Point Relief Cold Spot Pain Relieving Roll-on

Description

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

Uses and Indications

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

There are no 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

The product is contraindicated for application on open wounds or damaged skin due to the potential for irritation or adverse reactions. Additionally, if symptoms persist for more than seven days, the use of this product should be discontinued, and a physician should be consulted to evaluate the condition further.

Warnings and Precautions

For external use only. It is imperative to avoid contact with the eyes to prevent irritation or injury.

In terms of general precautions, the product should not be applied to open wounds or damaged skin, as this may exacerbate the condition or lead to adverse effects. Should symptoms persist for more than seven days, it is essential to discontinue use and consult a physician for further evaluation and management.

In the event of accidental ingestion, immediate medical assistance should be sought. If symptoms continue beyond the seven-day mark, the patient should stop using the product and contact their healthcare provider for guidance.

No specific laboratory tests are recommended for monitoring during the use of this product.

Side Effects

Patients should be aware that the product is for external use only and must avoid contact with the eyes. It is contraindicated to apply the product to open wounds or damaged skin. In clinical practice, if symptoms persist for more than seven days, patients are advised to discontinue use and consult a physician.

Additionally, it is crucial to keep the product out of reach of children. In the event of accidental ingestion, patients should seek medical advice promptly. Furthermore, patients should not bandage the area tightly after application to prevent any adverse effects.

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 Point Relief Cold Spot Pain Relieving Roll-on (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 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

There is no information available regarding the use of Point Relief Cold Spot Pain Relieving Roll-On during pregnancy. As such, safety concerns, dosage modifications, or special precautions for pregnant patients have not been established. Healthcare professionals should exercise caution when considering the use of this product in women of childbearing potential and weigh the potential risks and benefits. It is advisable to consult with a healthcare provider for individualized recommendations.

Lactation

No specific information regarding nursing mothers or lactation is provided in the drug insert for Point Relief Cold Spot Pain Relieving Roll-On. Therefore, the effects on breastfed infants and the excretion of the drug in breast milk remain unknown. Healthcare professionals should exercise caution when recommending this product to lactating mothers.

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 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, 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 guidance.

Potential symptoms of overdosage may vary depending on the specific circumstances and the individual’s health status. Therefore, monitoring the patient closely for any adverse effects is essential.

Management of overdosage should be tailored to the specific situation and may include supportive care and symptomatic treatment as necessary. Healthcare providers are advised to follow established protocols for managing overdosage and to report any serious adverse events to the appropriate regulatory authorities.

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.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to consult a physician immediately if the product is swallowed. It is important to instruct patients not to bandage the area tightly after application, as this may lead to complications. Additionally, patients should be informed that the product should not be applied to open wounds or damaged skin to prevent adverse effects.

Patients should also be made aware that if their symptoms persist for more than seven days, they should discontinue use of the product and seek medical advice. This guidance is essential to ensure patient safety and effective management of their condition.

Storage and Handling

The product is supplied in a container that must be kept tightly closed to maintain its integrity. It should be stored at room temperature, away from direct light exposure to ensure optimal stability. Once opened, the product should be discarded to prevent any potential degradation or contamination.

Additional Clinical Information

The medication is administered topically, with application directly to the affected area. Patients should not exceed four applications per day. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Point Relief Cold Spot Pain Relieving Roll-on, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)