Point Relief Cold Spot Pain Relieving

Description

The product is identified by SPL code 34089-3 and is presented as a sterile, non-pyrogenic, isotonic solution. It comprises sodium chloride, sodium bicarbonate, and dextrose as its active components. The pH of the solution is adjusted to a range of 7.0 to 7.5, ensuring optimal stability and compatibility. The solution is characterized by its clear and colorless appearance. It is packaged in a 475 ml container, suitable for medical use.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains of muscles and joints. It is specifically effective for conditions associated with simple backache, arthritis, bruises, strains, and sprains.

Limitations of Use: There are no known teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

The medication should be applied directly to the affected area. Healthcare professionals are advised to limit the application to a maximum of four times per day. Care should be taken to ensure that the dosage does not exceed this frequency to avoid potential adverse effects.

Contraindications

Use of this product is contraindicated in situations where tight bandaging is required, as this may lead to complications such as impaired circulation or tissue damage. No other contraindications have been identified.

Warnings and Precautions

For external use only. It is imperative to avoid contact with the eyes to prevent irritation or injury. The product should not be applied to open wounds or damaged skin, as this may exacerbate the condition or lead to adverse effects.

In cases where symptoms persist for more than seven days, it is recommended to discontinue use and consult a physician for further evaluation and management. If the product is ingested, immediate consultation with a physician is advised to address any potential complications.

Additionally, care should be taken not to bandage the area tightly, as this may impede circulation and lead to further complications.

Side Effects

Patients using this product should be aware of several important warnings and precautions. The product is intended for external use only and should not come into contact with the eyes. It is contraindicated for application on open wounds or damaged skin. In the event that symptoms persist for more than seven days, patients are advised to discontinue use and consult a physician.

Additionally, it is crucial to keep this product out of reach of children. If ingested, patients should seek medical advice immediately. Furthermore, patients should avoid tightly bandaging the area where the product is applied to prevent any adverse effects.

Drug Interactions

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

Packaging & NDC

Below are the non-prescription pack sizes of Point Relief Cold Spot Pain Relieving (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients should be advised to keep this medication out of reach of children. In the event of accidental ingestion, it is important to consult a physician immediately.

Geriatric Use

There is no specific information available 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

The prescribing information for POINT RELIEF COLD SPOT Pain Relieving Gel does not provide specific data regarding its use during pregnancy. There are no contraindications noted for pregnant patients, nor are there any identified risks to the fetus associated with the use of this product. Additionally, the insert does not outline any special precautions or dosage modifications for individuals who are pregnant. As such, healthcare professionals should exercise clinical judgment when considering the use of this product in pregnant patients, taking into account the absence of data and the individual circumstances of each case.

Lactation

There is no specific information regarding the use of POINT RELIEF COLD SPOT Pain Relieving Gel in lactating mothers or any lactation considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution and consider the potential risks and benefits when advising lactating mothers on the use of this product. There are no known data on excretion in breast milk or effects on breastfed infants associated with this gel.

Renal Impairment

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials for this medication. Consequently, there is no information available 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 in these patients to ensure safety and therapeutic effectiveness.

Overdosage

In the event of an overdosage, it is imperative that healthcare professionals take immediate action. If the product is ingested, the first step is to consult a physician for further evaluation and management.

Potential symptoms of overdosage may vary depending on the specific circumstances and the amount ingested. Therefore, a thorough assessment of the patient's condition is essential to determine the appropriate course of action.

Management procedures should be initiated promptly, guided by the physician's recommendations. This may include supportive care and symptomatic treatment as necessary. Continuous monitoring of the patient's vital signs and overall clinical status is crucial during the management of an overdosage situation.

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 in these areas limits the understanding of the compound's safety profile in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients that if the product is swallowed, they should consult a physician immediately. It is important to emphasize the need for prompt medical attention in such cases to ensure patient safety.

Additionally, healthcare providers should instruct patients not to bandage the area tightly. This precaution helps prevent potential complications and ensures proper circulation and healing.

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 avoid any potential safety risks.

Additional Clinical Information

The medication is administered topically, with application directly to the affected area. Patients should not exceed four applications per day. 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 Point Relief Cold Spot Pain Relieving, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)