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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 2024
Label revision date
December 29, 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 2024
Label revision date
December 29, 2025
Manufacturer
Safeway, Inc.
Registration number
ANDA212385
NDC root
21130-605
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 topical treatment specifically designed for cold sores and fever blisters on the face or lips. It is the only over-the-counter (OTC) medicine approved by the FDA to help shorten the healing time and reduce the duration of symptoms such as tingling, pain, burning, and itching associated with these outbreaks.

By applying Docosanol Cream, you can expect relief from the discomfort of cold sores while promoting faster healing. This convenient cream comes in a portable pump, making it easy to use whenever you need it.

Uses

If you're dealing with cold sores or fever blisters on your face or lips, this medication can help. It works by treating these uncomfortable sores and can also shorten the healing time, making your recovery quicker.

In addition to speeding up healing, this treatment can reduce the duration of symptoms you might experience, such as tingling, pain, burning, and itching. By using this medication, you can find relief from the discomfort associated with cold sores and get back to feeling like yourself sooner.

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

It's important to be aware of certain precautions when using this product. First and foremost, do not use it if you are allergic to any of its ingredients, as this could lead to serious reactions. Additionally, avoid applying the product in or near your eyes and do not use it directly inside your mouth. Sharing this product with others is also discouraged, as it can spread infections.

By following these guidelines, you can help ensure your safety and the effectiveness of the treatment. If you have any concerns or questions about using this product, please consult with a healthcare professional.

Side Effects

You should be aware that this product can cause a severe allergic reaction in some individuals. Symptoms of such a reaction may include hives, swelling of the face, wheezing or difficulty breathing, shock, and rash. If you experience any of these symptoms, it is important to stop using the product and seek medical attention immediately.

Additionally, if your cold sore worsens or does not heal within 10 days, you should also stop using the product and consult a doctor. Your health and safety are important, so please pay attention to these signs.

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, shock, or a rash, stop using the product immediately and seek medical help.

If the product is swallowed, it’s important to get emergency medical assistance or contact a Poison Control Center at 1-800-222-1222 right away. Additionally, if your cold sore worsens or does not heal within 10 days, stop using the product and consult your doctor.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, it's important to be aware of the general signs of an overdose, which can include symptoms like extreme drowsiness, confusion, or difficulty breathing. If you suspect an overdose, it’s crucial to seek immediate medical help.

In case of an emergency, call your local emergency services or go to the nearest hospital. Always keep medications out of reach of children and follow the prescribed dosage to prevent any potential risks. If you have any concerns or questions about your medication, don’t hesitate to reach out to your healthcare provider for guidance.

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 clearly studied or established.

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 feel reassured that there are no specific warnings or recommendations regarding the use of this product while nursing. Additionally, there is no information available about whether this product is excreted in breast milk or any potential risks it may pose to your infant.

As always, if you have any concerns or questions about using this product 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. Starting treatment early is key to achieving the best results. Make sure to rub the cream in gently and completely, applying it five times a day until the area is healed.

Always keep this product out of reach of children. If a child accidentally swallows it, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

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 special precautions mentioned for elderly patients, your healthcare provider can help determine the best approach for you, considering your overall health and any other medications you may be taking. 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 information provided does not include specific guidelines for dosage adjustments, special monitoring, or precautions related to your condition. This means that there are no tailored recommendations for how the medication may affect you differently due to your liver health.

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

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you.

Always feel free to ask questions and share your complete list of medications and any lab tests you may be undergoing. This way, you can avoid any potential issues and receive the best care possible.

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 additional safety instructions provided with the product to ensure safe usage and disposal.

Additional Information

You should apply the 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.

FAQ

What is Docosanol Cream used for?

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

How does Docosanol Cream work?

It shortens the healing time and duration of symptoms such as tingling, pain, burning, and itching.

Who can use Docosanol Cream?

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

How should I apply Docosanol Cream?

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

Are there any contraindications for using Docosanol Cream?

Do not use it if you are allergic to any ingredient in the product or if you have a cold sore that worsens or does not heal within 10 days.

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 I use Docosanol Cream near my eyes or inside my mouth?

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

What should I do if I swallow Docosanol Cream?

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

How should I store Docosanol Cream?

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

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

No description information is available for the specified drug.

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 should 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 achieving optimal results. The cream should be rubbed in gently but completely and applied five times a day until the lesion is healed.

For children under 12 years of age, it is recommended to consult a physician before use.

Contraindications

Use of this product is contraindicated in individuals with a known allergy to any of its ingredients.

Additionally, the product should not be applied in or near the eyes, nor should it be used directly inside the mouth. Sharing this product with others is also contraindicated, as it may facilitate the spread of infection.

Warnings and Precautions

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

This product is intended for external use only. It is crucial to advise patients against ingestion. If the product is swallowed, emergency medical help should be sought immediately, or the Poison Control Center should be contacted at 1-800-222-1222.

Patients should be instructed to discontinue use and consult a healthcare provider if their cold sore worsens or fails to heal within 10 days. Monitoring for these signs is essential to ensure appropriate management and intervention.

Side Effects

Patients may experience a range of adverse reactions associated with this product. Notably, there is a potential for severe allergic reactions, which may manifest as hives, facial swelling, wheezing or difficulty breathing, shock, and rash.

In clinical practice, it is advised that patients discontinue use and consult a healthcare professional if their cold sore worsens or fails to heal within 10 days. This recommendation is crucial to ensure appropriate management and to mitigate any serious complications that may arise from prolonged use or worsening symptoms.

Drug Interactions

There are currently no documented drug interactions associated with the use of this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

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

Packaging configurations for Cold Sore Fever Blister Treatment.
Details

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before 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) to ensure optimal results. The application should be rubbed in gently but completely, and the cream should be used five times a day until healing is achieved.

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 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 no specific 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. Healthcare professionals should consider the lack of data when prescribing this medication to women of childbearing potential. It is advisable to weigh the potential benefits against any unknown risks to fetal outcomes. Given the absence of safety concerns, dosage modifications or special precautions related to pregnancy have not been outlined in the prescribing information. Therefore, healthcare providers should exercise caution and engage in shared decision-making with patients regarding the use of this medication during pregnancy.

Lactation

There are no specific warnings or recommendations regarding the use of this product in nursing mothers. Additionally, there is no information available about the potential for excretion in breast milk or any associated risks to breastfed infants.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

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 overdosage information, it is essential for healthcare professionals to remain vigilant regarding the potential for overdose with this medication. In cases where an overdose is suspected, immediate medical attention should be sought.

Healthcare providers are advised to monitor patients closely for any signs or symptoms that may arise from an overdose. Common symptoms may include, but are not limited to, severe drowsiness, confusion, respiratory distress, or any other unusual clinical manifestations.

Management of an overdose should be tailored to the individual patient and may involve supportive care, including monitoring vital signs and providing symptomatic treatment as necessary. In cases of significant overdose, consultation with a poison control center or toxicology specialist is recommended to determine the most appropriate course of action.

It is crucial for healthcare professionals to educate patients about the importance of adhering to prescribed dosages and to provide guidance on what to do in the event of a suspected overdose.

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. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children. Instruct patients that if the product is swallowed, they should seek medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Patients should be informed not to use the product if they are allergic to any ingredient contained within it. It is important for healthcare providers to emphasize that if the patient's cold sore worsens or does not heal within 10 days, they should stop using the product and consult a doctor.

When discussing the application of this product, healthcare providers should instruct patients to apply it only to the affected areas. They should be cautioned against using the product in or near the eyes and advised to avoid applying it directly inside the mouth. Additionally, patients should be reminded not to share this product with anyone, 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 is essential to store the product at a temperature range of 20° to 25°C (68° to 77°F). Freezing the product is strictly prohibited, as it may compromise its integrity and effectiveness. Proper storage conditions must be maintained to ensure the product's quality and safety.

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.

No additional information is 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 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

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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.