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Cold Sore Fever Blister 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 2022
Label revision date
June 6, 2023
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 2022
Label revision date
June 6, 2023
Manufacturer
Meijer Distribution Inc.
Registration number
ANDA208754
NDC root
79481-9220
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 is a topical cream that is used to treat cold sores and fever blisters on the face or lips. It works by shortening the healing time and reducing the duration of symptoms, which can include tingling, pain, burning, and itching. As a non-prescription medicine, it is designed for easy access and can be applied directly to the affected area to help alleviate discomfort and promote healing.

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.

By using this treatment, you can expect quicker relief and a faster return to normalcy, making those pesky cold sores less of a hassle.

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

It's important to be aware of certain precautions when using this product. First, 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 apply it directly inside your mouth. Sharing this product with others is also discouraged, as it can spread infections.

Remember, taking care of your health means using medications responsibly. If you have any concerns or questions about using this product, please consult with a healthcare professional.

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 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 guidance.

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.

You should also stop using this product and consult your doctor if your cold sore worsens or does not heal within 10 days. If the product is swallowed, it’s important to get emergency medical help 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, as this will help healthcare professionals provide the best care. Remember, your safety is the top priority, so don’t hesitate to reach out for help.

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.

Given this lack of information, it is advisable to consult with your healthcare provider before using Docosanol Cream to ensure it is safe for you and your baby. Always prioritize open communication with your doctor about any medications or treatments you are considering during pregnancy.

Lactation Use

If you are breastfeeding, you can use Docosanol Cream without specific warnings or recommendations against it. Currently, there is no information available about whether this cream passes into breast milk or if it poses any risk to your nursing infant. As always, if you have concerns or questions about using any medication while breastfeeding, it's a good idea to consult with your healthcare provider for personalized advice.

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

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 the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to change based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your specific situation. They can help monitor your kidney health and make any necessary adjustments to your medications.

Hepatic Impairment

If you have liver problems, it's important to know that there are no specific guidelines, dosage adjustments, or special monitoring instructions provided for your condition in the available information. This means that the medication may not have been studied in depth for its effects on individuals with liver impairment.

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver health and medication use. They can help ensure that your treatment is safe and effective based on your individual health needs.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking, even if there are no known drug interactions or laboratory test interactions associated with them. This ensures that your treatment plan is safe and effective for your individual health needs.

Always feel free to ask questions and share any concerns you may have regarding your medications or tests. Your healthcare provider is there to help you understand how to manage your health safely.

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 and safety. Always follow any additional instructions provided with the product for optimal use 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, and you should not share it with others to avoid spreading the infection. If your cold sore worsens or does not heal within 10 days, stop using the product and consult a doctor. In case of accidental swallowing, seek medical help or contact a Poison Control Center immediately.

FAQ

What is Docosanol used for?

Docosanol is a cream used to treat cold sores and fever blisters on the face or lips.

How does Docosanol work?

Docosanol shortens the healing time and duration of symptoms, which include tingling, pain, burning, and/or itching.

How should I apply Docosanol?

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?

Do not use Docosanol if you are allergic to any ingredient in this product.

What are the allergy alerts for Docosanol?

Docosanol may cause a severe allergic reaction, with symptoms like hives, facial swelling, wheezing, shock, or rash. If an allergic reaction occurs, stop use and seek medical help immediately.

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

Stop using Docosanol and ask a doctor if your cold sore gets worse or is not healed within 10 days.

Can I use Docosanol if I am under 12 years old?

If you are under 12 years old, you should ask a doctor before using Docosanol.

Is Docosanol safe to use during pregnancy or while nursing?

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

How should I store Docosanol?

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

What should I do if I accidentally swallow Docosanol?

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 Fever Blister Treatment (docosanol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Cold Sore Fever Blister Treatment.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Docosanol is a topical cream formulated at a concentration of 10%. It is indicated for the treatment of cold sores and is designed for non-prescription use. The product aims to shorten the healing time and duration of symptoms associated with cold sores. It is intended solely for external application. This product is not manufactured or distributed by GSK Consumer Healthcare, the owner of the registered trademark Abreva®.

Uses and Indications

This drug is indicated for the treatment of cold sores and fever blisters 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 should 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 achieving 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 advised to consult a physician before use.

Contraindications

Use of this product is contraindicated in individuals with a known allergy to any of its ingredients.

Additionally, the product should not be applied in or near the eyes, nor should it be applied 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 crucial to advise patients to stop using the product and consult a healthcare provider if their cold sore worsens or fails to heal within 10 days.

In cases of accidental ingestion, immediate medical attention is required. Patients should be instructed to contact a Poison Control Center or seek emergency medical help without delay.

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 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 Fever Blister Treatment (docosanol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Cold Sore Fever Blister Treatment.
Details

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before using this medication. 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 but completely rubbed in and used 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 potential 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.

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

There is no information available regarding the use of this medication in patients with hepatic impairment. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions specified for individuals with compromised liver function. Healthcare professionals should exercise clinical judgment when considering the use of this medication in patients with liver problems, as the absence of data does not preclude the need for careful evaluation and monitoring based on individual patient circumstances.

Overdosage

In the absence of specific details regarding overdosage for this product (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. Symptoms may vary based on the pharmacological profile of the substance involved.

Management Procedures Management of overdosage should be tailored to the individual patient and may include decontamination procedures, such as activated charcoal, if appropriate and within the timeframe for effective intervention. Consultation with a poison control center or toxicology expert is recommended for guidance on specific management strategies.

In summary, due to the lack of specific overdosage information, healthcare professionals should prioritize patient safety and employ standard overdosage management protocols while remaining alert to any potential symptoms that may develop.

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 text.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center if the product is swallowed. It is essential to inform patients not to use the product if they have a known allergy 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 the product, patients must apply it only to the affected areas and should be cautioned against using it in or near the eyes. Additionally, they should avoid applying the product directly inside the mouth.

Healthcare providers should emphasize the importance of not sharing this product with others, as doing so may facilitate the spread of the infection.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It should be stored at a temperature range of 20° to 25°C (68° to 77°F). Freezing is not permitted, as it may compromise the integrity of the product. Proper handling and storage conditions are essential to maintain the product's efficacy and safety.

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 should not be shared, as this may spread the infection. Patients are advised to discontinue use and consult a doctor if the cold sore worsens or does not heal within 10 days. In the event of accidental ingestion, immediate medical assistance or contact with a Poison Control Center is recommended.

Drug Information (PDF)

This file contains official product information for Cold Sore Fever Blister 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 Fever Blister 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.

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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.