Symptom checker
Select audience type

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

ADD CONDITION

items per page

Abreva

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 2022
Label revision date
June 20, 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 2022
Label revision date
June 20, 2024
Manufacturer
Haleon US Holdings LLC
Registration number
ANDA208754
NDC root
0135-0300
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

Abreva is a non-prescription cream that contains 10% docosanol, designed specifically to treat cold sores and fever blisters on the face or lips. It works by shortening the healing time and reducing the duration of symptoms such as tingling, pain, burning, and itching associated with these outbreaks.

This topical medication is easy to use and can help you manage the discomfort of cold sores more effectively. If you experience a cold sore, applying Abreva may help speed up your recovery and alleviate some of the bothersome 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 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 apply it in or near your eyes, or directly inside your mouth. Additionally, please do not share this product with anyone, as doing so 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, stop using the product immediately and seek medical help.

You should not use this product if you are allergic to any of its ingredients. Additionally, if your cold sore worsens or does not heal within 10 days, it’s important to 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. If you experience symptoms like hives, facial swelling, wheezing or difficulty breathing, shock, or a rash, stop using the product immediately and seek medical help.

Do not use this product if you are allergic to any of its ingredients. If your cold sore worsens or does not heal within 10 days, stop using the product and consult your doctor. Additionally, keep this product out of reach of children. If swallowed, seek medical assistance or contact a Poison Control Center right away.

Overdose

If you or someone else has swallowed too much of a medication, it’s important to seek medical help immediately. You can do this by contacting a Poison Control Center or going to the nearest emergency room. Acting quickly can make a significant difference in the outcome.

Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms, don’t hesitate to get help right away. Remember, it’s always better to be safe and seek assistance if you suspect an overdose.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that there is no specific information available about the use of ABREVA (docosanol cream) during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions related to its use in pregnant individuals have not been established.

As always, it's best to consult with your healthcare provider before using any medication during pregnancy to ensure the safety of both you and your baby.

Lactation Use

If you are breastfeeding and considering using ABREVA (docosanol cream), you can feel reassured that there are no specific warnings or considerations mentioned for nursing mothers in the drug insert. This means that, based on the available information, using this cream should not pose any additional risks to you or your breastfeeding infant.

However, as with any medication, it's always a good idea to consult with your healthcare provider before starting any new treatment while breastfeeding, just to ensure it’s the right choice for 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 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. Gently rub the cream in completely and use it 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. If you or a loved one is an older adult, it’s always a good idea to discuss any medications with a healthcare provider, especially since older adults may have different health needs and may be taking other medications.

Since there are no dosage adjustments or special precautions mentioned for elderly patients, your healthcare provider can help determine the best approach for you, considering your overall health and any other medications you may be taking. 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 the drug insert does not provide specific information about dosage adjustments, special monitoring, or safety considerations for your condition. This means that there are no tailored guidelines for how this medication should be used if you have renal impairment (kidney issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your health situation. They can help determine the best course of action based on your kidney function and overall health.

Hepatic Impairment

If you have liver problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication should be used if you have hepatic impairment (issues with liver function).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your liver health. They can help you understand how to manage your treatment effectively.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking, even if there are no specific drug interactions or laboratory test interactions noted for your treatment. This ensures that your healthcare team can provide the best care tailored to your needs.

Always inform your doctor about all the medications, supplements, and tests you are undergoing. This helps them monitor your health effectively and make informed decisions about your treatment plan. Your safety and well-being are the top priority, so don't hesitate to ask questions or express any concerns you may have.

Storage and Handling

To ensure the best performance of your product, store it at a temperature between 20°C and 25°C (68°F - 77°F). It's important to keep it in this temperature range and avoid freezing, as freezing can damage the product and affect its effectiveness.

When handling the product, make sure to do so in a clean environment to maintain its integrity. Always follow any specific instructions provided for use to ensure safety and effectiveness. If you have any questions about disposal or further handling, please refer to the guidelines provided with your product.

Additional Information

You can use ABREVA to treat cold sores by applying it directly to the affected area five times a day until the sore is healed. For the best results, start using it at the first sign of a tingle, redness, bump, or itch. Both adults and children aged 12 and over can use ABREVA.

If you want to wear cosmetics like lipstick while using ABREVA, you can do so. Just make sure to use a separate applicator, such as a cotton swab, to avoid spreading the infection. For optimal effectiveness, it's best to remove any cosmetics before applying ABREVA.

FAQ

What is Abreva used for?

Abreva is used to treat cold sores and fever blisters on the face or lips.

How does Abreva work?

Abreva shortens the healing time and duration of symptoms such as tingling, pain, burning, and itching.

Who can use Abreva?

Adults and children 12 years or older can use Abreva. Children under 12 should ask a doctor.

How should I apply Abreva?

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 five times a day until healed.

Are there any precautions I should take?

Do not use Abreva if you are allergic to any ingredient in the product, and avoid using it in or near the eyes or inside your mouth.

What should I do if I experience an allergic reaction?

If you experience symptoms like hives, facial swelling, or difficulty breathing, stop using Abreva and seek medical help immediately.

What if my cold sore does not heal?

If your cold sore worsens or does not heal within 10 days, stop using Abreva and consult a doctor.

Can I use cosmetics while using Abreva?

Yes, you can apply cosmetics over Abreva, but use a separate applicator to avoid spreading the infection.

How should I store Abreva?

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

Packaging Info

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

Packaging configurations for Abreva.
Details

Drug Information (PDF)

This file contains official product information for Abreva, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

Abreva is a non-prescription topical cream formulated with 10% docosanol as the active ingredient. It is indicated for the treatment of cold sores and fever blisters, aiming to shorten the healing time. The product is intended for external use only and is packaged in a net weight of 2 grams (0.07 ounces). The product code for abreva is PA1001738.

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 characterized by a tingling sensation. 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 fully 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.

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

  • Direct application inside the mouth should be avoided to prevent 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.

This product is contraindicated in individuals with a known allergy to any of its ingredients. It is essential to assess patient history for any potential allergies prior to administration.

Patients should be advised to discontinue use and consult a physician if their cold sore worsens or fails to heal within 10 days. Monitoring the progression of the cold sore is crucial to ensure appropriate management.

Additionally, this product is intended for external use only. It must be kept out of reach of children. In the case of accidental ingestion, immediate medical attention should be sought, or contact with a Poison Control Center is recommended.

Side Effects

Patients may experience a range of adverse reactions associated with this product. A significant concern is the potential for severe allergic reactions, which may manifest as hives, facial swelling, wheezing or difficulty breathing, shock, and rash. In the event of an allergic reaction, patients are advised to discontinue use immediately and seek medical assistance.

It is crucial for patients to avoid using this product if they have a known allergy to any of its ingredients. Additionally, patients should stop using the product and consult a healthcare professional if their cold sore worsens or does not heal within 10 days.

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions with laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

Packaging & NDC

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

Packaging configurations for Abreva.
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). It should be gently rubbed in completely and used 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 is no specific information available regarding the use of ABREVA (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, and alternative treatments may be considered in the absence of established safety data.

Lactation

There are no specific warnings or considerations regarding nursing mothers or lactation in the provided drug insert for ABREVA (docosanol cream). Therefore, lactating mothers may use this medication without concern for adverse effects on breastfed infants.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals 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

Patients with hepatic impairment have not been specifically studied in relation to 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 prescribing information.

Overdosage

In the event of an overdosage, immediate medical intervention is crucial. If the substance is ingested, it is imperative to seek medical assistance or contact a Poison Control Center without delay.

Healthcare professionals should be aware that prompt action can significantly influence the outcome of an overdosage situation. Symptoms of overdosage may vary depending on the specific substance involved; therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures may include supportive care and symptomatic treatment as necessary. It is recommended that healthcare providers follow established protocols for the management of overdosage, which may involve the administration of activated charcoal, intravenous fluids, or other interventions based on the clinical presentation and severity of symptoms.

In all cases of suspected overdosage, the involvement of a Poison Control Center can provide valuable guidance on the appropriate management strategies tailored to the specific circumstances of the case.

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 compound in these areas.

Postmarketing Experience

No specific postmarketing experience details have been reported in the available data. As such, there are no additional adverse events or rare case reports to summarize at this time.

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 should not share this product with anyone, 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 for identification. It should be stored at a temperature range of 20°C to 25°C (68°F to 77°F). Care must be taken to ensure that the product does not freeze, as freezing may compromise its integrity. Proper container requirements should be adhered to, and special handling needs must be observed to maintain the product's quality and efficacy.

Additional Clinical Information

ABREVA is indicated for the treatment of cold sores and should be applied five times a day until the lesion is healed. It is most effective when applied at the first sign of symptoms, such as tingling, redness, bump, or itch. Both adults and children aged 12 years and older are eligible to use ABREVA.

Patients may apply cosmetics, including lipstick, over ABREVA; however, it is recommended to use a separate applicator, such as a cotton swab, to prevent the spread of infection from an unhealed cold sore. For optimal results, it is advisable to remove any cosmetics before applying ABREVA.

Drug Information (PDF)

This file contains official product information for Abreva, 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 Abreva, 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.