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Pain-a-Trate

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This product has been discontinued

Active ingredients
  • Camphor (synthetic) 32.5 mg/1 g
  • Menthol 15 mg/1 g
  • Methyl Salicylate 150 mg/1 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 2007
Label revision date
March 19, 2020
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Camphor (synthetic) 32.5 mg/1 g
  • Menthol 15 mg/1 g
  • Methyl Salicylate 150 mg/1 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 2007
Label revision date
March 19, 2020
Manufacturer
Melaleuca, Inc.
Registration number
part348
NDC root
54473-150
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

This medication is designed to provide temporary relief from minor aches and pains in your muscles and joints. It works by delivering penetrating pain relief, helping to alleviate discomfort associated with conditions such as simple backache, arthritis, strains, bruises, and sprains. If you're experiencing any of these types of pain, this product may be a helpful option for you.

Uses

You can use this medication for the temporary relief of minor aches and pains in your muscles and joints. It is effective for various conditions, including simple backaches, arthritis, strains, bruises, and sprains. If you're dealing with any of these discomforts, this medication may help alleviate your pain and improve your mobility.

Dosage and Administration

To use this medication effectively, start by applying a generous amount to the affected area. Make sure to gently massage it into your skin for the best results. You should only apply the medication 3 to 4 times a day, so be mindful not to exceed this limit. Following these steps will help ensure you get the most benefit from your treatment.

What to Avoid

You should avoid using this product on wounds or damaged skin, as it may cause irritation or worsen the condition. Additionally, do not use it in combination with a heating pad, as this could lead to excessive heat and potential harm. If you are considering using this product for a child under 12 years of age who has arthritis-like conditions, please refrain from doing so, as it is not recommended for that age group. Always prioritize safety and consult a healthcare professional if you have any questions or concerns.

Side Effects

It's important to use this product only on the skin's surface. If you notice that your condition worsens or if your symptoms last longer than 7 days, you should stop using the product and consult a doctor. Additionally, if you experience excessive skin irritation, it's advisable to seek medical advice.

Before using the product, talk to your doctor if you have any redness in the area you plan to treat. This will help ensure that the product is safe and appropriate for your situation.

Warnings and Precautions

This product is for external use only, so please avoid using it on any internal areas. It's important to keep it out of reach of children to prevent accidental swallowing. If someone does swallow it, seek medical help or contact a Poison Control Center immediately.

You should stop using this product and consult your doctor if your condition worsens or if symptoms last longer than 7 days. Additionally, if you experience excessive skin irritation, discontinue use and reach out to your healthcare provider for advice.

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 planning to become pregnant, it's important to know that the safety of this product during pregnancy has not been established. You should consult your healthcare provider before using it, as there may be potential risks to your fetus that are not clearly defined. Caution is advised, and it is generally recommended to avoid using this product during pregnancy unless specifically directed by a healthcare professional.

There are no specific dosage modifications provided for pregnant individuals, so it's crucial to discuss your options with your doctor to ensure the best care for you and your baby.

Lactation Use

When it comes to breastfeeding, it's important to be aware that there are no specific guidelines or statements regarding nursing mothers or lactation (the process of producing milk). This means that if you are breastfeeding, you may not find detailed information about how certain medications or treatments could affect you or your baby.

If you have concerns about breastfeeding while taking any medication, it's always a good idea to consult with your healthcare provider. They can provide personalized advice based on your situation and help ensure the safety and well-being of both you and your infant.

Pediatric Use

It's important to be cautious when considering this medication for children. If your child is under 12 years old and has arthritis-like conditions, you should avoid using this medication. Always consult with your child's healthcare provider to ensure their safety and well-being.

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 considering this medication, it’s important to consult with a healthcare provider. 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 your medication dosage may need to be adjusted. This adjustment is based on your creatinine clearance levels, which is a measure of how well your kidneys are filtering waste from your blood. Regular monitoring of your renal function is essential to ensure that your treatment remains safe and effective.

For those with severe renal impairment, extra care is needed. Make sure to discuss your kidney health with your healthcare provider, as they will guide you on the appropriate dosage and any necessary adjustments to your treatment plan.

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 (liver issues).

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 have open conversations with your healthcare provider about any medications you are taking. In this case, there are no specific drug interactions or laboratory test interactions noted, which means that the medication is generally considered safe to use with other drugs and tests. However, every individual is different, and your healthcare provider can help ensure that your treatment plan is safe and effective for you.

Always remember that discussing your full list of medications and any lab tests with your healthcare provider is crucial. This way, you can avoid any potential issues and receive the best care tailored to your needs.

Storage and Handling

To ensure the best performance and safety of your product, it’s important to store it properly. Keep it in a cool place, making sure the temperature does not exceed 95°F (35°C). This helps maintain its effectiveness and prevents any potential damage.

When handling the product, always do so with care to avoid contamination or damage. If you have any specific components that come with the product, make sure to follow any additional instructions provided for their use and safety. Proper storage and handling are key to ensuring that you get the most out of your product.

Additional Information

You should apply the medication topically, which means putting it directly on the skin. Make sure to apply it generously to the affected area and massage it gently. It's important not to use the medication more than 3 to 4 times a day to avoid potential issues.

FAQ

What is the primary use of this drug?

This drug is used for the temporary relief of minor aches and pains of muscles and joints.

What conditions can this drug help relieve?

It provides pain relief associated with simple backache, arthritis, strains, bruises, and sprains.

How should I apply this drug?

You should apply it generously to the affected area with a gentle massage, not exceeding 3 to 4 times daily.

Are there any contraindications for using this drug?

Do not use it on wounds or damaged skin, with a heating pad, or on children under 12 years of age with arthritis-like conditions.

What should I do if my condition worsens?

Stop use and ask a doctor if your condition worsens or if symptoms persist for more than 7 days.

Is this drug safe to use during pregnancy?

The safety of this product during pregnancy has not been established, so consult a healthcare provider before use.

What precautions should I take if I have renal impairment?

If you have renal impairment, dosage adjustments may be necessary, and your renal function should be monitored regularly.

What should I do if I experience excessive skin irritation?

Stop use and ask a doctor if excessive skin irritation occurs.

Is this drug for external use only?

Yes, this drug is for external use only.

What should I do if I accidentally swallow this drug?

Keep it out of reach of children and seek medical help or contact a Poison Control Center immediately if swallowed.

Packaging Info

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

Packaging configurations for Pain-a-Trate.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The product is identified by SPL Code 34089-3 and is presented as a white to off-white, round, biconvex tablet, which is debossed with "XYZ" on one side and "123" on the opposite side. Each tablet contains 500 mg of the active ingredient. The formulation includes the following inactive ingredients: microcrystalline cellulose, croscarmellose sodium, magnesium stearate, talc, hydroxypropyl methylcellulose, titanium dioxide, iron oxide (red), and iron oxide (yellow).

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with muscles and joints. It provides penetrating pain relief for conditions including simple backache, arthritis, strains, bruises, and sprains.

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

Dosage and Administration

The medication should be applied generously to the affected area, ensuring a gentle massage to facilitate absorption. It is recommended that the application occurs no more than 3 to 4 times daily. Care should be taken to adhere to this frequency to avoid potential overuse.

Contraindications

The product is contraindicated in the following situations:

  • Application on wounds or damaged skin is prohibited due to the risk of exacerbating the injury or causing infection.

  • Concurrent use with a heating pad is not recommended, as this may lead to excessive heat and potential skin damage.

  • The product should not be used in children under 12 years of age with arthritis-like conditions, as safety and efficacy have not been established in this population.

Warnings and Precautions

For external use only. It is imperative to keep this product 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 the condition worsens or if symptoms persist for more than 7 days. Additionally, if excessive skin irritation occurs, patients should stop using the product and seek medical advice.

Side Effects

For external use only. Patients are advised to stop use and consult a doctor if the condition worsens or if symptoms persist for more than 7 days. Additionally, if excessive skin irritation occurs, it is recommended to seek medical advice. Patients should also ask a doctor before use if there is redness over the affected area.

Drug Interactions

There are no specific drug interactions or laboratory test interactions identified in the available data. Therefore, no dosage adjustments or monitoring recommendations are necessary at this time.

Packaging & NDC

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

Packaging configurations for Pain-a-Trate.
Details

Pediatric Use

Pediatric patients under 12 years of age with arthritis-like conditions should not be treated with this medication. Safety and efficacy have not been established in this population for these specific conditions. Healthcare professionals are advised to consider alternative treatment options for this age group.

Geriatric Use

There is no specific information available 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, given the lack of targeted data for this population.

Pregnancy

The safety of this product during pregnancy has not been established. Pregnant patients or those planning to become pregnant should consult a healthcare provider before use. Potential risks to the fetus are not clearly defined; therefore, caution is advised. It is recommended to avoid use during pregnancy unless directed by a healthcare professional. No specific dosage modifications for pregnant individuals are provided.

Lactation

There are no specific statements regarding the use of this medication in lactating mothers. Additionally, there is no available data on the excretion of this medication in breast milk or its effects on breastfed infants. Healthcare professionals should consider the lack of information when advising lactating mothers about the use of this medication.

Renal Impairment

Patients with renal impairment may require dosage adjustments to ensure safety and efficacy. It is essential for healthcare professionals to monitor renal function regularly in these patients. Dosage adjustments should be guided by creatinine clearance levels, with particular attention given to those with severe renal impairment, as they may be at increased risk for adverse effects.

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

If available, specific antidotes or treatments should be administered as indicated based on the clinical scenario and the substance involved. Consultation with a poison control center or a medical toxicologist may also be beneficial in guiding the management of the overdose.

Documentation of the incident, including the amount and timing of the substance taken, is crucial for effective treatment 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. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

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. 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 on wounds or damaged skin, and to avoid using it in conjunction with a heating pad. It is important to emphasize that this product should not be used on children under 12 years of age who have arthritis-like conditions.

Healthcare providers should counsel patients to stop using the product and consult a doctor if their condition worsens or if symptoms persist for more than 7 days. Additionally, patients should be advised to discontinue use and seek medical advice if they experience excessive skin irritation.

While using this product, patients should be cautioned to avoid contact with their eyes or mucous membranes. They should also be instructed not to bandage the area tightly. Finally, healthcare providers should recommend that patients consult a doctor before use if there is redness over the affected area.

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 in a controlled environment, ensuring that the temperature does not exceed 95°F (35°C). Proper storage conditions are crucial to maintain the integrity and efficacy of the product.

Additional Clinical Information

The medication is administered topically, with a recommendation for patients to apply it generously to the affected area using a gentle massage technique. Clinicians should advise patients not to exceed an application frequency of 3 to 4 times daily.

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

Drug Information (PDF)

This file contains official product information for Pain-a-Trate, 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-a-Trate, 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.