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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
May 23, 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
May 23, 2024
Manufacturer
Rugby Laboratories
Registration number
ANDA215839
NDC root
0536-1427
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 non-prescription medication designed to help treat cold sores and fever blisters on the face or lips. It works by shortening the healing time and reducing the duration of symptoms such as tingling, pain, burning, and itching. This cream is the only non-prescription cold sore treatment approved by the FDA for these purposes, making it a reliable option for those seeking relief from these uncomfortable outbreaks.

When applied topically, Docosanol Cream can help you manage the discomfort associated with cold sores effectively. It is important to note that this product is not manufactured or distributed by the same company that produces Abreva®, which contains a different active ingredient.

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 and get back to your daily activities more quickly. Rest assured, this medication does not have any teratogenic effects, meaning it does not cause birth defects.

Dosage and Administration

It seems that there is no specific dosage or administration information available for the medication you are inquiring about. This means that details such as how much to take, how to take it, or how often to use it are not provided.

If you have any questions about how to use this medication or need guidance on its administration, it's best to consult with your healthcare provider or pharmacist. They can give you the most accurate and personalized information based on your health needs.

What to Avoid

There are no specific contraindications, controlled substance classifications, or risks of abuse, misuse, or dependence associated with this medication. This means that, based on the available information, there are no particular situations or conditions under which you should avoid using it. Always consult with your healthcare provider for personalized advice and to ensure that this medication is appropriate for your individual health needs.

Side Effects

This product may cause a severe allergic reaction, which can include symptoms such as hives, facial swelling, wheezing or difficulty breathing, shock, and rash. If you have a known allergy to any ingredient in this product, it is important not to use it.

You should stop using the product and consult a doctor if your cold sore worsens or does not heal within 10 days.

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, so do not apply it near your eyes or inside your mouth, and avoid sharing it with others to prevent spreading any infection.

When using this product, apply it only to the affected areas. 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

If you suspect an overdose, it's important to stay calm and take immediate action. While there is no specific information available about the effects of an overdose for this medication, you should be aware of general signs that may indicate a problem. These can include unusual drowsiness, confusion, or difficulty breathing.

If you notice any of these symptoms or if you believe you have taken too much of the medication, seek medical help right away. Contact your healthcare provider or go to the nearest emergency room. It's always better to be safe and get checked out if you have any concerns about your health.

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 Cream during pregnancy. The product insert does not indicate any safety concerns, dosage changes, or special precautions for pregnant individuals.

As always, it's best to consult with your healthcare provider before using any medication during pregnancy to ensure it is safe for you and your baby.

Lactation Use

If you are breastfeeding, you can use Docosanol Cream without specific warnings or precautions. Currently, there is no information available about whether this cream passes into breast milk or if it poses any risk to your nursing infant. Always consult with your healthcare provider if you have any concerns or questions about using medications while breastfeeding.

Pediatric Use

If your child is under 12 years old, it's important to consult a doctor before using this cream. For 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. Starting treatment early can lead to better results. Make sure to rub the cream in gently and completely, using it 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 issues, 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 include special monitoring or safety considerations tailored for patients with renal impairment (kidney problems).

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 provide guidance based on your individual situation.

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, your healthcare provider can help ensure that your overall treatment plan is safe and effective, taking into account all the medications and tests you may be using. Always feel free to ask questions and share your complete health history to get 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 with the product to ensure safe usage and disposal.

Additional Information

You should apply this medication topically, using it five times a day until the area is healed. If you experience an allergic reaction, stop using the product immediately and seek medical assistance. Additionally, if your cold sore worsens or does not heal within 10 days, consult your doctor. In case of accidental swallowing, contact a medical professional or reach out to a Poison Control Center right away.

FAQ

What is Docosanol Cream used for?

Docosanol Cream is used to treat cold sores and fever blisters on the face or lips, shortening healing time and alleviating symptoms like tingling, pain, burning, and itching.

How should I use Docosanol Cream?

Apply the cream to the affected area at the first sign of a cold sore, using it 5 times a day until healed. Make sure to wash your hands before and after application.

Are there any allergies associated with Docosanol Cream?

Yes, this product may cause a severe allergic reaction. Symptoms can include hives, facial swelling, wheezing, shock, and rash. Stop use and seek medical help if an allergic reaction occurs.

What should I do if my cold sore worsens?

If your cold sore gets worse or is not healed within 10 days, stop using the cream and consult a doctor.

Can I use Docosanol Cream if I am pregnant or nursing?

There is no specific information regarding the use of Docosanol Cream during pregnancy or nursing, so consult your doctor for advice.

What are the storage instructions for Docosanol Cream?

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

Is there any information on drug interactions with Docosanol Cream?

No drug interactions have been mentioned for Docosanol Cream.

What should I do if I accidentally swallow Docosanol Cream?

If swallowed, get medical help or contact a Poison Control Center immediately.

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 is a topical formulation containing 10% docosanol. It is intended for external use only and is packaged in a net weight of 2 grams (0.07 ounces).

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

No dosage or administration information is available for this product. Healthcare professionals are advised to consult the prescribing information or relevant clinical guidelines for specific dosing recommendations and administration techniques.

Contraindications

There are no contraindications associated with the use of this product. It is not classified as a controlled substance, and there are no known risks of abuse, misuse, or dependence.

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.

This product is intended for external use only. It is crucial to apply it solely to the affected areas and to avoid contact with the eyes or direct application inside the mouth. Additionally, sharing this product is strongly discouraged, as it may facilitate the spread of infection.

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

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

Side Effects

Patients may experience a range of adverse reactions associated with this product. A severe allergic reaction is a notable concern, with symptoms that may include hives, facial swelling, wheezing or difficulty breathing, shock, and rash. Due to the potential for such reactions, individuals who are allergic to any ingredient in this product are advised not to use it.

In clinical practice, it is important for patients to monitor their condition closely. If a cold sore worsens or does not heal within 10 days, patients should discontinue use and consult a healthcare professional for further evaluation and guidance.

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 aged 12 years and older, it is recommended to wash hands before and after applying the cream. The cream should be applied to the affected area on the face or lips at the first sign of a cold sore or fever blister (tingle). Early treatment is essential for optimal results. The cream should be rubbed in gently but completely and used five times a day until healing is achieved.

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 efficacy, given the lack of targeted data for this population.

Pregnancy

There is no information available regarding the use of Docosanol Cream during pregnancy. The prescribing information does not indicate any safety concerns, dosage modifications, or special precautions for pregnant patients. As such, healthcare professionals should consider the lack of data when advising women of childbearing potential about the use of this medication during pregnancy. It is recommended that the potential benefits be weighed against any unknown risks to fetal outcomes.

Lactation

There are no specific warnings or precautions regarding the use of Docosanol Cream in lactating mothers. Additionally, there is no information available about the potential for excretion of Docosanol in breast milk or any associated risks to breastfed infants.

Renal Impairment

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

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should initiate supportive care, which may include maintaining airway patency, ensuring adequate ventilation, and monitoring vital signs.

If available, the use of specific antidotes or treatments should be considered based on the clinical scenario and the substance involved. Consultation with a poison control center or a medical toxicologist may provide additional guidance on the management of overdose cases.

Documentation of the incident, including the substance, amount ingested, and time of ingestion, is crucial for effective management and treatment planning.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the use of the compound in these contexts.

Postmarketing Experience

No postmarketing experience details are available for SPL code 90375-7.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. It is important to emphasize that if the medication is swallowed, patients should seek medical help or contact a Poison Control Center immediately. This guidance is crucial for ensuring patient safety and minimizing potential risks associated with accidental exposure.

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

The product is administered topically, with a recommended frequency of five times a day until healing occurs. Clinicians should counsel patients to discontinue use and seek medical assistance immediately if an allergic reaction develops. Additionally, patients are advised to stop use and consult a healthcare provider if their cold sore worsens or does not heal within 10 days. In the event of accidental ingestion, patients should seek medical help or contact a Poison Control Center without delay.

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.