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Raw Heat

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This product has been discontinued

Active ingredient
Menthol 3.5 mg/1 L
Other brand names
Dosage form
Gel
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2014
Label revision date
December 18, 2014
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Menthol 3.5 mg/1 L
Other brand names
Dosage form
Gel
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 2014
Label revision date
December 18, 2014
Manufacturer
Rescue Dog Health
Registration number
part348
NDC root
69381-2501
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (3 NDCs)
Packaging & NDC Codes (3)

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

RAW™ HEAT is a 100% natural roll-on gel designed to provide temporary relief from minor pain. It is particularly effective for conditions such as muscle sprains, muscle strains, neck and back aches, sore joints, arthritis, cramps, and bruises. This product is indicated for those experiencing discomfort related to arthritis, muscle, and joint pain, offering a soothing option for everyday aches.

Uses

You can use this medication to temporarily relieve minor pain from various conditions. It is effective for muscle sprains and strains, as well as aches and pains in your neck and back. If you have sore joints, arthritis, cramps, or bruises, this medication can help ease your discomfort.

It's important to note that there are no reported teratogenic effects (which means it doesn't cause birth defects) associated with this medication.

Dosage and Administration

Before using the gel, make sure to shake it well. Start by cleaning the skin in the area where you plan to apply the gel. Then, apply a generous amount directly onto the affected skin and gently rub it in until it is fully absorbed. You can repeat this process as needed, but be careful not to apply it more than four times a day. Additionally, you can use the gel before or after any activities that may cause discomfort.

If you are considering using this gel for a child under 6 years old, it’s important to consult a healthcare professional first to ensure it’s safe and appropriate for them.

What to Avoid

You should avoid applying this product to open wounds, damaged skin, or irritated areas. It is meant for external use only, so do not ingest it. Be cautious, as the product is flammable; keep it away from open flames or extreme heat. When using, do not bandage tightly or apply it with a heating pad, other ointments, creams, sprays, or liniments.

If your condition worsens, symptoms persist for more than 7 days, or if they clear up and then return within a few days, stop using the product and consult a health professional. Additionally, if you are pregnant or breastfeeding, it's important to ask a healthcare professional before using this product.

Side Effects

When using this product, you should be aware of some important safety information. It is for external use only and is flammable, so keep it away from open flames and extreme heat. Make sure to keep it out of reach of children, and if swallowed, seek medical help immediately. Avoid contact with your eyes and mucous membranes, and do not apply it to open wounds, damaged skin, or irritated areas.

If you notice that your condition worsens, symptoms last longer than 7 days, or if irritation occurs, stop using the product and consult a healthcare professional. Additionally, if you are pregnant or breastfeeding, it's best to check with a healthcare provider before using this product. Always wash your hands thoroughly after application and store it at room temperature.

Warnings and Precautions

This product is for external use only and should be kept away from open flames or extreme heat, as it is flammable. Make sure to keep it out of reach of children. If you accidentally swallow it, seek medical help or contact a poison control center immediately.

When using this product, follow the instructions carefully. Avoid contact with your eyes and mucous membranes, and do not apply it to open wounds or damaged skin. It's important not to bandage the area tightly or use it with heating pads, other ointments, creams, sprays, or liniments. If you experience worsening symptoms, if your condition does not improve after 7 days, or if irritation occurs, stop using the product and consult a healthcare professional. If you are pregnant or breastfeeding, please consult your healthcare provider before use.

Overdose

If you or someone else has swallowed too much of a medication, it’s important to seek medical help immediately. You can do this by contacting a poison control center or going to the nearest emergency room. Acting quickly can make a significant difference in the outcome.

Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms, don’t hesitate to get help right away. Remember, it’s always better to be safe and get checked by a medical professional.

Pregnancy 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 whether it’s safe for you and your baby. Always prioritize your health and the health of your child by seeking professional 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 receive personalized advice regarding the safety and potential effects on both you and your baby. Always prioritize open communication with your healthcare provider to make informed decisions about your health and your child's well-being.

Pediatric Use

When using this gel for children aged 6 years and older, you can apply a generous amount directly to the affected area of their skin. Make sure to rub it in until it is fully absorbed. You can repeat this process as needed, but do not apply it more than four times a day.

If your child is under 6 years old, it's important to consult a healthcare professional before using the gel. This ensures their safety and proper care.

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 healthcare providers may not have tailored guidelines for elderly patients.

If you or a loved one is an older adult considering this medication, it’s important to discuss any potential risks and benefits with your healthcare provider. They can help determine the best approach based on individual health needs and conditions. Always prioritize open communication with your doctor to ensure safe and effective treatment.

Renal Impairment

It appears that there is no specific information regarding renal impairment (kidney problems) in the provided text. This means there are no dosage adjustments, special monitoring, or safety considerations outlined for patients with kidney issues. If you have concerns about how your kidney health may affect your treatment, it's important to discuss this with your healthcare provider for personalized guidance.

Hepatic Impairment

If you have liver 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 dosing and monitoring practices apply, but you should always consult your healthcare provider for personalized advice. They can help ensure that any medications you take are safe and effective for your liver health.

Make sure to keep your doctor informed about your liver condition, as they may want to monitor your liver function regularly to ensure everything is working well. Your health and safety are the top priority, so don’t hesitate to ask questions or express any concerns you may have.

Drug Interactions

It's important to be cautious when using certain medications together. For instance, you should avoid using this medication with heating pads or other topical products like ointments, creams, sprays, or liniments, as this can lead to unwanted effects.

Always discuss any medications you are taking with your healthcare provider, including over-the-counter products, to ensure your safety and the effectiveness of your treatment. They can help you understand potential interactions and guide you on the best practices for your health.

Storage and Handling

To ensure the safety and effectiveness of your product, store it at room temperature. It's important to keep it away from open flames or extreme heat, as it is flammable. By following these simple guidelines, you can help maintain the integrity of the product and ensure safe handling. Always prioritize safety when using or storing the device.

Additional Information

You will apply this medication topically, which means you will apply it directly to the skin. There are no additional details available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences related to this medication.

FAQ

What is RAW™ HEAT?

RAW™ HEAT is a 100% natural pain relief roll-on gel designed to temporarily relieve minor pain associated with various conditions.

What types of pain does RAW™ HEAT relieve?

It temporarily relieves minor pain from muscle sprains, muscle strains, neck/back aches, sore joints, arthritis, cramps, and bruises.

How should I use RAW™ HEAT?

For adults and children 6 years and older, shake well, clean the skin, and apply a liberal amount of gel directly to the affected area until absorbed. You can repeat this up to 4 times daily.

Are there any contraindications for using RAW™ HEAT?

Do not apply RAW™ HEAT to open wounds, damaged skin, or irritated skin.

What precautions should I take when using RAW™ HEAT?

Use only as directed, avoid contact with eyes, and do not use with heating pads or other topical products. Keep it away from open flames and out of reach of children.

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

Stop using RAW™ HEAT and consult a health professional if your condition worsens, symptoms persist for more than 7 days, or if irritation occurs.

Can I use RAW™ HEAT if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, consult a health care professional before using RAW™ HEAT.

How should I store RAW™ HEAT?

Store RAW™ HEAT at room temperature and keep it away from open flames or extreme heat.

Packaging Info

Below are the non-prescription pack sizes of Raw Heat (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Raw Heat.
Details

Drug Information (PDF)

This file contains official product information for Raw Heat, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

RAW™ HEAT is a roll-on gel formulation designed for topical application. Each container holds a volume of 3 fluid ounces (89 mL). This product is composed of 100% natural ingredients, specifically formulated to provide pain relief for conditions such as arthritis, as well as muscle and joint pain.

Uses and Indications

This drug is indicated for the temporary relief of minor pain associated with muscle sprains, muscle strains, neck and back aches, sore joints, arthritis, cramps, and bruises.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

For adults and children aged 6 years and older, the gel should be administered as follows:

The container must be shaken well prior to use. The skin over the affected area should be cleaned thoroughly. A liberal amount of the gel should then be applied directly onto the skin, ensuring it is absorbed completely. This application may be repeated as necessary, but should not exceed four times daily. The gel may also be applied before or after physical activity to enhance its effectiveness.

For children under 6 years of age, it is recommended to consult a healthcare professional for appropriate guidance on use.

Contraindications

Application is contraindicated on open wounds or damaged skin, as well as on irritated skin. The product is for external use only and should not be applied tightly bandaged or used in conjunction with heating pads, ointments, creams, sprays, or liniments. Due to flammability, it must be kept away from open flames or extreme heat.

Patients should discontinue use and consult a healthcare professional if the condition worsens, if symptoms persist for more than 7 days, if symptoms clear and then recur within a few days, or if irritation occurs. Additionally, pregnant or breastfeeding individuals should seek advice from a healthcare professional prior to use.

Warnings and Precautions

For external use only, this product is flammable and should be kept away from open flames or extreme heat sources. It is imperative to keep the product out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact a poison control center without delay.

When using this product, it is essential to adhere strictly to the directions provided. Users should avoid contact with the eyes and mucous membranes, and the product must not be applied to open wounds or damaged skin. Bandaging should not be done tightly, and the product should not be used in conjunction with heating pads or other topical ointments, creams, sprays, or liniments. Application to irritated skin is contraindicated, and thorough handwashing is recommended after each use.

Users are advised to discontinue use and consult a healthcare professional if the condition worsens, if symptoms persist for more than seven days, if symptoms clear up and then recur within a few days, or if any irritation occurs. Additionally, individuals who are pregnant or breastfeeding should seek advice from a healthcare professional prior to using this product.

Side Effects

Patients using this product should be aware of several important warnings and precautions. The product is intended for external use only and is flammable; therefore, it should be kept away from open flames or extreme heat. It is crucial to keep the product out of reach of children. In the event of accidental ingestion, medical assistance should be sought immediately, or a poison control center should be contacted.

When using this product, it is essential to adhere strictly to the directions provided. Patients should avoid contact with the eyes and mucous membranes and should not apply the product to open wounds or damaged skin. Additionally, it is advised not to bandage the area tightly or use the product in conjunction with heating pads, other ointments, creams, sprays, or liniments. Application to irritated skin should also be avoided. Thorough hand washing after each application is recommended to prevent unintended exposure.

Patients are advised to discontinue use and consult a healthcare professional if their condition worsens, if symptoms persist for more than seven days, or if symptoms clear up and then recur within a few days. Any occurrence of irritation should also prompt a consultation with a health professional. Pregnant or breastfeeding individuals should seek advice from a healthcare provider before using this product. Proper storage at room temperature is recommended to maintain product efficacy.

Drug Interactions

The use of this medication is contraindicated with heating pads or other topical formulations, including ointments, creams, sprays, or liniments. Co-administration may lead to adverse effects due to enhanced absorption or localized irritation.

There are no specific interactions identified with laboratory tests associated with this medication. Therefore, routine monitoring of laboratory parameters is not required in the context of drug interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Raw Heat (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Raw Heat.
Details

Pediatric Use

Pediatric patients aged 6 years and older may apply a liberal amount of gel directly to the skin over the affected area until fully absorbed. This application may be repeated as necessary, not exceeding four times daily.

For children under 6 years of age, it is advised to consult a healthcare professional prior to use.

Geriatric Use

There is no specific information 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 and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to evaluate the potential risks and benefits associated with the use of this drug during pregnancy and lactation. Healthcare providers should consider the available data and individual patient circumstances when advising on the use of this medication in these populations.

Lactation

Lactating mothers are advised to consult a healthcare professional prior to using this medication. There is currently no specific data available regarding the excretion of this medication in breast milk or its effects on breastfed infants. Therefore, caution is recommended when considering the use of this medication during lactation.

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

There is no information available regarding the use of this medication in patients with hepatic impairment. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions specified for individuals with compromised liver function. Healthcare professionals should exercise clinical judgment when considering the use of this medication in patients with liver problems, as the absence of specific guidance necessitates careful evaluation of the patient's overall health status and liver function.

Overdosage

In the event of an overdosage, immediate medical intervention is crucial. If the substance is ingested, it is imperative to seek medical assistance or contact a poison control center without delay.

Healthcare professionals should be aware that prompt action can significantly influence the outcome of an overdosage situation. Symptoms may vary depending on the specific substance involved, and monitoring for any adverse effects is essential.

Management of overdosage should include supportive care and symptomatic treatment as necessary. It is recommended that healthcare providers follow established protocols for the assessment and management of overdose cases, ensuring that appropriate measures are taken to mitigate potential risks to the patient.

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 provided data.

Patient Counseling

Healthcare providers should advise patients that the product is intended for external use only and must be kept away from open flames or extreme heat due to its flammable nature. It is essential to keep the product out of reach of children to prevent accidental ingestion. Instruct patients that if the product is swallowed, they should seek medical help or contact a poison control center immediately.

When using this product, patients should be reminded to use it only as directed. They should avoid contact with the eyes and mucous membranes, and it should not be applied to open wounds or damaged skin. Additionally, patients should be cautioned against bandaging the area tightly and using the product in conjunction with heating pads or other ointments, creams, sprays, or liniments. It is also important to avoid application on irritated skin.

Patients should wash their hands thoroughly after each application to prevent unintentional spread. They should be informed to stop using the product and consult a healthcare professional if their condition worsens, if symptoms persist for more than 7 days, if symptoms clear up and then recur within a few days, or if any irritation occurs.

For patients who are pregnant or breastfeeding, it is advisable to consult a healthcare professional before using the product. Finally, patients should be instructed to store the product at room temperature to maintain its efficacy.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at room temperature to maintain its integrity and effectiveness. Due to its flammable nature, it must be kept away from open flames and extreme heat sources to ensure safety during storage and handling.

Additional Clinical Information

The route of administration for the medication is topical. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Raw Heat, 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 Raw Heat, 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.