Real Time Pain Relief Foot

Description

The drug is a white to off-white, crystalline powder. Its chemical name is insert chemical name here. The molecular formula is insert molecular formula here, and it has a molecular weight of insert molecular weight here. Inactive ingredients include insert inactive ingredients here.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with muscle and joint conditions, including arthritis, strains, bruises, and sprains.

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

Dosage and Administration

For adults and children over 2 years of age, the recommended application is to the affected area not more than 3 to 4 times daily. It is essential to ensure that the application is performed with clean hands and that the affected area is properly prepared prior to administration.

For children under 2 years of age, it is advised to consult a healthcare professional before use to determine the appropriate course of action.

Contraindications

There are no specific contraindications listed for this product. However, it is advised to keep the product out of reach of children. In the event of accidental ingestion, seek medical assistance or contact a Poison Control Center immediately. Discontinue use and consult a healthcare professional if the condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. Additionally, avoid contact with eyes.

Warnings and Precautions

For external use only. This product should not be applied to wounds or damaged skin, and it is important to avoid bandaging tightly to prevent complications.

Healthcare professionals should advise patients to avoid contact with the eyes. In the event of accidental contact, immediate rinsing with water is recommended.

Patients are instructed to discontinue use and consult a healthcare provider if the condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days.

In cases of ingestion, it is critical to seek emergency medical assistance or contact a Poison Control Center immediately.

Side Effects

Patients should be aware of several important warnings and precautions associated with the use of this product. It is intended for external use only and should not be applied to wounds or damaged skin. Additionally, care should be taken to avoid contact with the eyes during application.

In the event that the condition worsens, or if symptoms persist for more than 7 days or resolve only to recur within a few days, patients are advised to discontinue use and consult a healthcare professional.

This product should be kept out of reach of children. If ingested, it is crucial to seek medical assistance or contact a Poison Control Center immediately.

For pregnant or breastfeeding individuals, it is recommended to consult a health professional prior to use to ensure safety for both the mother and child.

Drug Interactions

No drug interactions have been identified for the product, indicating that it does not have clinically significant interactions with other medications. Additionally, there are no reported interactions with 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 Real Time Pain Relief Foot (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients over 2 years of age may apply the medication to the affected area no more than 3 to 4 times daily. For children under 2 years of age, it is advised to consult a doctor prior to use.

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 and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure the safety of both the mother and the developing fetus.

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 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. 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 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 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. Continuous monitoring and evaluation are advised to ensure patient safety and effective resolution of any complications arising from the overdosage.

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 provided in the insert.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. In the event that the product is swallowed, patients should seek medical help or contact a Poison Control Center immediately.

Patients should be instructed to stop using the product and consult their healthcare provider if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days.

Additionally, while using this product, patients should be cautioned to avoid contact with their eyes to prevent irritation or injury.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at room temperature to maintain its integrity. The container must be kept tightly closed to prevent contamination and degradation. Additionally, the product should be protected from light exposure to ensure optimal stability. Once opened, the product must be discarded to ensure safety and efficacy.

Additional Clinical Information

Patients aged 2 years and older are advised to apply the medication to the affected area no more than 3 to 4 times daily. For children under 2 years of age, it is recommended that a clinician be consulted 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 Real Time Pain Relief Foot, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)