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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 2021
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 2021
Label revision date
April 11, 2025
Manufacturer
H2-Pharma, LLC
Registration number
ANDA208754
NDC root
61269-981
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 is a topical cream that contains 10% of the active ingredient and is used to treat cold sores and fever blisters on the face or lips. This non-prescription medication works by shortening the healing time and reducing the duration of symptoms such as tingling, pain, burning, and itching associated with these outbreaks.

When applied to the affected area, Docosanol helps to alleviate discomfort and promote faster recovery. It is important to use this cream only on the skin and as directed for the best results.

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.

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, be sure 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

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 apply it directly inside your mouth.

To ensure your safety and the safety of others, never share this product with anyone, as doing so may spread infections. By following these guidelines, you can help protect yourself and others while using this 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 these potential reactions to ensure your safety while using this product.

Warnings and Precautions

This product is for external use only and may cause a severe allergic reaction. If you experience symptoms like hives, facial swelling, wheezing or difficulty breathing, shock, or rash, 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.

Please be cautious and keep this product out of reach of children. Do not share it with others, as this can spread infection. Apply it only to the affected areas and avoid contact with your eyes or applying it directly inside your mouth. If your cold sore worsens or does not heal within 10 days, stop using the product and consult your doctor. Additionally, if the product is swallowed, seek emergency medical help or contact a Poison Control Center right away.

Overdose

If you or someone else has swallowed too much of a medication, it’s important to seek medical help immediately. You can do this by contacting a Poison Control Center or going to the nearest emergency room. Acting quickly can make a significant difference in the outcome.

Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms, don’t hesitate to get help right away. Remember, it’s always better to be safe and get checked by a medical professional.

Pregnancy Use

You can feel reassured that there are no specific warnings or precautions regarding the use of Docosanol during pregnancy. The information available does not indicate that Docosanol is contraindicated (not recommended) for pregnant individuals, nor does it mention any risks to the fetus. Additionally, there are no dosage modifications or special precautions required for those who are pregnant.

As always, it's a good idea to discuss any medications with your healthcare provider to ensure they are safe for you and your baby.

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, the information available does not indicate any concerns about docosanol being passed into breast milk or posing any risk to your infant. Always consult with your healthcare provider if you have any questions or concerns 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 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 or contact a Poison Control Center immediately.

Geriatric Use

While there is no specific information about the use of Docosanol cream in older adults, it’s important to approach any new medication with caution. Since the drug insert does not mention dosage adjustments or safety concerns for elderly patients, you should consult with a healthcare provider before starting this treatment. They can help ensure that it is appropriate for your needs and discuss any potential risks or considerations based on your overall health and any other medications you may be taking. Always prioritize open communication with your healthcare team to ensure safe and effective care.

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 may affect you if your kidneys are not functioning properly.

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your kidney health. They can help monitor your condition and make any necessary adjustments to your treatment plan.

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 may affect you if you have hepatic impairment (liver issues).

Before starting any new medication, including this one, you should discuss your liver health with your healthcare provider. They can help determine the best approach for your treatment and ensure your safety.

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 this topical treatment five times a day until your cold sore is healed. If your cold sore worsens or does not heal within 10 days, stop using the product and consult your doctor. Additionally, if you experience any allergic reactions, discontinue use immediately and seek medical assistance.

It's important not to share this product with others, as doing so could spread the infection.

FAQ

What is Docosanol used for?

Docosanol is a 10% cream used for the treatment of cold sores and fever blisters on the face or lips.

How does Docosanol work?

Docosanol helps to shorten the healing time and duration of symptoms such as tingling, pain, burning, and itching associated with cold sores.

How should I apply Docosanol?

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

What should I do if I experience an allergic reaction?

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

Can children use Docosanol?

Docosanol is for adults and children 12 years or older. For children under 12, consult a doctor before use.

Are there any precautions I should take?

Do not use Docosanol if you are allergic to any of its ingredients, and avoid applying it in or near the eyes or inside the mouth.

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

If your cold sore worsens or does not heal within 10 days, stop using Docosanol and consult a doctor.

How should I store Docosanol?

Store Docosanol 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

Docosanol is a topical cream formulated at a concentration of 10% for the treatment of cold sores and fever blisters. It is classified as a non-prescription medicine intended to shorten healing time. The product is manufactured by H² pharma and is available in a net weight of 2 grams (0.07 ounces). The National Drug Code (NDC) for this formulation is 61269-981-35.

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 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 the following situations:

  • Patients with a known allergy to any ingredient in this product, due to the risk of allergic reactions.

  • Application in or near the eyes is contraindicated, as it may cause irritation or damage to ocular tissues.

  • Direct application inside the mouth is not recommended, as it may lead to adverse effects.

  • Sharing this product with others is contraindicated to prevent the potential spread of infection.

Warnings and Precautions

This product has the potential to induce a severe allergic reaction. Symptoms indicative of such a reaction 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 contraindicated for individuals with a known allergy to any of its ingredients.

Healthcare professionals should advise patients to cease use and consult a physician if the cold sore worsens or fails to heal within 10 days.

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

General precautions must be observed to ensure safe use of this product. It should be kept out of reach of children, and sharing the product with others is strongly discouraged to prevent the spread of infection. Application should be limited strictly to the affected areas, and the product must not be used in or near the eyes. Additionally, direct application inside the mouth should be avoided.

Side Effects

Patients may experience severe allergic reactions to this product, which can manifest as 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 use. For adolescents aged 12 years and older, it is recommended to wash hands before and after applying the cream. The cream should be applied to the affected area on the face or lips at the first sign of a cold sore or fever blister (tingle) to ensure optimal results. Application should be done gently but completely, 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, 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 Docosanol cream in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as the absence of data necessitates careful consideration of individual patient factors and potential risks. Monitoring for efficacy and adverse effects is recommended in this population, given the lack of established guidelines for geriatric use.

Pregnancy

There are no specific warnings or precautions regarding the use of Docosanol during pregnancy. The prescribing information does not indicate whether Docosanol is contraindicated in pregnant patients or if there are any associated risks to the fetus. Additionally, no dosage modifications or special precautions for individuals who are pregnant are provided. Healthcare professionals should consider the absence of data when advising women of childbearing potential regarding the use of Docosanol during pregnancy.

Lactation

There are no specific warnings or recommendations regarding the use of docosanol cream in lactating mothers. Additionally, there is no information available concerning 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. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this medication. 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 overdosage, immediate medical assistance is crucial. If the substance is ingested, healthcare professionals should be contacted without delay, or the individual should reach out to a Poison Control Center for guidance.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. It is recommended that healthcare providers assess the situation thoroughly, including the amount ingested and the time of ingestion, to determine the appropriate course of action.

Monitoring for symptoms related to overdosage is critical, as these may vary depending on the specific substance involved. Healthcare professionals should be prepared to manage any symptoms that arise and provide supportive care as necessary.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

No postmarketing experience details are available in the provided text.

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.

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 their mouth. Additionally, patients must be advised not to share this product with anyone, 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 is essential to store the product at a temperature range of 20° to 25°C (68° to 77°F). Freezing the product is strictly prohibited, as it may compromise its integrity and effectiveness. Proper storage conditions must be maintained to ensure the product's quality and safety.

Additional Clinical Information

The product is administered topically and should be applied five times a day until the lesion is healed. Patients are advised to discontinue use and consult a healthcare professional if the cold sore worsens or does not heal within 10 days. In the event of an allergic reaction, immediate medical attention is recommended. Additionally, it is important for patients not to share the product with others to prevent the spread of infection.

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.