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Cold Sore Fever Blister

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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 2025
Label revision date
January 3, 2025
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 2025
Label revision date
January 3, 2025
Manufacturer
P & L Development, LLC
Registration number
ANDA212385
NDC root
59726-221
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 topical cream is similar to the active ingredient found in Abreva® and is intended for external use only. If you're looking for relief from cold sore symptoms, docosanol cream may be a helpful option to consider.

Uses

If you're dealing with cold sores or fever blisters on your face or lips, this medication can help. It 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, 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

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

This product may cause a severe allergic reaction, which can be serious. Symptoms to watch for include hives, facial swelling, wheezing or difficulty breathing, shock, and rash. If you experience any of these symptoms, it’s important to stop using the product immediately and seek medical help. Your safety is a priority, so please be aware of these potential reactions.

Warnings and Precautions

This product may cause a severe allergic reaction, which can include symptoms like hives, facial swelling, wheezing or difficulty breathing, shock, and rash. If you experience any of these symptoms, stop using the product immediately and seek medical help. Remember, this product is for external use only, and you should not use it 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 for further advice. Additionally, if the product is swallowed, seek emergency medical help or contact a Poison Control Center right away. Your safety is important, so please take these precautions seriously.

Overdose

If you suspect an overdose of this medication, it's important to know that there is no specific information available about what to expect or how to respond. However, if you experience unusual symptoms or feel unwell after taking the medication, you should seek medical help immediately.

Signs of an overdose can vary, but if you notice anything concerning, such as extreme drowsiness, confusion, or difficulty breathing, it's crucial to contact a healthcare professional right away. Always err on the side of caution and reach out for help if you are unsure about your symptoms or the amount of medication taken.

Pregnancy Use

The safety of docosanol during pregnancy has not been established, meaning there is limited information on how it may affect you or your developing baby. While there are no specific contraindications (conditions that would prevent use) mentioned for pregnant individuals, it’s important to note that there is also no data available regarding potential risks to the fetus.

If you are pregnant or planning to become pregnant, it is crucial to consult your doctor before using docosanol. They can provide personalized advice and help you weigh the benefits and risks based on your individual situation. There are no specific dosage modifications recommended for pregnant individuals, but your healthcare provider will guide you on the best course of action.

Lactation Use

If you are breastfeeding or planning to breastfeed, you can feel reassured that there are no specific warnings or considerations regarding the use of Docosanol Cream for nursing mothers. This means that, based on the information available, it is generally considered safe to use while breastfeeding. However, as always, it's a good idea to consult with your healthcare provider if you have any concerns or questions about using this product while nursing.

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. Since older adults may have different health needs and responses to medications, you should always consult with a healthcare provider before starting any new medication. They can help determine the right dosage and monitor for any potential side effects, ensuring that the treatment is safe and effective for you or your loved one.

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 determine the best approach for your treatment and monitor your liver function as needed.

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, so don't hesitate to ask questions or express any concerns you may have.

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 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 tailored to you.

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 specific instructions provided for use to ensure safety and effectiveness. If you have any questions about disposal or further handling, please refer to the guidelines provided with your 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 or fever blister, such as tingling. For best results, use it five times a day until the sore is healed. There are no additional details regarding laboratory tests, abuse potential, or patient counseling information available.

FAQ

What is docosanol cream used for?

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

How should I apply docosanol cream?

You should wash your hands before and after applying the cream to the affected area on the face or lips at the first sign of a cold sore. Apply 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 cream and seek medical help immediately.

Can children use docosanol cream?

Docosanol cream is intended for adults and children 12 years or older. For children under 12, you should ask a doctor before use.

Is docosanol cream safe to use during pregnancy?

The safety of docosanol during pregnancy has not been established, so consult a doctor before use if you are pregnant or planning to become pregnant.

What should I do if I swallow docosanol cream?

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

Where should I store docosanol cream?

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

Are there any contraindications for using docosanol cream?

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

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

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

Packaging Info

Below are the non-prescription pack sizes of Cold Sore Fever Blister (docosanol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Cold Sore Fever Blister.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Docosanol cream is a 10% topical formulation indicated for the treatment of cold sores and fever blisters. This non-prescription medicine is designed to shorten the healing time and reduce the duration of symptoms associated with these conditions. The product is intended for external use only and is packaged in a net weight of 2 grams (0.07 ounces).

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 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 when a tingling sensation is felt. 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 prohibited due to potential irritation or harm.

  • Direct application inside the mouth should be avoided 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.

For external use only, this product should not be applied if the patient has a known allergy to any of its ingredients. It is essential to assess the patient's allergy history prior to administration.

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

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

Side Effects

This product may cause a severe allergic reaction in some patients. Symptoms of such reactions can include hives, facial swelling, wheezing or difficulty breathing, shock, and rash. In the event of an allergic reaction, it is imperative that patients discontinue use immediately and seek medical assistance without delay.

Patients should be aware of these potential adverse reactions and monitor for any signs of allergy during treatment.

Drug Interactions

There are no specific drug interactions reported for this medication. Additionally, no laboratory test interactions have been identified in the available data. 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 (docosanol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Cold Sore Fever Blister.
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 but completely rubbed in five times a day until healing occurs.

It is important to keep the product out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought 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 potential adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

The safety of docosanol during pregnancy has not been established. There are no specific contraindications for its use during pregnancy; however, no data are available regarding potential risks to the fetus. As such, healthcare professionals should exercise caution when considering the use of docosanol in pregnant patients.

It is recommended that women who are pregnant or planning to become pregnant consult a healthcare provider before using this medication. No specific dosage modifications for pregnant individuals are provided, but the lack of established safety data necessitates careful consideration and consultation with a physician.

Lactation

There are no specific warnings or considerations regarding nursing mothers or lactation associated with the use of Docosanol Cream. Therefore, lactating mothers may use this medication without concern for adverse effects on breastfed infants. However, as with any medication, it is advisable for lactating mothers to consult with their healthcare provider before use.

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

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 caution and consider the overall clinical context when prescribing this medication to patients with liver problems, as the absence of specific guidance necessitates careful evaluation of potential risks and benefits.

Overdosage

In the context of overdosage, it is important to note that the available sections of the drug insert do not provide specific information regarding potential overdosage scenarios.

Healthcare professionals are advised to exercise caution and consider the possibility of overdosage when administering the medication. In the absence of detailed guidance, it is recommended that clinicians monitor patients closely for any unusual symptoms or adverse reactions that may arise following administration.

In the event of suspected overdosage, standard supportive measures should be implemented. This may include symptomatic treatment and monitoring of vital signs. Healthcare providers should also consider consulting a poison control center or a medical toxicologist for further management recommendations tailored to the specific clinical situation.

Given the lack of specific overdosage information, it is crucial for healthcare professionals to remain vigilant and proactive in managing any potential complications that may arise from excessive dosing.

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.

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 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.

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 should be reminded to apply it only to the affected areas and to avoid contact with the eyes. Additionally, patients should be cautioned against applying the product directly inside their mouths.

It is important to emphasize to patients that this product should not be shared 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). Care must be taken to ensure that the product does not freeze, as this may compromise its integrity. Proper container requirements and handling procedures should be followed to maintain the quality and efficacy of the product.

Additional Clinical Information

The medication is administered topically, specifically applied to the affected area on the face or lips at the first sign of a cold sore or fever blister, such as a tingling sensation. Patients are advised to use the treatment five times a day until the lesion is healed.

There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

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