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Maybelline New York Baby Lips Dr Rescue Medicated Balm

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Active ingredient
Menthol 5 mg/1 g
Other brand names
Dosage form
Lipstick
Route
Topical
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2013
Label revision date
December 28, 2023
Active ingredient
Menthol 5 mg/1 g
Other brand names
Dosage form
Lipstick
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2013
Label revision date
December 28, 2023
Manufacturer
L'Oreal USA Products Inc
Registration number
M017
NDC root
49967-489

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

Drug Overview

You may find this medication helpful for the temporary relief of pain associated with fever blisters and cold sores. It is designed to ease discomfort during these common viral outbreaks, allowing you to feel more comfortable as you recover.

This treatment is effective starting from December 28, 2023, so you can expect it to provide support when you need it most. If you have any questions about how to use it or its benefits, feel free to ask a healthcare professional for more information.

Uses

If you're dealing with the discomfort of fever blisters or cold sores, this medication can help provide temporary relief from the pain associated with these conditions. It's designed specifically to ease the discomfort you may experience during an outbreak, allowing you to feel more at ease while your body heals.

Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) or other nonteratogenic effects associated with this medication. This makes it a safer option for those in need of relief from the pain of fever blisters and cold sores.

Dosage and Administration

When using this medication, you should apply it directly to the affected area. It's important to do this no more than 3 to 4 times each day. Make sure to follow this guideline to ensure the best results and avoid any potential side effects. Always remember that this medication is intended for adult use only, so it’s not suitable for children.

What to Avoid

It's important to use this medication safely. You should avoid getting it into your eyes, as this can cause irritation or other issues. There are no specific contraindications, controlled substance classifications, or concerns about abuse, misuse, or dependence associated with this medication. Always follow the instructions provided to ensure your safety and well-being.

Side Effects

This product is intended for external use only. If your condition worsens, or if your symptoms last more than 7 days or improve only to return within a few days, it’s important to stop using the product and consult a doctor. Your health and safety are paramount, so please pay attention to these signs.

Warnings and Precautions

This product is intended for external use only. If you accidentally swallow it, seek medical help or contact a Poison Control Center immediately.

While using this product, be cautious not to get it in your eyes. If your condition worsens, or if your symptoms last more than 7 days or improve and then return within a few days, stop using the product and consult your doctor. Your health and safety are important, so please take these precautions seriously.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While there is no specific information available about the signs of overdose for this medication, general symptoms can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these signs, or if you are unsure, seek medical help right away.

In case of an overdose, contact your local emergency services or go to the nearest hospital. It's always better to be safe and get checked by a healthcare professional if you have any concerns about your health. Remember, timely intervention can make a significant difference.

Pregnancy Use

There is currently no information available about the use of Maybelline New York Baby Lips Dr. Rescue Medicated Balm during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions for pregnant individuals have not been addressed in the product's insert.

If you are pregnant or planning to become pregnant, it's always best 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 note that there is no specific information available about the use of Maybelline New York Baby Lips Dr Rescue Medicated Balm during nursing. This means that the effects on breast milk or your nursing infant are not clearly understood.

As always, it's a good idea to consult with your healthcare provider before using any new products while breastfeeding to ensure the safety and well-being of both you and your baby.

Pediatric Use

It's important to keep this medication out of reach of children. If a child accidentally swallows it, you should seek medical help immediately or contact a Poison Control Center for guidance.

This medication is intended for adult use only, so make sure to follow the directions carefully. Adults should apply it to the affected area no more than 3 to 4 times a day. Always prioritize safety and consult a healthcare professional if you have any questions or concerns about its use around children.

Geriatric Use

When it comes to using this medication in older adults, there are no specific guidelines or dosage adjustments mentioned. This means that, as an older adult or caregiver, you should be aware that the usual safety concerns and precautions that apply to younger patients may also apply here. It's always a good idea to discuss any potential risks or side effects with your healthcare provider, especially if you have other health conditions or are taking multiple medications.

If you have any questions or concerns about how this medication may affect you or your loved one, don't hesitate to reach out to a healthcare professional for personalized advice.

Renal Impairment

If you have kidney problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to change based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your specific situation. They can help monitor your kidney health and make any necessary adjustments to your medications.

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 differently due to your liver health.

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver condition and the use of this medication. They can help ensure that you receive the safest and most effective treatment based on your individual health needs.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking. In this case, there are no specific drug interactions or laboratory test interactions noted, which means that this medication is generally considered safe to use alongside other treatments and tests. However, every individual is different, and your healthcare provider can help ensure that your overall treatment plan is safe and effective for you.

Always remember that discussing your full list of medications and any lab tests with your healthcare provider is crucial. This way, you can avoid any potential issues and receive the best care tailored to your needs.

Storage and Handling

To ensure the best performance of your product, store it at room temperature and keep it in its blister pack until you are ready to use it. This helps protect the product from damage and maintains its effectiveness.

It's important to avoid freezing the product, as this can compromise its quality. By following these simple storage guidelines, you can help ensure that your product remains safe and effective for your needs.

Additional Information

You should apply this medication topically to the affected area, but only if you are an adult. Use it no more than 3 to 4 times a day for best results. There are no additional details available regarding laboratory tests, abuse potential, or patient counseling.

FAQ

What is the primary use of this drug?

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

How often can I apply this medication?

You should apply it to the affected area no more than 3 to 4 times daily.

Is this medication safe for use during pregnancy?

No specific information regarding use during pregnancy is provided.

Can I use this medication if I am nursing?

There is no specific information regarding use for nursing mothers provided.

What should I do if I accidentally swallow this medication?

If swallowed, get medical help or contact a Poison Control Center right away.

Are there any warnings I should be aware of?

This product is for external use only, and you should avoid getting it into your eyes.

What should I do if my condition worsens or does not improve?

Stop use and ask a doctor if your condition worsens or if symptoms last more than 7 days or clear up and occur again within a few days.

How should I store this medication?

Store at room temperature and keep the product in a blister pack until use. Do not freeze.

Is there any information about drug interactions?

No specific drug interactions are mentioned for this medication.

Is this medication suitable for children?

Keep out of reach of children, and it is intended for adult use only.

Packaging Info

Below are the non-prescription pack sizes of Maybelline New York Baby Lips Dr Rescue Medicated Balm (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Maybelline New York Baby Lips Dr Rescue Medicated Balm.
Details

Drug Information (PDF)

This file contains official product information for Maybelline New York Baby Lips Dr Rescue Medicated 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.

Uses and Indications

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

There are no teratogenic or nonteratogenic effects mentioned in the available data.

Dosage and Administration

For adult patients, the recommended application frequency is to apply the medication to the affected area no more than 3 to 4 times daily. Care should be taken to ensure that the application is limited to the specified dosage range to avoid potential adverse effects.

Contraindications

Use of this product is contraindicated in individuals with a known hypersensitivity to any of its components. Additionally, the product should not be applied to the eyes, as contact may result in irritation or injury.

Warnings and Precautions

For external use only. In the event of accidental ingestion, it is imperative to seek medical assistance or contact a Poison Control Center immediately.

Healthcare professionals should advise patients to discontinue use and consult a physician if the condition worsens. Additionally, if symptoms persist for more than 7 days or if they resolve and then recur within a few days, medical advice should be sought.

It is crucial to instruct patients to avoid contact with the eyes while using this product to prevent irritation or injury.

Side Effects

For external use only. Patients should discontinue use and consult a doctor if the condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days.

Drug Interactions

No specific drug interactions have been identified for this medication. 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 Maybelline New York Baby Lips Dr Rescue Medicated Balm (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Maybelline New York Baby Lips Dr Rescue Medicated Balm.
Details

Pediatric Use

Pediatric patients should be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is advised.

The product is intended for adult use only, with directions specifying application to the affected area no more than 3 to 4 times daily. There is no established dosing or safety profile for pediatric patients, and caution should be exercised when considering use in this population.

Geriatric Use

Elderly patients may not have specific information available 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 information available regarding the use of MAYBELLINE NEW YORK BABY LIPS DR RESCUE MEDICATED BALM during pregnancy. As such, safety concerns, dosage modifications, or special precautions for pregnant patients have not been established. Healthcare professionals should consider this lack of data when advising women of childbearing potential regarding the use of this product during pregnancy.

Lactation

There is no specific information regarding nursing mothers or lactation considerations provided in the drug insert for Maybelline New York Baby Lips Dr Rescue Medicated Balm. Therefore, healthcare professionals should exercise caution when recommending this product to lactating mothers. The potential effects on breastfed infants have not been established, and further evaluation may be necessary to ensure safety during breastfeeding.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials for this medication. Consequently, there is no available information regarding 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 absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

If the substance involved is known, specific antidotes or treatments may be indicated, and healthcare professionals should refer to established guidelines for the management of overdose related to that substance.

In all cases, contacting a poison control center or a medical toxicologist for guidance is recommended to ensure appropriate management and intervention.

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 question.

Postmarketing Experience

No postmarketing experience details are available in the insert.

Patient Counseling

Patients should be advised to seek medical help or contact a Poison Control Center immediately if the product is swallowed. It is important for patients to understand that they should discontinue use and consult a healthcare provider if their condition worsens. Additionally, patients should be informed to stop using the product and reach out to a doctor if symptoms persist for more than 7 days or if symptoms resolve and then recur within a few days.

Healthcare providers should emphasize the importance of avoiding contact with the eyes while using this product, as this could lead to irritation or other complications. Clear communication of these points will help ensure patient safety and effective use of the product.

Storage and Handling

The product is supplied in blister packs, which should be kept intact until use to ensure optimal integrity and efficacy. It is essential to store the product at room temperature, avoiding exposure to extreme temperatures. Freezing the product is strictly prohibited, as it may compromise its quality and effectiveness.

Additional Clinical Information

The medication is administered topically and is intended for adult use only. Patients are advised to apply it to the affected area no more than 3 to 4 times daily.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Maybelline New York Baby Lips Dr Rescue Medicated 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 Maybelline New York Baby Lips Dr Rescue Medicated 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.