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Amazon Basics 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 2026
Label revision date
March 18, 2026
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 2026
Label revision date
March 18, 2026
Manufacturer
Amazon. com Services LLC
Registration number
ANDA217090
NDC root
72288-006
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 topical treatment specifically designed for cold sores and fever blisters that appear on the face or lips. This medication 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 cream as directed to achieve the best results in managing your symptoms.

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.

Dosage and Administration

Before 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 start 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, please 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 doing so could spread infections. Always prioritize your safety and well-being when using any medication.

Side Effects

This product 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, it is important to stop using the product immediately and seek medical assistance.

Always be aware of these potential reactions to ensure your safety while using this product.

Warnings and Precautions

This product is for external use only and may cause a severe allergic reaction. 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. If you know you are allergic to any ingredient in this product, please do not use it.

You should also stop using the product and contact your doctor if your cold sore worsens or does not heal within 10 days. In case of accidental swallowing, seek emergency medical help or contact a Poison Control Center at 1-800-222-1222 right away.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, it’s always important to be aware of the signs of an overdose, which can include unusual drowsiness, confusion, or difficulty breathing. If you suspect that you or someone else may have taken too much of a medication, it’s crucial to seek immediate medical help.

In case of an overdose, contact your local emergency services or go to the nearest hospital. Having the medication packaging or information on hand can help medical professionals provide the best care. Always remember that when in doubt, it’s better to err on the side of caution and seek assistance.

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 this time. This means that, based on the available information, using this cream is generally considered safe for pregnant individuals. 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 appropriate for your specific situation.

Lactation Use

If you are breastfeeding, you can use docosanol cream without specific warnings or recommendations against it. The information available does not indicate any concerns about the cream being passed into breast milk or posing any risk to your nursing infant.

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

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, it’s important to consult with a healthcare provider before starting the medication. 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 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. 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 feel free to ask questions and share your complete list of medications and any lab tests you may be undergoing. This way, you can receive the best possible care tailored to your needs.

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 and safety. Always follow any additional instructions provided with the product for optimal use and disposal.

Additional Information

Docosanol cream is designed for adults and children aged 12 and older to treat cold sores. For the best results, apply the cream directly to the cold sore five times a day, starting at the first sign of symptoms like tingling, redness, bump, or itch.

Cold sores affect about one in five Americans each year, with most people experiencing two to three outbreaks annually. It's important to recognize early warning signs and avoid close contact with others during an outbreak, as the infection can easily spread. Starting treatment with docosanol cream as soon as you notice symptoms can enhance its effectiveness.

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.

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. Rub it in gently and use it five times a day until healed.

What should I do if I am allergic to any ingredient in Docosanol Cream?

Do not use the cream if you are allergic to any of its ingredients.

What are the signs of a severe allergic reaction?

Signs may include hives, facial swelling, wheezing, difficulty breathing, shock, or rash. If any of these occur, stop use and seek medical help immediately.

Can children use Docosanol Cream?

Children under 12 years should ask a doctor before use. For those 12 years and older, follow the same application instructions as adults.

What should I do if my cold sore does not heal within 10 days?

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

Is Docosanol Cream safe to use during pregnancy or while nursing?

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

How should I store Docosanol Cream?

Store the 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 Amazon Basics Docosanol (docosanol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Amazon Basics Docosanol.
Details

Drug Information (PDF)

This file contains official product information for Amazon Basics 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

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, typically when a tingling sensation is felt. Early treatment is crucial for achieving optimal results.

The cream should be gently but completely rubbed into the affected area. 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 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 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 has the potential to induce 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.

For patients with known allergies to any ingredient in this product, it is advised that they refrain from use to prevent adverse reactions.

In cases where a cold sore worsens or fails to heal within 10 days, patients should be instructed to stop using the product and consult their healthcare provider for further evaluation and management.

If the product is ingested, it is crucial to obtain emergency medical help or contact a Poison Control Center at 1-800-222-1222 without delay.

This product is intended for external use only, and adherence to this guideline is essential to ensure patient safety.

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 the use of this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Amazon Basics Docosanol (docosanol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Amazon Basics 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, 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 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 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 to women of childbearing potential. It is advisable for healthcare providers to discuss the use of this medication with their patients, considering individual circumstances and the absence of extensive clinical data on its use during pregnancy.

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

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

There is currently no specific information available regarding overdosage for this medication. In the absence of documented overdosage data, healthcare professionals are advised to exercise caution and monitor patients closely for any unusual symptoms or adverse effects that may arise following administration.

In the event of suspected overdosage, it is recommended that healthcare providers initiate supportive care and symptomatic treatment as necessary. Continuous monitoring of vital signs and clinical status is essential to ensure patient safety.

Healthcare professionals should also consider consulting a poison control center or relevant toxicology resources for guidance on management strategies tailored to the specific circumstances of the overdosage event.

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 ability to draw conclusions regarding the potential toxicological profile of the substance in nonclinical settings.

Postmarketing Experience

Postmarketing experience has revealed reports of various adverse reactions. These include allergic reactions such as hives, facial swelling, wheezing or difficulty breathing, shock, and rash. These events have been reported voluntarily or identified through surveillance programs.

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 patients to disclose any known allergies to ingredients in this product prior to use.

Healthcare providers should instruct patients to discontinue use and consult a doctor if their cold sore worsens or does not heal within 10 days. When using this product, patients must be informed to apply it only to the affected areas and to avoid contact with the eyes. Additionally, patients should be cautioned against applying the product directly inside the mouth and reminded not to share it with others, 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 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

For adults and children aged 12 years and older, docosanol cream should be applied directly to the cold sore five times a day until healing occurs. It is most effective when used at the first sign of symptoms, such as tingling, redness, bump, or itch.

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. Prompt application of docosanol cream at the onset of symptoms enhances its effectiveness.

Drug Information (PDF)

This file contains official product information for Amazon Basics 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 Amazon Basics 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.

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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.