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Leader Ultra Strength Muscle Rub

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Active ingredients
  • Menthol, Unspecified Form 100 mg/1 g
  • Camphor (synthetic) 40 mg/1 g
  • Methyl Salicylate 300 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 2017
Label revision date
February 9, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Menthol, Unspecified Form 100 mg/1 g
  • Camphor (synthetic) 40 mg/1 g
  • Methyl Salicylate 300 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 2017
Label revision date
February 9, 2024
Manufacturer
Cardinal Health, 110 dba LEADER
Registration number
M017
NDC root
70000-0208
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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

ULTRA STRENGTH Muscle Rub is a topical analgesic pain relief cream designed to provide deep penetrating relief for muscle and arthritis pain. This non-greasy cream is intended for the temporary relief of minor aches associated with conditions such as arthritis, simple backache, strains, and sprains.

By applying this cream to the affected areas, you can experience soothing relief from discomfort, helping you to manage everyday aches and pains more effectively.

Uses

You can use this medication for the temporary relief of minor aches and pains in your muscles and joints. It is effective for conditions such as arthritis, simple backache, strains, and sprains. If you're dealing with any of these issues, this medication may help alleviate your discomfort and improve your mobility.

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

Dosage and Administration

If you are 12 years old or older, you can apply this medication to the affected area up to three or four times a day. Make sure to follow this guideline to ensure the best results. If you are caring for a child under 12, it’s important to consult a doctor before using this medication, as they can provide specific advice tailored to your child's needs. Always remember to apply it only to the areas that need treatment.

What to Avoid

It's important to use this product safely to avoid any potential harm. You should never use it with a heating pad, on wounds or damaged skin, or on children under 12 years old who have arthritis-like conditions. When using the product, remember not to swallow it, avoid wrapping it tightly with a bandage, and keep it away from your eyes and mucous membranes.

Always keep this product out of reach of children. If a child accidentally swallows it, seek medical help or contact a Poison Control Center immediately. Following these guidelines will help ensure your safety and the safety of those around you.

Side Effects

When using this product, it's important to be aware of potential side effects. You should stop using it and consult a doctor if you experience skin redness or irritation, if your condition worsens, or if pain lasts longer than 7 days. Additionally, if symptoms improve and then return within a few days, seek medical advice.

This product is for external use only and should not be applied to wounds, damaged skin, or on children under 12 years of age with arthritis-like conditions. Avoid using it with a heating pad, bandaging tightly, or getting it in your eyes or mucous membranes. If swallowed, seek medical help immediately or contact a Poison Control Center.

Warnings and Precautions

This product is for external use only, so please avoid applying it to wounds, damaged skin, or irritated areas. It should not be used with a heating pad or on children under 12 years old who have arthritis-like conditions. If you notice any redness in the area you’re treating, it’s best to consult your doctor before using the product.

If you experience skin redness or irritation, or if your condition worsens or pain lasts more than 7 days, stop using the product and reach out to your doctor. Additionally, if your symptoms improve and then return within a few days, you should also consult your doctor. Always keep this product out of reach of children, and if it is swallowed, seek medical help or contact a Poison Control Center immediately.

Overdose

If you or someone else has swallowed too much of a medication, it’s important 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 seek assistance if you suspect an overdose.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to be cautious with certain medications. You should avoid using this product on children under 12 years old who have arthritis-like conditions. Before using it, consult your doctor if you notice any redness in the area you plan to treat.

If you experience skin redness or irritation after using the product, stop using it immediately and talk to your doctor. Additionally, if your condition worsens or if pain persists for more than seven days, seek medical advice. If your symptoms improve but then return within a few days, it's also essential to consult with your healthcare provider. Your health and the health of your baby are the top priority, so always err on the side of caution.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to consult your doctor before using this product. There is a possibility that it may be excreted in breast milk, which means it could potentially affect your baby. Since the effects on nursing infants have not been thoroughly studied, it's best to approach this with caution. Always prioritize your health and your baby's well-being by discussing any concerns with your healthcare provider.

Pediatric Use

If your child is under 12 years old and has arthritis-like conditions, it's important not to use this medication. For children in this age group, you should consult a doctor before use.

For those aged 12 and older, you can apply the medication to the affected area up to three or four times a day. Always follow the guidance of a healthcare professional to ensure safe and effective use.

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, it’s important to consult with a healthcare provider for personalized advice. 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 should be used if you have renal impairment (kidney issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your health situation. They can help determine the best course of action based on your kidney function and overall health.

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 should be used if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your liver health. They can help you understand how to manage your treatment effectively.

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 room temperature, ideally between 15° and 30° C (59° and 86° F). This temperature range helps maintain the integrity and effectiveness of the device.

When handling the product, make sure to do so in a clean environment to avoid contamination. Always follow any specific instructions provided for use and disposal to ensure safety and effectiveness.

Additional Information

For adults and children aged 12 and older, you should apply the medication to the affected area no more than 3 or 4 times a day. If the patient is under 12 years old, it's important to consult a doctor before use. There are no additional details available regarding laboratory tests, abuse potential, or postmarketing experiences related to this medication.

FAQ

What is ULTRA STRENGTH Muscle Rub?

ULTRA STRENGTH Muscle Rub is a topical analgesic pain relief cream designed for deep penetrating relief of muscle and arthritis pain.

What conditions does ULTRA STRENGTH Muscle Rub help relieve?

It provides temporary relief for minor aches and pains associated with arthritis, simple backache, strains, and sprains.

How should I use ULTRA STRENGTH Muscle Rub?

Apply to the affected area not more than 3 or 4 times daily for adults and children 12 years and older. For children under 12, consult a doctor.

Are there any warnings for using ULTRA STRENGTH Muscle Rub?

Yes, it is for external use only. Do not use it with a heating pad, on wounds or irritated skin, or on children under 12 with arthritis-like conditions.

What should I do if I experience skin redness or irritation?

Stop using the product and consult a doctor if skin redness or irritation develops, or if the condition worsens or pain lasts for more than 7 days.

Is it safe to use ULTRA STRENGTH Muscle Rub during pregnancy or while nursing?

There are no teratogenic effects mentioned, but nursing mothers should consult a doctor before use due to potential excretion in breast milk.

What should I do if ULTRA STRENGTH Muscle Rub is swallowed?

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

How should I store ULTRA STRENGTH Muscle Rub?

Store at room temperature between 15° - 30° C (59° - 86° F).

Packaging Info

Below are the non-prescription pack sizes of Leader Ultra Strength Muscle Rub (camphor (synthetic) , menthol, unspecified form, and methyl salicylate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Leader Ultra Strength Muscle Rub.
Details

Drug Information (PDF)

This file contains official product information for Leader Ultra Strength Muscle Rub, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

No description information is available for the drug.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains in muscles and joints associated with various conditions, including arthritis, simple backache, strains, and sprains.

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 area not more than 3 to 4 times daily. The specific frequency of application should be determined based on the severity of the condition and the response to treatment.

For children under 12 years of age, it is advised to consult a healthcare professional for appropriate dosing and administration guidance.

Contraindications

The product is contraindicated in the following situations:

Use is contraindicated with heating pads due to the potential for increased heat exposure. Application on wounds, damaged, broken, or irritated skin is also contraindicated to prevent further irritation or adverse reactions. Additionally, the product should not be used on children under 12 years of age with arthritis-like conditions, as safety and efficacy have not been established in this population.

When using this product, it is essential to avoid swallowing and to refrain from applying tight bandages, which may lead to complications. Contact with the eyes and mucous membranes should be avoided to prevent irritation.

Keep the product out of reach of children. In the event of accidental ingestion, seek medical assistance or contact a Poison Control Center immediately.

Warnings and Precautions

For external use only. This product is contraindicated for use with a heating pad and should not be applied to wounds, damaged, broken, or irritated skin. It is also not recommended for use on children under 12 years of age who present with arthritis-like conditions.

Healthcare professionals should advise patients to consult a doctor prior to use if there is any redness present over the affected area.

Patients are instructed to discontinue use and seek medical advice if any of the following occur: skin redness or irritation develops, the condition worsens, or if pain persists for more than 7 days. Additionally, if symptoms resolve and then recur within a few days, medical consultation is warranted.

It is imperative to keep this product out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center should be made without delay.

Side Effects

Patients using this product should be aware of several important safety considerations. The product is intended for external use only and should not be applied with a heating pad, on wounds, damaged, broken, or irritated skin, or on children under 12 years of age with arthritis-like conditions.

Before using the product, patients are advised to consult a doctor if there is redness over the affected area. It is crucial to use the product only as directed, avoiding swallowing, tight bandaging, and contact with the eyes and mucous membranes.

Patients should discontinue use and seek medical advice if skin redness or irritation develops, if the condition worsens, or if pain persists for more than 7 days. Additionally, if symptoms resolve and then recur within a few days, medical consultation is recommended.

In the event of accidental ingestion, patients should seek medical help or contact a Poison Control Center immediately.

Drug Interactions

There are currently no documented drug interactions associated with the use of this medication. Additionally, there are no known interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Leader Ultra Strength Muscle Rub (camphor (synthetic) , menthol, unspecified form, and methyl salicylate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Leader Ultra Strength Muscle Rub.
Details

Pediatric Use

Pediatric patients under 12 years of age with arthritis-like conditions should not use this medication. For children in this age group, it is advised to consult a healthcare professional before use.

For adolescents aged 12 years and older, the recommended application is to the affected area no more than 3 to 4 times daily.

Geriatric Use

There is no specific information available regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

Pregnant patients should be advised against the use of this medication in children under 12 years of age with arthritis-like conditions. It is important for healthcare professionals to instruct pregnant patients to consult a doctor prior to use if there is any redness over the affected area.

In the event that skin redness or irritation develops during treatment, pregnant patients should discontinue use and seek medical advice. Additionally, if the condition worsens or if pain persists for more than 7 days, consultation with a healthcare provider is recommended. Pregnant patients should also be informed to stop use and consult a doctor if symptoms resolve and then recur within a few days.

Due to the lack of specific risk data in pregnant populations, caution is advised when considering the use of this medication during pregnancy.

Lactation

Nursing mothers should consult a doctor before using this product. There is a potential for excretion in breast milk, and the effects on nursing infants are not well studied; therefore, caution is advised.

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 may impact the drug's efficacy and safety profile in this population. Regular monitoring of renal function is advisable to ensure patient safety.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this drug. Consequently, there are no 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 intervention is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical assistance or contact a Poison Control Center without delay.

Prompt action 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 and management procedures.

Healthcare providers should ensure that patients are aware of the importance of timely reporting of any suspected overdosage to facilitate effective treatment and minimize risks.

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 provided in the insert.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children. In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately.

Patients should be instructed to use the medication only as directed by their healthcare provider. It is important to emphasize that the medication should not be swallowed. Additionally, patients should be cautioned against bandaging the area tightly, as this may lead to complications.

Healthcare providers should also inform patients to avoid contact with the eyes and mucous membranes to prevent irritation or adverse reactions.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It should be stored at room temperature, within the range of 15° to 30° C (59° to 86° F). Care should be taken to ensure that the product is kept in a suitable container to maintain its integrity. Special handling requirements should be observed to prevent exposure to extreme temperatures.

Additional Clinical Information

Patients aged 12 years and older are advised to apply the medication to the affected area no more than 3 to 4 times daily. For children under 12 years of age, it is recommended to consult a doctor regarding the appropriate use and frequency of administration. No further information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Leader Ultra Strength Muscle Rub, 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 Leader Ultra Strength Muscle Rub, 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.