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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 2023
Label revision date
March 22, 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 2023
Label revision date
March 22, 2023
Manufacturer
P & L Development, LLC
Registration number
ANDA208754
NDC root
59726-877
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 an over-the-counter treatment specifically designed for cold sores and fever blisters. It is the only FDA-approved medication that helps shorten the healing time and reduce the duration of symptoms such as tingling, pain, burning, and itching associated with these outbreaks.

This cream is comparable to the active ingredient found in Abreva® and comes in a convenient portable pump, making it easy to apply when needed. If you're looking for relief from cold sore symptoms, Docosanol Cream may be a helpful option for you.

Uses

If you’re dealing with cold sores or fever blisters on your face or lips, this medication can help. It’s specifically designed to treat these uncomfortable outbreaks and is the only medicine approved by the FDA to shorten the healing time.

Not only does it help clear up the sores, but it also reduces the duration of symptoms like tingling, pain, burning, and itching. By using this treatment, you can expect a quicker recovery and relief from the discomfort associated with cold sores.

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 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, 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

You should avoid using this product if you are allergic to any of its ingredients. It's also important not to apply it in or near your eyes, or 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

You should be aware that this product can cause a severe allergic reaction in some individuals. Symptoms of such a reaction may include hives, swelling of the face, 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 a 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 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 emergency medical assistance or contact a Poison Control Center at 1-800-222-1222 right away.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While there is no specific information available about the signs of overdose for this medication, general 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 always better to be safe and get checked by a healthcare professional if you have any concerns about your health.

Pregnancy Use

There are no specific guidelines or warnings regarding the use of Docosanol Cream during pregnancy. The information available does not indicate any risks or contraindications for pregnant individuals, nor does it suggest any dosage modifications. As always, it's important 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, 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 the best 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 there are no specific guidelines, dosage adjustments, or monitoring requirements mentioned for your condition in the provided information. This means that the standard recommendations for medication use may apply to you, but it's always best to consult with your healthcare provider for personalized advice. They can help ensure that any medications you take are safe and effective for your specific health needs.

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, and there are no special monitoring requirements or precautions outlined for patients with liver impairment.

However, it's always a good idea to discuss your liver health with your healthcare provider before starting any new medication. They can provide personalized advice and ensure that your treatment is safe and effective for 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, your healthcare provider can help ensure that your overall treatment plan is safe and effective, taking into account all the medications and tests you may be using. Always feel free to ask questions and share your complete health history to get the best care possible.

Storage and Handling

To ensure the best performance of your product, store it at a temperature between 20° and 25°C (68° and 77°F). It's important to keep it in this range to maintain its effectiveness. Please avoid freezing the product, as this can damage it and affect its safety.

When handling the product, make sure to do so in a clean environment to prevent contamination. Following these storage and handling guidelines will help you use the product safely and effectively.

Additional Information

You should apply this topical medication to the affected area on your face or lips at the first sign of a cold sore or fever blister, such as a tingling sensation. Use it five times a day until the sore is healed.

Be aware that this product may cause a severe allergic reaction, which can include symptoms like hives, facial swelling, wheezing, or rash. If you experience any of these symptoms, stop using the product and seek medical help immediately. Remember, this medication is for external use only, and you should not share it with others to prevent spreading the infection. If your cold sore worsens or does not heal within 10 days, consult your doctor. Keep this product out of reach of children, and if swallowed, contact a Poison Control Center or seek medical assistance right away.

FAQ

What is Docosanol Cream used for?

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

How does Docosanol Cream work?

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

How should I apply Docosanol Cream?

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

What should I do if I am allergic to any ingredient in Docosanol Cream?

Do not use the cream if you are allergic to any of its ingredients, as it may cause a severe allergic reaction.

Can children use Docosanol Cream?

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

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.

Is Docosanol Cream safe to use during pregnancy or while 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 storage instructions for Docosanol Cream?

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

What should I do if I accidentally swallow Docosanol Cream?

If swallowed, seek medical help or contact a Poison Control Center immediately at 1-800-222-1222.

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 an over-the-counter formulation indicated for the treatment of cold sores and fever blisters. This cream is presented in a portable and convenient pump, with a net weight of 2 g (0.07 oz). Docosanol Cream, 10% contains the only FDA-approved active ingredient for shortening the healing time and duration of symptoms associated with these conditions.

Uses and Indications

This drug is indicated for the treatment of cold sores and fever blisters on the face or lips. It is the only FDA-approved medication that shortens the healing time and reduces 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, typically indicated by 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 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 discontinue use 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 at 1-800-222-1222 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 serious complications that may arise from prolonged use or worsening symptoms.

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 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 prior to 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). Early treatment is essential for optimal results. The cream should be gently but completely rubbed in and applied five times a day until healing is achieved.

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 they may have altered pharmacokinetics and pharmacodynamics. Close monitoring is recommended to ensure safety and efficacy in this population.

Pregnancy

There are no specific statements regarding the use of Docosanol Cream during pregnancy. The available data does not indicate any contraindications or risks associated with the use of this product in pregnant individuals. Additionally, no dosage modifications for pregnant individuals are provided. The insert does not include any special precautions regarding the use of this product during pregnancy. As with any medication, healthcare professionals should weigh the potential benefits against any unknown risks when considering the use of Docosanol Cream in pregnant patients.

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

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

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 specific guidance necessitates careful evaluation of the patient's overall health status and liver function.

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 initiate supportive care, which may include monitoring vital signs, providing symptomatic treatment, and ensuring the patient's safety.

If available, consultation with a poison control center or a medical toxicologist is recommended to guide further management and treatment options.

Documentation of the incident, including the substance involved, the amount taken, and the time of ingestion, 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

Patients should be advised to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 if the product is swallowed. It is essential to inform patients that they should not use the product if they have a known allergy to any of its ingredients.

Healthcare providers should instruct patients 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 be reminded to apply it only to the affected areas and to avoid contact with the eyes. They should also be cautioned against applying the product directly inside the mouth and advised not to share it with others, as this may facilitate the spread of infection.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It is essential to store the product at a temperature range of 20° to 25°C (68° to 77°F). Freezing the product is strictly prohibited, as it may compromise its integrity and efficacy. Proper handling and storage conditions must be adhered to in order to maintain the quality of the product.

Additional Clinical Information

Patients should apply the product topically to the affected area on the face or lips at the first sign of a cold sore or fever blister (tingle). The recommended frequency of application is five times a day until the lesion is healed.

Clinicians should counsel patients on the potential for severe allergic reactions, which may manifest as hives, facial swelling, wheezing, shock, or rash. Patients are advised to discontinue use and seek immediate medical attention if any allergic symptoms occur. This product is for external use only and should not be shared to prevent the spread of infection. Patients should also be instructed to stop use and consult a doctor if the cold sore worsens or does not heal within 10 days. Additionally, the product should be kept out of reach of children, and in the event of ingestion, medical help or contact with a Poison Control Center should be sought immediately.

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.