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Pain Therapy

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This product has been discontinued

Active ingredients
  • Menthol 2.24 g/112 g
  • Methyl Salicylate 11.2 g/112 g
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 2021
Label revision date
May 14, 2021
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Menthol 2.24 g/112 g
  • Methyl Salicylate 11.2 g/112 g
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 2021
Label revision date
May 14, 2021
Manufacturer
Renu Laboratories, Inc.
Registration number
part348
NDC root
76348-640
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

ARCTIC HEAT is a topical product that features a dual active botanical warming formula combined with emu oil. It is designed to temporarily relieve minor aches and pains in muscles and joints caused by conditions such as arthritis, simple backache, sprains, strains, and bruises. This soothing formula aims to provide comfort and support for those experiencing discomfort in their everyday activities.

Uses

If you're dealing with minor aches and pains in your muscles and joints, this medication can help provide temporary relief. It's effective for discomfort caused by conditions such as arthritis, simple backaches, sprains, strains, and bruises.

You can rely on this treatment to ease your pain and help you get back to your daily activities. Remember, it's designed for short-term use to manage these specific types of discomfort.

Dosage and Administration

You should apply the medication directly to the affected area of your skin. For both adults and children aged 12 years and older, it’s important to use the medication no more than 3 to 4 times each day. This ensures that you get the best results while minimizing the risk of side effects. Remember to follow this frequency closely for effective treatment.

What to Avoid

It's important to use this product safely to avoid any potential issues. You should not apply it to wounds or damaged skin, and be careful not to bandage tightly after application. Additionally, avoid using it in or near your eyes; if it does get into your eyes, rinse thoroughly with water. Lastly, do not use this product with an electric heating pad, as this could lead to complications. Following these guidelines will help ensure your safety while using the product.

Side Effects

This product is intended for external use only. You should stop using it and consult your doctor if your condition worsens, if symptoms persist for more than 7 days, or if they clear up and then return within a few days. Additionally, if you notice any rash or irritation, it's important to seek medical advice.

Warnings and Precautions

This product is for external use only, so please avoid ingesting it. Keep it out of reach of children, and if it is swallowed, seek medical help immediately or contact a Poison Control Center.

You should stop using this product and call your doctor if your condition worsens, if your symptoms last more than 7 days, or if they clear up and then return within a few days. Additionally, if you develop a rash or any irritation, it's important to consult your doctor.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While there is no specific information available about the signs of overdose for this medication, general symptoms can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these signs or feel unwell after taking the medication, seek medical help right away.

In case of an overdose, contact your healthcare provider or local poison control center for guidance. If you experience severe symptoms, such as trouble breathing or loss of consciousness, call emergency services immediately. Always keep your medications in a safe place and follow the prescribed dosage to help prevent any potential issues.

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 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

When using this medication for children, it's important to note that it is intended for adults and children aged 12 years and older. You should apply it directly to the affected area no more than 3 to 4 times a day. Always keep the medication out of reach of younger children to prevent accidental ingestion. If your child swallows any of the medication, seek medical help or contact a Poison Control Center immediately.

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 the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to change based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment is safe and effective for your specific condition. They can help determine the best approach for managing your health, especially if you have concerns about your kidneys.

Hepatic Impairment

If you have liver problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication should be used if you have hepatic impairment (issues with liver function).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your liver health. They can help determine the best course of action based on your individual situation.

Drug Interactions

It's important to be cautious when using certain products together. For instance, you should avoid using an electric heating pad while taking this medication, as it can lead to unwanted effects. Always discuss any medications or treatments you are considering with your healthcare provider to ensure your safety and well-being.

Additionally, there are no specific laboratory test interactions noted, but it's still a good practice to inform your healthcare provider about all medications you are taking. This helps them provide the best care tailored to your needs.

Storage and Handling

To ensure the best performance of your product, store it at room temperature and keep it away from direct light. It's important not to freeze the product, as this can affect its effectiveness. Once you open the product, be sure to discard it after use to maintain safety and quality. Following these simple guidelines will help you use the product safely and effectively.

Additional Information

No further information is available.

FAQ

What is ARCTIC HEAT?

ARCTIC HEAT is a dual active botanical warming formula that contains emu oil, designed to temporarily relieve minor aches and pains of muscles and joints.

What conditions does ARCTIC HEAT help relieve?

It temporarily relieves minor aches and pains due to arthritis, simple backache, sprains, strains, and bruises.

How should I use ARCTIC HEAT?

Apply ARCTIC HEAT directly to the affected area no more than 3 to 4 times daily.

Are there any contraindications for using ARCTIC HEAT?

No specific contraindications are listed for ARCTIC HEAT.

What precautions should I take when using ARCTIC HEAT?

Do not apply to wounds or damaged skin, do not bandage tightly, and avoid contact with eyes. If the product gets into your eyes, rinse thoroughly with water.

What should I do if I experience worsening conditions or irritation?

Stop using ARCTIC HEAT and consult your doctor if conditions worsen, symptoms last more than 7 days, or if a rash or irritation develops.

Is ARCTIC HEAT safe for children?

ARCTIC HEAT is intended for adults and children 12 years of age and older. Keep it out of reach of younger children.

What should I do if I accidentally swallow ARCTIC HEAT?

If swallowed, seek medical help or contact a Poison Control Center immediately.

Can I use ARCTIC HEAT while pregnant or breastfeeding?

If you are pregnant or breastfeeding, consult a health professional before using ARCTIC HEAT.

How should I store ARCTIC HEAT?

Store ARCTIC HEAT at room temperature, protect it from light, and do not freeze. Discard it after opening.

Packaging Info

Below are the non-prescription pack sizes of Pain Therapy (menthol, methyl salicylate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Pain Therapy.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The Rancho San Diego Pain Relief Tube is a topical formulation designed for pain management. It is presented in a tube format, facilitating easy application. The product is specifically formulated to provide localized relief from discomfort.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with muscle and joint conditions, including arthritis, simple backache, sprains, strains, and bruises.

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

Dosage and Administration

Adults and children 12 years of age and older should apply the medication directly to the affected area. The application should not exceed 3 to 4 times daily. Care should be taken to ensure that the medication is applied only to the areas requiring treatment.

Contraindications

The product is contraindicated in the following situations:

Application to wounds or damaged skin is prohibited due to the potential for irritation or adverse reactions. Tight bandaging is not recommended as it may impede circulation and exacerbate skin irritation. The product should not be used in or near the eyes; in the event of contact, it is essential to rinse thoroughly with water to prevent ocular irritation. Additionally, the use of an electric heating pad in conjunction with this product is contraindicated, as it may increase the risk of skin burns or other complications.

Warnings and Precautions

For external use only. It is imperative that this product is kept out of reach of children to prevent accidental ingestion. In the event of swallowing, immediate medical assistance should be sought, or contact a Poison Control Center without delay.

Healthcare professionals should advise patients to discontinue use and consult a physician if any of the following occur: worsening of conditions, persistence of symptoms beyond 7 days, or if symptoms resolve and then recur within a few days. Additionally, patients should be instructed to stop use if a rash or irritation develops.

In cases of accidental ingestion, it is crucial to seek emergency medical help or contact a Poison Control Center immediately.

Side Effects

For external use only. Patients should discontinue use and consult a healthcare professional if conditions worsen, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. Additionally, if a rash or irritation develops, it is advised to stop use and seek medical advice.

Drug Interactions

The use of this medication is contraindicated with electric heating pads due to the potential for increased risk of burns or other adverse effects.

There are no specific laboratory test interactions associated with this medication. Therefore, routine monitoring of laboratory tests is not required in relation to this drug.

Packaging & NDC

Below are the non-prescription pack sizes of Pain Therapy (menthol, methyl salicylate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Pain Therapy.
Details

Pediatric Use

Pediatric patients aged 12 years and older may apply the medication directly to the affected area no more than 3 to 4 times daily. It is important to keep the product out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is advised.

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 they may have altered pharmacokinetics and pharmacodynamics. Close monitoring is recommended to ensure safety and efficacy 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 the safety of both the mother and the developing fetus.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is no specific data available regarding the excretion of this medication in 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 available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of 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 information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

If the substance involved is known, specific antidotes or treatments may be indicated, and healthcare professionals should refer to established guidelines for the management of overdose related to that particular substance.

In all cases, contacting a poison control center or a medical toxicologist for guidance is recommended to ensure appropriate management and intervention.

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 available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. In the event of swallowing the product, patients should seek medical help or contact a Poison Control Center immediately.

Patients should be instructed to discontinue use and consult a healthcare professional if their condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. Additionally, patients should be informed to stop using the product and seek medical advice if they experience any rash or irritation.

While using this product, patients must be cautioned against applying it to wounds or damaged skin. They should also be advised not to bandage the area tightly after application. It is important to inform patients that the product should not be used in or near the eyes; if contact occurs, they should rinse their eyes thoroughly with water. Furthermore, patients should be warned against using the product in conjunction with an electric heating pad.

Storage and Handling

The product is supplied in packaging that includes specific NDC numbers. It should be stored at room temperature, ensuring that it is protected from light exposure. Freezing the product is not permitted, as it may compromise its integrity. Additionally, once opened, the product must be discarded to ensure safety and efficacy.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Pain Therapy, 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 Pain Therapy, 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.