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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 (4 NDCs)
Packaging & NDC Codes (4)

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.

The cream works by applying heat to the affected area, which can help soothe pain and promote relaxation in the muscles and joints. If you're looking for a way to ease your discomfort, this cream may be a supportive option to consider.

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, this treatment can be a useful option to consider for quick relief.

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 considering this medication for a child under 12 years of age, it’s important to consult a doctor first to ensure it’s safe and appropriate for their use.

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 your safety and the effectiveness of the product.

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 your condition worsens, if you notice redness, or if irritation develops. Additionally, if your symptoms last more than 7 days, improve and then return shortly after, or if you experience signs of injury like pain, swelling, or blistering in the area where the product was applied, seek medical advice.

Remember, this product is for external use only. If you have redness over the affected area before using it, please consult a doctor first.

Warnings and Precautions

This product is for external use only, so please avoid swallowing it. If you do accidentally swallow it, seek emergency medical help or contact a Poison Control Center immediately. Before using the product, consult your doctor if you notice any redness in the area you plan to treat.

You should stop using the product and call your doctor if your condition worsens, if you see redness or irritation, if symptoms last more than 7 days, or if they return shortly after clearing up. Additionally, if you experience any signs of injury, such as pain, swelling, or blistering at the application site, it’s important to seek medical advice 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 this medication. They can provide guidance on any potential risks and help ensure the safety of both you and your baby. Always prioritize open communication with your healthcare provider 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. Gently massage it in a circular motion and allow it to set for a few seconds. You can repeat this process as needed, but be sure not to exceed 3 to 4 applications in a day. After applying, remember to wash your hands thoroughly with soap and water.

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 considering this medication, it’s important to consult with a healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken.

Always keep in mind that older adults may have different responses to medications, so discussing any concerns with a doctor is essential for ensuring safety and effectiveness.

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 usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment plan.

Hepatic Impairment

If you have liver problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or precautions related to your condition. This means that there are no tailored recommendations for how the medication may affect you differently due to your liver health.

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

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 tightly closed container in a dry place. Keep the temperature between 59°-86° F (15°-30° C), which is considered a controlled 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.

Additional Information

No further information is available.

FAQ

What is SUNSET - HEATING PAIN RELIEF CREAM used for?

SUNSET - HEATING PAIN RELIEF CREAM is used for 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 on 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, use with a heating pad, or apply to wounds or damaged skin. Avoid contact with eyes and mucous membranes, and do not expose 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.

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 after applying the cream?

Wash your hands with soap and water after use to avoid accidental contact with your eyes or mucous membranes.

What should I do if symptoms persist?

If symptoms persist for more than 7 days or return after clearing up, stop using the cream and consult a doctor.

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

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

How should I store SUNSET - HEATING PAIN RELIEF CREAM?

Store the cream tightly closed in a dry place at 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 as part of a broader pain management strategy.

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 per day. It is important to wash hands thoroughly with soap and water after each use to prevent unintended exposure.

For children under 12 years of age, it is recommended to consult a healthcare professional prior to use.

Contraindications

The product should not be used in the following situations:

  • Bandaging tightly or using with a heating pad is contraindicated due to the risk of impaired circulation and potential skin damage.

  • Contact with eyes and mucous membranes must be avoided to prevent irritation or injury.

  • Application to wounds or damaged, broken, or irritated skin is contraindicated to avoid exacerbating the condition or causing further harm.

  • Exposure of the treated area to heat or direct sunlight is not recommended, as it may lead to adverse reactions or decreased efficacy of the product.

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, immediate medical assistance should be sought, or the patient should contact a Poison Control Center without delay.

Patients are instructed to discontinue use and contact their healthcare provider 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 only to recur within a few days. Additionally, if the patient experiences signs of injury, such as pain, swelling, or blistering at the site of application, they should seek medical attention promptly.

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 is present, patients are advised to discontinue use and seek medical advice. Additional reasons to stop use and consult a doctor include the development of irritation, persistence of symptoms for more than 7 days, or if symptoms clear up and then recur within a few days. Furthermore, if patients experience signs of injury, such as pain, swelling, or blistering at the site of application, they should also seek medical attention.

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, massaged in a circular motion, and allowed to set for a few seconds. This application may be repeated as necessary, but should not exceed 3 to 4 times daily. It is advised to wash hands with soap and water after application.

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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

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 their 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 currently no available data regarding the excretion of this medication 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 no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the text. Therefore, healthcare professionals should exercise caution and consider individual patient factors when prescribing to this population. Regular assessment of renal function may be warranted to ensure safe and effective use of the medication in patients with reduced kidney function.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to 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 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 further management.

Nonclinical Toxicology

The use of this product during pregnancy or breastfeeding should be approached with caution. It is advisable to consult a health professional prior to use in these circumstances.

In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

Postmarketing Experience

No postmarketing experience details are provided in the insert.

Patient Counseling

Patients should be advised to seek medical help or contact a Poison Control Center immediately if the product is swallowed. It is important to instruct patients to stop using the product and consult a healthcare provider if any of the following occur: the condition worsens, redness develops, irritation occurs, symptoms persist for more than 7 days, or if symptoms clear up only to return within a few days. Additionally, patients should be informed to seek medical attention if they experience signs of injury, such as pain, swelling, or blistering at the site of application.

Patients must 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. They should also be cautioned 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 discontinue use immediately and consult a healthcare provider. Furthermore, patients should be advised to avoid exposing 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 a controlled room temperature, maintained between 59°-86° F (15°-30° C). Proper storage conditions are essential to preserve the quality of the product.

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

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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.