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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 2025
Label revision date
October 1, 2025
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 2025
Label revision date
October 1, 2025
Manufacturer
SUNSET NOVELTIES, INC
Registration number
M017
NDC root
72937-018
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, offering soothing relief when you need it most.

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. Remember, this is meant for short-term use to help manage those occasional aches.

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 to ensure it's safe and appropriate for them.

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 within a few days, 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. Before using it, 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 or irritation, if symptoms last longer 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.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, it's always important to be aware of the potential risks associated with taking more than the recommended dose. If you suspect an overdose, look for signs such as unusual drowsiness, confusion, or difficulty breathing.

In the event of an overdose, it is crucial to seek immediate medical help. You can contact your local emergency services or go to the nearest hospital. Always keep the medication packaging on hand to provide healthcare professionals with important information about what was taken. Remember, when in doubt, it's better to err on the side of caution and get help right away.

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

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. As you age, your body may process medications differently, which can affect how well they work and the potential for side effects.

If you or a loved one is considering this medication, it’s wise to discuss it with a healthcare provider. They can help determine if any special precautions or adjustments are needed based on individual health conditions and overall well-being. 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 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 feel free to ask questions and share your complete list of medications and any lab tests you may be undergoing. This way, you can receive the best possible care tailored to your needs.

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 will help maintain the product's effectiveness and safety.

When handling the product, always ensure that you are in a clean environment to avoid contamination. Following these simple storage and handling guidelines will help you use the product safely and effectively.

Additional Information

No further information is available.

FAQ

What is SUNSET - HEATING PAIN RELIEF CREAM used for?

SUNSET - HEATING PAIN RELIEF CREAM is an aid 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 should I do after using the cream?

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

Can children under 12 use this cream?

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

Are there any precautions I should take?

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?

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

Is this cream safe for pregnant or breastfeeding women?

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 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 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 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 use with a heating pad is not recommended, as it may exacerbate 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 risk of further irritation or complications.

  • Exposure of the treated area to heat or direct sunlight is not advised, as it may lead to increased sensitivity or 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 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 for more than 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 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 seek medical attention if they experience 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 the use of 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 and massaged in a circular motion. The 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 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 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 considered, 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 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, 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 regarding the potential for overdose with this medication. In cases where an overdose is suspected, immediate medical attention should be sought.

Healthcare providers are advised to monitor patients closely for any signs or symptoms that may arise from an overdose. Common symptoms may include, but are not limited to, severe drowsiness, confusion, respiratory distress, or any other unusual clinical manifestations.

Management of an overdose should be guided by the clinical presentation of the patient. Supportive care is paramount, and symptomatic treatment should be initiated as necessary. Healthcare professionals should also consider contacting a poison control center for additional guidance on the management of overdose cases.

In summary, while specific overdosage information is not available, healthcare professionals should exercise caution, monitor for symptoms, and provide appropriate management in the event of an overdose.

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 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 be cautioned to watch for signs of injury, such as pain, swelling, or blistering at the application site, and to use the product only as directed. They should be informed not to bandage the area tightly or use a heating pad in conjunction with the product. Additionally, patients should avoid contact with eyes and mucous membranes and should not apply the product to wounds or damaged, broken, or irritated skin.

In the event of an allergic reaction, patients should be advised to discontinue use immediately and consult a doctor. Furthermore, patients should be reminded to avoid exposing 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.