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Noble Lion Medicated Balm

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This product has been discontinued

Active ingredients
  • Menthol 14.5 mL/100 mL
  • Methyl Salicylate 30 mL/100 mL
Other brand names
Dosage form
Liniment
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2012
Label revision date
June 21, 2012
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Menthol 14.5 mL/100 mL
  • Methyl Salicylate 30 mL/100 mL
Other brand names
Dosage form
Liniment
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 2012
Label revision date
June 21, 2012
Manufacturer
ABBP (ARRINGTON, BATTLE, BELL & PERRY) , LLC
Registration number
part348
NDC roots
50462-107, 50462-110, 50462-113, 50462-114, 50462-115, 50462-119
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (18 NDCs)
Packaging & NDC Codes (18)

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

Men's Mountain Spice is a medicated balm designed to provide penetrating pain relief. It is formulated to temporarily alleviate minor aches and pains in muscles and joints, which can be associated with conditions like simple backaches, arthritis, bruises, sprains, and strains. This balm is based on an ingredient that has been used for centuries and is now available worldwide, making it a trusted option for those seeking relief from discomfort.

Uses

If you're dealing with minor aches and pains in your muscles and joints, this medication can help provide temporary relief. It's effective for discomfort associated with simple backaches, arthritis, bruises, sprains, and strains.

You can rely on this treatment to ease your pain and get you back to your daily activities more comfortably. Remember, it's designed for short-term use to help manage those everyday aches.

Dosage and Administration

If you are 12 years old or older, you can apply this medication to the affected areas of your skin up to 3 to 4 times a day. Make sure to follow this guideline to ensure safe and effective use.

If you are caring for a child under 12, it’s important to consult a doctor before using this medication. This will help ensure that it’s appropriate and safe for their specific needs.

What to Avoid

It's important to use this medication safely to ensure your well-being. You should avoid applying it to any wounds or damaged skin, as this can lead to complications. Additionally, do not bandage the area tightly or use a heating pad, as these actions may cause irritation or other issues.

By following these guidelines, you can help ensure that you use the medication effectively and safely. If you have any questions or concerns about its use, please consult your healthcare provider for further guidance.

Side Effects

It's important to use this product only on the outside of your body. If your condition worsens, if symptoms last longer than seven days, or if your symptoms improve and then return within a few days, you should stop using the product and consult a doctor. These steps will help ensure your safety and well-being while using the product.

Warnings and Precautions

This product is for external use only, so please avoid swallowing it. If you accidentally ingest it, seek emergency medical help or contact a Poison Control Center right away.

You should stop using this product and call your doctor if your condition worsens, if your symptoms last longer than seven days, or if your symptoms improve and then return within a few days. It's important to stay vigilant about any changes in your health while using this product.

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 concerned about a possible overdose, seek medical help right away.

In case of an overdose, contacting your local emergency services or going to the nearest hospital is crucial. Always keep the medication packaging with you, as it can help healthcare professionals understand what you've taken. Remember, it's better to be safe and get checked out if you have any doubts about your health.

Pregnancy Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using this medication. They can provide guidance on whether it’s safe for you and your baby. Always prioritize your health and the health of your child by seeking expert advice.

Lactation Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using any medication. This ensures that you understand any potential risks and can make informed decisions about your health and the health of your baby. Always prioritize open communication with your doctor regarding your breastfeeding journey.

Pediatric Use

If your child is under 12 years old, it's important to consult a doctor before using this medication. For children aged 12 and older, you can apply it to the affected areas, but make sure to do so no more than 3 to 4 times a day. Always follow these guidelines to ensure your child's safety and well-being.

Geriatric Use

When considering the use of Noble Lion Medicated Balm for older adults, it's important to note that the drug insert does not provide specific information about how this product may affect elderly patients. This means there are no established dosage adjustments, safety concerns, or special precautions outlined for older individuals.

As a caregiver or an older adult, you should approach the use of this balm with caution, especially if you have underlying health conditions or are taking other medications. Always consult with a healthcare professional before starting any new treatment to ensure it is safe and appropriate for your specific health needs.

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 if you have hepatic impairment (issues with liver function).

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 based on your individual needs.

Drug Interactions

It's important to know that there are no reported interactions between Noble Lion Medicated Balm (which contains methyl salicylate and menthol) and other medications or laboratory tests. However, even with this information, it's always a good idea to discuss any medications or treatments you are using with your healthcare provider. They can help ensure that everything you take is safe and effective for your specific health needs.

By keeping an open line of communication with your healthcare team, you can avoid potential issues and make informed decisions about your health.

Storage and Handling

To ensure the best quality and safety of your product, store it at room temperature, away from direct light. It's important to keep the container tightly closed when not in use to prevent contamination. Once you open the container, be sure to discard any remaining product after use to maintain safety and effectiveness. Following these guidelines will help you use the product safely and effectively.

Additional Information

You can apply this product to the affected areas of your skin 3 to 4 times a day if you are an adult or a child aged 12 years and older. If your child is under 12, it's important to consult a doctor before using it.

Be aware that this product may cause an allergic reaction in some people, so it's a good idea to test it on a small area of skin before applying it more widely.

FAQ

What is Men's Mountain Spice?

Men's Mountain Spice is a medicated balm that provides penetrating pain relief for minor aches and pains of muscles and joints.

What conditions does Men's Mountain Spice help relieve?

It is used for the temporary relief of minor aches and pains associated with simple backaches, arthritis, bruises, sprains, and strains.

How should I use Men's Mountain Spice?

Adults and children 12 years and older should apply it to affected areas no more than 3 to 4 times daily. Children under 12 should consult a doctor before use.

Are there any contraindications for using Men's Mountain Spice?

No specific contraindications are mentioned, but do not apply it to wounds or damaged skin.

What should I do if my condition worsens while using this product?

Stop use and ask a doctor if your condition worsens, symptoms persist for more than seven days, or if symptoms clear up and occur again within a few days.

Is Men's Mountain Spice safe to use during pregnancy or breastfeeding?

If you are pregnant or breastfeeding, consult a health professional before use.

What are the storage instructions for Men's Mountain Spice?

Store at room temperature, protect from light, and keep the container tightly closed. Discard after opening.

What should I do if I accidentally swallow Men's Mountain Spice?

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

Can Men's Mountain Spice cause allergic reactions?

Yes, this product may cause allergic reactions in some individuals. It is recommended to test on a small area before use.

Packaging Info

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

Packaging configurations for Noble Lion Medicated Balm.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

NOBLE LION is a medicated balm formulated to provide penetrating pain relief. This product is presented in a 0.5 Fl. Oz. (15 ml) dosage form and features a Men's Mountain Spice scent. NOBLE LION is based on an ingredient that has been utilized for centuries and is now distributed worldwide. The product is manufactured in the USA and is distributed by ABBP, LLC, a natural healthcare products company located in Charlotte, NC. The National Drug Code (NDC) for this product is 50462-113-05. Further information can be found at www.MYNOBLELION.com.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains of muscles and joints associated with simple backaches, arthritis, bruises, sprains, and strains.

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

Dosage and Administration

For adults and children aged 12 years and older, the recommended application is to the affected areas not more than 3 to 4 times daily. It is essential to ensure that the application is performed with clean hands and that the affected area is free from any other topical products prior to administration.

For children under 12 years of age, it is advised to consult a healthcare professional before use to determine the appropriate course of action and to ensure safety and efficacy.

Contraindications

The product should not be applied to wounds or damaged skin due to the potential for irritation or adverse reactions. Additionally, it is contraindicated to bandage tightly or use a heating pad, as this may exacerbate local irritation or lead to complications.

Warnings and Precautions

FOR EXTERNAL USE ONLY. This product is intended solely for topical application and should not be ingested.

In the event of accidental ingestion, it is imperative to seek emergency medical assistance or contact a Poison Control Center without delay.

Patients should discontinue use and consult their healthcare provider under the following circumstances: if the condition worsens, if symptoms persist for more than seven (7) days, or if symptoms resolve and then recur within a few days. Monitoring of the patient's condition is essential to ensure appropriate management and to prevent potential complications.

Side Effects

Patients should be advised that the product is for external use only. In the event that the condition worsens, symptoms persist for more than seven days, or symptoms clear up and then recur within a few days, it is recommended that they stop using the product and consult a healthcare professional.

Drug Interactions

Noble Lion Medicated Balm, which contains methyl salicylate and menthol, has not been associated with any known drug interactions or interactions with laboratory tests. As such, no specific dosage adjustments or monitoring requirements are indicated for patients using this product.

Packaging & NDC

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

Packaging configurations for Noble Lion Medicated Balm.
Details

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. For adolescents and children aged 12 years and older, the recommended application is to the affected areas not more than 3 to 4 times daily.

Geriatric Use

There is no specific information regarding the use of Noble Lion Medicated Balm in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when considering the use of this product in elderly patients, as the absence of data necessitates careful monitoring and individualized assessment of treatment risks and benefits.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully considered in these populations to ensure the safety of both the mother and the fetus or infant.

Lactation

Lactating mothers are advised to consult a healthcare professional prior to using this medication. There is no specific data available regarding the excretion of this drug in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

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 relation to the use of 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 available information.

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, ensuring adequate ventilation, and monitoring vital signs.

If available, the use of specific antidotes or treatments should be considered based on the substance involved and the clinical presentation. Consultation with a poison control center or a medical toxicologist may provide additional guidance on the management of overdose cases.

Documentation of the incident, including the substance, amount ingested, and time of ingestion, is crucial for effective management and treatment planning.

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

Postmarketing experience has indicated that this product may cause allergic reactions in some individuals. It is recommended that users conduct a patch test on a small area of skin prior to full application to assess for any potential sensitivity.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center if the product is swallowed.

Patients should be instructed to discontinue use and consult a doctor if their condition worsens, if symptoms persist for more than seven days, or if symptoms resolve and then recur within a few days.

When using this product, it is important for patients to avoid contact with the eyes and mucous membranes. They should also be cautioned against applying the product to wounds or damaged skin. Additionally, patients should not bandage the area tightly or use a heating pad in conjunction with the product.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers. It should be stored at room temperature, ensuring that it is protected from light exposure. The container must be kept tightly closed to maintain the integrity of the product. Additionally, it is important to discard the product after opening to ensure safety and efficacy.

Additional Clinical Information

Patients aged 12 years and older are advised to apply the product to affected areas no more than 3 to 4 times daily. For children under 12 years of age, consultation with a doctor is recommended prior to use. Clinicians should inform patients that the product may cause allergic reactions in some individuals; therefore, it is advisable to conduct a patch test on a small area of skin before full application.

Drug Information (PDF)

This file contains official product information for Noble Lion 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 Noble Lion 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

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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.