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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
December 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 2024
Label revision date
December 11, 2025
Manufacturer
KROGER COMPANY
Registration number
ANDA217090
NDC root
30142-286
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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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. It 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.

This cream is intended for external use only and can provide relief when applied at the first sign of a cold sore. By addressing the symptoms early, Docosanol can help you feel more comfortable and promote faster healing.

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 works to shorten the healing time and reduce the duration of symptoms such as tingling, pain, burning, and itching.

By using this treatment, you can find relief from the discomfort associated with cold sores and get back to feeling like yourself more quickly.

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 soon as you feel that tingle, as early intervention leads to the best results. Gently rub the cream into the skin until it is fully 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 ingredient list carefully. Additionally, avoid using this product in or near your eyes, and do not apply it directly inside your mouth.

It's also crucial to remember that this product is for your use only—do not share it with anyone else, as this could lead to the spread of infection. Always prioritize your safety and well-being when using any medication.

Side Effects

This product may cause a severe allergic reaction in some individuals. Symptoms to watch for include hives, facial swelling, wheezing or difficulty breathing, shock, and rash. If you experience any of these symptoms, it is important to stop using the product immediately and seek medical assistance.

Please be aware that allergic reactions can be serious and require prompt attention. Always consult with a healthcare professional if you have concerns about potential side effects.

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 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

It appears that there is no specific information available regarding overdosage for this medication. However, it's important to be aware of the general signs of an overdose, which can include symptoms like extreme drowsiness, confusion, or difficulty breathing. If you suspect an overdose, it is crucial to seek immediate medical help.

In case of an emergency, call your local emergency number or go to the nearest hospital. Always keep medications out of reach of children and follow the prescribed dosage to prevent any potential risks. If you have any concerns or questions about your medication, don’t hesitate to reach out to your healthcare provider for guidance.

Pregnancy Use

There is currently no specific information available regarding the use of Docosanol cream during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions for pregnant individuals have not been addressed in the product insert. If you are pregnant or planning to become pregnant, it is important to consult with your healthcare provider before using this cream to ensure it is safe for you and your baby.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to know that the drug insert for Docosanol cream does not provide specific information about its use during nursing. This means there are no established guidelines or known effects on breast milk or your nursing infant.

As always, it's best to consult with your healthcare provider before using any medication while breastfeeding to ensure the safety and well-being of both you and your baby.

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. Use the cream 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 usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment plan.

Hepatic Impairment

If you have liver problems, it's important to know that there are no specific guidelines, dosage adjustments, or special monitoring instructions provided for your condition in the available information. This means that the medication may not have been studied in depth for its effects on individuals with liver impairment.

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver health and medication use. They can help ensure that your treatment is safe and effective based on your individual health needs.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you. Always share your complete list of medications and any recent lab tests to avoid any potential issues. Your health and safety should always come first.

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 the medication to the affected area on your face or lips as soon as you notice the first signs of a cold sore, such as tingling. Use it five times a day until the sore is healed.

It's also important to avoid close physical contact while you have a cold sore to prevent spreading the infection. If you need to apply cosmetics over an unhealed cold sore, use a separate applicator, like a cotton swab, to minimize the risk of transmission.

FAQ

What is Docosanol Cream used for?

Docosanol Cream is used to treat 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.

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, and use it 5 times a day until healed.

Are there any precautions I should take?

Do not use the cream in or near the eyes, avoid applying it directly inside your mouth, and do not share it with others to prevent spreading infection.

What should I do if I have 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 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 it 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

No description information is available for the specified drug.

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.

Additionally, the product should not be applied in or near the eyes, nor should it be used 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 cause a severe allergic reaction. 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.

Patients should be advised to stop use and consult a healthcare provider if their cold sore worsens or does not heal within 10 days. Monitoring for these conditions is essential to ensure appropriate management and intervention.

Side Effects

Patients using this product should be aware of the potential for 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 that patients discontinue use immediately and seek medical assistance without delay.

The occurrence of these serious adverse reactions necessitates careful monitoring and prompt intervention to ensure patient safety.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known interactions with laboratory tests. As such, 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, the following guidelines apply: hands should be washed 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

There is no specific information 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 they may have altered pharmacokinetics and pharmacodynamics. Close monitoring is recommended to ensure safety and efficacy in this population.

Pregnancy

There is no specific information regarding the use of Docosanol cream during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients. As with any medication, the potential benefits must be weighed against any unknown risks to fetal outcomes. Women of childbearing potential should be counseled accordingly.

Lactation

There is no specific information regarding the use of Docosanol cream in lactating mothers or lactation considerations. The prescribing information does not address the excretion of Docosanol in breast milk or its effects on breastfed infants. Healthcare professionals should exercise caution and consider the potential risks and benefits when recommending this medication to lactating mothers.

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 these patients to ensure safety and efficacy.

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 caution and consider the lack of data when prescribing this medication to patients with liver problems.

Overdosage

In the absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant regarding the potential for overdose with this medication. In cases where an overdose is suspected, immediate medical attention should be sought.

Healthcare providers are advised to monitor patients closely for any signs or symptoms that may indicate an overdose. These may include, but are not limited to, increased severity of known side effects, unusual behavioral changes, or any other atypical clinical manifestations.

Management of an overdose should be guided by the clinical presentation of the patient. Supportive care is paramount, and symptomatic treatment should be initiated as necessary. It is recommended that healthcare professionals consult local poison control centers or relevant toxicology resources for specific guidance on the management of overdose cases.

In summary, while specific overdosage information is not available, healthcare professionals should exercise caution, remain observant for potential overdose symptoms, and implement appropriate management strategies as needed.

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 Docosanol cream.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 if the product is swallowed.

Patients should be instructed to apply the product only to the affected areas, ensuring that it is not used in or near the eyes. It is important to emphasize that the product should not be applied directly inside the mouth.

Additionally, healthcare providers should inform patients that the product is for individual use only and should not be shared with others, as this may lead to 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

Patients should apply the medication to the affected area on the face or lips at the first sign of a cold sore or fever blister (tingle), using it five times a day until healing is complete. Clinicians should advise patients to avoid close physical contact during an active cold sore outbreak. Additionally, it is recommended that patients use a separate applicator, such as a cotton swab, when applying cosmetics over an unhealed cold sore 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.