Symptom checker
Select audience type

Switch between content for healthcare professionals (PRO) and general audience (GEN).

ADD CONDITION

items per page

Cold Sore Fever Blister Treatment

Last content change checked dailysee data sync status

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
Meijer Distribution Inc.
Registration number
ANDA212385
NDC root
79481-0065
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 medicine approved by the FDA specifically designed to shorten the healing time for cold sores and fever blisters. It is used to treat these sores on the face or lips, helping to alleviate symptoms such as tingling, pain, burning, and itching.

This cream comes in a convenient portable pump, making it easy to apply when needed. By using Docosanol, you can expect a reduction in the duration of your cold sore symptoms, allowing for a quicker 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 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 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 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, 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 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, swelling of the face, 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 is for external use only and may cause a severe allergic reaction in some people. 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.

You should also stop using this product and consult your doctor if your cold sore worsens or does not heal within 10 days. If the product is swallowed, it’s important to get emergency medical help 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 the specific signs of an overdose are not detailed, common symptoms can include extreme drowsiness, confusion, or difficulty breathing. If you notice any of these signs, seek medical help right away.

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

Pregnancy Use

When considering the use of Docosanol Cream, 10% during pregnancy, it's important to note that there is no specific information available about its safety, dosage adjustments, or any special precautions for pregnant individuals. This means that the effects of this cream on pregnancy have not been studied or documented.

If you are pregnant or planning to become pregnant, it is always best 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 needs and circumstances.

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, as well as adults, make sure to wash your hands before and after applying the cream. You should 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. Use the cream five times a day until the area is healed.

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. If you or a loved one is an older adult, it’s always a good idea to discuss any medications with a healthcare provider, especially since older adults may have different health needs and may be taking other medications.

Since there are no dosage adjustments or safety concerns specifically noted for elderly patients, your healthcare provider can help determine the best approach based on individual health conditions and overall treatment goals. Always ensure that any changes in medication are closely monitored to maintain safety and effectiveness.

Renal Impairment

If you have kidney problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to change based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your specific situation. They can help monitor your kidney health and make any necessary adjustments to your medications.

Hepatic Impairment

If you have liver problems, it's important to know that the information provided does not include specific guidelines about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored recommendations for how the medication may affect you or how your treatment should be managed based on your liver health.

Always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective, especially if you have any concerns about your liver function.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking, even if there are no known drug interactions or laboratory test interactions associated with them. This ensures that your treatment plan is safe and effective, tailored specifically to your health needs.

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

Storage and Handling

To ensure the best performance of your product, store it at a temperature between 20° to 25°C (68° to 77°F). It's important to keep it away from freezing temperatures, as freezing can damage the product.

When handling the product, make sure to 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 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?

You should wash your hands before and after applying the cream to the affected area 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?

Children under 12 years should ask a doctor before use. Adults and children 12 years or over can use it as directed.

What should I avoid while using Docosanol Cream?

Do not use the cream in or near your eyes, apply it directly inside your mouth, or share it with anyone, as this may spread the infection.

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

If your cold sore gets worse or is not healed within 10 days, stop using the cream and consult a doctor.

How should I store Docosanol Cream?

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

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

There is no specific information regarding the use of Docosanol Cream during pregnancy or nursing mothers in the product insert.

Packaging Info

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

Packaging configurations for Cold Sore Fever Blister Treatment.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Docosanol Cream, 10%, is a topical formulation indicated for the treatment of cold sores and fever blisters. This cream is the only over-the-counter (OTC) medication approved by the FDA for the purpose of shortening the healing time and duration of symptoms associated with these conditions. The product 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 effective in shortening the healing time and reducing the duration of associated symptoms, including tingling, pain, burning, and/or 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 achieving optimal results.

The cream should be gently but completely rubbed into the affected area. 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.

This product is intended for external use only. It is crucial to advise patients to stop using the product and consult a healthcare provider if their cold sore worsens or fails to heal within 10 days.

In cases of accidental ingestion, immediate medical attention is required. Patients should be instructed to contact a Poison Control Center at 1-800-222-1222 or seek emergency medical help without delay.

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.

Healthcare professionals should be vigilant in monitoring for these serious adverse reactions, as timely intervention is crucial for patient safety.

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 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) and used 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 individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

Pregnancy

There is no information available regarding the use of Docosanol Cream, 10% during pregnancy. As such, the safety of this medication in pregnant patients has not been established, and there are no known risks or precautions associated with its use in this population. Healthcare professionals should consider the lack of data when prescribing this medication to women of childbearing potential and weigh the potential benefits against any unknown risks to fetal outcomes.

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

Patients with renal impairment may not have specific information regarding dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment and monitoring of these patients.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

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

It is essential to monitor patients closely for any signs or symptoms that may arise following an overdose. Common symptoms may include, but are not limited to, alterations in vital signs, neurological changes, and gastrointestinal disturbances.

In the event of an overdose, immediate medical attention should be sought. Supportive care is the cornerstone of management, which may include the following steps:

  1. Assessment: Conduct a thorough evaluation of the patient's clinical status, including vital signs and level of consciousness.

  2. Supportive Care: Provide symptomatic treatment as necessary, which may involve intravenous fluids, oxygen supplementation, or other interventions based on the patient's condition.

  3. Consultation: Engage with a poison control center or toxicology specialist for guidance on specific management strategies tailored to the substance involved.

Healthcare professionals should remain vigilant and prepared to implement appropriate interventions based on the clinical presentation of the patient.

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 important 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 should be stored at a temperature range of 20° to 25°C (68° to 77°F). Freezing is not permitted, as it may compromise the integrity of the product. Proper handling and storage conditions are essential to maintain the product's efficacy and safety.

Additional Clinical Information

The medication is administered topically and should be applied five times a day until the affected area is healed. Patients are advised to discontinue use and consult a healthcare professional if their cold sore worsens or does not heal within 10 days. In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center (1-800-222-1222) should be contacted.

No additional 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.

Learn more in our Editorial Policy

Last AI update:

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.