Frankincense and Myrrh Foot Pain Relief

Description

Frankincense and Myrrh is a topical analgesic formulated for pain relief specifically for the foot. This product is presented as a rubbing oil containing 2% menthol, which contributes to its analgesic properties. The formulation is contained in a 2 fluid ounce (59 mL) bottle, designed for easy application to affected areas.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains, specifically targeting foot pain. It is classified as a topical analgesic and contains Menthol 2% as its active ingredient.

Dosage and Administration

For adults and children aged 12 years and older, the recommended dosage is to apply 10 to 30 drops into the hand and massage into the affected areas. This application may be performed up to four times daily, as needed.

For children under 12 years of age, it is advised to consult a healthcare professional for appropriate dosing and administration guidance.

Contraindications

Use is contraindicated in the following situations:

Application on wounds or damaged skin is prohibited due to the potential for adverse effects and impaired healing. Additionally, use over large areas of the body is contraindicated to minimize the risk of systemic absorption and associated complications.

Warnings and Precautions

This product is intended for external use only. It is contraindicated for application on wounds or damaged skin and should not be used over large areas of the body.

When utilizing this product, it is imperative to avoid contact with the eyes. Additionally, users should refrain from applying tight bandages over the treated area to prevent complications.

Healthcare professionals should advise patients to discontinue use and seek medical advice if any of the following occur: worsening of the condition, onset of irritation, or if symptoms persist for more than 7 days. Patients should also be instructed to consult a physician if symptoms resolve and then recur within a few days.

For individuals who are pregnant or breastfeeding, it is essential to consult a healthcare professional prior to use to ensure safety for both the mother and child.

This product must be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center should be made without delay.

Side Effects

Patients using this product should be aware that it is intended for external use only. It is contraindicated for application on wounds or damaged skin and should not be used over large areas of the body.

During use, patients are advised to avoid contact with the eyes and to refrain from tightly bandaging the area of application.

Patients should discontinue use and consult a healthcare professional if the condition worsens, if irritation occurs, or if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days.

In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately.

Drug Interactions

There are no specific drug interactions identified for this medication. Additionally, no laboratory test interactions have been reported. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. For adolescents and adults aged 12 years and older, the recommended dosage is 10-30 drops applied to the hands and massaged into the affected areas, with a maximum frequency of four times daily.

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 a Poison Control Center.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully considered in these populations to ensure the safety of both the mother and the fetus or infant.

Lactation

Lactating mothers are advised to consult a healthcare 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

Patients with renal impairment have not been specifically addressed in the drug insert 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 absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to 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 prescribing information.

Overdosage

In the event of an overdosage, immediate medical assistance is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical help or contact a Poison Control Center without delay.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved; therefore, a thorough assessment by a medical professional is recommended to determine the appropriate course of action.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. It is imperative that healthcare providers remain vigilant and prepared to address any complications that may arise from an overdosage scenario.

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 the product out of reach of children and to seek immediate medical assistance or contact a Poison Control Center if the product is swallowed. Patients should be instructed not to use the product on wounds or damaged skin and to avoid applying it over large areas of the body.

It is important for healthcare providers to emphasize that patients should avoid contact with the eyes while using this product. Additionally, patients should be cautioned against bandaging the area tightly when using the product.

Patients should be informed to stop using the product and consult a doctor if their condition worsens, if irritation occurs, or if symptoms persist for more than 7 days. They should also be advised to seek medical advice if symptoms clear up and then recur within a few days.

Storage and Handling

The product is supplied in a tamper-resistant container. It is essential to inspect the seal around the bottle neck; do not use the product if the seal is broken or missing.

For optimal storage, the product should be kept in a cool, dry place. Additionally, it is important to retain the carton, as it contains vital information regarding the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Frankincense and Myrrh Foot Pain Relief, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)