Symptom checker
Select audience type

Switch between content for healthcare professionals (PRO) and general audience (GEN).

ADD CONDITION

items per page

Docosanol

Last content change checked dailysee data sync status

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 2020
Label revision date
October 5, 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 2020
Label revision date
October 5, 2023
Manufacturer
Care One (Retail Business Services, LLC.)
Registration number
ANDA208754
NDC root
72476-922
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 shorten the healing time for cold sores and fever blisters that appear on the face or lips. It works by treating the symptoms associated with these sores, including tingling, pain, burning, and itching, allowing you to feel more comfortable as the sore heals.

This cream is intended for topical use only and is similar to the active ingredient found in Abreva®. If you experience cold sores, Docosanol Cream may provide relief and help speed up the healing process.

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, 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 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

You should avoid using this product if you are allergic to any of its ingredients. It's also important not to use it in or near your eyes, and you should refrain from applying it directly inside your mouth. Additionally, please do not share this product with anyone, as doing so could spread an infection. Always prioritize your safety and well-being when using any medication.

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 experience any of these symptoms, it’s important to stop using the product and seek medical help immediately.

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

Warnings and Precautions

This product is for external use only and may cause a severe allergic reaction in some people. 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.

Before using this product, make sure you are not allergic to any of its ingredients. 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 assistance 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 the specific signs of an overdose are not detailed, common symptoms can include extreme 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, contact your local emergency services or go to the nearest hospital. It's crucial to provide them with as much information as possible about the substance taken and the amount, if known. Remember, acting quickly can make a significant difference in your health and safety.

Pregnancy Use

There are no specific guidelines or warnings about using Docosanol Cream during pregnancy. The information provided does not indicate any safety concerns, contraindications, or special precautions for pregnant individuals.

If you are pregnant or planning to become pregnant, it's always a good idea to consult with your healthcare provider before using any new medication or product, including over-the-counter creams like Docosanol. Your healthcare provider can help you make informed decisions based on your individual health needs.

Lactation Use

If you are breastfeeding or planning to breastfeed, 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 you have a child under 12 years old, it's important to consult a doctor before using this cream. For children aged 12 and older, as well as adults, make sure to wash your hands before and after applying the cream. You should 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

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. Since older adults may have different health needs and responses to medications, you should always consult with a healthcare provider before starting any new medication. They can help determine the best approach for you or your loved one, considering any existing health conditions or medications that may interact.

Remember, your safety and well-being are the top priority, so don’t hesitate to ask questions and discuss any concerns with your doctor or pharmacist.

Renal Impairment

If you have kidney problems, it's important to know that there are no specific guidelines, dosage adjustments, or monitoring requirements mentioned for your condition in the provided information. This means that the standard recommendations for medication use may apply to you, but it's always best to consult with your healthcare provider for personalized advice. They can help ensure that any treatment you receive is safe and effective based on your kidney 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, and there are no special monitoring requirements or precautions outlined for patients with liver impairment.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe for your liver health. They can provide guidance based on your individual situation and help monitor your liver function as needed.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking. In this case, there are no specific drug interactions or laboratory test interactions noted, which means that the medication is generally considered safe to use with other drugs and tests. However, every individual is different, and your healthcare provider can help ensure that your treatment plan is safe and effective for you.

Always discuss any changes in your medications or upcoming lab tests with your healthcare provider to avoid any potential issues and 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 topical treatment to the affected area on your face or lips at the first sign of a cold sore or fever blister, such as a tingling sensation. Use it five times a day until the sore is healed. Remember, this product is for external use only, so avoid using it near your eyes or inside your mouth.

Make sure you are not allergic to any of the ingredients before using it, and do not share the product with others to prevent spreading the infection. If your cold sore worsens or does not heal within 10 days, stop using the product and consult a doctor. Keep it out of reach of children, and if swallowed, seek medical help or contact a Poison Control Center immediately.

FAQ

What is Docosanol Cream used for?

Docosanol Cream is a non-prescription medicine used to shorten the healing time for cold sores and fever blisters on the face or lips.

How does Docosanol Cream work?

It treats cold sores and fever blisters by shortening the healing time and reducing 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.

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 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 precautions should I take when using Docosanol Cream?

Do not use it if you are allergic to any ingredient, avoid contact with eyes and inside the mouth, and do not share the product to prevent spreading the infection.

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

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

How should I store Docosanol Cream?

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

Is Docosanol Cream safe to use during pregnancy?

The provided information does not specify safety concerns regarding the use of Docosanol Cream during pregnancy.

What should I do if I accidentally swallow Docosanol Cream?

If swallowed, seek 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 10% is a non-prescription topical formulation indicated for the treatment of cold sores. Each tube contains a net weight of 2 grams (0.07 ounces) of the cream. This formulation is designed to shorten the healing time of cold sores when applied as directed.

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/or 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, use is strictly prohibited in these individuals.

  • Application in or near the eyes is contraindicated to prevent potential irritation or injury.

  • Direct application inside the mouth should be avoided to minimize the risk of adverse effects.

  • Sharing this product with others is contraindicated, as it may facilitate the spread of infection.

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.

For external use only, this product should not be applied to individuals with known allergies to any of its ingredients. Prior to administration, a thorough review of the patient's allergy history is recommended to mitigate the risk of adverse reactions.

Patients should be advised to discontinue use and consult a healthcare provider if their cold sore worsens or fails to heal within 10 days. This precaution is essential to ensure appropriate management and to rule out any underlying complications.

In cases of accidental ingestion, immediate medical attention is required. Patients or caregivers should contact a Poison Control Center or seek emergency medical help without delay. Monitoring for any signs of toxicity or adverse effects following ingestion is crucial for patient safety.

Side Effects

Patients should be aware that this product may cause a severe allergic reaction. Symptoms of such a reaction can include hives, facial swelling, wheezing or difficulty breathing, shock, and rash. In the event of an allergic reaction, it is imperative to stop use immediately and seek medical assistance.

Additionally, patients are advised to discontinue use and consult a healthcare professional if their cold sore worsens or does not heal within 10 days.

Drug Interactions

There are no specific drug interactions or laboratory test interactions identified in the available data. Therefore, no dosage adjustments or monitoring recommendations 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 prior to 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) 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 adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

There are no specific statements regarding the use of Docosanol Cream during pregnancy. The available prescribing information does not indicate any safety concerns, contraindications, or special precautions associated with the use of this product in pregnant patients. As such, healthcare professionals should consider the lack of data when advising women of childbearing potential regarding the use of Docosanol Cream 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 of the drug in human milk. Healthcare professionals may consider the use of this medication in nursing mothers, as no adverse effects have been documented in this population.

Renal Impairment

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

Hepatic Impairment

There is no information available regarding the use of this medication in patients with hepatic impairment. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions specified for individuals with compromised liver function. Healthcare professionals should exercise clinical judgment when considering the use of this medication in patients with liver problems, as the absence of specific guidance necessitates careful evaluation of the patient's overall health status and liver function.

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.

If available, specific antidotes or treatments should be administered as indicated based on the clinical scenario and the substance involved. Consultation with a poison control center or a medical toxicologist may also be beneficial in guiding the management of the overdose.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available in the insert 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 handling and storage conditions must be adhered to in order to maintain the quality of the product.

Additional Clinical Information

The product is administered topically, applied to the affected area on the face or lips at the first sign of a cold sore or fever blister (tingle). Patients should use the product five times a day until healing occurs.

Clinicians should counsel patients that the product is for external use only and should not be applied if there is an allergy to any ingredient. It is important to apply the product solely to the affected areas, avoiding the eyes and direct application inside the mouth. Patients should not share the product to prevent spreading the infection. They should discontinue use and consult a doctor if the cold sore worsens or does not heal within 10 days. Additionally, the product should be kept out of reach of children, and immediate medical assistance should be sought if swallowed.

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.