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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
December 22, 2023
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
December 22, 2023
Manufacturer
Alembic Pharmaceuticals Inc.
Registration number
ANDA215839
NDC root
62332-682
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 a non-prescription medication specifically designed to treat cold sores and fever blisters on the face or lips. It works by addressing symptoms such as tingling, pain, burning, and itching, helping to shorten both the healing time and the duration of these uncomfortable symptoms. This cream is the only non-prescription cold sore treatment approved by the FDA for this purpose, making it a reliable option for those seeking relief.

Manufactured by Alembic Pharmaceuticals, Inc., Docosanol Cream is available in both tube and pump packaging. It is important to use this cream topically, applying it directly to the affected area to achieve 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 like tingling, pain, burning, and itching.

You can expect relief from the discomfort associated with cold sores, allowing you to feel more like yourself again. Rest assured, this medication does not have any teratogenic effects, meaning it does not cause birth defects.

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

There are no specific contraindications, controlled substance classifications, or risks of abuse or misuse associated with this medication. Additionally, there are no concerns regarding dependence (a condition where the body becomes reliant on a substance).

Since there are no explicit "do not take" or "do not use" instructions, it is important to consult with your healthcare provider for personalized advice and to ensure this medication is appropriate for you. Always prioritize open communication with your doctor about any concerns or questions you may have regarding your treatment.

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, you should not use it.

If your cold sore worsens or does not heal within 10 days, stop using the product and consult your doctor. It's important to be aware of these potential side effects to ensure your safety while using this medication.

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

While 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 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 signs of overdose for this medication, general symptoms can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these signs, or if you are unsure, seek medical help right away.

In case of an overdose, contacting your local emergency services or going to the nearest hospital is crucial. Always keep the medication packaging with you, as it can help healthcare professionals understand what you've taken. Remember, it's better to be safe and get checked out if you have any concerns about an overdose.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that there are no specific warnings or contraindications regarding the use of Docosanol Cream during pregnancy. This means that, based on the information available, using this cream is not expected to pose risks to you or your developing baby. However, as with any medication, it's always a good idea to consult with your healthcare provider before starting any new treatment to ensure it’s safe for your individual situation.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or considerations regarding the use of Docosanol Cream while nursing. This means that, based on the information available, it is generally considered safe for you to use this cream without concerns about affecting your milk production or posing risks to your nursing infant. Always consult with your healthcare provider if you have any questions or concerns about 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 is key to achieving the best 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 considering this medication, it’s important to consult with a healthcare provider. 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 standard recommendations for the medication do not include special monitoring or safety considerations tailored for patients with renal impairment (kidney issues).

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific health needs. They can provide guidance based on your kidney function and overall health.

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 tests to ensure your safety while using any medication. Your well-being is a priority, so don’t hesitate to ask questions or express any concerns you may have.

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 in this range and avoid freezing, as extreme temperatures can affect its effectiveness.

When handling the product, make sure to do so with clean hands and in a safe environment to maintain its integrity. Always follow any additional safety guidelines provided with the product to ensure proper use and disposal.

Additional Information

No further information is available.

FAQ

What is Docosanol Cream used for?

Docosanol Cream is used to treat cold sores and fever blisters on the face or lips, helping to shorten healing time and reduce symptoms.

How should I apply Docosanol Cream?

You should 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 the cream and seek medical help immediately.

Can I use Docosanol Cream if I am pregnant?

There are no specific warnings or contraindications mentioned regarding the use of Docosanol Cream during pregnancy.

Is Docosanol Cream safe for children?

For children under 12 years, you should ask a doctor before use. For those 12 years and older, follow the application instructions carefully.

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 the cream and consult a doctor.

How should I store Docosanol Cream?

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

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 a topical formulation indicated for the treatment of cold sores and fever blisters. This non-prescription medicine is designed to shorten healing time and reduce the duration of symptoms associated with cold sores. The product is packaged in a net weight of 2g (0.07 oz) and is manufactured for Alembic Pharmaceuticals, Inc., located in Bedminster, NJ, USA, with production conducted in India. This formulation contains the only non-prescription cold sore medicine approved by the FDA for its efficacy in shortening healing time. It is important to note that this product is not manufactured or distributed by GSK Consumer Healthcare, the distributor of Abreva®.

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

Adults and children aged 12 years and older should wash their 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, 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

There are no contraindications associated with the use of this product. It is deemed safe for use in the absence of specific conditions or situations that would warrant avoidance.

Warnings and Precautions

This product carries a significant risk of severe allergic reactions. Symptoms indicative 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 to discontinue use immediately and seek medical assistance. The product is intended for external use only and should not be applied if the user has a known allergy to any of its ingredients.

When utilizing this product, it is essential to apply it solely to the affected areas. Users must avoid contact with the eyes and refrain from applying the product directly inside the mouth. Additionally, sharing this product is strongly discouraged, as it may facilitate the spread of infection.

Patients should 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. Users should 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 with known allergies 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

There are no reported drug interactions associated with the use of this medication. Additionally, no interactions with laboratory tests have been identified. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug interactions.

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). Early treatment is crucial for achieving optimal results. The cream should be rubbed in gently but completely and used five times a day until the lesion is healed.

Geriatric Use

There is no specific information available 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 are no specific warnings or contraindications regarding the use of Docosanol Cream during pregnancy. Available data do not indicate any known risks associated with the use of this medication in pregnant patients. However, as with any medication, healthcare professionals should weigh the potential benefits against any unknown risks when prescribing Docosanol Cream to women of childbearing potential. It is advisable to consider the individual circumstances of each patient and to discuss any concerns regarding the use of this product during pregnancy.

Lactation

There are no specific warnings or considerations regarding the use of Docosanol Cream in lactating mothers. The available data does not indicate any known effects on breastfed infants or excretion in breast milk. Healthcare professionals may consider the use of this medication in nursing mothers, as no adverse effects have been documented in relation to lactation.

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 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 implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

Additionally, it is recommended to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols and antidotes, if applicable.

Documentation of the incident, including the amount and timing of the substance taken, is crucial for effective treatment and follow-up care.

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

No postmarketing experience details are available for Docosanol Cream, 10%.

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. Proper storage conditions are essential to maintain the quality and efficacy of the product.

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

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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.