Real Time Pain Relief Foot Cream

Description

The product is identified by the SPL code 34089-3. No specific description details are provided in the text.

Uses and Indications

This drug is indicated for the temporary relief of minor pain associated with various conditions, including arthritis, muscle strains, sprains, bruises, and cramps.

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

Dosage and Administration

Healthcare professionals are advised to apply the medication generously to the affected area. It is important to massage the formulation into the painful area until it is thoroughly absorbed into the skin. This application may be repeated as necessary, but should not exceed four times daily.

For pediatric patients aged 2 years or younger, it is recommended to consult a physician prior to use.

Contraindications

There are no specific contraindications listed for this product. However, it is imperative to seek immediate medical assistance or contact a poison control center if the product is swallowed.

Warnings and Precautions

For external use only, this product must be utilized strictly as directed. It is imperative to avoid bandaging tightly or using it in conjunction with a heating pad, as these practices may lead to adverse effects. Care should be taken to prevent contact with the eyes or mucous membranes, and the product should not be applied to wounds or damaged skin.

Healthcare professionals should advise patients to discontinue use and seek medical advice if any of the following occur: the condition worsens, symptoms persist for more than 7 days, symptoms resolve and then recur within a few days, redness is observed, or irritation develops.

In the case of pregnancy or breastfeeding, it is essential for individuals to consult a healthcare professional prior to use to ensure safety for both the mother and child.

Emergency medical assistance should be sought immediately if the product is ingested. Patients should be instructed to contact a poison control center or seek medical help without delay in such instances.

Side Effects

Patients should be aware that this product is for external use only. It is essential to use the product strictly as directed. Patients are advised against bandaging tightly or using it in conjunction with a heating pad. Additionally, contact with the eyes or mucous membranes should be avoided, and the product should not be applied to wounds or damaged skin.

In clinical practice, patients are instructed to discontinue use and consult a healthcare professional if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up only to recur within a few days. The presence of redness or the development of irritation also necessitates stopping the use of the product and seeking medical advice.

For patients who are pregnant or breastfeeding, it is recommended to consult a health professional prior to use to ensure safety and appropriateness.

Drug Interactions

No specific drug interactions have been identified for this medication. Additionally, there are no reported interactions with laboratory tests. 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 Real Time Pain Relief Foot Cream (menthol 1.5%). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

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 over 2 years of age, the recommended application involves generous use on the affected area, with massage into the skin until fully absorbed. This can be repeated as necessary, not exceeding four times daily. For children aged 2 years or younger, consultation with a healthcare professional is required 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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

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, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to discuss their individual circumstances with a healthcare provider to ensure safe use during pregnancy and lactation.

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 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 individuals 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 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 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 monitoring vital signs, providing symptomatic treatment, and ensuring the patient's safety.

If available, consultation with a poison control center or a medical toxicologist is recommended to guide the management of the overdose. Additionally, healthcare professionals should refer to local protocols and guidelines for the management of overdose situations, as these may provide specific recommendations based on the substance involved.

Overall, vigilance and prompt intervention are critical in managing any suspected overdose effectively.

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. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

Postmarketing Experience

No postmarketing experience details are provided in the insert.

Patient Counseling

Healthcare providers should advise patients that in the event of accidental ingestion, it is crucial to seek medical assistance immediately or contact a poison control center. This prompt action is essential to ensure patient safety and appropriate management of any potential risks associated with the ingestion.

Storage and Handling

The product is supplied in a configuration that ensures optimal usability. It should be stored at room temperature, away from direct sunlight and moisture. To maintain safety, it is essential to keep the product out of reach of children. Once opened, the product must be discarded to ensure proper handling and safety.

Additional Clinical Information

The product is administered topically, with specific instructions for different age groups. Adults and children over 2 years should apply the product generously to the affected area, massaging it into the skin until fully absorbed, with a maximum frequency of four times daily. For children aged 2 years or younger, it is advised to consult a doctor before use.

Clinicians should counsel patients on important safety information. If the product is swallowed, immediate medical assistance or contact with a poison control center is recommended. Additionally, pregnant or breastfeeding patients should seek advice from a healthcare professional prior to use.

Drug Information (PDF)

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

View product document (PDF)