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Revalife Pain Relief Cream

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This product has been discontinued

Active ingredients
  • Menthol 0.05 kg/1 kg
  • Methyl Salicylate 0.075 kg/1 kg
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 2020
Label revision date
February 14, 2022
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Menthol 0.05 kg/1 kg
  • Methyl Salicylate 0.075 kg/1 kg
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 2020
Label revision date
February 14, 2022
Manufacturer
International Nutraceutical Company of America, LLC
Registration number
part348
NDC root
42452-379
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 help treat certain skin conditions. It works by targeting the underlying issues that cause these conditions, providing relief from symptoms. You may find it effective for managing your skin health, but it's important to monitor your progress and consult a healthcare professional if your symptoms worsen or do not improve within a week.

Uses

It seems that there are no specific uses or indications provided for this medication. Additionally, there are no mentions of teratogenic effects (which refer to substances that can cause developmental abnormalities in a fetus) or nonteratogenic effects (which do not affect fetal development). If you have any questions or need further information about this medication, please consult your healthcare provider.

Dosage and Administration

When using this medication, make sure to follow the instructions provided. You should apply it generously to the affected area and gently massage it in as needed. However, be careful not to use it more than 3 to 4 times a day to avoid any potential issues.

If you are considering this medication for a child under 12 years old, it’s important to consult with a doctor first to ensure it’s safe and appropriate for them. Always prioritize safety and follow the guidance given for the best results.

What to Avoid

You should avoid using this product on wounds or damaged skin, as it may cause irritation or complications. Additionally, do not use it with a heating pad, as this can increase the risk of burns or other adverse effects. 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 this age group. Always prioritize safety and consult a healthcare professional if you have any questions or concerns.

Side Effects

When using this product, it's important to remember that it is for external use only. If you notice any redness in the area where you apply it, or if you are pregnant, breastfeeding, or have sensitive skin, please consult your doctor before using it.

Additionally, be careful to avoid contact with your eyes. If the product does get into your eyes, rinse them thoroughly with water. Always prioritize your safety and well-being while using this product.

Warnings and Precautions

This product is for external use only, so please do not apply it to wounds or damaged skin. Avoid using it with a heating pad and do not use it on children under 12 years old who have arthritis-like conditions. While using this product, be careful to keep it away from your eyes and mucous membranes, and do not wrap the area tightly. If you notice any redness in the affected area, or if you are pregnant, breastfeeding, or have sensitive skin, consult your doctor before using it.

If you accidentally swallow this product, seek medical help or contact a Poison Control Center right away. Remember to flush your eyes thoroughly with water if the product comes into contact with them.

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

If you are pregnant or breastfeeding, or if you have sensitive skin, it’s important to consult your doctor before using this medication. Your healthcare provider can help you understand any potential risks and ensure that you make safe choices for you and your baby. Always prioritize open communication with your doctor regarding any medications you consider during this time.

Lactation Use

If you are pregnant or breastfeeding, it's important to consult your doctor before using any medication, especially if you have sensitive skin. This ensures that you receive the best advice tailored to your situation and helps protect both you and your baby. Always prioritize open communication with your healthcare provider regarding any concerns you may have about medications during this time.

Pediatric Use

It's important to keep this medication out of reach of children. If a child accidentally swallows it, seek medical help or contact a Poison Control Center right away.

For children under 12 years old, especially those with arthritis-like conditions, you should not use this medication without first consulting a doctor. Always check with a healthcare professional before giving it to children in this age group to ensure their safety.

Geriatric Use

While there is no specific information about the use of Revalife Pain Relief Cream in older adults, it’s important to approach any new treatment with caution. Since the drug insert does not mention dosage adjustments or safety concerns for elderly patients, you should consult with a healthcare professional before starting this cream. They can help ensure that it’s appropriate for your needs and discuss any potential interactions with other medications you may be taking. Always prioritize your health and safety by seeking guidance tailored to your individual situation.

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 if you have hepatic impairment (issues with liver function).

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver health and medication use. They can help ensure that you receive the safest and most effective treatment based on your individual needs.

Drug Interactions

It's important to be cautious about the medications you take. If you are allergic to salicylates, which include aspirin, you should not use this medication without first consulting your healthcare provider. Allergies can lead to serious reactions, so discussing your medical history and any allergies with your doctor is crucial.

Additionally, there are no specific interactions with other drugs or laboratory tests noted, but it's always a good practice to inform your healthcare provider about all the medications and supplements you are taking. This ensures your safety and helps your provider make the best decisions for your health.

Storage and Handling

To ensure the best performance and safety of your product, store it at room temperature, ideally between 68°F and 77°F (20° to 25°C). It's important to keep it away from excessive heat, as this can affect its effectiveness.

When handling the product, always do so with clean hands and in a clean environment to maintain its integrity. If you have any specific disposal instructions, be sure to follow them carefully to ensure safe and responsible disposal.

Additional Information

You should use this product only as directed. It is applied topically (on the skin) to the affected area, and you can use it generously, massaging it in as needed. However, do not apply it more than 3 to 4 times a day.

Keep this product out of reach of children. If swallowed, seek medical help or contact a Poison Control Center immediately. Before using, consult your doctor if you have redness in the affected area, are pregnant or breastfeeding, or have sensitive skin. Avoid contact with your eyes; if it happens, rinse thoroughly with water. If your condition worsens, symptoms persist for more than 7 days, or if you experience excessive skin irritation, stop using the product and consult your doctor.

FAQ

What should I do if my condition worsens or symptoms persist for more than 7 days?

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

Can I use this product on wounds or damaged skin?

No, you should not use this product on wounds or damaged skin.

Is it safe to use this product with a heating pad?

No, do not use this product with a heating pad.

What should I do if I accidentally swallow this product?

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

Can children under 12 years of age use this product?

Children under 12 years of age should ask a doctor before use, especially if they have arthritis-like conditions.

What precautions should I take if I have sensitive skin or am pregnant?

If you are pregnant, breastfeeding, or have sensitive skin, ask your doctor before use.

How should I apply this product?

Apply generously and massage to the affected area as needed, but do not use more than 3 to 4 times per day.

What should I do if I experience excessive skin irritation?

You should stop use and ask a doctor if excessive skin irritation occurs.

What should I do if I get this product in my eyes?

If contact occurs, flush thoroughly with water.

How should I store this product?

Store at room temperature between 68°F to 77°F (20° to 25°C) and do not expose it to excessive heat.

Packaging Info

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

Packaging configurations for Revalife Pain Relief Cream.
Details

Drug Information (PDF)

This file contains official product information for Revalife Pain Relief 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. No additional specific description details are provided in the text.

Uses and Indications

This drug is indicated for use in patients as determined by the prescribing healthcare professional. Currently, there are no specific indications or usage details provided.

There are no known teratogenic or nonteratogenic effects associated with this drug. Healthcare professionals should consider the absence of these effects when evaluating treatment options for their patients.

Dosage and Administration

Healthcare professionals should instruct patients to use the product only as directed. The recommended application involves applying a generous amount to the affected area and massaging it in as needed. It is advised not to exceed the application frequency of 3 to 4 times per day.

For pediatric patients, specifically those under 12 years of age, it is essential to consult a physician prior to use to ensure safety and appropriateness of treatment.

Contraindications

The product is contraindicated in the following situations:

Use is not recommended on wounds or damaged skin due to the potential for irritation and delayed healing. Additionally, the application of the product in conjunction with a heating pad is contraindicated, as this may increase the risk of adverse effects. Furthermore, the product should not be used in children under 12 years of age who present with arthritis-like conditions, as safety and efficacy have not been established in this population.

Warnings and Precautions

External use only. This product is contraindicated for application on wounds or damaged skin and should not be used in conjunction with a heating pad. It is also not recommended for children under 12 years of age who present with arthritis-like conditions.

When utilizing this product, it is imperative to avoid contact with the eyes and mucous membranes. Additionally, users should refrain from applying tight bandages over the treated area. If there is any redness present over the affected area, it is advisable to consult a healthcare professional prior to use. Pregnant or breastfeeding individuals, as well as those with sensitive skin, should seek medical advice before using this product.

In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

Should any adverse reactions occur, it is essential to discontinue use and consult a healthcare provider for further guidance.

Side Effects

External use only. Patients should be advised to consult a doctor prior to use if there is redness over the affected area. Additionally, it is recommended that individuals who are pregnant, breastfeeding, or have sensitive skin seek medical advice before using the product.

Care should be taken to avoid contact with the eyes. In the event of contact, it is important to flush the eyes thoroughly with water.

Drug Interactions

Patients should avoid the use of this medication if they have a known allergy to salicylates, including aspirin, unless they have consulted with a physician. This precaution is essential to prevent potential allergic reactions.

No specific drug or laboratory test interactions have been identified in the available data. Therefore, routine monitoring for drug interactions or laboratory test interference is not necessary. However, healthcare providers should remain vigilant and consider individual patient circumstances when prescribing this medication.

Packaging & NDC

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

Packaging configurations for Revalife Pain Relief Cream.
Details

Pediatric Use

Pediatric patients should be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance or contact with a Poison Control Center is advised.

For children under 12 years of age, it is recommended to consult a healthcare professional prior to use. Additionally, this product should not be administered to children under 12 years of age who present with arthritis-like conditions.

Geriatric Use

Elderly patients may not have specific information regarding the use of Revalife Pain Relief Cream, including dosage adjustments, safety concerns, or special precautions. As such, healthcare providers should exercise caution when prescribing this medication to geriatric patients.

Due to the absence of clinical findings or data specific to this population, it is advisable for healthcare providers to closely monitor elderly patients for any adverse effects or unusual responses to treatment. Consideration of individual patient factors, including comorbidities and concurrent medications, is essential in managing therapy for this demographic.

Pregnancy

Pregnant patients and those who are breastfeeding should consult their healthcare provider prior to use, particularly if they have sensitive skin. This precaution is essential to ensure the safety of both the mother and the fetus, as well as to address any potential risks associated with the use of this medication during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult their healthcare provider prior to using this medication, especially if they are breastfeeding or have sensitive skin. 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 considering its use during lactation.

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, as the lack of data necessitates careful consideration of potential risks and benefits.

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 specific postmarketing experience details are available. As such, there are no additional adverse events or rare case reports to summarize at this time.

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 the 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.

When using this product, patients should be cautioned to avoid contact with eyes and mucous membranes. They should also be advised not to bandage the affected area tightly while using the product.

Healthcare providers should encourage patients to consult a doctor before use if there is redness over the affected area. Additionally, patients who are pregnant, breastfeeding, or have sensitive skin should be advised to seek medical advice prior to using the product. In the event of accidental eye contact, patients should be instructed to flush the eyes thoroughly with water.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It should be stored at room temperature, ideally between 68°F to 77°F (20° to 25°C). Care must be taken to avoid exposure to excessive heat, as this may compromise the integrity of the product. Proper storage conditions are essential to maintain the product's efficacy and safety.

Additional Clinical Information

The product is administered topically, with a recommendation for patients to apply it generously to the affected area as needed, not exceeding 3 to 4 applications per day. Clinicians should advise patients to keep the product out of reach of children and to seek medical assistance or contact a Poison Control Center immediately if ingested.

Patients are encouraged to consult a doctor prior to use if they experience redness in the affected area, are pregnant or breastfeeding, or have sensitive skin. It is important to avoid contact with eyes and mucous membranes; if contact occurs, the area should be flushed thoroughly with water. Patients should also be instructed to avoid tight bandaging of the area and to discontinue use and consult a doctor if the condition worsens, symptoms persist beyond 7 days, symptoms resolve and then recur within a few days, or if excessive skin irritation occurs.

Drug Information (PDF)

This file contains official product information for Revalife Pain Relief 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 Revalife Pain Relief 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

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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.