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Heating Pain Relief

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Active ingredients
  • Menthol 10 g/100 mL
  • Methyl Salicylate 18 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 2026
Label revision date
January 29, 2026
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Menthol 10 g/100 mL
  • Methyl Salicylate 18 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 2026
Label revision date
January 29, 2026
Manufacturer
SUNSET NOVELTIES, INC
Registration number
M017
NDC root
72937-017
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 comes in a convenient 4 fluid ounce tube, making it easy to apply directly to the affected area for soothing comfort. If you're experiencing discomfort from muscle or joint pain, this cream may help alleviate your symptoms.

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 that purpose, making it a useful option when you need quick comfort from discomfort.

Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) associated with this medication, so it can be considered safe in that regard. Always consult with a healthcare professional if you have any concerns or questions about using this product.

Dosage and Administration

For adults and children over 12 years old, you should apply a small amount of the medication 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 using the medication, remember to wash your hands thoroughly with soap and water to keep them clean.

If you have a child under 12 years of age, it’s important to consult a doctor before using this medication. They can provide guidance on the appropriate treatment 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 redness or irritation, or if your symptoms last more than seven days or return shortly after improving. Additionally, if you experience signs of injury, such as pain, swelling, or blistering at the application site, please contact your healthcare provider.

Warnings and Precautions

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

You should stop using the product and call your doctor if your condition worsens, if you notice redness, if irritation develops, or if your symptoms last more than 7 days or return shortly after improvement. Additionally, if you experience any signs of injury, such as pain, swelling, or blistering at the application site, please 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 is crucial to seek immediate medical help.

In case of an emergency, call your local emergency number 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. 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 using the product, 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, it’s important to consult with a healthcare provider before starting the medication. 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 requirements mentioned for your condition in the provided information. This means that the standard recommendations for medication use may apply to you without any special considerations. However, always consult your healthcare provider for personalized advice and to ensure your treatment is safe and effective based on your kidney health.

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 detailed recommendations available 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 condition. They can help you understand how to manage your health effectively while using this medication.

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 tests you might be undergoing. This way, you can avoid any potential issues and ensure the best possible care.

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 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, please follow them carefully to ensure safety and compliance with local regulations.

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.

Are there any precautions I should take when using this cream?

Yes, do not bandage tightly, avoid contact with eyes and mucous membranes, and do not apply to wounds or irritated 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 under 12?

Consult a doctor before using SUNSET - HEATING PAIN RELIEF CREAM on children under 12 years of age.

What should I do if my condition worsens or irritation develops?

Stop using the cream and consult a doctor if your condition worsens, if redness or irritation develops, or if symptoms persist for more than 7 days.

What are the storage instructions for this cream?

Store SUNSET - HEATING PAIN RELIEF 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 using SUNSET - HEATING PAIN RELIEF CREAM.

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 associated with this drug.

Dosage and Administration

For adults and children over 12 years of age, a small amount of the product should be applied 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

Use of this product is contraindicated in the following situations:

Tight bandaging or the use of heating pads in conjunction with this product is not recommended, as it may lead to adverse effects. Contact with eyes and mucous membranes should be avoided to prevent irritation or injury. Application to 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, immediate medical assistance should be sought, or the local Poison Control Center should be contacted without delay.

Patients are instructed to discontinue use and seek medical advice if any of the following occur: the condition worsens, redness develops, irritation arises, symptoms persist beyond seven days, or if symptoms resolve only to recur within a few days. 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 healthcare provider.

Side Effects

Patients using this product should be aware of potential adverse reactions. The product is intended for external use only. It is advised that patients consult a healthcare professional prior to use if there is any redness over the affected area.

Patients are instructed 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 seek medical attention if they experience signs of injury, such as 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 prior to use. For adolescents and children aged 12 years and older, the recommended application involves applying a small amount to the affected area, massaging in a circular motion, and allowing it to set for a few seconds. This process may be repeated as necessary, but should not exceed 3 to 4 applications daily. It is advised to wash hands with soap and water after application to ensure safety and hygiene.

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 efficacy, given the lack of targeted data for 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. Therefore, it is essential for women of childbearing potential to seek medical advice to weigh the benefits and risks before initiating treatment.

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

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, as the lack of data may impact the safety and efficacy of treatment in this population. Regular monitoring of liver function may be warranted based on clinical judgment.

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 significantly 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, and specific interventions may be required based on the symptoms presented.

Management of an overdose may involve the administration of activated charcoal if the patient presents within a suitable timeframe and is not at risk for aspiration. In cases of severe toxicity, advanced interventions such as airway management, intravenous fluids, or antidotes may be warranted, depending on the specific agent involved.

It is crucial for healthcare professionals to consult local poison control centers or toxicology experts for guidance on the management of overdose cases, as they can provide tailored recommendations based on the latest evidence and clinical protocols.

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 ability to draw conclusions regarding the potential toxicological profile of the substance in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

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 instructed to discontinue use and consult a doctor if their condition worsens, if redness occurs, or if irritation develops. It is important to inform patients that they should stop using the product and seek medical advice if symptoms persist for more than 7 days or if symptoms clear up and then recur within a few days.

Patients should also be made aware that they need to stop use and consult a healthcare professional if they experience any signs of injury, such as pain, swelling, or blistering at the application site. Emphasize the importance of using the product only as directed and advise against tightly bandaging the area or using it in conjunction with a heating pad.

Healthcare providers should caution patients to avoid contact with 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 be instructed to 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 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

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.