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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 2024
Label revision date
October 1, 2024
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
October 1, 2024
Manufacturer
Amerisource Bergen
Registration number
ANDA217090
NDC root
46122-800
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 that appear on the face or lips. This medication works by helping to shorten the healing time and reduce the duration of symptoms such as tingling, pain, burning, and itching associated with these outbreaks.

When you apply docosanol cream, it acts to alleviate discomfort and promote faster recovery from cold sores, making it a helpful option for managing these common viral infections.

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 you start using the cream for cold sores or fever blisters, make sure to wash your hands thoroughly. When you notice the first signs of a cold sore, like 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. It's important to be cautious and avoid applying the product in or near your eyes, as well as directly inside your mouth. Additionally, please do not share this product with anyone, as doing so could lead to the spread of infection.

Remember, your safety is a priority, so always read the label and follow these guidelines carefully.

Side Effects

This product may cause a severe allergic reaction in some individuals. If you experience symptoms such as hives, facial swelling, wheezing or difficulty breathing, shock, or a rash, it is important to stop using the product immediately and seek medical assistance.

Always be aware of these potential reactions to ensure your safety while using this medication.

Warnings and Precautions

This product is for external use only and may cause a severe allergic reaction in some individuals. 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.

If your cold sore worsens or does not heal within 10 days, it’s important to stop using the product and consult your doctor. Always prioritize your health and safety when using any medication.

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, as this will help healthcare professionals provide the best care. Remember, your safety is the top priority, so don’t hesitate to reach out for help.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that there are no specific guidelines or warnings about using docosanol cream during this time. The information available does not indicate any risks or contraindications for pregnant individuals, and there are no recommended dosage changes for those who are pregnant.

While the absence of warnings may suggest that docosanol cream is generally considered safe, it's always best to consult with your healthcare provider before using any medication during pregnancy to ensure it’s appropriate for your individual situation.

Lactation Use

If you are breastfeeding and considering the use of docosanol cream, you can feel reassured that there are no specific warnings or recommendations against its use for nursing mothers. Additionally, there is no information indicating that docosanol cream is passed into breast milk or poses any risk to your infant. Always consult with your healthcare provider if you have any concerns or questions about using any medication while breastfeeding.

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, 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. The cream should be used five times a day until the area is healed.

Geriatric Use

When using Docosanol cream, you can feel reassured that there are no specific concerns or dosage adjustments needed for older adults. This means that the cream is considered safe for use without special precautions for elderly patients. However, as with any medication, it's always a good idea to consult with your healthcare provider to ensure it fits well with your overall health needs and any other treatments you may be using.

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 there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations apply, but you should always consult your healthcare provider for personalized advice. They can help determine the best approach for your treatment and monitor your liver function as needed.

Make sure to keep your doctor informed about your liver health, as they may want to conduct regular liver function tests (which check how well your liver is working) to ensure your safety while using any medication.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. In this case, there are no known drug interactions or laboratory test interactions associated with the medication. However, always ensure that your healthcare provider is aware of all the medications you are using, as this helps them provide the best care tailored to your needs.

By discussing your full medical history and any other treatments, you can help prevent potential issues and ensure your safety.

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 docosanol cream to the affected area on your face or lips as soon as you notice the first signs of a cold sore, such as tingling or redness. For the best results, use it five times a day until the cold sore is healed. It's important to start treatment early, as this can make the medicine more effective.

Cold sores affect about one in five Americans each year, with most people experiencing two to three outbreaks annually. Be mindful of early warning signs and avoid close physical contact when you have an outbreak. Docosanol cream is unique because it contains 10% docosanol, which can help shorten healing time and alleviate symptoms like tingling, pain, itching, and burning.

FAQ

What is Docosanol Cream used for?

Docosanol Cream 10% 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. Apply it to the affected area at the first sign of a cold sore, using it 5 times a day until healed.

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

Do not use the cream if you are allergic to any of its ingredients.

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

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

What should I do if my cold sore gets worse?

Stop using the cream and consult a doctor if your cold sore worsens or does not heal within 10 days.

Is Docosanol Cream safe for children?

Children under 12 years should ask a doctor before use, while adults and children 12 years or older can use it as directed.

What are the storage instructions for Docosanol Cream?

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

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.

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

The insert does not provide specific information regarding the use of Docosanol Cream during pregnancy or lactation.

Packaging Info

Below are the non-prescription pack sizes of Docosanol. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Docosanol.
Details

Drug Information (PDF)

This file contains official product information for Docosanol, 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 intended for topical use only. Each tube contains a net weight of 2 grams (0.07 ounces) of the cream.

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

Adults and children aged 12 years and older should wash their hands thoroughly 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, such as a tingling sensation. Early treatment is essential for optimal results. The cream must be rubbed in gently but completely. 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 of its ingredients.

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 may cause a severe allergic reaction. Healthcare professionals should be vigilant for symptoms such as hives, facial swelling, wheezing or difficulty breathing, shock, and rash. In the event of an allergic reaction, it is imperative to discontinue use immediately and seek medical assistance.

This product is intended for external use only.

Patients should be advised to stop using the product and consult a healthcare provider if their cold sore worsens or does not heal within 10 days. Monitoring for these conditions is essential to ensure appropriate management and intervention.

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 drug interactions or drug and laboratory test interactions have been identified in the available data. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Docosanol. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Docosanol.
Details

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before using this product. For adolescents and adults 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). Treatment should be administered five times a day until the lesion is healed.

Geriatric Use

Elderly patients do not have specific geriatric use considerations, dosage adjustments, or safety concerns associated with the use of Docosanol cream as indicated in the provided drug insert. Therefore, no additional precautions or modifications are necessary when prescribing this medication to geriatric patients. However, as with all medications, healthcare providers should continue to monitor elderly patients for any potential adverse effects or unusual responses during treatment.

Pregnancy

There are no specific statements regarding the use of docosanol cream during pregnancy. The available prescribing information does not indicate any contraindications or risks associated with the use of docosanol cream in pregnant individuals. Additionally, no dosage modifications for pregnant patients are provided. The insert does not include any special precautions regarding the use of docosanol cream during pregnancy. As such, healthcare professionals should consider the absence of data when advising pregnant patients on the use of this medication.

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 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 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), healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdosage.

Recommended Actions In the event of an overdosage, it is essential to seek immediate medical attention. Healthcare providers should assess the patient's clinical status and consider the need for supportive care. Monitoring vital signs and providing symptomatic treatment may be necessary.

Potential Symptoms While specific symptoms of overdosage are not detailed, healthcare professionals should remain vigilant for any unusual or severe reactions that may arise. Symptoms can vary widely depending on the medication involved and the individual patient's response.

Management Procedures Management of overdosage should be tailored to the specific circumstances, including the amount ingested and the time since ingestion. Healthcare professionals may consider activated charcoal if the patient presents within a suitable timeframe and if the ingestion is deemed significant. Additionally, supportive measures should be implemented as required, including intravenous fluids and monitoring for complications.

In summary, due to the lack of specific overdosage information, healthcare professionals are encouraged to apply standard overdosage management protocols and to consult relevant toxicology resources or poison control centers for guidance.

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.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions reported voluntarily or through surveillance programs: allergic reactions, which include hives, facial swelling, wheezing or difficulty breathing, shock, and rash.

Patient Counseling

Healthcare providers should advise patients 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 to disclose any known allergies to ingredients in the product prior to use.

Patients should be instructed to discontinue use and consult a doctor if their cold sore worsens or does not heal within 10 days. When using the product, patients must 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

Patients should apply the medication to the affected area on the face or lips at the first sign of a cold sore or fever blister, specifically when they experience a tingling sensation. The recommended frequency of application is five times a day until the lesion is healed.

Clinicians should inform patients that approximately one in five Americans is affected by cold sores annually, with most individuals experiencing two to three outbreaks each year. It is crucial for patients to recognize early warning signs of an impending outbreak and to avoid close physical contact during an active infection. The effectiveness of docosanol cream increases with early application; therefore, it is advised to use the cream at the onset of symptoms such as tingling, redness, bump, or itch. Notably, docosanol cream is distinct from other over-the-counter cold sore treatments, as it contains 10% docosanol, which is effective in shortening healing time and alleviating symptoms like tingling, pain, itching, and burning.

Drug Information (PDF)

This file contains official product information for 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 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.

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.