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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 18, 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 18, 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 dual active botanical warming formula that includes emu oil, designed to provide temporary relief from minor aches and pains in muscles and joints. This product is particularly useful for discomfort associated with conditions like arthritis, simple backaches, sprains, strains, and bruises. By applying ARCTIC HEAT, you can experience soothing warmth that helps alleviate pain and promote comfort in affected areas.

Uses

You can use this medication to temporarily relieve minor aches and pains in your muscles and joints. It is effective for discomfort caused by conditions such as arthritis, simple backaches, sprains, strains, and bruises. If you're dealing with any of these issues, this medication may help ease your pain and improve your comfort.

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 it no more than 3 to 4 times each day. This means you can apply it several times throughout the day, but be sure to stay within that limit to ensure safe and effective use.

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 avoid bandaging tightly after application. Additionally, keep the product away from your eyes; if it accidentally gets into your eyes, rinse them thoroughly with water. Lastly, do not use this product in conjunction 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 swallowing it. If you accidentally swallow it, 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 longer than 7 days, or if they improve and then return within a few days. Additionally, if you notice any rash or irritation, it's important to consult your doctor right away.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While the specific signs of an overdose are not detailed, common symptoms can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these signs, or if you are unsure, seek medical help right away.

In case of an overdose, contact your local emergency services or go to the nearest hospital. It's crucial to provide them with as much information as possible about the substance taken and the amount, if known. Remember, acting quickly can make a significant difference in your health and safety.

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 the standard dosage may be appropriate, but it’s always wise to consult with a healthcare provider. They can help ensure that the medication is safe and effective for your individual health needs, especially if you have other medical conditions or are taking other medications.

As an older adult or caregiver, it's important to stay informed and proactive about any medications being taken. Always discuss any concerns or questions with your doctor to ensure the best care.

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 usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

It's always best to discuss your individual situation with your healthcare provider, who can offer personalized advice and ensure that any medications you take are safe and effective for you.

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 may affect you if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to discuss any concerns regarding your liver health and how it may relate to your treatment. They can help ensure that your medication is safe and effective for you.

Drug Interactions

It's important to be cautious when using certain products together. For instance, you should avoid using this medication with an electric heating pad, as it may lead to unwanted effects. Always discuss any medications or treatments you are considering with your healthcare provider to ensure they are safe for you.

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 quality and safety of your product, store it at room temperature, away from direct light. It's important to keep the container tightly closed when not in use to prevent contamination. Once you open the container, be sure to discard any remaining product after use to maintain safety and effectiveness. Following these 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.

What does ARCTIC HEAT relieve?

It temporarily relieves minor aches and pains of muscles and joints 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 ARCTIC HEAT?

No contraindications are listed for ARCTIC HEAT.

What precautions should I take when using ARCTIC HEAT?

Do not apply it to wounds or damaged skin, do not bandage tightly, and avoid using it in or near the eyes.

What should I do if I swallow ARCTIC HEAT?

If swallowed, get medical help or contact a Poison Control Center right away.

What should I do if my symptoms worsen or last more than 7 days?

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

Can I use ARCTIC HEAT if I am pregnant or breastfeeding?

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

How should I store ARCTIC HEAT?

Store ARCTIC HEAT at room temperature, protect it from light, and keep the container tightly closed.

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 specialized formulation designed for targeted pain management. It is presented in a tube format, facilitating precise application. The product is intended for use in various pain relief scenarios, providing a convenient option for patients seeking localized treatment.

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, thorough rinsing with water is necessary 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 healthcare professionals advise patients to adhere strictly to this guideline to prevent any adverse effects associated with inappropriate use.

In the event of accidental ingestion, immediate medical assistance should be sought. Patients should be instructed to contact a Poison Control Center or seek medical help without delay.

Healthcare providers should counsel patients to discontinue use and consult a physician under the following circumstances: if the condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. Additionally, any development of a rash or irritation necessitates prompt communication with a healthcare professional.

In cases of ingestion, it is crucial to obtain emergency medical help or contact a Poison Control Center immediately to ensure patient safety and appropriate management of potential toxicity.

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 thermal injuries. It is advised that patients avoid the simultaneous use of these devices while on this medication.

There are no specific laboratory test interactions associated with this medication. Therefore, routine laboratory monitoring is not required for interactions with laboratory tests.

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 individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is essential 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 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 specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing 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 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 and consider the overall clinical context when prescribing this medication to patients with hepatic impairment.

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 implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

Additionally, it is recommended to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols and antidotes, if applicable.

Documentation of the incident, including the substance involved, estimated dose, and time of exposure, is crucial for effective management and follow-up care.

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 question.

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 doctor 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 develop a rash or experience 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 a configuration that includes specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at room temperature to maintain its integrity. Additionally, the product must be protected from light exposure to prevent degradation.

To ensure optimal preservation, the container should be kept tightly closed when not in use. It is also important to note that the product should be discarded after opening 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.