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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 2021
Label revision date
October 12, 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
October 12, 2023
Manufacturer
H E B
Registration number
ANDA208754
NDC root
37808-223
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 intended for topical use only and is similar to the active ingredient found in Abreva®. If you experience cold sores, Docosanol Cream may provide relief and help speed up your recovery.

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 and get back to your daily activities more quickly. Rest assured, there are no concerns about teratogenic effects (which means it doesn’t cause birth defects) associated with this treatment.

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

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

Please be aware of these potential reactions to ensure your safety while using this product.

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 or difficulty breathing, 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 medical assistance or contact a Poison Control Center 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 or symptoms of an overdose for this medication, general signs can include unusual drowsiness, confusion, or difficulty breathing.

If you notice any of these symptoms or have concerns about a possible overdose, seek medical help right away. It's always better to err on the side of caution when it comes to your health. Remember, if you are ever in doubt, contacting a healthcare professional is the best course of action.

Pregnancy Use

There is currently no specific information available about using Docosanol Cream during pregnancy. The provided information does not mention any contraindications (situations where the drug should not be used) or safety concerns related to pregnancy. Additionally, there are no dosage modifications or special precautions recommended for pregnant individuals.

If you are pregnant or planning to become pregnant, it's always a good idea to consult with your healthcare provider before using any medication, including over-the-counter products like Docosanol Cream. They can provide personalized advice based on your health and circumstances.

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 for you to use this cream 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 any medication while nursing. They can provide personalized advice based on your individual situation.

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. Gently rub the cream in completely and use it five times a day until the area is healed.

Always keep this product out of reach of children. If the cream is swallowed, 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, and factors like kidney function (renal impairment) and changes in cognition can affect how well a drug works or how it may impact you.

If you are an older adult or a caregiver, it’s wise to discuss any medications with your healthcare provider. They can help determine the best approach for your individual health needs and ensure that any potential risks are managed effectively. Always keep an open line of communication with your doctor about any concerns or side effects you may experience.

Renal Impairment

If you have kidney problems, it's important to know that there are no specific guidelines, dosage adjustments, or monitoring recommendations provided for your condition in the available information. This means that the standard instructions do not address how your kidney health might affect the use of this medication.

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for you, especially if you have renal impairment (kidney issues). Your doctor can help determine the best approach based on your individual 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.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe for your liver health. They can provide guidance tailored to your specific situation.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking, even if there are no specific drug interactions or laboratory test interactions noted for your treatment. This ensures that your healthcare team can provide the best care tailored to your needs.

Always inform your doctor about all the medications, supplements, and tests you are undergoing. This helps them monitor your health effectively and make informed decisions about your treatment plan. Your safety and well-being are the top priority, so don't hesitate to ask questions or express any concerns you may have.

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 and affect its effectiveness.

When handling the product, make sure to do so in a clean environment to maintain its integrity. Always follow any additional safety guidelines provided with the product to ensure safe usage and disposal.

Additional Information

You should apply this medication topically, using it five times a day until the area is healed. It's important to be aware of a few key points: if you experience an allergic reaction, stop using the product and seek medical help immediately. Additionally, if your cold sore worsens or does not heal within 10 days, consult your doctor. Always keep this medication out of reach of children, and if it is swallowed, contact a Poison Control Center or seek medical assistance right away.

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, helping to shorten healing time and alleviate symptoms like tingling, pain, burning, and itching.

How should I apply Docosanol Cream?

You should 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 contraindications for using Docosanol Cream?

Do not use Docosanol Cream if you are allergic to any ingredient in the product. It should also not be used in or near the eyes or inside the mouth.

What should I do if I experience an allergic reaction?

If you experience symptoms of a severe allergic reaction, such as 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.

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

If your cold sore worsens or does not heal within 10 days, stop using the cream and consult a doctor.

How should I store Docosanol Cream?

Store Docosanol Cream at a temperature between 20° to 25°C (68° to 77°F) and do not freeze it.

Is there any information about using Docosanol Cream during pregnancy?

The provided information does not mention any specific concerns or contraindications regarding the use of Docosanol Cream during pregnancy.

What should I do if I accidentally swallow Docosanol Cream?

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

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 10% is a non-prescription topical formulation indicated for the treatment of cold sores. Each tube contains 2 grams (0.07 ounces) of the cream. This product is designed to shorten the healing time and duration of symptoms associated with cold sores. It is important to note that this product is not manufactured or distributed by GSK Consumer Healthcare, the distributor of Abreva®.

Uses and Indications

This drug is indicated for the treatment of cold sores and fever blisters located on the face or lips. It is effective in shortening the healing time and reducing the duration of associated symptoms, including tingling, pain, burning, and/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, typically when a tingling sensation is felt. 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 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 should not use it due to the risk of allergic reactions. 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 contraindicated, as it may facilitate the spread of infection.

Warnings and Precautions

This product has the potential to induce a severe allergic reaction. Healthcare professionals should be vigilant for symptoms such as hives, facial swelling, wheezing or difficulty breathing, shock, and rash. In the event of an allergic reaction, it is imperative to discontinue use immediately and seek medical assistance without delay. This product is intended for external use only.

Patients should be advised not to use this product if they have a known allergy to any of its ingredients. It is essential to assess the patient's allergy history prior to administration to mitigate the risk of adverse reactions.

In cases where a cold sore worsens or does not heal within 10 days, patients should be instructed to stop using the product and consult their healthcare provider for further evaluation and management.

If the product is ingested, immediate medical attention is required. Patients or caregivers should contact a Poison Control Center or seek emergency medical help without hesitation.

Side Effects

Patients may experience severe allergic reactions associated with this product. 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.

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 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 should be sought or contact with a Poison Control Center is advised.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

Pregnancy

There is no specific information available regarding the use of Docosanol Cream during pregnancy. The prescribing information does not indicate any contraindications or safety concerns related to its use in pregnant patients. Additionally, there are no dosage modifications or special precautions recommended for women of childbearing potential. 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 considerations regarding the use of Docosanol Cream in lactating mothers. The available data does not indicate any known effects on breastfed infants or excretion in breast milk. Healthcare professionals may consider the use of this medication in lactating mothers, as no adverse effects have been documented in this population.

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 implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

Additionally, it is recommended to consult local poison control centers or toxicology experts for guidance on specific management protocols and interventions tailored to the situation.

Documentation of the incident, including the substance involved, estimated dose, and time of exposure, 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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

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). Care must be taken to ensure that the product does not freeze, as this may compromise its integrity. Proper storage conditions are essential to maintain the quality and efficacy of the product.

Additional Clinical Information

The product is administered topically and should be applied five times a day until the affected area is healed. Clinicians should counsel patients to discontinue use and seek medical attention immediately if an allergic reaction occurs. Additionally, patients are advised to stop use and consult a doctor if their cold sore worsens or does not heal within 10 days. It is important to keep the product out of reach of children, and in the event of ingestion, medical help or contact with a Poison Control Center should be sought promptly.

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.