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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
August 16, 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
August 16, 2024
Manufacturer
Aurohealth LLC
Registration number
ANDA217090
NDC root
58602-019
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (9 NDCs)
Packaging & NDC Codes (9)

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

Drug Overview

Docosanol Cream 10% is a topical treatment specifically designed for cold sores and fever blisters that appear on the face or lips. This cream works by helping to shorten the healing time and reduce the duration of uncomfortable symptoms such as tingling, pain, burning, and itching associated with these outbreaks.

When you apply Docosanol Cream, it acts to alleviate the discomfort of cold sores, allowing you to feel more at ease while your skin heals. It's important to use this medication as directed 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 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 in a shorter amount of time.

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 soon as you feel that tingle, as early intervention leads to 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 this treatment 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. Allergies can cause serious reactions, so it's important to check the ingredients carefully before using the product.

While using this product, please avoid applying it in or near your eyes and do not apply it directly inside your mouth. Additionally, do not share this product with anyone else, as sharing can lead to the spread of infections. Always prioritize your safety and the safety of others when using any 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 this allergy alert and take it seriously to ensure your safety.

Warnings and Precautions

This product is for external use only and may cause a severe allergic reaction in some individuals. If you experience symptoms such as hives, facial swelling, wheezing or difficulty breathing, shock, or a rash, stop using the product immediately and seek medical help.

You should also stop using this product and consult your doctor if your cold sore worsens or does not heal within 10 days. It's important to monitor your condition and take action if necessary to ensure your safety and well-being.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While the specific signs of an overdose are not detailed, common symptoms can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these signs or feel concerned, seek medical help right away.

In case of an overdose, contacting a healthcare professional or poison control center is crucial. They can provide guidance on what to do next and help ensure your safety. Always remember that it's better to be cautious and get help if you think an overdose may have occurred.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that there are no specific guidelines or warnings regarding the use of docosanol cream during pregnancy. The information available does not indicate any risks or contraindications for pregnant individuals, nor does it suggest any changes to the dosage for those who are pregnant.

While there are no special precautions mentioned, it's always a good idea to consult with your healthcare provider before using any medication or treatment during pregnancy to ensure it is 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 regarding its use for nursing mothers. Additionally, there is no information indicating that docosanol cream is excreted in breast milk or that it poses any risk to your infant.

As always, if you have any concerns or questions about using this product while breastfeeding, it's a good idea to consult with your healthcare provider for personalized advice.

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. The cream should be used five times a day until the area is healed.

Geriatric Use

If you are considering using docosanol cream, it's important to know that it is suitable for adults and children aged 12 years and older. However, if you have a child under 12, you should consult a doctor before use to ensure safety and proper guidance. This precaution helps address any specific needs or concerns that may arise for younger patients. Always prioritize safety and seek professional advice when it comes to medication for children.

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.

It's always best to discuss your individual situation with your healthcare provider, who can offer personalized advice and ensure that any medications you take are safe and effective for you.

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 appropriately.

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 effective for you.

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

Docosanol cream is designed to help treat cold sores. You should apply it directly to the cold sore five times a day, starting at the first sign of a tingle, redness, bump, or itch for the best results. It's important to remove any cosmetics before application to ensure the cream works effectively.

Cold sores affect about one in five Americans each year, with most people experiencing two to three outbreaks annually. Be mindful that the virus can be easily transmitted to others just before and during an outbreak, so avoid close contact during this time. 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 Cream used for?

Docosanol Cream is used for the treatment of 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.

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. Use it five times a day until healed.

Are there any precautions I should take when using Docosanol Cream?

Do not use it in or near the eyes, avoid applying it directly inside your mouth, and do not share the product with others.

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 should I do if my cold sore does not heal?

Stop use and ask a doctor if your cold sore gets worse or is not healed within 10 days.

How should I store Docosanol Cream?

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

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

The provided information does not include specific warnings or recommendations for use during pregnancy or lactation.

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 indicated for the treatment of cold sores and fever blisters. This formulation is intended for topical use only. Each tube contains a net weight of 2 grams (0.07 ounces) of the cream.

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

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 achieving 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 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 due to the potential risk of spreading infection.

Warnings and Precautions

This product may induce a severe allergic reaction in some individuals. 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 without delay.

This product is intended for external use only.

Healthcare professionals should advise patients to discontinue use and consult a physician if the cold sore worsens or fails to heal within 10 days. Monitoring the progression of the cold sore is essential to ensure appropriate management and intervention if necessary.

Side Effects

Patients may experience severe allergic reactions associated with this product. Symptoms of such reactions can 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.

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 and children 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). Treatment should be administered five times a day until the lesion is healed.

Geriatric Use

Elderly patients, as well as adults and children aged 12 years and older, may use docosanol cream. However, for children under 12 years of age, it is advised to consult a healthcare provider prior to use.

When considering the use of docosanol cream in geriatric patients, healthcare providers should remain vigilant regarding potential age-related physiological changes that may affect drug metabolism and efficacy. Although specific dosage adjustments for elderly patients are not indicated, careful monitoring for any adverse effects is recommended, given the increased likelihood of comorbidities and polypharmacy in this population.

Pregnancy

There are no specific statements regarding the use of docosanol cream during pregnancy. The available prescribing information does not mention any contraindications or risks associated with the use of docosanol cream in pregnant individuals. Additionally, no dosage modifications for pregnant individuals are provided. The insert also does not include any special precautions regarding the use of docosanol cream during pregnancy. As such, healthcare professionals should consider the absence of data when advising pregnant patients on the use of this medication.

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

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the text. Therefore, healthcare professionals should exercise caution and consider individual patient factors when prescribing to patients with reduced kidney function. Regular monitoring of renal function may be warranted in these patients, although specific guidelines are not outlined.

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

There is currently no information available regarding overdosage for this medication. Healthcare professionals are advised to monitor patients closely for any adverse effects and to follow standard protocols for managing potential overdose situations. In the absence of specific overdosage data, it is recommended that clinicians exercise caution and consider 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 specific postmarketing experience details are available in the insert text. As such, there are no reported adverse events or case reports to summarize.

Patient Counseling

Patients should be advised to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 if the product is swallowed. It is important for healthcare providers to inquire about any known allergies to ingredients in the product before recommending its use.

Patients should be instructed to discontinue use and consult a doctor if their cold sore worsens or does not heal within 10 days. When applying the product, patients should only apply it to the affected areas and avoid contact with the eyes. They should also be cautioned against applying the product directly inside the mouth.

Additionally, healthcare providers should emphasize that this product should not be shared with others, as doing so may facilitate the spread of infection.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It should be stored at a temperature range of 20° to 25°C (68° to 77°F). Freezing is not permitted, as it may compromise the integrity of the product. Proper handling and storage conditions are essential to maintain the product's efficacy and safety.

Additional Clinical Information

Docosanol cream should be applied directly to the cold sore at the first sign of a tingle, redness, bump, or itch, and is recommended for use five times a day until the cold sore is healed. For optimal results, patients are advised to remove any cosmetics before application.

Clinicians should inform 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 and to avoid close physical contact during this time, as the infection can be easily transmitted. After healing, the herpes simplex virus remains dormant 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.