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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
July 19, 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
July 19, 2023
Manufacturer
Walgreens
Registration number
ANDA212385
NDC root
0363-6510
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 the only over-the-counter (OTC) medicine approved by the FDA specifically designed to shorten the healing time for cold sores and fever blisters on the face or lips. It helps alleviate symptoms such as tingling, pain, burning, and itching, making it a convenient option for those looking to manage these common skin irritations.

This cream comes in a portable pump, allowing for easy application whenever you need it. By using Docosanol Cream, you can expect a reduction in the duration of your cold sore symptoms, helping you feel more comfortable and confident.

Uses

If you’re dealing with cold sores or fever blisters on your face or lips, there’s a specific treatment available that can help. This medication is the only one approved by the FDA to not only treat these sores but also to shorten the healing time and reduce the duration of uncomfortable symptoms like tingling, pain, burning, and itching.

Using this treatment can make a significant difference in how quickly you recover from cold sores, allowing you to feel more comfortable and get back to your daily activities sooner.

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—like a tingling sensation—apply the cream directly to the affected area on your face or lips. It's important to begin treatment as soon as you feel that tingle, as early intervention leads to 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 this treatment for a child under 12, it’s best to consult a doctor first. 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. If you experience symptoms such as hives, facial swelling, wheezing or difficulty breathing, shock, or a rash, you should seek medical attention immediately.

Additionally, if your cold sore worsens or does not heal within 10 days, it’s important to stop using the product and consult your doctor.

Warnings and Precautions

This product is for external use only and may cause a severe allergic reaction in some people. Symptoms of an allergic reaction can include 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.

Before using this product, make sure you are not 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.

In case of accidental swallowing, it’s important to get medical help right away or contact a Poison Control Center at 1-800-222-1222.

Overdose

If you suspect an overdose, it's important to act quickly. Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms, seek immediate medical help.

In the event of an overdose, contact your local emergency services or go to the nearest hospital. It's crucial to provide them with as much information as possible about the substance taken and the amount, if known. Remember, timely intervention can make a significant difference in outcomes.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that there is no specific information available about the use of docosanol cream during pregnancy. This means that the safety of this product for pregnant individuals has not been established.

Since there are no documented safety concerns, dosage changes, or special precautions mentioned for its use during pregnancy, it is advisable to consult with your healthcare provider before using docosanol cream. They can help you weigh the potential benefits and risks based on your individual situation.

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 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. Apply the cream gently but thoroughly five times a day until the area is healed.

Always keep this cream out of reach of children. If the cream is swallowed, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

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 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 ensure that any medication you take is safe and appropriate for your liver health. They can help monitor your condition and make any necessary adjustments to your treatment plan.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking. In this case, there are no specific drug interactions or laboratory test interactions noted, which means that this medication is generally considered safe to use alongside other treatments and tests. However, every individual is different, and your healthcare provider can help ensure that your overall treatment plan is safe and effective for you. Always feel free to ask questions or express any concerns you may have regarding your medications or tests.

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 maintain a clean environment to avoid contamination. Always follow any specific instructions provided for safe use and disposal to ensure your safety and the effectiveness of the product.

Additional Information

You should apply the topical medication five times a day until the cold sore is healed. If your cold sore worsens or does not heal within 10 days, stop using the product and consult your doctor. Additionally, if the medication is accidentally swallowed, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

FAQ

What is Docosanol Cream used for?

Docosanol Cream, 10% is the only FDA-approved medicine to shorten healing time for cold sores and fever blisters on the face or lips.

How should I apply Docosanol Cream?

Wash your hands before and after applying the cream. Apply it to the affected area at the first sign of a cold sore, rubbing it in gently, and use 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 for adults and children 12 years or older. For children under 12, consult a doctor.

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.

Are there any precautions I should take?

Do not use Docosanol Cream if you are allergic to any of its ingredients, and avoid applying it near your eyes or inside your mouth.

How should I store Docosanol Cream?

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

What should I do if I accidentally swallow Docosanol Cream?

If swallowed, get medical help or contact a Poison Control Center at 1-800-222-1222 right away.

Packaging Info

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

Packaging configurations for Cold Sore Fever Blister Treatment.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

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

Uses and Indications

This drug is indicated for the treatment of cold sores and fever blisters on the face or lips. It is specifically designed to shorten the healing time and reduce the duration of associated symptoms, including tingling, pain, burning, and itching. This medication is the only FDA-approved treatment that effectively shortens healing time for cold sores.

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 the following situations:

  • Patients with a known allergy to any ingredient in this product. Due to the risk of allergic reactions, use is strictly prohibited in these individuals.

  • Application in or near the eyes is contraindicated to prevent potential irritation or injury.

  • Direct application inside the mouth should be avoided to minimize the risk of 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 at 1-800-222-1222 or seek emergency medical help without delay.

Side Effects

Patients should be aware that this product may cause a severe allergic reaction. Symptoms of such a reaction can include hives, facial swelling, wheezing or difficulty breathing, shock, and rash. In the event of these symptoms, it is imperative to stop use immediately and seek medical attention.

Additionally, patients are advised to discontinue use and consult a healthcare professional if their cold sore worsens or does not heal within 10 days. This precaution is essential to ensure proper management and to avoid 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 crucial for optimal results, and the cream should be gently rubbed in completely, applied five times a day until healing occurs.

It is important to keep this medication out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact a Poison Control Center at 1-800-222-1222.

Geriatric Use

There is no specific information available 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 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 exercise caution when considering the use of this medication in women who are pregnant or may become pregnant, given the absence of data on potential fetal impacts. It is advisable to weigh the benefits against any unknown risks when prescribing docosanol cream to this population.

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 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 these patients to ensure safety and efficacy.

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 details regarding overdosage for this medication (SPL code 34088-5), it is essential for healthcare professionals to remain vigilant and consider general principles of management in cases of suspected overdosage.

Recommended Actions In the event of an overdosage, healthcare providers should initiate appropriate supportive measures. This may include monitoring the patient's vital signs and providing symptomatic treatment as necessary. It is advisable to contact a poison control center or seek expert consultation for guidance tailored to the specific circumstances of the overdosage.

Potential Symptoms While specific symptoms associated with overdosage of this medication are not detailed, healthcare professionals should be aware that overdosage can lead to a range of adverse effects. Symptoms may vary based on the pharmacological properties of the drug and the individual patient's response.

Management Procedures Management of overdosage should be guided by the clinical presentation of the patient. Supportive care is paramount, and interventions may include the administration of activated charcoal if the patient presents within a suitable timeframe. Continuous monitoring and reassessment of the patient's condition are critical to ensure timely intervention and to mitigate potential complications.

In summary, while specific overdosage information is not provided, healthcare professionals should apply general overdosage management principles and remain alert to the potential for adverse effects.

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

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 crucial 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. Additionally, it is important to emphasize that the product should not be shared with others, as this 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 throughout its storage period.

Additional Clinical Information

The product is administered topically and should be applied five times a day until the lesion is healed. Clinicians should advise patients to discontinue use and consult a healthcare professional if the cold sore worsens or does not heal within 10 days. In the event of accidental ingestion, patients are instructed to seek medical assistance or contact a Poison Control Center immediately at 1-800-222-1222.

No further information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

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.