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Hot Stuff

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This product has been discontinued

Active ingredients
  • Menthol 0.03 g/1 g
  • Methyl Salicylate 0.15 g/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 2019
Label revision date
April 22, 2019
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Menthol 0.03 g/1 g
  • Methyl Salicylate 0.15 g/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 2019
Label revision date
April 22, 2019
Manufacturer
Mueller Sports Medicine
Registration number
part348
NDC root
52564-108
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

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

This medication is designed to temporarily relieve pain associated with sore muscles, minor aches, sprains, strains, and bruises. It works by targeting the discomfort in these areas, helping you feel more comfortable and able to move. If you're dealing with any of these types of pain, this drug may provide the relief you need to get back to your daily activities.

Uses

You can use this medication to temporarily relieve pain from various conditions. It is effective for sore muscles, minor aches, sprains, strains, and bruises. If you're dealing with any of these issues, this medication may help ease your discomfort and support your recovery.

Rest assured, there are no 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 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 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 the medication only to the areas that need treatment.

What to Avoid

It's important to use this product safely to avoid any potential issues. You should not apply it to wounds or damaged skin, as this can lead to irritation or complications. Additionally, avoid bandaging tightly over the area where you applied the product, and do not use it in conjunction with a heating pad, as this can increase the risk of skin irritation. Lastly, refrain from using it immediately after a shower or bath, as your skin may be more sensitive at that time. Following these guidelines will help ensure your safety and the effectiveness of the product.

Side Effects

If you have a history of allergic reactions to menthol, aspirin, or salicylates, it's important to consult your doctor before using this medication. You should stop using it and seek medical advice if your condition worsens, if symptoms last longer than 7 days, or if they improve and then return within a few days. Additionally, if you notice any skin redness or experience excessive skin irritation, please contact your healthcare provider.

Warnings and Precautions

This product is for external use only. If you have a history of allergic reactions to menthol, aspirin, or salicylates, please consult your doctor before using it. Always use the product as directed, and avoid contact with your eyes or any mucous membranes. Do not apply it to wounds or damaged skin, and refrain from tightly bandaging the area or using it with a heating pad. It's also best to wait a while after showering or bathing before applying.

If your condition worsens, or if symptoms persist for more than 7 days, come back after clearing up only to return within a few days, or if you notice skin redness or excessive irritation, stop using the product and consult your doctor. In case of accidental swallowing, seek emergency medical help or contact a Poison Control center immediately.

Overdose

If you or someone else has swallowed a medication and you suspect an overdose, it’s important to act quickly. You should seek medical help immediately or contact a Poison Control center for guidance.

Signs of an overdose can vary, but they may include unusual symptoms that are not typical for the medication. Always err on the side of caution and get help if you are unsure. Remember, timely action can make a significant difference in ensuring safety and 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 with a doctor before using this medication. For those aged 12 and older, you can apply it to the affected area, but be sure not to exceed 3 to 4 applications in a day. Always follow these guidelines to ensure safe and effective use for your child.

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 to using this medication safely and effectively, considering any unique health needs or conditions that may be present. Always prioritize open communication with your healthcare team to ensure the best outcomes.

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 may affect you if you have hepatic impairment (liver issues).

Before starting any new medication, including this one, you should discuss your liver health with your healthcare provider. They can help determine the best approach for your treatment and ensure your safety.

Drug Interactions

It's important to talk to your healthcare provider before using this medication, especially if you have a history of allergic reactions to menthol, aspirin, or salicylates. Allergies can lead to serious health issues, so ensuring your safety is a priority.

Additionally, there are no specific interactions with other drugs or laboratory tests noted, but it's always wise to keep your healthcare provider informed about all medications and tests you are undergoing. This helps them provide the best care tailored to your needs.

Storage and Handling

To ensure the best performance and safety of your product, store it at normal 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 integrity. Always follow any specific disposal instructions provided to ensure safe and responsible disposal.

Additional Information

No further information is available.

FAQ

What types of pain does this drug relieve?

This drug temporarily relieves pain from sore muscles, minor aches, sprains, strains, and bruises.

How should adults and children over 12 use this drug?

Adults and children 12 years of age and over should apply it to the affected area not more than 3 to 4 times daily.

What should children under 12 do before using this drug?

Children under 12 years of age should ask a doctor before use.

What precautions should I take when using this drug?

Use only as directed, avoid contact with eyes or mucous membranes, and do not apply to wounds or damaged skin.

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

Stop use and ask a doctor if skin redness is present or if excessive skin irritation occurs.

Is this drug safe to use during pregnancy or breastfeeding?

If pregnant or breastfeeding, you should ask a health professional before using this drug.

What should I do if I accidentally swallow this drug?

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

Are there any known drug interactions?

If you are prone to allergic reactions from menthol, aspirin, or salicylates, consult a doctor before use.

What storage conditions are recommended for this drug?

Store at normal room temperature.

Packaging Info

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

Packaging configurations for Hot Stuff.
Details

Drug Information (PDF)

This file contains official product information for Hot Stuff, 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 specific description details are provided in the text.

Uses and Indications

This drug is indicated for the temporary relief of pain associated with sore muscles, minor aches, sprains, strains, and bruises.

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

Dosage and Administration

For adults and children aged 12 years and over, 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 dry before applying the medication.

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

Contraindications

The product is contraindicated for use in the following situations:

Application to wounds or damaged skin is prohibited due to the potential for irritation or adverse reactions. Tight bandaging is not recommended as it may impede circulation and lead to complications. The use of heating pads in conjunction with the product is contraindicated, as it may enhance absorption and increase the risk of adverse effects. Additionally, application immediately after a shower or bath is discouraged, as the skin may be more sensitive and prone to irritation.

Warnings and Precautions

For external use only. Individuals with a known allergy to menthol, aspirin, or salicylates should consult a healthcare professional prior to use to mitigate the risk of an allergic reaction.

It is imperative to use this product strictly as directed. Care should be taken to avoid contact with the eyes or mucous membranes, as this may lead to irritation. The product should not be applied to wounds or damaged skin, and it is advised against tight bandaging of the area post-application. Additionally, the use of a heating pad in conjunction with this product is contraindicated, as is application immediately following a shower or bath, to prevent adverse effects.

Patients should discontinue use and seek medical advice if the condition worsens. Specific indicators for this include persistence of symptoms beyond 7 days, recurrence of symptoms after initial improvement within a few days, presence of skin redness, or excessive skin irritation.

In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control center is recommended to ensure prompt and appropriate care.

Side Effects

Patients should be aware of potential adverse reactions associated with the use of this product. Individuals with a known allergy to menthol, aspirin, or salicylates are advised to consult a healthcare professional prior to use to mitigate the risk of allergic reactions.

In the event that the condition worsens, symptoms persist for more than 7 days, or symptoms resolve only to recur within a few days, patients should discontinue use and seek medical advice. Additionally, if skin redness or excessive skin irritation occurs, it is recommended that patients stop using the product and consult a doctor. These precautions are essential to ensure patient safety and to address any serious reactions that may arise during treatment.

Drug Interactions

Patients with a known allergy to menthol, aspirin, or salicylates should consult a healthcare professional prior to use, as there is a potential for allergic reactions.

No specific drug or laboratory test interactions have been identified in the available data. Therefore, routine monitoring or dosage adjustments related to drug interactions are not necessary.

Packaging & NDC

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

Packaging configurations for Hot Stuff.
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 area no more than 3 to 4 times daily.

Geriatric Use

There is no specific information 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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, given the lack of targeted data for this population.

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 weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data on 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 drug insert 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 absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this medication. 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 strategies.

Healthcare providers should ensure that patients are aware of the importance of timely reporting of any overdosage incidents 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 compound in these areas.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. Instruct patients that if the product is swallowed, they should seek medical help or contact a Poison Control center immediately.

Patients should be informed to stop using the product and consult a doctor if symptoms persist for more than 7 days, if symptoms clear up and then recur within a few days, if there is any skin redness, or if excessive skin irritation occurs.

When using this product, patients must be reminded to use it only as directed. They should avoid contact with the eyes and mucous membranes, and it should not be applied to wounds or damaged skin. Additionally, patients should be cautioned against bandaging the area tightly, using the product in conjunction with a heating pad, or applying it immediately after a shower or bath.

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 normal room temperature to maintain its integrity and efficacy. No special handling requirements are noted, ensuring straightforward management within standard storage conditions.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Hot Stuff, 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 Hot Stuff, 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.