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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 2022
Label revision date
September 8, 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 2022
Label revision date
September 8, 2025
Manufacturer
Encube Ethicals, Inc.
Registration number
ANDA212385
NDC root
21922-023
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 10% CREAM is a topical treatment specifically designed for cold sores and fever blisters that appear on the face or lips. It is the only FDA-approved medication that helps to shorten the healing time of these sores, as well as reduce the duration of associated symptoms like tingling, pain, burning, and itching.

When you apply DOCOSANOL cream, it works by creating a barrier that helps to prevent the virus from spreading, allowing your skin to heal more quickly. This can provide relief and help you feel more comfortable during an outbreak.

Uses

This medication is used to treat cold sores or fever blisters that appear on your face or lips. If you experience symptoms like tingling, pain, burning, or itching, this treatment can help shorten the healing time and reduce the duration of these uncomfortable sensations.

You can feel confident using this medication, as there are no reported teratogenic effects (which means it does not cause birth defects) or nonteratogenic effects associated with it.

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 soon as you feel that tingle, as early intervention leads to the best results. Gently rub the cream into the skin until it is fully absorbed.

For adults and children aged 12 years and older, you should apply the cream five times a day until the cold sore is healed. If you are considering using this cream for a child under 12, 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 apply the product only to the affected areas and avoid using it 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 spread infection.

Remember, your safety is a priority, so always follow these guidelines to ensure proper use and avoid any potential complications.

Side Effects

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

Please be aware of this allergy alert and monitor yourself for any signs of an allergic reaction. Your safety is a priority, so don’t hesitate to get help if needed.

Warnings and Precautions

This product is for external use only and may cause a severe allergic reaction. Symptoms of an allergic reaction can include 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. Make sure you are not allergic to any of the ingredients before using it, and apply it only to the affected areas. Avoid using it near your eyes or inside your mouth, and do not share it with others to prevent spreading infection.

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 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, it's always important to be aware of the potential risks associated with taking more than the recommended dose. If you suspect an overdose, look for signs such as unusual drowsiness, confusion, or difficulty breathing.

In the event of an overdose, you should seek immediate medical help. Contact your local emergency services or go to the nearest hospital. It's crucial to act quickly, as timely intervention can make a significant difference in your health outcomes. Always remember to keep medications out of reach and follow the prescribed dosage to avoid any risks.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that there is no specific information available about the use of Docosanol during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions related to its use in pregnant individuals have not been established.

Given this lack of information, it is advisable to consult with your healthcare provider before using Docosanol or any medication during pregnancy. They can help you weigh the potential risks and benefits based on your individual situation.

Lactation Use

If you are breastfeeding, you can use Docosanol Cream without specific warnings or recommendations against it. The information available does not indicate any concerns about the cream being passed into breast milk or any risks to your nursing infant. However, as with any medication, it's always a good idea to consult with your healthcare provider if you have any questions or concerns.

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. Use the cream five times a day until the area is healed.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that if you or a loved one is an older adult, it’s important to consult with a healthcare provider for personalized advice. They can help determine the best approach based on individual health needs and any other medications being taken. 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 there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations for the medication do not change based on liver impairment. However, it’s always a good idea to discuss your liver health with your healthcare provider, as they can offer personalized advice and monitor your condition effectively.

Make sure to keep your doctor informed about any liver issues you may have, as they can help ensure that your treatment is safe and appropriate for you.

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 share your complete list of medications and any recent lab tests to avoid any potential issues. Your health and safety should always come first.

Storage and Handling

To ensure the best performance of your product, store it at a temperature between 20°-25°C (68°-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 can apply this medication topically to the affected area on your face or lips at the first sign of a cold sore, such as a tingling sensation. For best results, use it five times a day until the cold sore is healed.

It's important to know that about one in five Americans experiences cold sores each year, with most having two to three outbreaks annually. Cold sores can be easily transmitted to others just before and during an outbreak, so be cautious and avoid close contact during this time. Even after a cold sore heals, the virus remains in your body and can reactivate due to common triggers like stress, sunlight, extreme temperatures, colds, lack of sleep, or menstruation.

FAQ

What is Docosanol 10% Cream used for?

Docosanol 10% Cream is used to treat cold sores and fever blisters on the face or lips.

How does Docosanol work?

It is the only FDA-approved treatment that 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. Use it 5 times a day until healed.

Are there any contraindications for using Docosanol?

You should not use Docosanol if you are allergic to any ingredient in the product.

What should I do if I experience an allergic reaction?

If you experience symptoms like hives, facial swelling, or difficulty breathing, stop using the product and seek medical help immediately.

Can children use Docosanol Cream?

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

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

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

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

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

How should I store Docosanol Cream?

Store the cream at 20°-25°C (68°-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 specified 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, which may include 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

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 doctor before use.

Contraindications

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

Additionally, the following precautions should be observed:

  • The product should only be applied to the affected areas.

  • Application in or near the eyes is contraindicated.

  • Direct application inside the mouth is not recommended.

  • Sharing this product is contraindicated due to the potential risk of spreading infection.

Warnings and Precautions

This product carries a significant risk of severe allergic reactions. Symptoms indicative of an allergic response may include hives, facial swelling, wheezing or difficulty breathing, shock, and rash. In the event of an allergic reaction, it is imperative to discontinue use immediately and seek medical assistance.

This product is intended for external use only. It is crucial that individuals do not use this product if they have a known allergy to any of its ingredients. When applying the product, it should be restricted to the affected areas only. Care must be taken to avoid contact with the eyes and to refrain from applying the product directly inside the mouth. Additionally, sharing this product with others is strongly discouraged, as it may facilitate the spread of infection.

Patients should be advised to discontinue use and consult a healthcare professional if their cold sore worsens or fails to heal within 10 days.

In cases of accidental ingestion, immediate medical attention is required. Individuals should contact a Poison Control Center or seek emergency medical help without delay.

Side Effects

Patients using this product should be aware of the potential for severe allergic reactions. Symptoms of such reactions may 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.

The occurrence of these serious adverse reactions necessitates careful monitoring and prompt intervention to ensure patient safety.

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 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) and used five times a day until the lesion is healed.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any potential adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

There is no specific information available regarding the use of Docosanol 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. Given the absence of established risk categories or known fetal impacts, the potential benefits and risks should be carefully evaluated on a case-by-case basis. Women of childbearing potential should be counseled accordingly.

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

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in 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 and prepared for potential scenarios involving overdose.

Healthcare providers should be aware that the clinical presentation of an overdose may vary significantly depending on the substance involved and the individual patient’s characteristics. Symptoms may include, but are not limited to, altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

In the event of suspected overdosage, immediate assessment of the patient's condition is crucial. Recommended actions include:

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

  2. Supportive Care: Initiate supportive measures as necessary, including airway management, oxygen supplementation, and intravenous fluids.

  3. Decontamination: If appropriate and within a reasonable timeframe, consider gastrointestinal decontamination methods such as activated charcoal, provided the patient is alert and able to protect their airway.

  4. Monitoring: Continuous monitoring of the patient’s vital signs and clinical status is essential to detect any deterioration promptly.

Healthcare professionals should also consult local poison control centers or toxicology experts for guidance on specific management protocols tailored to the substance involved in the overdose.

Documentation of the incident, including the substance, amount ingested, time of ingestion, and any interventions performed, is critical for ongoing patient management and for informing future care decisions.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are provided in the insert for Docosanol Cream.

Patient Counseling

Patients should be advised 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.

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 reminded not to share this product with others, as this may lead to the spread of infection.

Patients should also be instructed to discontinue use and consult a healthcare provider if their cold sore worsens or does not heal within 10 days.

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 efficacy. Proper handling and storage conditions must be adhered to in order to maintain the quality of the product.

Additional Clinical Information

The route of administration for the treatment is topical, with application recommended to the affected area on the face or lips at the first sign of a cold sore or fever blister (tingle). Patients should apply the treatment five times a day until the lesion is healed.

Clinicians should counsel patients that approximately one in five Americans experiences cold sores annually, with most individuals having two to three outbreaks each year. It is crucial for patients to recognize early warning signs of an impending outbreak, as the infection can be easily transmitted to others during this period. After healing, the virus remains dormant in the body and may reactivate due to common triggers such as stress, sunlight, extreme temperatures, colds, flu, lack of sleep, or menstruation.

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.