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Heating Pain Relief

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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 (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

SUNSET - HEATING PAIN RELIEF CREAM is a topical cream designed to provide temporary local relief from minor pain in muscles or joints. This product can be particularly helpful if you're experiencing discomfort due to everyday activities or minor injuries.

While the specific mechanism of action isn't detailed, the cream is formulated to target pain directly at the site of application, making it a convenient option for quick relief.

Uses

If you're experiencing minor pain in your muscles or joints, this medication can help provide temporary local relief. It's designed specifically for those occasional aches that can disrupt your daily activities.

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

Dosage and Administration

When using this medication, if you are an adult or a child over 12 years old, start by applying a small amount directly to the affected area. 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 exceed 3 to 4 applications in a single day. After applying the medication, remember to wash your hands thoroughly with soap and water to avoid any unwanted contact with other areas.

If you are caring for a child under 12 years of age, it’s important to consult a doctor before use to ensure safety and proper guidance.

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 be aware that this product is for external use only. If you notice any redness over the affected area, it's important to consult a doctor before using it.

If your condition worsens, if you develop irritation, or if symptoms last more than 7 days—or clear up and then return—stop using the product and seek medical advice. Additionally, if you experience signs of injury, such as pain, swelling, or blistering at the application site, you should also contact a healthcare professional.

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 is 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 your child is under 12 years old, it's important to consult a doctor before using this product. For children aged 12 and older, you can apply a small amount to the affected area as needed, but be sure not to exceed 3 to 4 applications in a day. After applying the product, remember to wash your hands thoroughly with soap and water to avoid any unintended contact with other areas.

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 there are no specific guidelines, dosage adjustments, or monitoring recommendations provided for your condition in the available information. This means that the standard instructions do not address how your kidney 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 effective for you, especially if you have renal impairment. Your doctor can help determine the best approach based on your individual health needs.

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 to use this medication safely 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 tailored to your needs.

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 recent lab tests to avoid any potential issues. Your health and safety should always come first.

Storage and Handling

To ensure the best performance of your product, store it in a tightly closed container in a dry place. Keep the temperature between 59°-86° F (15°-30° C), which is considered a comfortable room temperature. This will help maintain its 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 aid in the temporary local relief of minor pain in muscles or joints.

How should I apply SUNSET - HEATING PAIN RELIEF CREAM?

For adults and children over 12 years, apply a small amount to the affected area, massage in circular motion, and let it set for a few seconds. You can repeat this up to 3 to 4 times daily.

What precautions should I take when using this cream?

Do not bandage tightly, avoid contact with eyes and mucous membranes, and do not apply to wounds or damaged skin. Also, do not expose the treated area to heat or direct sunlight.

What should I do if I experience an allergic reaction?

If you experience an allergic reaction, discontinue use immediately and consult a doctor.

Is SUNSET - HEATING PAIN RELIEF CREAM safe for children?

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

What should I do if my condition worsens or if I have redness over the affected area?

If your condition worsens, redness is present, or irritation develops, stop using the cream and consult a doctor.

What should I do if I accidentally swallow the cream?

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

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).

Can I use this cream if I am pregnant or breastfeeding?

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

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.

There are no teratogenic or nonteratogenic effects mentioned associated with the use of this drug.

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 unintended contact with other areas.

For children under 12 years of age, it is recommended to consult a healthcare professional prior to use to ensure safety and appropriateness of treatment.

Contraindications

The product should not be used in the following situations:

  • Tight bandaging or use with a heating pad is contraindicated, as it may exacerbate local irritation or injury.

  • Contact with eyes and mucous membranes must be avoided to prevent potential irritation or adverse reactions.

  • Application to wounds or damaged, broken, or irritated skin is contraindicated due to the risk of further irritation or infection.

  • Exposure of the treated area to heat or direct sunlight should be avoided to prevent adverse effects on the skin.

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 under the following circumstances: if the condition worsens, if redness develops, if irritation occurs, if symptoms persist for more than seven days, or if symptoms resolve only to recur within a few days. Additionally, any signs of injury, such as pain, swelling, or blistering at the site of application, warrant immediate medical consultation.

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

Side Effects

Patients using this product should be aware that it is intended for external use only. It is important to consult a healthcare professional prior to use if there is any redness over the affected area.

Participants are advised to discontinue use and seek medical advice if any of the following occur: worsening of the condition, presence of redness, development of irritation, persistence of symptoms beyond 7 days, or if symptoms resolve and then recur within a few days. Additionally, patients should be vigilant for signs of injury, which may include pain, swelling, or blistering at the site of application.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding 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 consult a healthcare professional before use. For adolescents and children aged 12 years and older, a small amount of the product should be applied to the affected area. This application may be repeated as necessary, but should not exceed 3 to 4 times daily. It is important for patients to wash their hands with soap and water after application to prevent unintended exposure.

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 consult a healthcare professional prior to using this medication. The safety of this drug during pregnancy has not been established, and potential risks to fetal outcomes are not fully understood. It is essential for women of childbearing potential to discuss their individual circumstances with a healthcare provider to weigh the benefits and risks associated with the use of this medication during pregnancy.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is no specific data available regarding the excretion of this drug in 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 renal impairment, dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function. Healthcare professionals should exercise clinical judgment when prescribing to patients with renal impairment, as specific recommendations are not provided in the available data.

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.

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 altered mental status, 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 a medical toxicologist may also be beneficial in managing the case effectively.

It is crucial to document all findings and interventions in the patient's medical record to ensure continuity of care and facilitate any necessary follow-up.

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 seek immediate medical assistance or contact a Poison Control Center if the product is swallowed. Patients should be informed to monitor their condition closely and to report any worsening of symptoms, including the presence of redness or the development of irritation.

It is important to instruct patients to seek medical attention if symptoms persist for more than 7 days or if they resolve only to recur within a few days. Patients should also be made aware of the signs of injury, such as pain, swelling, or blistering at the site of application, and to report these symptoms promptly.

Healthcare providers should emphasize the importance of using the product only as directed. Patients should be cautioned against bandaging the area tightly or using a heating pad in conjunction with the product. Additionally, they should be advised to avoid contact with the eyes and mucous membranes, and not to apply the product to wounds or any damaged, broken, or irritated skin.

In the event of an allergic reaction, patients should be instructed to discontinue use immediately and consult a doctor. Furthermore, it is essential to inform patients not to expose the treated area to heat or direct sunlight to prevent adverse effects.

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 between 59°-86° F (15°-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.