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Heating Pain Relief

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This product has been discontinued

Active ingredients
  • Menthol 9.8 g/100 mL
  • Methyl Salicylate 17.6 g/100 mL
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 2023
Label revision date
November 20, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Menthol 9.8 g/100 mL
  • Methyl Salicylate 17.6 g/100 mL
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 2023
Label revision date
November 20, 2025
Manufacturer
SUNSET NOVELTIES, INC
Registration number
M017
NDC root
72937-180
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

SUNSET - HEATING PAIN RELIEF CREAM is a topical cream designed to provide temporary local relief from minor pain in muscles or joints. This product is particularly useful for those experiencing discomfort due to everyday activities or minor injuries.

By applying the cream to the affected area, you can help soothe pain and improve your comfort. It's a convenient option for anyone looking for quick relief from muscle or joint pain.

Uses

If you're dealing with minor pain in your muscles or joints, this medication can help provide temporary local relief. It's designed to ease discomfort, allowing you to go about your daily activities with less pain. Whether it's from a minor strain or overexertion, you can rely on this treatment to help soothe those aches.

Dosage and Administration

To use this medication, start by applying a small amount directly to the area that needs treatment. Gently massage it in using a circular motion and allow it to set for a few seconds. You can repeat this process as needed, but make sure not to apply it more than 3 to 4 times in a single day. After you’re done, remember to wash your hands thoroughly with soap and water to keep the medication from spreading to other areas.

If you are considering this treatment for a child under 12 years old, it’s important to consult a doctor first, as this medication is not recommended for younger children.

What to Avoid

It's important to use this product safely to avoid any potential issues. You should not bandage the area tightly or use a heating pad while using it. Additionally, make sure to avoid contact with your eyes and mucous membranes, and do not apply it to wounds or any damaged, broken, or irritated skin. Lastly, keep the treated area away from heat and direct sunlight to ensure the best results and minimize any risks.

Side Effects

You should use this product only on the skin and consult a doctor if you notice any redness in the area where you apply it. It's important to stop using the product and seek medical advice if your condition worsens, if you develop irritation, or if symptoms last longer than seven days. Additionally, if your symptoms improve and then return shortly after, or if you experience signs of injury like pain, swelling, or blistering at the application site, please contact your healthcare provider.

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 immediately. If you notice any redness in the area where you applied the product, or if your condition worsens, it’s important to stop using it and call your doctor.

You should also reach out to your healthcare provider if you experience any irritation, if symptoms last longer than 7 days, or if they return shortly after improving. Additionally, if you notice signs of injury, such as pain, swelling, or blistering at the application site, stop using the product and consult your doctor right away.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, it's important to be aware of the general signs of an overdose, which can include symptoms like extreme drowsiness, confusion, or difficulty breathing. If you suspect an overdose, it’s crucial to seek immediate medical help.

In case of an emergency, call your local emergency services or go to the nearest hospital. Always keep medications out of reach of children and follow the prescribed dosage to prevent any potential risks. If you have any concerns or questions about your medication, don’t hesitate to reach out to your healthcare provider for guidance.

Pregnancy Use

If you are pregnant or planning to become pregnant, it’s important to consult with a healthcare professional before using this medication. They can provide guidance tailored to your specific situation and help you understand any potential risks. Always prioritize your health and the health of your baby 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 you are considering this medication for your child, it's important to know that it is not recommended for children under 12 years of age. If your child is younger than this, please consult a doctor for guidance. Always prioritize your child's safety and well-being by seeking professional advice when it comes to their health.

Geriatric Use

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. Since older adults may have different health needs and responses to medications, you should always consult with a healthcare provider before starting any new medication. They can help determine the right dosage and monitor for any potential side effects, ensuring that the treatment is safe and effective for you or your loved one.

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 change based on renal impairment. However, it’s always best to consult with your healthcare provider about your kidney health and any medications you are taking. They can provide personalized advice and ensure that your treatment is safe and effective for you.

Hepatic Impairment

If you have liver problems, it's important to know that the information provided does not include any specific guidelines about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no established recommendations for how your liver health might affect the use of this medication.

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and appropriate for your liver health. They can help you understand how to manage your condition while considering any medications you may need.

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 share your complete list of medications and any health conditions you have to receive the best care possible.

Storage and Handling

To ensure the best performance of your product, store it in a dry place with the container tightly closed. Keep the temperature between 59°-86° F (15°-30° C), which is considered a comfortable room temperature. This helps maintain the product's effectiveness and safety.

When handling the product, always ensure that you are in a clean environment to avoid contamination. If you have any specific disposal instructions, be sure to follow them carefully to ensure safety and compliance.

Additional Information

No further information is available.

FAQ

What is SUNSET - HEATING PAIN RELIEF CREAM used for?

SUNSET - HEATING PAIN RELIEF CREAM is used to provide temporary local relief of minor pain in muscles or joints.

How should I apply SUNSET - HEATING PAIN RELIEF CREAM?

Apply a small amount to the affected area, massage in a circular motion, and let it set for a few seconds. You can repeat this up to 3 to 4 times daily.

Is SUNSET - HEATING PAIN RELIEF CREAM safe for children?

Do not use SUNSET - HEATING PAIN RELIEF CREAM on children under 12 years of age without consulting a doctor.

What precautions should I take when using this cream?

Avoid bandaging tightly, using with a heating pad, and contact with eyes or mucous membranes. Do not apply to wounds or irritated skin, and avoid exposing the treated area to heat or direct sunlight.

What should I do if I experience side effects?

If you experience redness, irritation, or if your condition worsens, stop using the cream and consult a doctor. Seek emergency help if swallowed.

Can I use SUNSET - HEATING PAIN RELIEF CREAM if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, ask a health professional before using SUNSET - HEATING PAIN RELIEF CREAM.

How should I store SUNSET - HEATING PAIN RELIEF CREAM?

Store the cream tightly closed in a dry place at a controlled room temperature between 59°-86° F (15°-30° C).

Packaging Info

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

Packaging configurations for Heating Pain Relief.
Details

Drug Information (PDF)

This file contains official product information for Heating Pain Relief, 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 specified drug.

Uses and Indications

This drug is indicated for the temporary local relief of minor pain in muscles or joints. It is intended for use in patients experiencing such discomfort, providing symptomatic relief to enhance daily activities.

Dosage and Administration

For adults and children over 12 years of age, a small amount of the product should be applied directly to the affected area. The application should be followed by a gentle massage in a circular motion, allowing the product to set for a few seconds. This process may be repeated as necessary, but should not exceed 3 to 4 applications within a 24-hour period. It is important to wash hands thoroughly with soap and water after each use to prevent accidental contact with other areas of the body or with other individuals.

For children under 12 years of age, the product is not recommended. Consultation with a healthcare professional is advised prior to use in this age group.

Contraindications

The product is contraindicated in the following situations:

Tight bandaging or the use of heating pads in conjunction with the product is not recommended, as this may lead to adverse effects. Contact with eyes and mucous membranes should be avoided to prevent irritation or injury. The application of the product on wounds or damaged, broken, or irritated skin is contraindicated due to the potential for exacerbating the condition. Additionally, exposure of the treated area to heat or direct sunlight should be avoided to minimize the risk of adverse reactions.

Warnings and Precautions

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

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

Patients should be instructed to discontinue use and contact their healthcare provider if any of the following occur: worsening of the condition, development of redness, onset of irritation, persistence of symptoms beyond 7 days, or recurrence of symptoms within a few days after initial improvement. Additionally, if patients experience signs of injury, such as pain, swelling, or blistering at the site of application, they must stop using the product and seek medical advice promptly.

Monitoring for these adverse effects is crucial to ensure patient safety and effective management of treatment.

Side Effects

Patients using this product may experience various adverse reactions. It is important to note that the product is intended for external use only. Patients should consult a healthcare professional prior to use if there is any redness over the affected area.

In the event that the condition worsens, or if redness, irritation, or other 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 seek medical advice. Additionally, if patients experience signs of injury, such as pain, swelling, or blistering at the site of application, they should stop using the product and consult a doctor.

These precautions are essential to ensure the safety and well-being of patients while using this product.

Drug Interactions

There are currently no documented drug interactions associated with 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 Heating Pain Relief (methyl salicylate, menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Heating Pain Relief.
Details

Pediatric Use

Pediatric patients under 12 years of age should not use this medication without consulting a healthcare professional. It is important for healthcare providers to evaluate the appropriateness of treatment in this age group, considering potential risks and the need for alternative therapies.

Geriatric Use

Elderly patients may not have specific information 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 therapeutic response, given the lack of targeted data for this population.

Pregnancy

Pregnant patients 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 are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure appropriate management during pregnancy.

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

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials for this medication. Consequently, there is no information available 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 in these patients, although specific parameters are not defined in the prescribing information.

Overdosage

In the absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant and prepared for potential scenarios involving overdose.

Healthcare providers should be aware that the clinical presentation of an overdose may vary depending on the substance involved and the individual patient’s characteristics. Symptoms of overdose can range from mild to severe and may include alterations in consciousness, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

In the event of suspected overdosage, immediate medical evaluation is recommended. Healthcare professionals should assess the patient's vital signs and conduct a thorough clinical examination. Supportive care should be initiated as necessary, which may include airway management, intravenous fluids, and monitoring of vital parameters.

If specific antidotes or treatments are available for the substance involved, they should be administered according to established protocols. Consultation with a poison control center or toxicology expert may also be warranted to guide management decisions.

It is crucial to document all findings and interventions in the patient's medical record and to report any adverse events to the appropriate regulatory authorities as per local guidelines.

Nonclinical Toxicology

The use of this product during pregnancy or lactation should be approached with caution. It is advisable for individuals who are pregnant or breastfeeding to consult a healthcare professional prior to use to ensure safety and mitigate any potential risks.

No non-teratogenic effects have been specified in the available data. Additionally, there are no details provided regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert.

Patient Counseling

Patients should be advised to seek immediate medical assistance or contact a Poison Control Center if the product is swallowed. Healthcare providers should emphasize the importance of monitoring for any worsening of the condition, as well as the presence of redness or the development of irritation. Patients should be instructed to report if symptoms persist for more than 7 days or if they resolve only to recur within a few days.

It is crucial to inform patients to be vigilant for signs of injury, such as pain, swelling, or blistering at the site of application. They should be reminded to use the product only as directed and to avoid tightly bandaging the area or using it in conjunction with a heating pad.

Healthcare providers should counsel patients to avoid contact with the eyes and mucous membranes, and to refrain from applying the product to wounds or any damaged, broken, or irritated skin. In the event of an allergic reaction, patients should discontinue use immediately and consult a doctor. Additionally, patients should be advised not to expose the treated area to heat or direct sunlight.

Storage and Handling

The product is supplied in a tightly closed container to ensure stability and integrity. It should be stored in a dry place at controlled room temperature, specifically within the range of 59° to 86° F (15° to 30° C). Proper storage conditions are essential to maintain the product's efficacy and safety.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Heating Pain Relief, 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 Heating Pain Relief, 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.