Frankincense and Myrrh Intensive Foot Therapy

Description

Frankincense and Myrrh Intensive Foot Therapy Lotion is formulated as a topical analgesic designed to provide fast pain relief while offering hydrating repair for the skin. This lotion contains 1.3% menthol, which contributes to its analgesic properties. It is specifically noted for its safety in use by diabetics. The product is packaged in a net weight of 3 oz (85 g).

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains.

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

Dosage and Administration

For adults and children aged 12 years and older, the recommended application is to the affected area not more than 3 to 4 times daily. It is important to ensure that the application is performed with clean hands and that the affected area is clean and dry prior to administration.

For children under 12 years of age, it is advised to consult a healthcare professional before use to determine the appropriate course of action.

Contraindications

The product is contraindicated for use on wounds or damaged skin due to the potential for irritation and delayed healing. Additionally, application over large areas of the body is not recommended, as it may increase the risk of systemic absorption and adverse effects.

Warnings and Precautions

This product is intended for external use only. It is imperative that it not be applied to wounds or damaged skin, nor should it be used over large areas of the body to prevent adverse effects.

During the application of this product, care must be taken to avoid contact with the eyes. Additionally, it is advised not to bandage the area tightly, as this may lead to complications.

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

It is crucial to keep this product out of the 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. If a patient's condition worsens, if irritation occurs, or if symptoms persist for more than 7 days or resolve and then recur within a few days, they should discontinue use and consult a healthcare professional.

For pregnant or breastfeeding individuals, it is recommended to seek advice from a health professional prior to use. Additionally, this product should be kept out of reach of children; if swallowed, immediate medical assistance should be sought or contact with a Poison Control Center should be made.

Drug Interactions

No drug interactions have been identified in the available data. Additionally, there are no reported interactions between drugs and laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug interactions.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional prior to use. For adolescents and adults aged 12 years and older, the recommended application is to the affected area not more than 3 to 4 times daily.

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 potential 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. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and breastfeeding safety. Healthcare providers should consider individual circumstances and the specific needs of the patient when making recommendations.

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 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 no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this drug. Consequently, there are no 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 intervention is crucial. If the substance is ingested, it is imperative to seek medical assistance or contact a Poison Control Center without delay.

Healthcare professionals should be aware that prompt action can significantly influence the outcome of an overdosage situation. Symptoms of overdosage may vary depending on the specific substance involved; therefore, a thorough assessment of the patient's condition is essential.

Management procedures should include supportive care and symptomatic treatment as necessary. Continuous monitoring of the patient's vital signs and clinical status is recommended to address any complications that may arise.

In summary, swift action and appropriate medical response are vital in managing cases of overdosage to ensure patient safety and effective treatment.

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 these contexts.

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 the reach of children to prevent accidental ingestion. In the event of swallowing, patients should seek medical help or contact a Poison Control Center immediately.

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 patients to monitor their condition and to stop use and consult a doctor if the condition worsens or if irritation occurs. Additionally, patients should be informed to discontinue use and seek medical advice if symptoms persist for more than 7 days or if symptoms clear up and then recur within a few days.

While using this product, patients should be cautioned to avoid contact with the eyes. Furthermore, they should be advised not to bandage the area tightly when applying the product to ensure proper usage and minimize the risk of adverse effects.

Storage and Handling

The product is supplied in a tamper-resistant container. It is essential to inspect the seal under the tube cap prior to use; 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 to maintain its integrity and effectiveness. Proper handling and storage conditions are crucial to ensure the product remains safe for use.

Additional Clinical Information

The medication is administered topically, with a recommended application frequency of 3 to 4 times daily for adults and children aged 12 years and older. For children under 12 years of age, it is advised to consult a doctor prior to use. There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)