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Medicated Lip Balm

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Active ingredient
Menthol 0.9 g/100 g
Other brand names
Dosage form
Stick
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2016
Label revision date
December 21, 2018
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Menthol 0.9 g/100 g
Other brand names
Dosage form
Stick
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 2016
Label revision date
December 21, 2018
Manufacturer
Burt's Bees, Inc.
Registration number
part348
NDC root
26052-029
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (3 NDCs)
Packaging & NDC Codes (3)

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

BURTS BEES MEDICATED LIP BALM WITH MENTHOL AND EUCALYPTUS is a medicated lip balm designed to provide temporary relief from pain and itching associated with fever blisters and cold sores. The inclusion of menthol and eucalyptus helps soothe and comfort your lips during these uncomfortable times.

This product is specifically formulated to address the symptoms of cold sores, making it a helpful option if you're looking for relief from the discomfort they can cause.

Uses

If you're dealing with the discomfort of fever blisters or cold sores, this medication can help provide temporary relief from the pain and itching associated with these conditions. It's designed to ease your symptoms, allowing you to feel more comfortable while you recover.

Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) or nonteratogenic effects associated with this medication. This makes it a safer option for those concerned about potential risks.

Dosage and Administration

If you are an adult or a child aged 2 years and older, you can apply the medication to the affected area up to 3 to 4 times a day. Make sure to follow this guideline to ensure the best results.

If your child is under 2 years old, it’s important to consult a doctor before using this medication. They can provide the best advice tailored to your child's needs. Always remember to use the medication as directed for safe and effective treatment.

What to Avoid

It's important to be aware of certain precautions when using this medication. If you accidentally swallow it, seek medical help or contact a poison control center immediately. Additionally, make sure to avoid any contact with your eyes, as this could lead to irritation or other issues.

While there are no specific contraindications, controlled substance classifications, or noted risks of abuse, misuse, or dependence associated with this medication, it's always best to use it responsibly and follow the instructions provided. Your safety is a priority, so please take these warnings seriously.

Side Effects

When using this product, it's important to remember that it is for external use only. Avoid getting it in your eyes, as this can cause irritation. If your condition worsens, or if symptoms persist for more than 7 days, or if they clear up and then return within a few days, you should stop using the product and consult a doctor.

Additionally, keep this product out of reach of children. If it is swallowed, seek medical help or contact a poison control center immediately.

Warnings and Precautions

This product is intended for external use only, so please avoid applying it to any areas that are not meant for topical treatment. If your condition worsens, or if your symptoms last more than 7 days, or if they clear up and then return within a few days, stop using the product and consult your doctor for further advice.

Be careful to keep the product away from your eyes, as contact can cause irritation. If you accidentally swallow the product, seek medical help immediately or contact a poison control center for assistance. Your safety is important, so please take these precautions seriously.

Overdose

If you or someone else has swallowed a medication and you suspect an overdose, it’s crucial 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 get professional advice in these situations.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to be aware that there is no specific information available regarding the use of this medication during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions have not been established.

Before taking this medication, you should consult with your healthcare provider to discuss any potential risks and to ensure that you are making informed decisions for your health and the health of your baby.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding nursing mothers or lactation in the information provided. This means that, based on the available data, there are no known risks associated with breastfeeding while using this medication. However, it's always a good idea to consult with your healthcare provider if you have any concerns or questions about your specific situation.

Pediatric Use

If your child is under 2 years old, it's important to consult a doctor before using this medication. For children aged 2 years and older, you can apply it to the affected area, but make sure to do so no more than 3 to 4 times a day. Always keep this medication out of reach of children to ensure their safety.

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 healthcare providers may not have tailored guidelines for elderly patients.

If you or a loved one is an older adult considering this medication, it’s important to discuss any potential risks and benefits with your healthcare provider. They can help determine the best approach based on individual health needs and circumstances. Always prioritize open communication about any concerns you may have regarding medication use.

Renal Impairment

It appears that there is no specific information regarding renal impairment (kidney problems) in the provided text. Therefore, there are no guidelines, dosage adjustments, or monitoring instructions to share for patients with kidney issues. If you have concerns about how your kidney health may affect your medication or treatment, it's important to discuss these with your healthcare provider for personalized advice.

Hepatic Impairment

If you have liver problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations apply, and there are no special monitoring requirements or precautions outlined for patients with liver impairment.

However, it's always a good idea to discuss your liver health with your healthcare provider before starting any new medication. They can provide personalized advice and ensure that your treatment is safe and effective for you.

Drug Interactions

It's great to know that there are no reported interactions between this medication and other drugs or laboratory tests. However, it's still very important to discuss all medications you are taking, including over-the-counter drugs and supplements, with your healthcare provider. This ensures that your treatment is safe and effective, and helps avoid any potential issues.

Always keep your healthcare provider informed about any changes in your health or medications. They can provide personalized advice and monitor your treatment to ensure the best outcomes for your health.

Storage and Handling

To ensure the best performance of your product, store it at room temperature. This means keeping it in a place that is neither too hot nor too cold, typically between 68°F and 77°F (20°C to 25°C).

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

Additional Information

You should apply this medication topically to the affected area, using it no more than 3 to 4 times a day if you are an adult or a child aged 2 years and older. If the patient is under 2 years old, it's important to consult a doctor before use. There are no additional details available regarding laboratory tests, abuse potential, or patient counseling.

FAQ

What is BURTS BEES MEDICATED LIP BALM used for?

BURTS BEES MEDICATED LIP BALM is used for the temporary relief of pain and itching associated with fever blisters and cold sores.

How should I use BURTS BEES MEDICATED LIP BALM?

Adults and children 2 years of age and older should apply it to the affected area not more than 3 to 4 times daily. Children under 2 years of age should consult a doctor.

Are there any warnings I should be aware of?

This product is for external use only. Avoid contact with eyes, and if swallowed, seek medical help or contact a poison control center immediately.

What should I do if my condition worsens?

If your condition worsens or symptoms persist for more than 7 days, or clear up and occur again within a few days, discontinue use and consult a doctor.

Is there any information regarding use during pregnancy or lactation?

There are no specific warnings or recommendations regarding the use of BURTS BEES MEDICATED LIP BALM during pregnancy or lactation.

How should I store BURTS BEES MEDICATED LIP BALM?

Store BURTS BEES MEDICATED LIP BALM at room temperature.

Are there any contraindications for this product?

No contraindications are listed for BURTS BEES MEDICATED LIP BALM.

Packaging Info

Below are the non-prescription pack sizes of Medicated Lip Balm (menthol and eucalyptus). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Medicated Lip Balm.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

BURTS BEES Medicated Lip Balm is formulated with menthol and eucalyptus. This product is designed to provide soothing relief for chapped lips. The combination of active ingredients offers a medicated approach to lip care, ensuring effective hydration and protection.

Uses and Indications

This drug is indicated for the temporary relief of pain and itching associated with fever blisters and cold sores.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

For adults and children aged 2 years and older, the recommended application is to the affected area not more than 3 to 4 times daily. It is important to ensure that the application is performed with clean hands and that the affected area is clean and dry prior to administration.

For children under 2 years of age, it is advised to consult a healthcare professional before use to determine the appropriate course of action.

Contraindications

Use of this product is contraindicated in the following situations:

In the event of accidental ingestion, immediate medical assistance should be sought or a poison control center contacted. Additionally, contact with the eyes should be strictly avoided to prevent potential harm.

Warnings and Precautions

For external use only. Healthcare professionals should advise patients to avoid contact with the eyes to prevent irritation or injury. In the event that the condition worsens or if symptoms persist for more than 7 days, it is recommended to discontinue use and consult a physician. Additionally, if the product is swallowed, immediate medical assistance should be sought, or the patient should contact a poison control center without delay.

Side Effects

Patients using this product should be aware that it is for external use only. In the event that the condition worsens, or if symptoms persist for more than 7 days, or clear up and then recur within a few days, it is advised to discontinue use and consult a doctor.

While using this product, patients should take care to avoid contact with the eyes. In case of accidental ingestion, immediate medical assistance should be sought, or contact with a poison control center is recommended. Additionally, this product should be kept out of reach of children to prevent accidental swallowing.

Drug Interactions

There are no known drug interactions associated with the use of this medication. Additionally, there are no reported interactions between this drug and laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Medicated Lip Balm (menthol and eucalyptus). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Medicated Lip Balm.
Details

Pediatric Use

Pediatric patients under 2 years of age should consult a doctor before use. For adults and children aged 2 years and older, the recommended application is to the affected area no more than 3 to 4 times daily. It is important to keep this product out of reach of children to ensure safety.

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 regarding the use of this medication 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. The potential risks and benefits should be carefully evaluated, and alternative treatments may be considered in the absence of established safety profiles. Women of childbearing potential should be counseled on the importance of effective contraception while using this medication.

Lactation

There are no specific warnings or recommendations regarding nursing mothers or lactation in the provided text. Therefore, healthcare professionals should consider the absence of data when advising lactating mothers about the use of this medication. It is advisable to monitor breastfed infants for any potential effects, although no specific information is available.

Renal Impairment

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

Hepatic Impairment

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 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 warranted based on clinical judgment.

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 may vary depending on the specific substance involved, and monitoring for any adverse effects is essential.

Management of overdosage typically involves supportive care and symptomatic treatment. It is recommended that healthcare providers assess the patient's condition thoroughly and initiate appropriate interventions based on the clinical presentation.

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 in the insert text.

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 crucial for patients to understand the potential risks associated with ingestion and the importance of prompt action in such situations.

Additionally, healthcare providers should emphasize the need to avoid contact with the eyes. Patients should be informed about the potential consequences of eye exposure and encouraged to take precautions to prevent such incidents.

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 room temperature to maintain its integrity and efficacy. No special handling requirements are noted; however, standard precautions should be observed to ensure optimal storage conditions.

Additional Clinical Information

The medication is administered topically, with a recommended application frequency of 3 to 4 times daily for adults and children aged 2 years and older. For children under 2 years of age, consultation with a doctor is advised prior to use. There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Medicated Lip Balm, 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 Medicated Lip Balm, 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.