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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 2021
Label revision date
October 18, 2022
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 2021
Label revision date
October 18, 2022
Manufacturer
P & L Development, LLC
Registration number
ANDA208754
NDC root
59726-924
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

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 medication designed to help treat cold sores and fever blisters on the face or lips. It works by shortening the healing time and reducing the duration of symptoms such as tingling, pain, burning, and itching associated with these outbreaks.

This cream is intended for topical use only, making it easy to apply directly to the affected area. If you're looking for relief from cold sores, docosanol cream may be a helpful option to consider.

Uses

If you’re dealing with cold sores or fever blisters on your face or lips, this medication can help. It works to shorten the healing time and reduce the duration of uncomfortable symptoms like tingling, pain, burning, and itching.

You can find this treatment available over-the-counter, making it easy to access when you need relief from cold sores. With its effective formula, you can expect quicker healing and a more comfortable experience.

Dosage and Administration

Before 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 start treatment as early as possible for the best results. Gently rub the cream in until it is completely 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, please consult a doctor first for guidance. Remember to wash your hands again after applying the cream to avoid spreading the virus.

What to Avoid

You should avoid using this product if you are allergic to any of its ingredients. It's also important not to use it in or near your eyes, and you should refrain from applying it directly inside your mouth. Additionally, please do not share this product with anyone, as doing so could spread an infection. Always prioritize your safety and well-being when using any medication.

Side Effects

This product may cause a severe allergic reaction in some individuals. Symptoms of an allergic reaction can include hives, swelling of the face, 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 this product. Your safety is a priority, 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. Symptoms of an allergic reaction 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.

Before using this product, make sure you are not allergic to any of its ingredients. If your cold sore worsens or does not heal within 10 days, stop using the product and contact your doctor. Additionally, if the product is swallowed, seek medical assistance or contact a Poison Control Center right away.

Overdose

If you suspect an overdose, it's important to act quickly. Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms, seek immediate medical help.

In the event of an overdose, contact your local emergency services or go to the nearest hospital. It's crucial to provide them with as much information as possible about the substance taken and the amount, if known. Remember, timely intervention can make a significant difference in outcomes.

Pregnancy Use

There are no specific guidelines or warnings about using docosanol cream during pregnancy. The information available does not indicate any risks or contraindications associated with its use while you are pregnant. Additionally, there are no recommended dosage changes for pregnant individuals, and no special precautions are noted.

As always, it's a good idea to consult with your healthcare provider before using any medication during pregnancy to ensure it is safe for you and your baby.

Lactation Use

If you are breastfeeding and considering the use of docosanol cream, you can feel reassured that there are no specific warnings or recommendations against its use for nursing mothers. Additionally, there is no information indicating that docosanol cream is passed into breast milk or poses any risk to your infant. Always consult with your healthcare provider if you have any concerns or questions 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 children aged 12 and older, you should wash your hands before and after applying the cream. Apply it to the affected area on the face or lips as soon as you notice the first signs of a cold sore or fever blister, such as a tingling sensation. Starting treatment early can lead to better results. Make sure to rub the cream in gently and completely, using it five times a day until the area is healed.

Geriatric Use

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. As you age, your body may process medications differently, which can affect how well they work and the potential for side effects.

If you or a loved one is considering this medication, it’s wise to discuss it with a healthcare provider. They can help determine if any adjustments are needed based on individual health conditions and ensure that the treatment is safe and effective for older adults. Always prioritize open communication with your healthcare team about any concerns or questions you may have.

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.

It's always best to discuss your individual situation with your healthcare provider, who can offer personalized advice and ensure that any medications you take are safe and effective for you.

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 should be used if you have hepatic impairment (liver issues).

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 determine the best course of action based on your individual situation.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking. In this case, there are no specific drug interactions or laboratory test interactions noted, which means that this medication is generally considered safe to use alongside other treatments and tests. However, every individual is different, and your healthcare provider can help ensure that your overall treatment plan is safe and effective for you. Always feel free to ask questions or express any concerns you may have regarding your medications or tests.

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 do so in a clean environment to maintain its integrity. Always follow any additional safety instructions provided with the product to ensure safe usage and disposal.

Additional Information

You should apply this medication topically to the affected area on your face or lips as soon as you notice the first signs of a cold sore, such as tingling. Use it five times a day until the sore is healed. Remember, this product is for external use only, so avoid using it in or near your eyes and do not apply it directly inside your mouth. It's important not to share this product with others, as it can spread the infection. If your cold sore worsens or does not heal within 10 days, stop using the product and consult a doctor.

FAQ

What is docosanol cream 10% used for?

Docosanol cream 10% is a non-prescription medicine used to shorten the healing time and duration of symptoms for cold sores or fever blisters on the face or lips.

How should I apply docosanol cream?

You should 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 am allergic to an ingredient in docosanol cream?

Do not use docosanol cream if you are allergic to any ingredient in the product.

Can I use docosanol cream if I am pregnant or nursing?

The insert does not provide specific information regarding the use of docosanol cream during pregnancy or lactation, so consult your doctor for advice.

What are the potential allergic reactions to docosanol cream?

Docosanol cream may cause severe allergic reactions, including hives, facial swelling, wheezing, shock, or rash. If any of these occur, stop use and seek medical help immediately.

What should I do if my cold sore does not heal within 10 days?

If your cold sore gets worse or is not healed within 10 days, stop using the cream and consult your doctor.

Where should I store docosanol cream?

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

Is docosanol cream safe for children?

Children under 12 years should ask a doctor before use, while those 12 years and older can use it as directed.

Can I use docosanol cream near my eyes or inside my mouth?

No, you should not use docosanol cream in or near the eyes or apply it directly inside your mouth.

What should I do if I accidentally swallow docosanol cream?

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

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

Docosanol cream 10% is a non-prescription topical formulation indicated for the treatment of cold sores and fever blisters. This cream is designed to shorten the healing time and reduce the duration of symptoms associated with these conditions. It is intended for external use only.

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 reduce the duration of associated symptoms, including tingling, pain, burning, and itching. As a non-prescription medicine, it provides an accessible option for patients seeking to alleviate the discomfort and expedite the healing process of cold sores.

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, typically indicated by a tingling sensation. Early treatment is crucial for achieving optimal results.

The cream should be gently but completely rubbed into the affected area. 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 the following situations:

  • Patients with a known allergy to any ingredient in this product, due to the risk of allergic reactions.

  • Application in or near the eyes is contraindicated to prevent potential irritation or damage.

  • Direct application inside the mouth should be avoided to reduce the risk of adverse effects.

  • Sharing this product with others is 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.

For external use only, this product should not be applied by individuals with known allergies to any of its ingredients. It is essential to assess patient history for any potential allergic responses prior to administration.

Patients should be advised to stop using the product and consult a healthcare provider if their cold sore worsens or fails to heal within 10 days. This precaution is critical to ensure appropriate management and to prevent complications.

In cases of accidental ingestion, immediate medical attention is required. Patients or caregivers should contact a Poison Control Center or seek emergency medical help without delay. Monitoring for these adverse events is crucial to ensure patient safety and effective treatment outcomes.

Side Effects

Patients using this product should be aware of the potential for severe allergic reactions. Symptoms of such reactions may 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.

The occurrence of these serious adverse reactions necessitates careful monitoring and prompt intervention to ensure patient safety.

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions with laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

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 and adults aged 12 years and older, it is recommended to wash 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 (tingle). Early treatment is essential for optimal results. The cream should be gently rubbed in completely and applied five times a day until healing is achieved.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

There are no specific statements regarding the use of docosanol cream during pregnancy. The available prescribing information does not mention any contraindications or risks associated with the use of this product in pregnant patients. Additionally, no dosage modifications for pregnant individuals are provided. The insert also does not include any special precautions regarding the use of this product during pregnancy. As such, healthcare professionals should consider the absence of data when advising women of childbearing potential and pregnant patients regarding the use of docosanol cream.

Lactation

There are no specific warnings or recommendations regarding the use of docosanol cream in lactating mothers. Additionally, there is no information available about the potential for excretion of docosanol in breast milk or any associated risks to breastfed infants.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined 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 prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

In the absence of specific details regarding overdosage for this medication (SPL code 34088-5), healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdosage.

Recommended Actions In the event of an overdosage, it is essential to seek immediate medical attention. Healthcare providers should assess the patient's clinical status and consider the need for supportive care. Monitoring vital signs and providing symptomatic treatment may be necessary.

Potential Symptoms While specific symptoms of overdosage are not detailed, healthcare professionals should remain vigilant for any unusual or severe reactions that may arise following excessive intake of the medication. Symptoms may vary based on the pharmacological properties of the drug and the individual patient's response.

Management Procedures Management of overdosage should be tailored to the individual case. Healthcare professionals are encouraged to consult established guidelines and protocols for the management of overdosage related to similar pharmacological agents. In cases where antidotes or specific interventions are available, these should be administered as appropriate.

In summary, due to the lack of specific overdosage information, healthcare professionals must rely on their clinical judgment and established medical guidelines to manage any suspected cases effectively.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the compound in these areas.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children. Instruct patients that if the product is swallowed, they should seek medical help or contact a Poison Control Center immediately.

Patients should be informed not to use the product if they are allergic to any ingredient contained within it. It is important for healthcare providers to emphasize that if the patient's cold sore worsens or does not heal within 10 days, they should stop using the product and consult a doctor.

When discussing the application of this product, healthcare providers should instruct patients to apply it only to the affected areas. They should be cautioned against using the product in or near the eyes and advised to avoid applying it directly inside the mouth. Additionally, patients should be reminded not to share this product with anyone, as this may facilitate the spread of the 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 this may compromise its integrity. Proper container requirements should be adhered to, and special handling needs must be observed to maintain the quality of the product throughout its storage period.

Additional Clinical Information

The product is administered topically, specifically applied 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 use the product five times a day until the lesion is healed.

Clinicians should counsel patients that the product is for external use only and must not be used in or near the eyes, nor applied directly inside the mouth. It is important to avoid sharing the product to prevent the spread of infection. Patients should discontinue use and consult a doctor if the cold sore worsens or does not heal within 10 days.

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.