prevent spreading the infection.
  • Apply the cream to the affected area on the face or lips at the first sign of symptoms.
  • Rub the cream in gently but completely.
  • Use the medication five times a day until the cold sore is healed, for a maximum of 10 days.
  • You may apply cosmetics like lipstick over the treated area once the cream has dried, but use a separate applicator to avoid contamination.

Clinical Evidence Supporting Docosanol

Clinical studies have provided the evidence for docosanol's effectiveness. In a randomized, double-blind, placebo-controlled multicenter study, docosanol reduced the median healing time for cold sores by approximately 18 hours compared to a placebo group when applied at the prodrome or erythema stage. The study also found a significant reduction in the duration of pain, burning, itching, and tingling. Other studies have shown a reduction in healing time by as much as 1.6 days when applied early. While its impact might seem modest, it represents a clinically significant improvement over untreated outbreaks.

A Comparison of OTC Cold Sore Treatments

Understanding how different OTC products work is key to choosing the right treatment. While docosanol is the only FDA-approved antiviral, other products address symptoms differently.

Feature Docosanol (e.g., Abreva) Other OTC Options (e.g., Orajel, Campho-Phenique)
Active Ingredient(s) Docosanol 10% Benzocaine, Benzyl Alcohol, Camphor, Phenol, Lysine
FDA-Approved to Shorten Healing Time? Yes No; primary FDA role is symptom relief
Mechanism of Action Inhibits viral entry into healthy cells Local anesthetic (pain relief), drying agent, skin protectant
Best Time to Apply At the first sign (tingle, burn, itch) As needed for symptom relief during any stage
Primary Benefit Shortens healing time and duration of symptoms Reduces pain and discomfort

The Landscape of Cold Sore Treatments

It's important to remember that docosanol is just one option within a broader treatment landscape. For more severe or frequent outbreaks, a healthcare provider might prescribe an oral antiviral medication, such as valacyclovir (Valtrex), which can be highly effective, especially when taken at the first sign of an outbreak. For those who experience frequent recurrences (6+ episodes per year), a doctor might even recommend suppressive therapy.

It is also worth mentioning that some OTC products focus on soothing and protecting the area rather than targeting the virus itself. These can help manage discomfort but will not alter the course of the viral infection.

Conclusion

For patients seeking an effective and readily available solution for cold sores, the only OTC FDA approved drug for cold sores that is clinically proven to shorten healing time is docosanol. By understanding its unique antiviral mechanism and applying it at the crucial early stage, individuals can significantly reduce the duration and discomfort of a cold sore outbreak. While other topical products offer symptom relief, docosanol is the only one available over-the-counter that actively helps speed up the healing process. Early intervention is the key to achieving the best results and getting your cold sore to heal faster.

For more detailed information, consult the Mayo Clinic guide on docosanol.

Frequently Asked Questions

The active ingredient in the only FDA-approved over-the-counter (OTC) cold sore treatment is docosanol, which is found in brand name products like Abreva.

Docosanol works by inhibiting the herpes simplex virus from fusing with healthy cells, thereby blocking its ability to spread and replicate. This helps to shorten the healing time and reduces the duration of symptoms.

For the best results, you should start applying docosanol cream at the very first sign of a cold sore, such as tingling, itching, or burning. Early application ensures maximum effectiveness.

Many other OTC cold sore products, such as those with pain relievers, are not FDA-approved to shorten healing time. They primarily offer symptom relief like numbing pain, while docosanol is the only one approved to speed up healing.

Yes, docosanol can be used with other treatments. For example, some products provide immediate pain relief, and docosanol can be used simultaneously to target the viral cause of the cold sore. Always follow the directions for each product.

If your cold sore gets worse or is not healed within 10 days of treatment with docosanol, you should stop use and consult a doctor.

Abreva is the leading brand name product containing docosanol. However, various generic versions containing 10% docosanol are also available at pharmacies and retail stores.

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Medical Disclaimer

This content is for informational purposes only and should not replace professional medical advice.