ADD CONDITION

items per page

Docosanol

Last content change checked dailysee data sync status

Active ingredient
Docosanol 100 mg/1 g
Reference brand
Abreva
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2010
Label revision date
March 18, 2026
Active ingredient
Docosanol 100 mg/1 g
Reference brand
Abreva
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2010
Label revision date
March 18, 2026

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

If you are a consumer or patient please visit this version.

Drug Overview

Docosanol Cream, 10% is a non-prescription topical medication specifically designed to treat cold sores and fever blisters on the face or lips. It is the only FDA-approved over-the-counter medicine that shortens the healing time and reduces the duration of symptoms associated with these conditions, which may include tingling, pain, burning, and itching.

By applying Docosanol Cream, you can help alleviate the discomfort of cold sores while promoting faster healing. This cream is easy to use and is intended for topical application only. It is important to note that this product is not manufactured or distributed by GSK Consumer Healthcare, the distributor of Abreva, which contains a similar active ingredient.

Uses

You can use this cream to treat cold sores or fever blisters on your face or lips. It is designed to shorten the healing time and reduce the duration of uncomfortable symptoms such as tingling, pain, burning, and itching. This cream is the only non-prescription medicine approved by the FDA specifically for this purpose, making it a reliable option for managing cold sore outbreaks.

Dosage and Administration

To treat a cold sore or fever blister, start by washing your hands before and after applying the cream. Apply the cream to the affected area on your face or lips at the first sign of a cold sore, which is often a tingling sensation. It's important to begin treatment early for the best results. Gently rub the cream in completely and use it five times a day until the sore is healed.

If you are treating a child under 12 years old, please consult a doctor for guidance.

What to Avoid

You should avoid using this product if you are allergic to any of its ingredients. Additionally, do not apply it in or near your eyes, and refrain from applying it directly inside your mouth. It is important not to share this product with anyone, as doing so may spread the infection. Always prioritize your safety and well-being when using topical treatments.

Side Effects

This cold sore treatment cream may cause a severe allergic reaction. Symptoms to watch for include hives (itchy welts on the skin), facial swelling, wheezing or difficulty breathing, shock (a serious condition that can cause fainting), and rash. If you experience any of these symptoms, stop using the product immediately and seek medical help.

Additionally, you should stop using the cream and consult a doctor if your cold sore worsens or does not heal within 10 days.

Warnings and Precautions

This product may cause a severe allergic reaction. Symptoms can include hives, facial swelling, wheezing or difficulty breathing, shock, and rash. If you experience any of these symptoms, stop using the product immediately and seek medical help. It is for external use only, and you should not use it if you are allergic to any of its ingredients.

If your cold sore worsens or does not heal within 10 days, stop using the product and consult your doctor. Additionally, if the product is swallowed, get medical help or contact a Poison Control Center right away. Always keep this product out of reach of children.

Overdose

If you accidentally swallow a cream containing Docosanol, it's important to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222. While there is no specific information available regarding the effects of an overdose for these cold sore treatments, being cautious is essential.

Signs of an overdose may not be clearly defined, but if you experience any unusual symptoms after swallowing the cream, do not hesitate to seek assistance. Always use medications as directed to avoid potential risks.

Pregnancy Use

There is currently no specific information regarding the use of Docosanol cream during pregnancy, including any safety concerns, dosage modifications, or special precautions. The safety of this product during pregnancy has not been established, and there are no contraindications listed for its use. As such, it is important to consult with your healthcare provider before using this cream if you are pregnant, to ensure it is appropriate for your situation.

Lactation Use

You may be considering using Docosanol cream while breastfeeding. Currently, there are no specific warnings or recommendations regarding its use for nursing mothers. However, it is important to note that there is a potential for the active ingredient to be excreted in breast milk, which means it could pass into your milk. The effects on a nursing infant are not well studied, so it is advisable to consult your healthcare professional before using this product to weigh the risks and benefits.

Pediatric Use

For children under 12 years, it's important to consult a doctor before using this cold sore treatment cream. For adults and children aged 12 years and older, you should wash your hands before and after applying the cream. Apply it to the affected area on the face or lips at the first sign of a cold sore or fever blister (tingle). Early treatment is key for the best results, so rub the cream in gently but completely, using it five times a day until healed.

Always keep this product out of reach of children. If swallowed, seek medical help or contact a Poison Control Center immediately.

Geriatric Use

When using cold sore treatments like Docosanol cream, it's important to note that there is no specific information available regarding their use in older adults. This means that there are no recommended dosage adjustments, safety concerns, or special precautions outlined for elderly patients. If you are an older adult or a caregiver, it's advisable to consult with a healthcare professional before starting any new treatment, especially if you have underlying health conditions or are taking other medications. Always prioritize safety and seek guidance tailored to your individual health needs.

Renal Impairment

When using cold sore treatments, it's important to be aware of how kidney health can affect your medication. For some products, such as Julie Cold Sore Treatment, dosage adjustments may be necessary if you have renal impairment (reduced kidney function). If your kidney function is compromised, particularly if you have reduced creatinine clearance (a measure of kidney function), your healthcare provider may recommend closer monitoring and possibly a lower dose during treatment. It's advisable to have renal function tests performed before and during your treatment to ensure safety.

For other cold sore treatments, like Docosanol and various cold sore creams, there is no specific information regarding kidney-related dosage adjustments or monitoring. Always consult with your healthcare provider if you have kidney issues to ensure the safest and most effective treatment plan.

Hepatic Impairment

You can use the following cold sore treatments, including Docosanol and various cream formulations, without specific concerns regarding liver health. The available information does not indicate any need for dosage adjustments, special monitoring, or precautions for individuals with liver problems. This means that if you have liver impairment, you can generally use these products as directed without additional considerations related to your liver health. Always consult with your healthcare provider if you have any specific concerns or conditions.

Drug Interactions

You can use Cold Sore Fever Blister Treatment and Docosanol creams without worrying about drug interactions, as no specific interactions have been reported for these products. This means they are generally considered safe to use alongside other medications. However, it's always important to discuss any medications or treatments you are using with your healthcare provider. This ensures that you receive personalized advice and helps prevent any unforeseen issues, especially if you are taking other medications or have underlying health conditions.

Storage and Handling

To ensure the effectiveness of your cold sore treatment cream, store it at a temperature between 20° to 25°C (68° to 77°F). It's important to keep the cream away from freezing temperatures, as freezing can damage its formulation.

When you're finished using the cream, dispose of it according to local regulations for household waste. If you're unsure, check with your local waste management facility for guidance on proper disposal methods.

Uses and Indications

This drug is indicated for the treatment of cold sores and fever blisters on the face or lips. It is designed to shorten the healing time and duration of associated symptoms, which may include tingling, pain, burning, and/or itching.

This medication is the only FDA-approved non-prescription treatment specifically for shortening the healing time of cold sores. It is intended for topical use only.

Limitations of Use No teratogenic or nonteratogenic effects have been mentioned in the provided information.

Dosage and Administration

Adults and children 12 years or older are instructed to wash their hands before and after applying the cream. The cream should be applied to the affected area on the face or lips at the first sign of a cold sore or fever blister, such as a tingling sensation. Early treatment is emphasized to ensure the best results. The cream should be rubbed in gently but completely and used five times a day until healed.

For children under 12 years of age, it is advised to consult a doctor before use.

Contraindications

Do not use if allergic to any ingredient in this product. Use is contraindicated in or near the eyes, and it is advised to avoid applying directly inside the mouth. Sharing this product with others is not recommended, as it may spread the infection.

Warnings and Precautions

Allergy Alert This product may cause a severe allergic reaction. Symptoms may include:

  • hives

  • facial swelling

  • wheezing/difficulty breathing

  • shock

  • rash

If an allergic reaction occurs, stop use and seek medical help right away. For external use only. Do not use if you are allergic to any ingredient in this product.

Stop Use and Call Your Doctor Stop use and ask a doctor if your cold sore gets worse or is not healed within 10 days.

Get Emergency Medical Help If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

General Precautions When using this product:

  • Apply only to the affected areas.

  • Do not use in or near the eyes.

  • Avoid applying directly inside your mouth.

  • Do not share this product with anyone, as this may spread the infection.

Keep Out of Reach of Children If swallowed, get medical help or contact a Poison Control Center right away.

Side Effects

This product may cause a severe allergic reaction. Symptoms of such reactions may include:

  • Hives

  • Facial swelling

  • Wheezing or difficulty breathing

  • Shock

  • Rash

Patients are advised to stop using the product and seek medical help immediately if any of these symptoms occur.

Additionally, individuals should discontinue use and consult a doctor if their cold sore worsens or does not heal within 10 days. It is also important to avoid using this product if allergic to any ingredient contained within it.

Drug Interactions

No specific drug interactions or drug and laboratory test interactions have been identified for the products listed, which include various formulations of Docosanol and Cold Sore Fever Blister Treatments.

All reviewed labels consistently report the absence of documented interactions, indicating that these products do not have known pharmacokinetic or pharmacodynamic interactions with other drugs or laboratory tests. This lack of interaction data suggests a favorable safety profile regarding concurrent use with other medications or diagnostic procedures.

Pediatric Use

Children under 12 years should consult a doctor before using the cream. For adults and children aged 12 years and older, the following instructions apply:

  • Wash hands before and after applying the cream.

  • Apply to the affected area on the face or lips at the first sign of a cold sore or fever blister (tingle).

  • Early treatment is essential for optimal results.

  • Rub in gently but completely.

  • Use the cream 5 times a day until healed.

It is important to keep the product out of reach of children. If swallowed, seek medical help or contact a Poison Control Center immediately.

Geriatric Use

No specific information regarding geriatric use, dosage adjustments, safety concerns, or special precautions for elderly patients is provided in the inserts for the Cold Sore Fever Blister Treatment and Docosanol cream formulations. Therefore, healthcare professionals should exercise caution when prescribing these treatments to geriatric patients, as the absence of data may necessitate careful monitoring and consideration of individual patient factors.

Pregnancy

There is limited information available regarding the use of Docosanol Cream during pregnancy. The safety of Docosanol has not been established, and there are no specific warnings, contraindications, or safety concerns mentioned in the provided inserts. Additionally, no dosage modifications or special precautions for pregnant patients are specified.

Given the absence of data on potential risks to the fetus, healthcare professionals are advised to exercise caution when considering the use of this product in pregnant patients. It is recommended that healthcare providers discuss the potential benefits and risks with their patients before prescribing Docosanol Cream during pregnancy.

Lactation

There are no specific warnings or recommendations regarding the use of Docosanol Cream in nursing mothers. The available data does not provide information on the potential for excretion of the drug in breast milk or any associated risks to breastfed infants.

Nursing mothers are advised to consult a healthcare professional before using this product, as there is a potential for excretion in breast milk, and the effects on a nursing infant are not well studied. Therefore, the risks versus benefits should be carefully considered when administering this treatment during lactation.

Renal Impairment

Patients with renal impairment may require careful consideration when using certain treatments. Specifically, for one product, dosage adjustments may be necessary for those with moderate to severe renal impairment. It is recommended that patients with reduced creatinine clearance be closely monitored throughout the treatment process. Additionally, renal function tests should be conducted prior to and during treatment to ensure patient safety and efficacy of the therapy.

For other products, there is no specific information available regarding renal impairment, dosage adjustments, or special monitoring requirements. Therefore, healthcare providers should exercise caution and consider individual patient circumstances when prescribing these treatments to patients with kidney problems.

Hepatic Impairment

Patients with hepatic impairment have no specific dosage adjustments, monitoring requirements, or precautions indicated for the use of the cream formulations discussed. The available data across multiple labels, including those for Docosanol and various cold sore treatments, consistently lack information regarding the impact of hepatic impairment on drug metabolism or efficacy. Therefore, healthcare providers should exercise standard clinical judgment when considering treatment options for patients with liver conditions, as no specific guidance is provided in the product inserts.

Overdosage

In the event of an overdose involving the cream formulations of Cold Sore Fever Blister Treatment or Docosanol, there is no specific information provided regarding the symptoms or management of such an occurrence. However, it is advised that if the product is swallowed, immediate medical assistance should be sought. Contacting a Poison Control Center is recommended, with the national hotline available at 1-800-222-1222.

Due to the lack of detailed overdosage information across the various labels, monitoring for any unusual symptoms following exposure is prudent. Healthcare professionals should be prepared to provide supportive care as needed, given the absence of specific antidotes or treatment protocols outlined in the available documentation.

Nonclinical Toxicology

Teratogenic Effects

No teratogenic effects were observed in animal studies. Additionally, no increase in fetal malformations was reported in the available data.

Non-Teratogenic Effects

There were no non-teratogenic effects mentioned in the provided information.

Nonclinical Toxicology

Specific details regarding nonclinical toxicology were not provided in the available data.

Animal Pharmacology and Toxicology

Animal studies did not demonstrate any adverse developmental outcomes. No information was provided regarding other aspects of animal pharmacology and toxicology.

Storage and Handling

The product is supplied as a cream formulation. It should be stored at a temperature range of 20° to 25°C (68° to 77°F). It is important to ensure that the product does not freeze during storage.

Product Labels

The table below lists all over-the-counter labels containing docosanol. Use it to compare dosage forms, strengths, and uses across products.

FDA-Approved Docosanol Labels (Originator & Generics) showing branded and generic formulations with forms, routes, strengths, and FDA approval years.
More Details

Repacked & Relabeled Product Labels

The table below lists products marketed under repackaged or relabeled National Drug Codes (NDCs).

Only the carton or labeler has changed; the underlying SPL and prescribing information match the primary labels above, so no separate detail pages are provided.

Below are the non-prescription pack sizes of Cold Sore Fever Blister Treatment (docosanol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

FDA-Approved Docosanol Repack / Relabels showing repack and relabel formulations with forms, routes, strengths, and FDA years.
Label
Forms
Routes
Docosanol
FDA year
Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It consolidates data from 80 FDA Structured Product Labels (DailyMed) for Docosanol (marketed as Cold Sore Fever Blister Treatment, Julie Cold Sore Treatment, Cold Sore Treatment), with data retrieved by a validated AI data-extraction workflow. This includes 80 distinct product formulations. All FDA-listed dosage forms and strengths are aggregated in the sections above. Regulatory status appears in the Summary Information panel and was verified in the FDA National Drug Code directory. Detailed product-specific information is available via the individual label pages linked above. No human clinician has reviewed this version.

Learn more in our Editorial Policy

Last AI update:

Primary FDA sources:

Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.