Revalife

Description

Revalife is presented in a 3-ounce tube carton. The formulation is designed for topical application, providing a convenient dosage form for users. The packaging ensures product integrity and ease of use.

Uses and Indications

This drug is indicated for the temporary relief of minor pain in joints and muscles associated with conditions such as arthritis, bursitis, tendonitis, and strains.

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

Dosage and Administration

The cream should be applied to clean, dry skin over the affected joint or muscle. It is recommended to gently massage the cream into the skin until it is fully absorbed. For optimal results, the application should be performed daily for a duration of 30 days, after which continued daily use is advised. The cream may be reapplied as necessary based on the patient's needs. It is important to ensure that the cap is closed tightly after each use to maintain the integrity of the product.

Contraindications

Use is contraindicated in children due to the risk of accidental ingestion. In the event of swallowing, immediate medical assistance or contact with a Poison Control Center is advised.

Warnings and Precautions

External use only is mandated for this product. It is imperative to avoid tight bandaging or the application of heating pads in conjunction with its use. Contact with the mouth, eyes, and mucous membranes must be strictly avoided. Additionally, the product should not be applied to wounds, damaged, broken, or irritated skin to prevent adverse effects.

Healthcare professionals should advise patients to discontinue use and seek medical advice if symptoms persist for more than 7 days, if symptoms resolve and then recur within a few days, if redness is observed, or if irritation develops. Special caution is warranted when using this product on children aged 12 years or younger, as it may not be suitable for this age group.

It is essential to keep this 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 recommended to ensure appropriate management.

Side Effects

Patients should be aware of several important warnings associated with the use of this product. It is intended for external use only and should not be bandaged tightly or used in conjunction with a heating pad. Care should be taken to avoid contact with the mouth, eyes, and mucous membranes. Additionally, the product should not be applied to wounds, damaged, broken, or irritated skin.

In the event that symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days, patients are advised to discontinue use and consult a healthcare professional. The presence of redness or the development of irritation also warrants stopping use and seeking medical advice. Special caution is advised when using this product on children aged 12 years or under, as it may not be suitable for this age group.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

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

Pediatric Use

Pediatric patients should be closely monitored when using this product. It is essential to keep the product out of reach of children to prevent accidental ingestion. In the event of swallowing, immediate medical assistance or contact with a Poison Control Center is advised.

Healthcare professionals should instruct caregivers to discontinue use and consult a physician if symptoms persist for more than 7 days, if symptoms resolve and then recur within a few days, if redness occurs, or if irritation develops. Special caution is warranted when using this product on children aged 12 years or younger.

Geriatric Use

There is no specific information regarding the use of REVALIFE topical menthol ointment in geriatric patients. The prescribing information does not indicate any dosage adjustments, safety concerns, or special precautions that are specifically applicable to elderly patients. Therefore, healthcare providers should exercise clinical judgment when considering the use of this medication in geriatric populations, as individual patient factors may necessitate careful monitoring and assessment.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing infant.

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 drug in human 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 data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring of these patients.

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, the following management procedures are recommended:

1. Assessment: Conduct a thorough assessment of the patient's clinical status, including vital signs and level of consciousness.

2. Supportive Care: Provide supportive care as necessary, which may include airway management, oxygen supplementation, and intravenous fluids.

3. Consultation: Engage with a poison control center or a medical toxicologist for guidance on specific interventions and antidotes, if applicable.

4. Documentation: Document all findings, interventions, and the patient's response to treatment meticulously.

Healthcare professionals should remain vigilant and prepared to implement these measures in the event of an overdose, despite the lack of specific information provided.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. No non-teratogenic effects have been specified. Additionally, there are no details provided regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

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 essential for patients to understand the importance of these precautions to ensure their safety and the safety of others.

Storage and Handling

The product is supplied in a secure container that must be tightly closed after each use to maintain its integrity. It is essential to keep the product out of reach of children to prevent accidental ingestion or misuse. This product is intended for external use only and should not be applied with a tight bandage or in conjunction with a heating pad, as these practices may alter its effectiveness or safety. Proper handling and adherence to these guidelines are crucial for ensuring the product's optimal performance and safety.

Additional Clinical Information

The product is administered topically, applied to clean, dry skin over the affected joint or muscle. Patients are advised to gently massage the cream until it disappears, with optimal results expected from daily use for 30 days, followed by continued daily application as needed.

Clinicians should counsel patients to keep the product out of reach of children and to seek medical assistance or contact a Poison Control Center immediately if ingested. It is for external use only; patients should avoid tight bandaging or using heating pads in conjunction with the cream, and should prevent contact with the mouth, eyes, and mucous membranes. The cream should not be applied to wounds, damaged, broken, or irritated skin. Patients are instructed to discontinue use and consult a doctor if symptoms persist for more than 7 days, if symptoms resolve and then recur within a few days, if redness or irritation occurs, or if the product is used on a child aged 12 years or younger. Pregnant or breastfeeding patients should consult a healthcare professional before use.

Drug Information (PDF)

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

View product document (PDF)