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Earth Mama Medicated Herbal Lip Balm

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Active ingredient
Menthol 0.0425 g/4.25 g
Other brand names
Dosage form
Stick
Route
Topical
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2025
Label revision date
August 15, 2025
Active ingredient
Menthol 0.0425 g/4.25 g
Other brand names
Dosage form
Stick
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2025
Label revision date
August 15, 2025
Manufacturer
Eleeo Brands LLC
Registration number
M017
NDC root
79747-155

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Drug Overview

This medication is designed to provide temporary relief from pain and itching caused by fever blisters and cold sores. It works by soothing the affected area, helping to alleviate discomfort associated with these common skin conditions. If you experience these symptoms, this product may help you feel more comfortable while your skin heals.

Uses

If you're dealing with fever blisters or cold sores, this medication can help provide temporary relief from the pain and itching that often accompany these conditions. It works to soothe discomfort, allowing you to feel more at ease while your skin heals. Remember, while it can alleviate symptoms, it’s important to follow any additional care instructions from your healthcare provider for the best results.

Dosage and Administration

When using this product, you should apply a small amount to the affected area no more than 3 to 4 times a day. It's important to wash your hands both before and after applying the balm to keep the area clean and prevent spreading any germs. Remember, this product is for your use only, so do not share it with anyone else.

If you have a child under 2 years of age, it's best to consult a doctor before using this product to ensure it's safe for them. Following these guidelines will help you use the balm effectively and safely.

What to Avoid

It's important to keep this product out of reach of children. If a child accidentally swallows it, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222. There are no specific contraindications, controlled substance classifications, or noted risks of abuse, misuse, or dependence associated with this product. Always prioritize safety and follow these guidelines to ensure proper use.

Side Effects

It's important to be aware of some key warnings when using this product. It is meant for external use only, so avoid getting it in your eyes. If your condition worsens, 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 the product out of reach of children. If it is accidentally swallowed, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

Warnings and Precautions

This product is intended for external use only, so please avoid getting it in your eyes. It's important to keep this product out of reach of children to prevent accidental ingestion. If you or someone else swallows it, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

You should stop using the product and consult your doctor if your condition worsens, if your symptoms last longer than 7 days, or if your symptoms improve and then return within a few days. Taking these precautions will help ensure your safety and well-being while using this product.

Overdose

If you or someone else has swallowed too much of this medication, it’s important to seek medical help immediately. You can contact a Poison Control Center at 1-800-222-1222 for guidance.

Signs of an overdose may include unusual symptoms, but specific details on these symptoms are not provided here. If you notice anything concerning, don’t hesitate to reach out for help. Remember, acting quickly can make a significant difference in ensuring safety and health.

Pregnancy Use

There is currently no specific information available about the use of Earth Mama Medicated Herbal Lip Balm during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions for pregnant individuals have not been addressed in the drug insert.

If you are pregnant or planning to become pregnant, it’s always a good idea to consult with your healthcare provider before using any new products, including lip balms, to ensure they are safe for you and your baby.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to know that there is no specific information available regarding the use of this medication during nursing. This means that the effects on breast milk and your baby are not clearly defined.

Since there are no guidelines or precautions provided, it's a good idea to consult with your healthcare provider to discuss any potential risks and to ensure the safety of both you and your infant while breastfeeding.

Pediatric Use

If your child is under 2 years old, it's important to consult with a doctor before using this product. For children aged 2 years and older, you can apply a small amount to the affected area, but make sure to do this no more than 3 to 4 times a day. Always wash your hands before and after applying the balm, and remember not to share the product with others to ensure safety.

Geriatric Use

While there is no specific information about the use of Earth Mama Medicated Herbal Lip Balm in older adults, it’s always wise to approach any new product with caution. Since the drug insert does not mention dosage adjustments or safety concerns for elderly patients, you should consider consulting with a healthcare professional before using this product, especially if you have any underlying health conditions or are taking other medications. This ensures that you can use the lip balm safely and effectively, keeping your unique health needs in mind.

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 standard recommendations for the medication do not include special monitoring or safety considerations tailored for patients with renal impairment (kidney issues).

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific health needs. They can provide guidance based on your kidney function and overall health.

Hepatic Impairment

If you have liver problems, it's important to know that there are no specific guidelines, dosage adjustments, or special monitoring requirements mentioned for your condition in the provided information. This means that the standard recommendations apply, but you should always consult your healthcare provider for personalized advice. They can help ensure that any medications you take are safe and appropriate for your liver health.

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 monitor your health effectively and make informed decisions about your care.

Always feel free to ask questions and share all the medications and supplements you are using. This helps to avoid any potential issues and ensures that you receive the best possible treatment tailored to your needs.

Storage and Handling

To ensure the best performance and safety of your product, store it in a cool, dry place away from excessive heat and direct sunlight. This will help maintain its effectiveness and prevent any damage.

When handling the product, be sure to follow any specific instructions provided to ensure safe use. Proper storage and careful handling are key to keeping the product in optimal condition.

Additional Information

You should apply a small amount of the product to the affected area no more than 3 to 4 times a day. Remember to wash your hands before and after applying the balm, and do not share it with others. This product is for external use only, so avoid contact with your eyes. If your condition worsens, lasts more than 7 days, or clears up and then comes back within a few days, stop using it and consult a doctor.

Keep the product out of reach of children. If it is swallowed, seek medical help or contact a Poison Control Center immediately at 1-800-222-1222.

FAQ

What is the drug indicated for?

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

What should I do before and after applying the balm?

You should wash your hands before and after applying the balm.

How often can I apply the balm?

You can apply a small amount of the product to the affected area not more than 3 to 4 times daily.

What should I do if I swallow the balm?

If swallowed, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

Is there any information about using this drug during pregnancy?

No specific information regarding use during pregnancy is provided in the drug insert.

Can children under 2 years of age use this balm?

Children under 2 years of age should ask a doctor before use.

What should I do if my symptoms last more than 7 days?

You should stop use and ask a doctor if your condition worsens or if symptoms last more than 7 days.

What precautions should I take when using this product?

For external use only, avoid contact with eyes, and keep out of reach of children.

Are there any contraindications for this drug?

No contraindications are listed for this drug.

How should I store the balm?

Protect the balm from excessive heat and direct sunlight.

Packaging Info

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

Packaging configurations for Earth Mama Medicated Herbal Lip Balm.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The product is identified by the SPL code 34089-3. No additional specific description details are provided in the available text.

Uses and Indications

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

Dosage and Administration

For adults and children aged 2 years and older, a small amount of the product should be applied to the affected area no more than 3 to 4 times daily. It is essential to wash hands thoroughly before and after the application of the balm to prevent contamination and ensure proper hygiene.

Healthcare professionals should advise patients not to share the product with others to avoid the risk of transmission of infections or adverse reactions. For children under 2 years of age, it is recommended to consult a physician prior to use.

Contraindications

Use is contraindicated in children due to the risk of accidental ingestion. In the event of swallowing, immediate medical assistance should be sought or contact with a Poison Control Center is advised (1-800-222-1222).

Warnings and Precautions

This product is intended for external use only. Healthcare professionals should advise patients to avoid contact with the eyes during application.

Patients are instructed to discontinue use and seek medical advice if any of the following occur: the condition worsens, symptoms persist for more than 7 days, or symptoms resolve and then recur within a few days.

It is essential to keep this product out of the reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center should be contacted at 1-800-222-1222.

Side Effects

Patients should be aware that the product is intended for external use only and must avoid contact with the eyes. In the event that the condition worsens, symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days, patients are advised to discontinue use and consult a healthcare professional.

It is crucial to keep the product out of reach of children. If the product is ingested, immediate medical assistance should be sought, or the Poison Control Center should be contacted at 1-800-222-1222.

Drug Interactions

There are no specific drug interactions or laboratory test interactions identified in the provided data. Therefore, no recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

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

Packaging configurations for Earth Mama Medicated Herbal Lip Balm.
Details

Pediatric Use

Pediatric patients under 2 years of age should consult a healthcare professional before using this product. For children aged 2 years and older, the recommended application is a small amount to the affected area, not exceeding 3 to 4 times daily. It is important for caregivers to wash their hands before and after applying the balm and to avoid sharing the product with others.

Geriatric Use

There is no specific information regarding the use of Earth Mama Medicated Herbal Lip Balm in geriatric patients. The prescribing information does not provide details on dosage adjustments, safety concerns, or special precautions that may be applicable to elderly patients. Therefore, healthcare providers should exercise caution and consider individual patient factors when recommending this product to geriatric patients, as the absence of specific data necessitates careful clinical judgment.

Pregnancy

There is no specific information available regarding the use of Earth Mama Medicated Herbal Lip Balm during pregnancy. As such, safety concerns, dosage modifications, or special precautions for pregnant patients have not been established. Healthcare professionals should consider the lack of data when advising women of childbearing potential and weigh the potential benefits against any unknown risks associated with the use of this product during pregnancy.

Lactation

There is no specific information available regarding the use of this medication in nursing mothers or lactation considerations. Healthcare professionals should exercise caution and consider the potential risks and benefits when prescribing this medication to lactating mothers. The effects on breastfed infants have not been established, and further data may be necessary to inform clinical decisions.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

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 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 without delay. It is recommended to contact a Poison Control Center at 1-800-222-1222 for guidance on the appropriate steps to take.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Healthcare providers should be prepared to assess the patient's condition and implement necessary management procedures based on the severity of the symptoms presented.

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 provided data.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. Instruct patients that if the medication is swallowed, they should seek medical help immediately or contact a Poison Control Center at 1-800-222-1222. It is important for patients to understand the potential risks associated with improper use and the necessity of prompt action in case of accidental ingestion.

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 in a manner that protects it from excessive heat and direct sunlight to maintain its integrity and efficacy. Proper storage conditions should be observed to ensure optimal performance.

Additional Clinical Information

Patients should apply a small amount of the product to the affected area no more than 3 to 4 times daily, ensuring to wash hands before and after application. It is important that patients do not share the product with others.

Clinicians should counsel patients that the product is for external use only and advise them to avoid contact with the eyes. Patients are instructed to discontinue use and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. Additionally, the product should be kept out of reach of children, and in the event of ingestion, medical assistance should be sought immediately or contact with a Poison Control Center should be made at 1-800-222-1222.

Drug Information (PDF)

This file contains official product information for Earth Mama Medicated Herbal 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 Earth Mama Medicated Herbal 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.

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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.