Real Time Pain Relief Maxx Topical Analgesic

Description

The product is identified by SPL code 34089-3 and is a sterile, non-pyrogenic, isotonic solution. It comprises sodium chloride, sodium bicarbonate, and water for injection, with the pH adjusted to a range of 7.0 to 7.5. The solution is clear and colorless, and it is packaged in a 100 mL bottle. Inactive ingredients include sodium chloride and sodium bicarbonate.

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 is to apply the product directly to the affected area. The application should be followed by gentle massage into the painful area until the formulation is thoroughly absorbed into the skin. This process may be repeated as necessary, but should not exceed four applications within a 24-hour period.

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

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 restrict circulation and lead to adverse effects.

Warnings and Precautions

For external use only. It is imperative that the product is utilized strictly as directed to ensure safety and efficacy. Healthcare professionals should advise patients to avoid contact with the eyes and mucous membranes, as such contact may lead to adverse effects. Additionally, the product should not be applied to wounds or damaged skin, and it is important to avoid tight bandaging of the area where the product is applied.

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 clear up and then recur within a few days, redness is observed, or if irritation develops.

In the event of accidental ingestion, immediate medical assistance should be sought, or the patient should contact a Poison Control Center without delay.

Side Effects

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

In the event that the condition worsens, symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days, patients are advised to stop use and consult a healthcare professional. Additionally, if redness or irritation develops, it is important to discontinue use and seek medical advice.

This product should be kept out of reach of children. In the case of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

Drug Interactions

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

Packaging & NDC

Below are the non-prescription pack sizes of Real Time Pain Relief Maxx Topical Analgesic (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients over 2 years of age may apply the product 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 prior to use. Care should be taken to keep the product out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought or contact with a Poison Control Center is recommended.

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 product has not been specifically evaluated for use during pregnancy. Currently, there are no explicit warnings or contraindications regarding its use in pregnant patients. Additionally, the prescribing information does not provide any dosage modifications for individuals who are pregnant. Furthermore, no special precautions related to the use of this product during pregnancy have been mentioned. Healthcare professionals should consider the lack of specific data when prescribing this product to pregnant patients and weigh the potential benefits against any unknown risks.

Lactation

There are no specific warnings or recommendations regarding the use of this product by nursing mothers. Additionally, there is no information provided about the potential for excretion in breast milk or any associated risk to breastfed infants.

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 to patients with reduced kidney function, as the lack of detailed guidance necessitates careful clinical judgment and individualized patient assessment. Regular monitoring of renal function is advisable to ensure patient safety and optimal therapeutic outcomes.

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; 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 compound in these areas.

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 their doctor 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.

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 it should not be applied 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 packaging that includes specific NDC numbers. It should be stored at room temperature, ensuring that it is protected from light exposure. Freezing the product is not permitted, as it may compromise its integrity. Once opened, the product must be discarded to ensure safety and efficacy.

Additional Clinical Information

The product is administered topically. For adults and children over 2 years of age, it should be applied to the affected area and massaged into the skin until fully absorbed. This application may be repeated as necessary, but should not exceed 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 Topical Analgesic, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)