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Abreva

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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 2010
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 2010
Label revision date
June 20, 2024
Manufacturer
Haleon US Holdings LLC
Registration number
NDA020941
NDC root
0135-0200
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (5 NDCs)
Packaging & NDC Codes (5)

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

Drug Overview

Abreva is a cream that contains 10% docosanol, which is used to treat cold sores or fever blisters on the face or lips. This medication works by shortening the healing time and reducing the duration of symptoms such as tingling, pain, burning, and itching associated with cold sores.

If you experience cold sores, Abreva can help you manage the discomfort and speed up the healing process, allowing you to feel more comfortable and confident.

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 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 this treatment for a child under 12, it’s best to consult a doctor first. Remember to wash your hands again after applying the cream to avoid spreading the virus.

What to Avoid

It's important to be aware of certain precautions when using this product. First and foremost, do not use it if you are allergic to any of its ingredients, as this could lead to serious reactions. Additionally, avoid applying the product in or near your eyes and do not apply it directly inside your mouth.

To ensure your safety and the safety of others, never share this product with anyone, as doing so can spread infections. Always prioritize your health by following these guidelines closely.

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, seek medical attention immediately. It’s important to avoid using this product if you are allergic to any of its ingredients.

While using this product, apply it only to the affected areas and avoid contact with your eyes or inside your mouth. If your cold sore worsens or does not heal within 10 days, stop using the product and consult a doctor. Keep this product out of reach of children, and if swallowed, seek medical help or contact a Poison Control Center right away.

Warnings and Precautions

This product is for external use only and may cause a severe allergic reaction in some people. 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. It's important not to 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 a medication and you suspect an overdose, it’s important to act quickly. You should seek medical help immediately or contact a Poison Control Center for guidance.

Signs of an overdose can vary, but they may include unusual symptoms that are not typical for the medication. Always err on the side of caution and reach out for professional assistance if you have any concerns about an overdose. Your safety is the top priority, so don’t hesitate to get help.

Pregnancy Use

You can use ABREVA (docosanol cream) during pregnancy, as there are no specific warnings or precautions mentioned regarding its use. The information available does not indicate that the product is contraindicated (not recommended) for pregnant individuals, nor does it raise any safety concerns. Additionally, there are no dosage modifications or special precautions required for pregnant individuals when using this cream.

As always, it's a good idea to consult with your healthcare provider before starting any new medication during pregnancy to ensure it’s safe for 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 nursing 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. 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 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 may affect you if your kidneys are not functioning properly.

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your kidney health. They can help monitor your condition and make any necessary adjustments to your treatment plan.

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 may affect you if you have hepatic impairment (liver issues).

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 you receive the safest and most effective treatment.

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°C and 25°C (68°F - 77°F). It's important to keep it in a cool, dry place and avoid freezing, as this can damage the product.

When handling the product, make sure to maintain a clean environment to prevent contamination. Always follow any specific instructions provided with the product for safe use and disposal. By taking these precautions, you can help ensure the product remains effective and safe for your needs.

Additional Information

You can effectively manage cold sores by applying the medication topically to the affected area on your face or lips at the first sign of a cold sore, such as a tingle. For optimal results, use it five times a day until the sore is healed. It's important to be aware that about one in five Americans experiences cold sores annually, with most having two to three outbreaks each year. During an outbreak, the infection can easily spread, so avoid close contact with others.

After a cold sore heals, the virus remains in your body and can reactivate due to triggers like stress, sunlight, or illness. To prevent spreading the infection, use a separate applicator, like a cotton swab, when applying cosmetics over an unhealed cold sore, and consider removing any makeup before applying the medication.

FAQ

What is Abreva?

Abreva is a topical cream containing 10% docosanol, 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 associated with cold sores.

Who can use Abreva?

Abreva is intended for adults and children 12 years or older. Children under 12 should consult a doctor before use.

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, using it 5 times a day until healed.

Are there any precautions I should take?

Do not use Abreva if you are allergic to any of its ingredients, and avoid applying 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.

How should I store Abreva?

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

Can I use Abreva during pregnancy or while breastfeeding?

The insert does not provide specific warnings or precautions regarding the use of Abreva during pregnancy or breastfeeding, but consult your doctor for personalized advice.

What should I do if I accidentally swallow Abreva?

If swallowed, seek medical help or contact a Poison Control Center immediately.

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 topical formulation containing 10% docosanol as the active ingredient, specifically designed for the treatment of cold sores and fever blisters. The product is presented in a cream dosage form, with a net weight of 2 grams (0.07 ounces).

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.

Limitations of Use: The safety and efficacy of this drug have not been established in patients with severe immunocompromised conditions.

Dosage and Administration

Healthcare professionals should 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 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 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 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 intended for external use only. It is contraindicated for individuals with known allergies to any of its ingredients.

Patients should be advised to stop using the product and consult a physician if their cold sore worsens or fails to heal within 10 days.

To ensure safety, this product must be kept out of reach of children. In cases 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 the use of this product. A severe allergic reaction is a notable concern, with symptoms that may include hives, facial swelling, wheezing or difficulty breathing, shock, and rash. Due to the potential for such serious reactions, individuals with known allergies to any ingredient in this product should not use it.

In clinical practice, it is advised that the product be applied only to the affected areas and not used in or near the eyes, or applied directly inside the mouth. Additionally, sharing this product is discouraged as it may facilitate the spread of infection.

Patients are instructed to discontinue use and consult a healthcare professional if their cold sore worsens or does not heal within 10 days. It is also critical to keep this product out of reach of children; in the event of accidental ingestion, immediate medical assistance or contact with a Poison Control Center is recommended.

Drug Interactions

There are currently no specific drug interactions identified for the medication. Additionally, no interactions with laboratory tests have been reported. Therefore, no dosage adjustments or monitoring recommendations are necessary at this time. It is advisable for healthcare professionals to remain vigilant and consult updated resources for any emerging data regarding potential 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 prior to use. For adolescents and adults 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 potential adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

There are no specific warnings or precautions regarding the use of ABREVA (docosanol cream) during pregnancy. The prescribing information does not indicate whether the product is contraindicated in pregnant patients or if there are any safety concerns related to its use in this population. Additionally, no dosage modifications or special precautions regarding pregnancy are provided in the insert. As such, healthcare professionals should consider the lack of data when advising women of childbearing potential about the use of this product during pregnancy.

Lactation

There are no specific warnings or considerations regarding nursing mothers or lactation associated with the use of ABREVA (docosanol cream). The available data does not indicate any known effects on breastfed infants or the excretion of docosanol in human milk. Lactating mothers may use this medication as directed without additional concerns related to breastfeeding.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data 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 assistance is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical help or contact a Poison Control Center without delay.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved; therefore, a thorough assessment by a medical professional is recommended to determine the appropriate course of action.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. It is imperative that healthcare providers remain vigilant and prepared to address any complications that may arise from an overdosage scenario.

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 understanding of the potential toxicological profile in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available for SPL code 90375-7.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center if the product is swallowed. It is essential to inform patients not to use the product if they have a known allergy to any of its ingredients.

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

Healthcare providers should emphasize the importance of not sharing this product 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 for identification. It is essential to store the product at a temperature range of 20°C to 25°C (68°F to 77°F). Care should be taken to ensure that the product does not freeze, as this may compromise its integrity and effectiveness. Proper storage conditions are crucial for maintaining the quality of the product throughout its shelf life.

Additional Clinical Information

Patients should apply the medication topically to the affected area on the face or lips at the first sign of a cold sore or fever blister, specifically when they experience a tingle. The recommended frequency of application is five times a day until the lesion is healed.

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 outbreak and to avoid close physical contact during this time, as the infection can be easily transmitted. After healing, the virus remains dormant and may reactivate due to common triggers such as stress, sunlight, extreme temperatures, illness, lack of sleep, or menstruation. For optimal results, patients are advised to use the medication at the onset of symptoms and to utilize a separate applicator for cosmetics to prevent infection spread, ensuring that any cosmetics are removed prior to application.

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

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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.