Raw Heat

Description

The All-Natural Warming Pain Reliever is formulated to address muscle strains, joint sprains, and neck and back aches, among other discomforts. This product is available in a dosage form of 3 fluid ounces (89 mL). For additional pain relief options, RAW-ICE is also available for cooling effects. Further information can be found at www.rawhealthintl.com.

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

The product is contraindicated in the following situations:

• Use with heating pads or other topical ointments, creams, sprays, or liniments is not recommended due to the potential for increased absorption and risk of adverse effects.

• Application to irritated skin is contraindicated as it may exacerbate irritation or cause further skin damage.

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

• Application to open wounds or damaged skin is contraindicated due to the risk of infection and adverse reactions.

• Tight bandaging after application is not advised, as it may restrict circulation and lead to complications.

Warnings and Precautions

For external use only, this product is flammable and must 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 utilizing 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. Additionally, it is advised not to bandage the area tightly after application. The use of this product in conjunction with heating pads or other topical ointments, creams, sprays, or liniments is contraindicated. Application to irritated skin should also be avoided. Thorough handwashing is recommended after each application to prevent unintended exposure.

Users should 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. Pregnant or breastfeeding individuals should seek advice from a healthcare professional prior to use. The product should be stored at room temperature to maintain its efficacy.

Side Effects

Patients should be aware of several important warnings and precautions associated with the use of this product. It is intended for external use only and is flammable; therefore, it should be kept away from open flames or extreme heat.

Patients are advised against using this product in conjunction with heating pads or other ointments, creams, sprays, or liniments, as this may lead to adverse effects. Additionally, it should not be applied to irritated skin.

In the event that the condition worsens, symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days, patients should discontinue use and consult a health professional. If irritation occurs, it is also recommended to stop use and seek medical advice. Furthermore, pregnant or breastfeeding individuals should consult a healthcare professional prior to using this product.

Drug Interactions

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

No specific interactions with laboratory tests have been identified. Therefore, routine monitoring of laboratory parameters is not required in conjunction with this medication.

Packaging & NDC

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

Pediatric Use

Pediatric patients aged 6 years and older may use the gel by shaking well, cleaning the skin, and applying a liberal amount directly to the affected area until fully absorbed. This application may be repeated as necessary, not exceeding four times daily, and can be applied before or after activity.

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. The potential risks and benefits must be carefully weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a healthcare professional prior to using this medication. There is currently no available data regarding the excretion of this drug 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 not been specifically addressed in the drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this drug. Consequently, there are no 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 prescribing information.

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 compound in these areas.

Postmarketing Experience

No postmarketing experience details are provided in the insert.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children. Instruct patients that if the product is swallowed, they should seek medical help or contact a poison control center immediately.

Patients should be informed not to use this product in conjunction with heating pads or other ointments, creams, sprays, or liniments. It is important to emphasize that the product should not be applied to irritated skin and that hands should be washed thoroughly after each application.

Healthcare providers should counsel patients to stop using the product and consult a health 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. Pregnant or breastfeeding patients should be advised to consult a healthcare professional before using the product. Additionally, patients should be instructed to store the product at room temperature.

When using this product, patients should be reminded to use it only as directed. They should avoid contact with eyes and mucous membranes, and the product should not be applied to open wounds or damaged skin. Patients should also be cautioned against tightly bandaging the area where the product is applied.

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 product is administered topically for both adults and children aged 6 years and older. Patients should shake the gel well, clean the affected skin area, and apply a liberal amount directly onto the skin until fully absorbed. This application may be repeated as necessary, not exceeding four times daily, and can be done before or after physical activity. For children under 6 years of age, consultation with a healthcare professional is advised.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

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)