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Cold Sore Treatment

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Active ingredient
Docosanol 100 mg/1 g
Other brand names
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2023
Label revision date
December 29, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Docosanol 100 mg/1 g
Other brand names
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2023
Label revision date
December 29, 2025
Manufacturer
P & L Development, LLC
Registration number
ANDA212385
NDC root
59726-112
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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 topical treatment specifically designed for cold sores and fever blisters that appear on the face or lips. It is the only medicine approved by the FDA to help shorten the healing time and reduce the duration of symptoms such as tingling, pain, burning, and itching associated with these outbreaks.

By applying Docosanol cream, you can expect to experience relief from the discomfort of cold sores while promoting faster healing. This makes it a valuable option for managing the symptoms and effects of cold sores effectively.

Uses

If you’re dealing with cold sores or fever blisters on your face or lips, this medication can help. It not only treats these uncomfortable sores but also shortens the healing time and reduces the duration of symptoms like tingling, pain, burning, and itching.

You can expect relief from these symptoms, allowing you to feel more comfortable and get back to your daily activities more quickly. Rest assured, there are no concerns about teratogenic effects (which means it doesn’t cause birth defects) associated with this treatment.

Dosage and Administration

Before you start using the cream, make sure to wash your hands thoroughly. When you notice the first signs of a cold sore or fever blister, such as a tingling sensation, apply the cream directly to the affected area on your face or lips. It's important to begin treatment as early as possible for the best results. Gently rub the cream into the skin until it is fully absorbed.

For adults and children aged 12 years and older, you should apply the cream five times a day until the cold sore is healed. If you are considering using this cream for a child under 12, it’s best to consult a doctor first for guidance. Remember to wash your hands again after applying the cream to avoid spreading the virus.

What to Avoid

It's important to be aware of certain precautions when using this product. First and foremost, do not use it if you are allergic to any of its ingredients, as this could lead to serious reactions. Additionally, avoid applying the product in or near your eyes and do not use it directly inside your mouth. Sharing this product with others is also discouraged, as it can spread infections.

Remember, your safety is a priority, so please follow these guidelines closely to ensure the best possible outcome.

Side Effects

This product may lead to a severe allergic reaction in some individuals. Symptoms of such a reaction can include hives, facial swelling, wheezing or difficulty breathing, shock, and rash. If you experience any of these symptoms, it is important to stop using the product immediately and seek medical assistance.

Please be aware of these potential side effects and monitor your body’s response when using the product. Your safety is paramount, so do not hesitate to reach out for help if you notice any concerning symptoms.

Warnings and Precautions

This product is for external use only and may cause a severe allergic reaction in some people. If you experience symptoms like hives, facial swelling, wheezing or difficulty breathing, shock, or a rash, stop using the product immediately and seek medical help. It's important not to use this product if you are allergic to any of its ingredients.

If you accidentally swallow the product, get emergency medical help or contact a Poison Control Center right away. Additionally, if your cold sore worsens or does not heal within 10 days, stop using the product and call your doctor for further advice.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, it's important to be aware of the general signs of an overdose, which can include symptoms like extreme drowsiness, confusion, or difficulty breathing. If you suspect an overdose, it is crucial to seek immediate medical attention.

In case of an emergency, call your local emergency services or go to the nearest hospital. Always keep your medications in a safe place and follow the prescribed dosage to prevent any potential risks. If you have any concerns or questions about your medication, don’t hesitate to reach out to your healthcare provider for guidance.

Pregnancy Use

When it comes to using Docosanol Cream during pregnancy, there is currently no specific information available about its safety or effectiveness. This means that there are no known safety concerns, dosage changes, or special precautions outlined for pregnant individuals.

If you are pregnant or planning to become pregnant, it’s always best to consult with your healthcare provider before using any medication, including over-the-counter products like Docosanol Cream. They can help you make informed decisions based on your individual health needs.

Lactation Use

If you are breastfeeding, you can use Docosanol Cream without specific warnings or recommendations against it. The information available does not indicate any concerns about the cream being passed into breast milk or any risks to your nursing infant. However, as always, it's a good idea to consult with your healthcare provider if you have any questions or concerns about using any medication while breastfeeding.

Pediatric Use

If your child is under 12 years old, it's important to consult a doctor before using this cream. For those aged 12 and older, you should wash your hands before and after applying the cream to the affected area on the face or lips as soon as you notice the first signs of a cold sore or fever blister, like a tingling sensation. Early treatment is key for the best results. Gently rub the cream in completely and use it five times a day until the area is healed.

Always keep this cream out of reach of children. If your child accidentally swallows it, seek medical help or contact a Poison Control Center immediately.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that if you or a loved one is an older adult considering this medication, it’s important to consult with a healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

Renal Impairment

If you have kidney problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment plan.

Hepatic Impairment

If you have liver problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication may affect you if you have hepatic impairment (issues with liver function).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your liver health. They can help monitor your condition and make any necessary adjustments to your treatment plan.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you. Always share your complete list of medications and any recent lab tests to avoid any potential issues. Your health and safety should always come first.

Storage and Handling

To ensure the best performance of your product, store it at a temperature between 20° to 25°C (68° to 77°F). It's important to keep it away from freezing temperatures, as freezing can damage the product.

When handling the product, make sure to maintain a clean environment to avoid contamination. Always follow any specific instructions provided for safe use and disposal to ensure your safety and the effectiveness of the product.

Additional Information

You should apply this cream topically to the affected area on your face or lips as soon as you notice the first signs of a cold sore or fever blister, such as tingling. For the best results, use it five times a day until the sore is healed.

Make sure to wash your hands before and after applying the cream to prevent spreading the infection. It's also important not to share this product with anyone else, as this can lead to the transmission of the virus. Starting treatment early is key to achieving the best outcome.

FAQ

What is Docosanol Cream used for?

Docosanol Cream 10% is used to treat cold sores and fever blisters on the face or lips.

How does Docosanol Cream work?

It is the only FDA-approved medicine that shortens healing time and reduces symptoms like tingling, pain, burning, and itching.

How should I apply Docosanol Cream?

Wash your hands before and after applying the cream to the affected area at the first sign of a cold sore. Rub it in gently and use it 5 times a day until healed.

What should I do if I experience an allergic reaction?

If you experience symptoms like hives, facial swelling, or difficulty breathing, stop using the cream and seek medical help immediately.

Can I use Docosanol Cream if I am pregnant or nursing?

There is no specific information regarding the use of Docosanol Cream during pregnancy or lactation, so consult your doctor for advice.

What precautions should I take when using Docosanol Cream?

Do not use the cream if you are allergic to any of its ingredients, and avoid applying it near your eyes or inside your mouth.

What should I do if I swallow Docosanol Cream?

If swallowed, get medical help or contact a Poison Control Center right away.

How should I store Docosanol Cream?

Store the cream at 20° to 25°C (68° to 77°F) and do not freeze it.

Is Docosanol Cream safe for children?

For children under 12 years, consult a doctor before use.

What should I do if my cold sore does not heal?

Stop using the cream and consult your doctor if your cold sore worsens or does not heal within 10 days.

Packaging Info

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

Packaging configurations for Cold Sore Treatment.
Details

Drug Information (PDF)

This file contains official product information for Cold Sore Treatment, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

No description information is available for the drug.

Uses and Indications

This drug is indicated for the treatment of cold sores and fever blisters located on the face or lips. It is effective in shortening the healing time and reducing the duration of associated symptoms, including tingling, pain, burning, and/or itching.

There are no teratogenic effects associated with this drug, and no nonteratogenic effects have been reported.

Dosage and Administration

Healthcare professionals are advised to instruct patients to wash their hands thoroughly before and after applying the cream. For adults and children aged 12 years and older, 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 crucial for optimal results. The cream should be rubbed in gently but completely, and it is recommended to apply the cream five times a day until the lesion is healed.

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

Contraindications

Use of this product is contraindicated in individuals with a known allergy to any ingredient contained within.

Additionally, the product should not be applied in or near the eyes, nor should it be used directly inside the mouth. Sharing this product with others is also contraindicated, as it may facilitate the spread of infection.

Warnings and Precautions

This product carries a significant risk of severe allergic reactions. Healthcare professionals should be vigilant for symptoms such as hives, facial swelling, wheezing or difficulty breathing, shock, and rash. In the event of an allergic reaction, it is imperative to discontinue use immediately and seek medical assistance.

This product is intended for external use only. It is contraindicated in individuals with known allergies to any of its ingredients. Therefore, a thorough review of the patient's allergy history is essential prior to administration.

In cases of accidental ingestion, immediate medical attention is required. Healthcare providers should advise patients to contact a Poison Control Center or seek emergency medical help without delay.

Patients should be instructed to discontinue use and consult a physician if their cold sore worsens or fails to heal within 10 days. Monitoring for these conditions is crucial to ensure appropriate management and intervention.

Side Effects

Patients using this product may experience severe allergic reactions. Symptoms of such reactions can include hives, facial swelling, wheezing or difficulty breathing, shock, and rash. In the event of an allergic reaction, it is imperative that patients discontinue use immediately and seek medical assistance without delay.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

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

Packaging configurations for Cold Sore Treatment.
Details

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. For adolescents aged 12 years and older, the recommended application involves washing hands before and after applying the cream 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, and the cream should be gently but completely rubbed in five times a day until healing occurs.

It is important to keep this product out of reach of children. In the event of accidental ingestion, immediate medical assistance or contact with a Poison Control Center is advised.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

Pregnancy

There is no information available regarding the use of Docosanol Cream during pregnancy. The prescribing information does not indicate any safety concerns, dosage modifications, or special precautions for pregnant patients. Healthcare professionals should consider the lack of data when prescribing this medication to women of childbearing potential and weigh the potential benefits against any unknown risks to fetal outcomes.

Lactation

There are no specific warnings or recommendations regarding the use of Docosanol Cream in lactating mothers. The insert does not provide information on the potential for excretion of Docosanol in breast milk or any associated risks to breastfed infants. Therefore, healthcare professionals should consider the absence of data when advising lactating mothers on the use of this medication.

Renal Impairment

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials for this medication. Consequently, there is no available information regarding dosage adjustments, special monitoring requirements, or precautions for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be warranted based on clinical judgment.

Overdosage

In the absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant regarding the potential for overdose with this medication. In cases where an overdose is suspected, immediate medical attention should be sought.

Healthcare providers are advised to monitor patients closely for any signs or symptoms that may indicate an overdose. These may include, but are not limited to, altered mental status, cardiovascular instability, or gastrointestinal disturbances.

Management of an overdose should be guided by the clinical presentation of the patient. Supportive care is paramount, and symptomatic treatment should be initiated as necessary. It is recommended that healthcare professionals consult local poison control centers or relevant toxicology resources for further guidance on the management of overdose cases.

In summary, while specific overdosage information is not available, healthcare professionals should exercise caution and be prepared to act swiftly in the event of an overdose, ensuring that appropriate measures are taken to safeguard patient health.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert.

Patient Counseling

Patients should be advised to keep this product out of reach of children to prevent accidental ingestion. In the event of swallowing the product, it is crucial to seek medical assistance or contact a Poison Control Center immediately.

Healthcare providers should inform patients not to use the product if they are allergic to any of its ingredients. Patients should be instructed to discontinue use and consult a doctor if their cold sore worsens or does not heal within 10 days.

When using this product, patients must apply it only to the affected areas and avoid contact with the eyes. They should be cautioned against applying the product directly inside the mouth. Additionally, patients should not share this product with others, as this may facilitate the spread of infection.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It should be stored at a temperature range of 20° to 25°C (68° to 77°F). Care must be taken to ensure that the product does not freeze, as freezing may compromise its integrity. Proper container requirements should be adhered to, and special handling needs must be observed to maintain the product's quality and efficacy.

Additional Clinical Information

The product is administered topically, with application to the affected area on the face or lips at the first sign of a cold sore or fever blister (tingle). Patients are advised to apply the cream five times a day until healing occurs.

Clinicians should counsel patients to wash their hands before and after applying the cream to prevent the spread of infection. Early treatment is emphasized to ensure optimal results, and patients are instructed not to share the product with others.

Drug Information (PDF)

This file contains official product information for Cold Sore Treatment, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Cold Sore Treatment, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

Learn more in our Editorial Policy

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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.