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Cold Sore Treatment Docosanol

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Active ingredient
Docosanol 100 mg/1 g
Other brand names
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2025
Label revision date
April 11, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Docosanol 100 mg/1 g
Other brand names
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2025
Label revision date
April 11, 2025
Manufacturer
Blistex Inc.
Registration number
ANDA217090
NDC root
10157-2124
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 medication specifically designed to 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 FDA approved and is often recommended by dermatologists for effective relief. It is important to use it as directed for the best results in managing cold sore symptoms.

Uses

If you’re dealing with cold sores or fever blisters on your face or lips, this medication can help. It not only treats these uncomfortable sores but also works to shorten the healing time and reduce the duration of symptoms such as tingling, pain, burning, and itching.

By using this treatment, you can find relief from the discomfort associated with cold sores and help speed up your recovery.

Dosage and Administration

Before you start using the cream, make sure to wash your hands thoroughly. When you notice the first signs of a cold sore or fever blister, such as a tingling sensation, apply the cream directly to the affected area on your face or lips. It's important to begin treatment as early as possible for the best results. Gently rub the cream 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, it's best to consult a doctor first for guidance. Remember to wash your hands again after applying the cream to avoid spreading the virus.

What to Avoid

If you are allergic to any ingredient in this product, you should not use it. Allergies can cause serious reactions, so it's important to check the ingredients carefully before use.

While using this product, avoid applying it in or near your eyes and do not apply it directly inside your mouth. Additionally, please do not share this product with anyone, as sharing can lead to the spread of infections. Always prioritize your safety and the safety of others 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 this allergy alert to ensure your safety while using the product.

Warnings and Precautions

This product may cause a severe allergic reaction, which can include symptoms like hives, facial swelling, wheezing or difficulty breathing, shock, and rash. If you experience any of these symptoms, stop using the product immediately and seek medical help. It's important not to use this product if you are allergic to any of its ingredients.

You should also stop using the product and consult your doctor if your cold sore worsens or does not heal within 10 days. Keep this product out of reach of children, and if it is swallowed, seek medical assistance or contact a Poison Control Center at 1-800-222-1222 right away.

Overdose

If you or someone else has swallowed too much of this medication, it’s important to seek medical help immediately. You can contact a Poison Control Center at 1-800-222-1222 for guidance.

Signs of an overdose may include unusual symptoms, but specific details on these symptoms are not provided here. If you notice anything concerning, don’t hesitate to reach out for help. Remember, acting quickly can make a significant difference in ensuring safety and health.

Pregnancy Use

When considering the use of Docosanol Cream 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 the 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. Your doctor 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 precautions. Currently, there is no information available about whether this cream passes into breast milk or if it poses any risk to your nursing infant. Always feel free to consult with your healthcare provider if you have any concerns or questions about using medications while breastfeeding.

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. 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. Early treatment is key for the best results. Make sure to rub the cream in gently and completely, using it 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 Docosanol Cream, there is no specific information available about how it should be used by older adults. This means that there are no special dosage adjustments, safety concerns, or precautions outlined for elderly patients.

If you are an older adult or a caregiver, it's always a good idea to consult with a healthcare professional before starting any new medication or treatment. They can provide personalized advice based on individual health needs and conditions.

Renal Impairment

If you have kidney problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or safety considerations for your condition. This means that there are no tailored guidelines for how this medication should be used if you have renal impairment (kidney issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your health situation. They can help you understand how to manage your treatment effectively while considering your kidney health.

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 should be used 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 you understand how to manage your treatment effectively.

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 and share any concerns you may have about 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 in this range, as freezing can damage the product and affect its effectiveness.

When handling the product, always do so with clean hands and in a clean environment to maintain its integrity. Following these guidelines will help you use the product safely and effectively.

Additional Information

You should apply this product 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. Use it five times a day until the sore is healed.

Be aware that this product can cause a severe allergic reaction, which may include symptoms like hives, facial swelling, wheezing or difficulty breathing, shock, and rash. If you experience any of these symptoms, stop using the product and seek medical help immediately. It's also important not to share this product with others, as this can spread infection. If your cold sore worsens or does not heal within 10 days, consult your doctor.

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.

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.

What should I do if I am allergic to an ingredient in Docosanol Cream?

Do not use the cream if you are allergic to any of its ingredients, as it may cause a severe allergic reaction.

What are the signs of a severe allergic reaction?

Signs may include hives, facial swelling, wheezing or difficulty breathing, shock, and rash. If these occur, stop use 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 do if my cold sore does not heal within 10 days?

Stop use and ask a doctor if your cold sore gets worse or is not healed within 10 days.

How should I store Docosanol Cream?

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

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.

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 Treatment Docosanol (docosanol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Cold Sore Treatment Docosanol.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Blistex® is a dermatologist-recommended cold sore treatment formulated as a 10% docosanol cream. This FDA-approved medication is indicated for the treatment of cold sores and fever blisters, designed to shorten healing time. The product is intended for topical use only and is packaged in a net weight of 2 g (0.07 oz). The National Drug Code (NDC) for this formulation is 10157-2124-2.

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 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 advised to consult a physician before use.

Contraindications

Use of this product is contraindicated in individuals with a known allergy to any ingredient contained within the formulation.

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 also contraindicated due to the potential risk of spreading infection.

Warnings and Precautions

This product has the potential to induce 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.

Patients should be advised against using this product if they have a known allergy to any of its ingredients. Additionally, if a cold sore worsens or does not heal within 10 days, the patient should stop using the product and consult a healthcare provider for further evaluation.

It is essential to keep this product out of the reach of children. In cases of accidental ingestion, immediate medical attention should be sought, or the Poison Control Center (1-800-222-1222) should be contacted without delay.

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

No specific drug interactions have been identified for this medication. 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 Treatment Docosanol (docosanol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Cold Sore Treatment Docosanol.
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). Early treatment is associated with the best outcomes. The cream should be gently rubbed in completely and applied five times a day until healing occurs.

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

Geriatric Use

Elderly patients may not have specific dosage adjustments, safety concerns, or special precautions outlined in the prescribing information for Docosanol Cream. As there is no available data regarding the use of this medication in geriatric populations, healthcare providers should exercise caution when prescribing to elderly patients. It is advisable to monitor these patients closely for any potential adverse effects or changes in efficacy, given the lack of targeted clinical findings for this demographic.

Pregnancy

There is no specific information available regarding the use of Docosanol Cream during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients. It is advisable to weigh the potential benefits against any unknown risks to fetal outcomes. Women of childbearing potential should be informed of the absence of established safety data and encouraged to discuss any concerns with their healthcare provider.

Lactation

There are no specific warnings or precautions 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 have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this drug. Consequently, there are no 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 prescribing information.

Overdosage

In the event of an overdose, immediate medical assistance is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical help without delay. It is recommended to contact a Poison Control Center at 1-800-222-1222 for expert guidance on managing the situation.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Healthcare providers should be prepared to assess the patient's condition and implement appropriate management strategies based on the severity of symptoms and the specific substance involved.

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 these contexts.

Postmarketing Experience

No postmarketing experience details are available in the insert.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. 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 of its ingredients. It is important to counsel patients to stop using the product and consult a doctor if their cold sore worsens or does not heal within 10 days.

When using this product, patients should apply it only to the affected areas and avoid contact with the eyes. They should be cautioned against applying the product directly inside the mouth. Additionally, patients must be advised not to share this product with anyone, as this may lead to 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 the product is strictly prohibited to maintain its integrity and efficacy. Proper handling and storage conditions are essential to ensure the product remains within the specified temperature range.

Additional Clinical Information

The product is administered topically, applied to the affected area on the face or lips at the first sign of a cold sore or fever blister (tingle). Patients should use the product five times a day until the lesion is healed.

Clinicians should counsel patients about the potential for severe allergic reactions, which may manifest as hives, facial swelling, wheezing or difficulty breathing, shock, or rash. Patients are advised to discontinue use and seek immediate medical attention if any allergic symptoms occur. Additionally, the product should not be shared to prevent the spread of infection. Patients should also be instructed to stop use and consult a doctor if the cold sore worsens or does not heal within 10 days.

Drug Information (PDF)

This file contains official product information for Cold Sore Treatment Docosanol, 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 Treatment Docosanol, 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.