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Docosanol

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This product has been discontinued

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
April 3, 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 2023
Label revision date
April 3, 2024
Manufacturer
Rite Aid Corporation
Registration number
ANDA212385
NDC root
11822-3450
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

If you are a consumer or patient please visit this version.

Drug Overview

Docosanol Cream, 10% is the only over-the-counter (OTC) medicine approved by the FDA specifically designed to shorten the healing time for cold sores and fever blisters on the face or lips. It works by treating the symptoms associated with these sores, such as tingling, pain, burning, and itching, helping you feel more comfortable while promoting faster recovery.

This cream is comparable to the active ingredient found in Abreva®, providing an effective option for managing cold sore outbreaks. With its unique formulation, Docosanol Cream can help you get back to your daily activities more quickly by reducing both the duration of symptoms and the healing time.

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 like tingling, pain, burning, and itching.

You can expect relief from these symptoms, allowing you to feel more comfortable as you recover. Rest assured, there are no known teratogenic effects (which means it doesn’t cause birth defects) associated with this treatment.

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.

Remember, taking care of your health means being cautious about what you use. If you have any concerns or questions about this product, please consult with a healthcare professional.

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 these potential reactions to ensure your safety while using this 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. Remember, this product is for external use only, and you should not use it if you are allergic to any of its ingredients.

If your cold sore worsens or does not heal within 10 days, stop using the product and contact your doctor. Additionally, if the product is swallowed, seek emergency medical help or contact a Poison Control Center right away.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, if you suspect an overdose, it is important to be aware of potential signs, which may include unusual drowsiness, confusion, or difficulty breathing.

If you or someone else may have taken too much of the medication, seek immediate medical help. You can call your local emergency number or go to the nearest hospital. Always keep medications out of reach of children and follow the prescribed dosage to prevent any risk of overdose.

Pregnancy Use

Currently, there is no specific information available about the use of this medication during pregnancy, including safety concerns, dosage adjustments, or any special precautions you should take. If you are pregnant or planning to become pregnant, it is essential to discuss any medications you are taking with your healthcare provider to ensure the best care for you and your baby. Always prioritize open communication with your doctor regarding any potential risks or considerations related to your health during pregnancy.

Lactation Use

While the provided drug insert does not include specific information about breastfeeding or considerations for nursing mothers, it's always important to consult with your healthcare provider regarding any medications you may be taking while breastfeeding. They can help you understand any potential effects on your milk production or your baby's health. If you have concerns about how a medication might affect you or your infant, don't hesitate to ask for guidance tailored to your situation.

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 can lead to 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 cream out of reach of children. If your child accidentally swallows it, seek medical help or contact a Poison Control Center immediately.

Geriatric Use

While there is no specific information about how this medication should be used by older adults, it’s important to approach any new treatment with caution. If you or a loved one is an older adult, it’s wise to discuss any potential risks or concerns with your healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken.

Always keep in mind that older adults may have different responses to medications, so regular check-ins with your doctor can ensure safety and effectiveness.

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 and what steps to take for your safety.

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 need to conduct regular tests 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. 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 tests you might 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 to ensure safe use and disposal.

Additional Information

If you have any questions or need assistance regarding your medication, you can call 1-877-753-3935. This helpline is available Monday through Friday from 9 AM to 5 PM EST.

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 associated with cold sores.

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 allergies associated with Docosanol Cream?

Yes, do not use it if you are allergic to any ingredient in the product, as it may cause a severe allergic reaction.

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.

What precautions should I take when using Docosanol Cream?

Avoid using it in or near the eyes, applying it directly inside your mouth, and sharing it with others to prevent spreading the infection.

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

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

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 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

No description information is available for the drug.

Uses and Indications

This drug is indicated for the treatment of cold sores and fever blisters located 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.

There are no teratogenic effects associated with this drug, and no nonteratogenic effects have been reported.

Dosage and Administration

Healthcare professionals are advised to instruct patients to wash their hands thoroughly before and after applying the cream. For adults and children aged 12 years and older, the cream should be applied to the affected area on the face or lips at the first sign of a cold sore or fever blister, such as a tingling sensation. Early treatment is crucial for optimal results. The cream should be rubbed in gently but completely, and it is recommended to apply the cream five times a day until the lesion is healed.

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

Contraindications

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

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, as it may facilitate the spread of infection.

Warnings and Precautions

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

For external use only, this product should not be applied by individuals with known allergies to any of its ingredients. It is essential to assess patient history for any potential allergic responses prior to administration.

Patients should be advised to stop using the product and consult a healthcare provider if their cold sore worsens or fails to heal within 10 days. This precaution is critical to ensure appropriate management and to prevent complications.

In cases of accidental ingestion, immediate medical attention is required. Patients or caregivers should contact a Poison Control Center or seek emergency medical help without delay. Monitoring for these adverse effects is crucial to ensure patient safety and effective treatment outcomes.

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, patients are advised to discontinue use immediately and seek medical assistance without delay.

It is important for patients to be aware of these potential adverse reactions and to monitor for any signs of an allergic response while using the product.

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 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 medication. 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. It should be gently but completely rubbed in and used five times a day until healing occurs.

Additionally, this product must be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought or contact with a Poison Control Center is advised.

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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

There is no specific information available regarding the use of this drug 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 and weigh the potential risks and benefits. Women of childbearing potential should be counseled on the absence of established safety data and the importance of discussing any potential pregnancy with their healthcare provider.

Lactation

There are no specific statements regarding nursing mothers or lactation considerations in the provided drug insert. Therefore, the effects of this medication on lactating mothers and breastfed infants are not addressed. Healthcare professionals should consider the absence of data when advising lactating mothers about the use of this medication.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

Hepatic Impairment

There is no information available regarding the use of this medication in patients with hepatic impairment. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions specified for individuals with compromised liver function. Healthcare professionals should exercise clinical judgment when considering the use of this medication in patients with liver problems, as the absence of data does not preclude the need for careful evaluation and monitoring based on individual patient circumstances.

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 a medical toxicologist is recommended to determine the most appropriate course of action.

It is crucial for healthcare professionals to educate patients and caregivers 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 were identified in the available data. Additionally, there are no details regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center if the product is swallowed. It is essential to inform patients not to use the product if they have a known allergy to any of its ingredients.

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 apply it only to the affected areas and avoid contact with the eyes. They should also refrain from applying the product directly inside the mouth. Additionally, healthcare providers should emphasize the importance of not sharing the product 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 for identification. It should be stored at a temperature range of 20° to 25°C (68° to 77°F). Care must be taken to ensure that the product does not freeze, as this may compromise its integrity and effectiveness. Proper storage conditions are essential to maintain the quality of the product throughout its shelf life.

Additional Clinical Information

No further data are available.

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

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.