Point Relief Cold Spot Pain Relieving

Description

Point Relief Cold Spot Pain Relieving Gel is presented in a volume of 120 mL. The product is identified by the SPL Code 51452-035-01.

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 to ensure safety and efficacy. Care should be taken to follow the recommended frequency to avoid potential adverse effects associated with overuse.

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, discontinuation of use is advised, and a consultation with a physician is recommended to evaluate the underlying condition.

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 to avoid tight bandaging of the treated area, as this may interfere with the product's efficacy and increase the risk of adverse reactions.

Side Effects

Patients should be aware that the product is for external use only and should 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, it is advised to discontinue use and consult a physician.

Additionally, the product should be kept out of reach of children. In the event of accidental ingestion, patients should seek medical advice promptly. It is also important to note that the product should not be bandaged tightly, as this may lead to adverse effects.

Drug Interactions

There are no specific drug interactions identified for this medication. Additionally, no laboratory test interactions have been reported. 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 (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, given the lack of targeted data for this population.

Pregnancy

There is no specific information regarding the use of Point Relief Cold Spot Pain Relieving Gel during pregnancy. The prescribing information does not provide safety concerns, dosage modifications, or special precautions for pregnant patients. Therefore, healthcare professionals should exercise caution when considering the use of this product in pregnant individuals, as the potential risks and effects on fetal outcomes remain undetermined. It is advisable to weigh the benefits against any unknown risks before recommending this product to women of childbearing potential.

Lactation

Lactating mothers should consult a physician before using this product. There is a potential for excretion in breast milk, and the effects on a nursing infant are not known.

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 relation to the use of this medication. Consequently, there are no established 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 prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

In the event of an overdosage, it is imperative that healthcare professionals take immediate action. If the product is ingested, the individual should be advised to consult a physician without delay.

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 of overdosage should be guided by clinical judgment and may include supportive care and symptomatic treatment as necessary. Continuous monitoring of the patient’s vital signs and overall health status is recommended to ensure prompt intervention if complications arise.

Healthcare professionals are encouraged to report any cases of overdosage to the relevant authorities to contribute to ongoing safety monitoring and risk assessment.

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 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 configuration that includes specific NDC numbers, which are essential for identification and inventory management. It is recommended to store the product at room temperature to maintain its efficacy.

To ensure optimal preservation, the product must be protected from light exposure. Additionally, it is crucial to keep the container tightly closed when not in use to prevent contamination and degradation. Once opened, the product should be discarded after use to ensure safety and effectiveness.

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)