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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
December 1, 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
December 1, 2022
Manufacturer
FSA Store Inc. (Caring Mills)
Registration number
ANDA208754
NDC root
81522-922
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 and is comparable to the active ingredient found in Abreva®. If you're looking for relief from cold sores, Docosanol Cream may be a suitable option to consider.

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 works to shorten the healing time and reduce the duration of symptoms such as tingling, pain, burning, and itching.

By using this treatment, you can expect relief from the discomfort associated with cold sores, allowing you to feel more like yourself again in a shorter amount of time.

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—like a tingling sensation—apply the cream directly to the affected area on your face or lips. It's important to begin treatment as soon as you feel that tingle, as early intervention leads to the best results. Gently rub the cream in completely, ensuring it covers the area well.

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 this treatment 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 keep the area clean and prevent 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 while using this product.

Side Effects

You should be aware that this product can cause a severe allergic reaction in some individuals. Symptoms of such a reaction may 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 and seek medical attention immediately.

Additionally, if your cold sore worsens or does not heal within 10 days, you should stop using the product and consult your doctor for further advice.

Warnings and Precautions

This product is for external use only and may cause a severe allergic reaction in some individuals. If you experience symptoms such as hives, facial swelling, wheezing or difficulty breathing, shock, or a rash, stop using the product immediately and seek medical help.

If the product is accidentally swallowed, it’s important to get emergency medical assistance 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 consult your doctor for further advice.

Overdose

If you suspect an overdose of this medication, it's important to stay calm and take immediate action. While the specific signs of overdose are not detailed, common symptoms can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these signs, or if you are unsure, seek medical help right away.

In case of an overdose, contact your local emergency services or go to the nearest hospital. It's crucial to provide healthcare professionals with as much information as possible about the medication taken and the amount. Remember, acting quickly can make a significant difference in your safety and health.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that there is no specific information available about the use of Docosanol Cream during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions related to its use in pregnant individuals have not been established.

As always, it's best to consult with your healthcare provider before using any medication during pregnancy to ensure the safety of both you and your baby.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of this product while nursing. Additionally, there is no information available about whether this product is excreted in breast milk or any potential risks to your infant. Always consult with your healthcare provider if you have any concerns or questions about using medications 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. Gently rub the cream in completely and use it five times a day until the area is healed.

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 there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations apply, but you should always consult your healthcare provider for personalized advice. They can help monitor your liver function and determine the best course of action for your treatment.

Make sure to keep your doctor informed about your liver health, as they may need to conduct regular tests to ensure your safety while using any medication. Your well-being is a priority, and your healthcare team is there to support you.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. In this case, there are no known drug interactions or laboratory test interactions associated with the medication. However, always ensure that your healthcare provider is aware of all the medications you are using, as this helps them provide the best care tailored to your needs.

By discussing your full medical history and any other treatments, you can help prevent potential issues and ensure your safety.

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 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 cold 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, apply it to the affected area at the first sign of a cold sore, 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 product and seek medical help immediately.

Can children use Docosanol Cream?

Children under 12 years should ask a doctor before using this product.

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

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

Where 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 to use during pregnancy or while nursing?

The provided information does not specify any warnings or recommendations regarding the use of Docosanol Cream during pregnancy or lactation.

What are the contraindications for using Docosanol Cream?

Do not use this product if you are allergic to any ingredient in it, and avoid using it in or near the eyes.

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 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 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 itching.

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 the following situations:

  • Patients with a known allergy to any ingredient in this product.

  • Application in or near the eyes is contraindicated due to the potential for irritation or injury.

  • Direct application inside the mouth is not recommended to prevent 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 without delay.

This product is intended for external use only. It is crucial to advise patients against ingestion. If the product is swallowed, immediate medical attention should be sought, or the Poison Control Center should be contacted.

Patients should be instructed to stop using the product and consult their healthcare provider if their cold sore worsens or fails to heal within 10 days. Monitoring for these symptoms is essential to ensure patient safety and effective management of their condition.

Side Effects

Patients may experience a range of adverse reactions associated with this product. Notably, there is a potential for severe allergic reactions, which may manifest as hives, facial swelling, wheezing or difficulty breathing, shock, and rash.

In clinical practice, it is advised that patients discontinue use and consult a healthcare professional if their cold sore worsens or fails to heal within 10 days. This recommendation is crucial to ensure appropriate management and to mitigate any potential complications arising from the use of the product.

Drug Interactions

No drug interactions or drug and laboratory test interactions have been identified in the available data. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary 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, 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). It should be gently rubbed in completely and used five times a day until healing occurs.

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, given the lack of targeted data for this population.

Pregnancy

There is no specific information available regarding the use of Docosanol Cream during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients. It is advisable to weigh the potential benefits against any unknown risks to fetal outcomes. Women of childbearing potential should be counseled accordingly, and alternative treatments may be considered in the absence of established safety data.

Lactation

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

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

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 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 information regarding overdosage, it is essential for healthcare professionals to remain vigilant and exercise caution when administering the medication.

Should an overdosage occur, it is recommended that healthcare providers assess the patient for any potential symptoms that may arise, although specific symptoms have not been detailed in the available data.

Management of an overdosage situation should involve standard supportive care measures. This may include monitoring vital signs, providing symptomatic treatment, and ensuring the patient is stable.

In cases where the overdosage is suspected, it is advisable to contact a poison control center or seek expert consultation for further guidance on management strategies.

Healthcare professionals are encouraged to report any observed adverse effects or complications related to overdosage to the appropriate regulatory authorities to enhance the understanding of the medication's safety profile.

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 use of the compound in question. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert.

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 of its ingredients. It is important to counsel patients to stop using the product and consult a doctor if their cold sore worsens or does not heal within 10 days.

When using this product, patients should 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 must be advised 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 freezing may compromise its integrity. Proper container requirements should be adhered to in order to maintain the product's quality during storage and handling.

Additional Clinical Information

The product is administered topically, applied to the affected area on the face or lips at the first sign of a cold sore or fever blister (tingle). Patients should 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 are advised to 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.