Real Time Pain Relief Maxx Plus Topical Analgesic

Description

The product is identified by SPL Code 34089-3 and is presented as a sterile, non-pyrogenic, isotonic solution. It contains sodium chloride, a common electrolyte, and is characterized by its clear and colorless appearance. The pH of the solution ranges from 4.5 to 7.0. It is packaged in an 88 ml container, with inactive ingredients comprising sodium chloride and water for injection.

Uses and Indications

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

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 dosage involves applying the product to the affected area. The application should be followed by a gentle massage into the painful area until the formulation is thoroughly absorbed into the skin. This process may be repeated as necessary, with a maximum frequency of four times daily.

For children aged 2 years or younger, it is advised to consult a physician prior to use.

The product is intended for topical application only, and the method of administration requires massaging the formulation into the painful area until complete absorption occurs.

Contraindications

The product is contraindicated for application on wounds or damaged skin due to the potential for irritation and impaired healing. Additionally, it should not be used with tight bandaging, as this may lead to compromised circulation and increased risk of adverse effects.

Warnings and Precautions

For external use only. This product is intended solely for topical application and should not be ingested.

It is imperative that the product is used only as directed. Healthcare professionals should advise patients to avoid contact with the eyes and mucous membranes, as exposure may lead to irritation or adverse effects. Additionally, the product should not be applied to wounds or damaged skin, and tight bandaging of the treated area is not recommended to prevent complications.

Patients should be instructed to discontinue use and seek medical attention 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. These signs may indicate a need for reevaluation of the treatment plan.

In the event of accidental ingestion, it is crucial to obtain emergency medical assistance or contact a Poison Control Center immediately. Prompt action is necessary to mitigate potential health risks associated with ingestion.

Side Effects

Patients using this product should be aware that it is intended for external use only. It is crucial to avoid contact with the eyes or mucous membranes, and the product should not be applied to wounds or damaged skin. Additionally, tight bandaging of the area where the product is applied should be avoided.

Participants are advised to discontinue use and consult a healthcare professional if any of the following occur: the condition worsens, symptoms persist for more than 7 days, symptoms clear up and then recur within a few days, redness is present, or irritation develops.

It is important to keep this product out of reach of children. In the event of accidental ingestion, medical assistance should be sought immediately, or contact with a Poison Control Center should be made without delay.

Drug Interactions

No drug interactions or drug and laboratory test interactions have been identified in the available data. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Real Time Pain Relief Maxx Plus Topical Analgesic (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, massaging it into the skin until fully absorbed. This application may be repeated as necessary, but should not exceed four times daily. For children 2 years of age or younger, it is advised to consult a doctor before 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

The available data regarding the use of this product during pregnancy is limited, as no specific information is provided in the drug insert. There are no statements indicating whether the product is contraindicated in pregnancy or any associated risks to the fetus. Additionally, no dosage modifications or special precautions regarding use during pregnancy are mentioned. Healthcare professionals should consider the lack of data when prescribing this product to pregnant patients and weigh the potential benefits against any unknown risks. Women of childbearing potential should be counseled accordingly.

Lactation

The safety of this product during lactation has not been established. Caution should be exercised when using this product in lactating mothers. There is a potential for excretion in breast milk, and the effects on breastfed infants are unknown.

Renal Impairment

Patients with renal impairment may not have specific dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. 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 and monitoring of these patients.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials for this medication. Consequently, there is no available information regarding dosage adjustments, special monitoring requirements, or precautions 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 warranted based on clinical judgment.

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, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and evaluation are recommended to ensure patient safety and effective resolution of any complications arising from the overdosage.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

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. Instruct patients that if the product is swallowed, they should seek medical help or contact a Poison Control Center immediately.

Patients should be informed to stop using the product and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, if symptoms clear up and then recur within a few days, if redness is present, or if irritation develops.

When using this product, patients must be reminded to use it only as directed. They should avoid contact with the eyes and mucous membranes, and should not apply the product to wounds or damaged skin. Additionally, patients should be cautioned against bandaging the area tightly after application.

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 protect the contents from light exposure, which can compromise the product's effectiveness. Additionally, it is important to discard the product after opening to ensure safety and efficacy.

Additional Clinical Information

For adults and children over 2 years of age, the product should be applied to the affected area and massaged into the skin until fully absorbed. This can be repeated as necessary, with a maximum frequency of four times daily. For children aged 2 years or younger, it is advised to consult a doctor before use.

No additional information is 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 Maxx Plus Topical Analgesic, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)