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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 2021
Label revision date
March 20, 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 2021
Label revision date
March 20, 2023
Manufacturer
Walgreens
Registration number
ANDA208754
NDC root
0363-9222
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 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 similar to the active ingredient found in Abreva® and is intended for topical use only. If you're looking for a way to manage the discomfort and speed up the healing process of cold sores, Docosanol Cream may be a suitable option for you.

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 as you recover. Rest assured, there are no known 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 cautious when using this product. You should not use it if you are allergic to any of its ingredients. Additionally, avoid applying it 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 lead to the spread of infection.

By following these guidelines, you can help ensure your safety and the effectiveness of the treatment. If you have any concerns or questions, please consult with a healthcare professional.

Side Effects

This product may cause a severe allergic reaction, which can include symptoms such as hives, facial swelling, wheezing or difficulty breathing, shock, and rash. If you experience any of these symptoms, it’s 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 advice.

Warnings and Precautions

This product is for external use only and may cause a severe allergic reaction. If you experience symptoms such as hives, facial swelling, wheezing, 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, contact a Poison Control Center or seek medical assistance 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, it's important to stay calm and take immediate action. While there are no specific signs or symptoms listed for an overdose, you should be aware of general warning signs such as extreme drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms, 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 them with as much information as possible about the situation, including what substance was taken and when. Remember, acting quickly can make a significant difference in ensuring your safety and well-being.

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. The product insert does not indicate any safety concerns, dosage changes, or special precautions for pregnant individuals.

Given this lack of information, it's always best to consult with your healthcare provider before using any medication, including docosanol cream, to ensure it is safe for you and your baby.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or precautions 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 it may pose to your infant. Always consult with your healthcare provider if you have any concerns or questions about 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 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. Make sure to apply the cream gently and completely, using 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

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.

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 (liver issues).

Always consult your healthcare provider for personalized advice and to discuss any concerns regarding your liver health and how it may relate to your treatment. They can help ensure that you receive the safest and most effective care.

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, tailored specifically to your health needs.

Always keep your healthcare team informed about all the medications and supplements you use, as well as any lab tests you may undergo. This way, they can provide the best care and monitor your health appropriately.

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 topical product 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. Be aware that this product is for external use only and should not be applied near your eyes or inside your mouth.

It's important to note that this product may cause a severe allergic reaction, which can include symptoms like hives, facial swelling, or difficulty breathing. If you experience any of these symptoms, stop using the product and seek medical help immediately. Additionally, do not use it if you are allergic to any of its ingredients, and keep it out of reach of children. If swallowed, contact a Poison Control Center or seek medical assistance right away. If your cold sore worsens or does not heal within 10 days, consult your doctor.

FAQ

What is Docosanol Cream used for?

Docosanol Cream is a non-prescription medicine used to treat cold sores and fever blisters on the face or lips.

How does Docosanol Cream work?

It shortens the healing time and duration of symptoms, including tingling, pain, burning, and itching.

Who can use Docosanol Cream?

Adults and children 12 years or older can use it. For children under 12, consult a doctor.

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.

Are there any allergies associated with Docosanol Cream?

Yes, it may cause a severe allergic reaction. Symptoms can include hives, facial swelling, wheezing, shock, and rash. If an allergic reaction occurs, stop use and seek medical help immediately.

What should I avoid while using Docosanol Cream?

Do not use it in or near the eyes, avoid applying it directly inside your mouth, and do not share the product with anyone.

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

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

Is there any information about using Docosanol Cream during pregnancy or while nursing?

There is no specific information provided regarding its use during pregnancy or by nursing mothers.

How should I store Docosanol Cream?

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

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 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. Each tube contains a net weight of 2 g (0.07 oz) of the product, which 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, which may include 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 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 may induce a severe allergic reaction in some individuals. Symptoms indicative of such a reaction include 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. Ingestion of the product necessitates prompt medical attention; individuals should contact a Poison Control Center or seek medical help without delay.

Patients should refrain from using this product if they have a known allergy to any of its ingredients. Additionally, if the condition worsens or if the cold sore has not healed within 10 days, it is essential to stop use and consult a healthcare professional for further evaluation and management.

Side Effects

Patients may experience a range of adverse reactions associated with this product. Notably, there is a significant risk of severe allergic reactions, which may manifest as hives, facial swelling, wheezing or difficulty breathing, shock, and rash. These symptoms warrant immediate medical attention.

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 potential complications associated with prolonged symptoms.

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 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 rubbed in completely. The dosing regimen for this age group is five times a day until the lesion is healed.

It is important to keep the 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

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 is currently 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. As such, healthcare professionals should consider the lack of data when advising women of childbearing potential about the use of this medication during pregnancy. It is recommended that the potential benefits be weighed against any unknown risks to fetal outcomes.

Lactation

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

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 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 information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

If available, the use of antidotes or specific treatments should be considered based on the clinical scenario and the substance involved. Consultation with a poison control center or a medical toxicologist may be beneficial for guidance on management strategies tailored to the specific situation.

Documentation of the incident, including the amount and timing of the substance taken, is crucial for effective management and follow-up care.

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 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 for identification. It should be stored at a temperature range of 20° to 25°C (68° to 77°F). Freezing is strictly prohibited, as it may compromise the integrity of the product. Proper storage conditions must be maintained to ensure 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 healing occurs.

Clinicians should counsel patients on potential allergic reactions, which may include symptoms such as hives, facial swelling, wheezing, shock, or rash. Patients are advised to discontinue use and seek medical assistance immediately if an allergic reaction occurs. The product is for external use only and should not be applied near the eyes or inside the mouth. It is important to avoid sharing the product and to keep it out of reach of children. Patients should stop 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 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.

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.