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Relief Pain Relieving Cream

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This product has been discontinued

Active ingredient
Menthol 2.5 g/100 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 2004
Label revision date
November 10, 2014
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Menthol 2.5 g/100 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 2004
Label revision date
November 10, 2014
Manufacturer
Corganics, LP
Registration number
part348
NDC root
58559-001
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (5 NDCs)
Packaging & NDC Codes (5)

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 pain associated with minor aches and pains in muscles and joints. It can be helpful for conditions such as simple backache, arthritis, strains, bruises, and sprains. If you're experiencing discomfort from these types of issues, this drug may be a suitable option to consider for alleviating your pain.

Uses

You can use this medication for the temporary relief of pain caused by minor aches and pains in your muscles and joints. This includes discomfort associated with simple backaches, arthritis, strains, bruises, and sprains. It’s designed to help you feel more comfortable during those times when you experience these types of pain.

Dosage and Administration

If you or your child is 2 years old or older and need to use this medication, apply a small amount to the affected area. You can do this up to 3 to 4 times a day. Make sure to gently massage the area until the medication is fully absorbed into the skin.

If your child is under 2 years old, it’s important to consult a doctor before using this medication. They can provide guidance on the best course of action for your child's specific needs.

What to Avoid

It's important to be aware of specific instructions regarding the use of this medication. If you accidentally swallow it, you should seek medical help or contact a Poison Control Center right away. This is crucial for your safety.

Currently, there are no listed contraindications, risks of abuse or misuse, or concerns about dependence (which means relying on a substance). Always follow the guidance provided to ensure safe use.

Side Effects

It's important to use this product only on unbroken skin and avoid applying it to wounds or areas that are damaged. If you notice that your condition worsens, or if symptoms last longer than 7 days or return after improvement, you should stop using the product and consult a physician.

Additionally, do not use this product if the area is tightly bandaged or if you are using other topical products at the same time. Always prioritize your health and safety by following these guidelines.

Warnings and Precautions

This product is intended for external use only. You should not apply it to wounds or damaged skin, and avoid using it when tightly bandaged or alongside other topical products. If your condition worsens, or if symptoms last more than 7 days or improve and then return within a few days, stop using the product and consult your doctor.

In case of accidental swallowing, seek emergency medical help or contact a Poison Control Center right away. Always prioritize your health and safety by following these guidelines closely.

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 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 always better to be safe and get checked by a healthcare professional if you have any concerns about your health.

Pregnancy Use

While the specific details regarding the use of this medication during pregnancy are not provided, it is always important to approach any medication with caution if you are pregnant or planning to become pregnant. You should consult your healthcare provider to discuss any potential risks and to ensure that you are making informed decisions about your health and the health of your baby.

If you have any concerns about medication use during pregnancy, your healthcare provider can offer guidance tailored to your individual situation. Always prioritize open communication with your medical team to address any questions or uncertainties you may have.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding nursing mothers in the information provided. Additionally, there are no particular considerations or precautions mentioned for lactation. This suggests that the use of the medication may not pose significant risks to you or your nursing infant. However, it's always a good idea to consult with your healthcare provider about any concerns you may have while breastfeeding.

Pediatric Use

If your child is under 2 years old, it's important to consult a doctor before using this medication. For children aged 2 years and older, you can apply a small amount to the affected area, but be sure to do this no more than 3 to 4 times a day. Always follow these guidelines to ensure your child's 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 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 circumstances.

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 plan is safe and effective for your specific situation. They can help monitor your kidney health and make any necessary adjustments to your medications.

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 differently due to your liver health.

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

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. In this case, there are no known drug interactions or laboratory test interactions associated with the medication. However, always ensure that your healthcare provider is aware of all the medications you are using, as this helps them provide the best care tailored to your needs. Your safety and well-being are the top priority, so don't hesitate to ask questions or share concerns during your appointments.

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, please remember to discard it after use to maintain safety and effectiveness. Following these guidelines will help you use the product safely and effectively.

Additional Information

You should apply a small amount of the medication to the affected area on your skin, not more than 3 to 4 times a day. Gently massage it in until it is fully absorbed. If you are using this medication for a child under 2 years old, be sure to consult a doctor first for guidance.

FAQ

What is the drug used for?

The drug is used for the temporary relief of pain from minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains.

How should I apply the drug?

For adults and children 2 years old and older, apply a small amount to the affected area no more than 3 to 4 times daily and gently massage until absorbed.

What should I do if I have a child under 2 years old?

If your child is under 2 years of age, you should consult a doctor before use.

Are there any warnings I should be aware of?

Yes, the drug is for external use only. If the condition worsens or symptoms persist for more than 7 days, discontinue use and consult a physician.

What should I avoid while using this drug?

Do not use the drug on wounds or damaged skin, when bandaged tightly, or with other topical products.

What should I do if the drug is swallowed?

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

How should I store the drug?

Store the drug at room temperature, protect it from light, keep the container tightly closed, and discard it after opening.

Packaging Info

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

Packaging configurations for Relief Pain Relieving Cream.
Details

Drug Information (PDF)

This file contains official product information for Relief Pain Relieving Cream, 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 the SPL code 34089-3. It is presented in a container label format, which provides essential information regarding the product's specifications and usage.

Uses and Indications

This drug is indicated for the temporary relief of pain associated with minor aches and pains of muscles and joints. Specifically, it is effective for conditions such as simple backache, arthritis, strains, bruises, and sprains.

Limitations of Use: There are no known teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

For adults and children aged 2 years and older, a small amount of the medication should be applied to the affected area no more than 3 to 4 times daily. The application should be followed by gentle massage until the product is fully absorbed into the skin.

For children under 2 years of age, it is recommended to consult a healthcare professional prior to use.

Contraindications

There are no specific contraindications listed for this product. However, it is advised that if the product is swallowed, medical assistance should be sought immediately or contact a Poison Control Center.

Warnings and Precautions

For external use only. This product should not be applied to wounds or damaged skin, nor should it be used when bandaged tightly. Additionally, it is contraindicated for use in conjunction with other topical products.

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, or if symptoms resolve and then recur within a few days.

In the event of accidental ingestion, immediate medical assistance should be sought, or the patient should contact a Poison Control Center without delay.

Side Effects

Patients should be aware that this product is intended for external use only. It is crucial to discontinue use and consult a physician if the condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days.

Additionally, the product should not be used on wounds or damaged skin, nor should it be applied when bandaged tightly. It is also advised to avoid using this product in conjunction with other topical products to prevent potential adverse reactions.

Drug Interactions

There are no reported drug interactions associated with the use of this medication. Additionally, no interactions with laboratory tests have been identified. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug interactions.

Packaging & NDC

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

Packaging configurations for Relief Pain Relieving Cream.
Details

Pediatric Use

Pediatric patients under 2 years of age should consult a healthcare professional prior to use. For children aged 2 years and older, the recommended application is a small amount to the affected area, not exceeding 3 to 4 times daily.

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 should be aware that the safety of this medication during pregnancy has not been specifically established. There are no available data regarding the potential risks or fetal outcomes associated with the use of this medication in pregnant individuals. Healthcare professionals are advised to consider the lack of information when prescribing this medication to women of childbearing potential and to weigh the potential benefits against any unknown risks. It is recommended that healthcare providers discuss the implications of medication use during pregnancy with their patients, ensuring informed decision-making.

Lactation

There are no specific warnings or recommendations regarding nursing mothers. Additionally, there are no specific considerations or precautions mentioned related to lactation. Therefore, healthcare professionals may consider the use of this medication in lactating mothers without specific concerns noted in the available data.

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 clinical trials for this medication. Consequently, there is no available information regarding dosage adjustments, special monitoring requirements, or precautions 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 warranted in these patients to ensure safety and therapeutic effectiveness.

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 monitoring vital signs, providing symptomatic treatment, and ensuring the patient's safety.

If available, consultation with a poison control center or a medical toxicologist is recommended to guide the management of the overdose effectively.

Documentation of the incident, including the substance involved, the amount taken, and the time of ingestion, is crucial for appropriate 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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available in the insert.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. In the event that the medication is swallowed, patients should be instructed to seek medical help or contact a Poison Control Center immediately. It is important for patients to understand the potential risks associated with improper use and to take necessary precautions to ensure safety.

Storage and Handling

The product is supplied in a container that must be kept tightly closed to maintain its integrity. It should be stored at room temperature, away from direct light exposure to protect its quality. Once opened, the product should be discarded to ensure safety and efficacy.

Additional Clinical Information

The product is administered topically, with a recommended application of a small amount to the affected area for adults and children aged 2 years and older, not exceeding 3 to 4 times daily. The application should be gently massaged until fully absorbed. For children under 2 years of age, consultation with a doctor is advised prior to use.

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

Drug Information (PDF)

This file contains official product information for Relief Pain Relieving Cream, 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 Relief Pain Relieving Cream, 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.