Goodsense Cooling Pain Relief

Description

The product is identified by the SPL code 34089-3 and is presented in a carton. It is associated with an image file in JPEG format, specifically referenced as GS_Cooling Pain Relief Gel_GDS-PAING-76_V5.jpg.

Uses and Indications

This drug is indicated for the topical treatment of affected areas in adults and children aged 12 years and older, with a recommended application frequency of no more than 3 to 4 times per day. For children under 12 years of age, consultation with a healthcare professional is advised prior to use.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

For the temporary relief of minor pain associated with arthritis, simple backache, muscle strains, sprains, and bruises, the recommended dosage should be determined based on the severity of the condition and the patient's response to treatment.

Healthcare professionals should assess the patient's individual needs and may consider administering the medication at regular intervals to maintain effective pain relief. It is essential to follow the prescribed dosing range and frequency to minimize the risk of adverse effects.

Patients should be advised on the appropriate method of administration, ensuring that they understand how to properly use the medication for optimal results. Regular monitoring of the patient's response to therapy is recommended to adjust the dosage as necessary.

Contraindications

The product should be kept 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 advised. No other contraindications have been identified.

Warnings and Precautions

This product is intended for external use only. Healthcare professionals should advise patients to avoid contact with the eyes. In the event of accidental eye contact, it is imperative to flush the eyes thoroughly with water. Additionally, the product should not be applied to broken skin, and it is recommended to avoid tight bandaging of the area treated. The use of heating pads in conjunction with this product is contraindicated.

Patients should be instructed to discontinue use and consult a healthcare provider if the condition worsens, or if a rash or irritation develops that persists for more than 7 days, or if symptoms resolve and then recur within a few days.

It is essential to keep this product out of reach of children. In cases where the product is ingested, immediate medical assistance should be sought, or contact with a Poison Control Center should be made without delay.

Side Effects

Patients should be aware that this product is for external use only. It is important to avoid contact with the eyes; in the event of contact, the eyes should be flushed thoroughly with water. Additionally, patients should refrain from applying the product to broken skin and should not bandage the area tightly. The use of heating pads in conjunction with this product is also not recommended.

Participants are advised to discontinue use and consult a healthcare professional if the condition worsens, if a rash or irritation develops and persists for more than 7 days, or if symptoms clear up and then recur within a few days. These precautions are essential to ensure the safe and effective use of the product.

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 Goodsense Cooling Pain Relief (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. For adolescents and adults aged 12 years and older, the recommended application is to the affected area, not exceeding 3 to 4 times daily. It is important to keep this product out of reach of children. In the event of accidental ingestion, immediate medical assistance or contact with a Poison Control Center is advised.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any potential adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

Pregnant patients should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully weighed, as the effects on fetal outcomes are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure the safety of both the mother and the developing fetus.

Lactation

There is no specific information regarding nursing mothers or lactation considerations provided in the drug insert for GoodSense Cooling Pain Relief Gel. Therefore, the effects on breastfed infants and the excretion of the drug in breast milk remain undetermined. Healthcare professionals should exercise caution and consider the potential risks versus benefits when recommending this product to lactating mothers.

Renal Impairment

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions outlined 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 absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, the following management procedures should be considered:

1. Assessment: Conduct a thorough assessment of the patient's clinical status, including vital signs and level of consciousness.

2. Supportive Care: Provide supportive care as needed, which may include airway management, oxygen supplementation, and intravenous fluids.

3. Consultation: Engage with a poison control center or a medical toxicologist for guidance on specific interventions and antidotes, if applicable.

4. Documentation: Document all findings, interventions, and the patient's response to treatment meticulously.

Healthcare professionals should remain vigilant and prepared to implement appropriate measures in the event of an overdose, even in the absence of specific guidelines.

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 keep the product out of reach of children to prevent accidental ingestion. It is important to emphasize that if the product is swallowed, patients should seek medical help or contact a Poison Control Center immediately. This information is crucial for ensuring the safety and well-being of patients and their families.

Storage and Handling

The product is supplied in a configuration that ensures optimal handling and storage. It should be stored at room temperature, away from direct sunlight and moisture. It is essential to keep the product out of reach of children to prevent accidental ingestion. Additionally, the product must not be frozen, as this could compromise its integrity and effectiveness. Proper adherence to these storage conditions will help maintain the quality of the product throughout its shelf life.

Additional Clinical Information

Patients aged 12 years and older are advised to apply the product to the affected area no more than 3 to 4 times daily. For children under 12 years of age, consultation with a doctor is recommended prior to use.

Clinicians should counsel patients to avoid contact with the eyes and to flush thoroughly with water if contact occurs. Patients should also avoid applying the product to broken skin, refrain from tight bandaging, and not use it in conjunction with a heating pad. They should discontinue use and consult a doctor if the condition worsens, if a rash or irritation develops and persists for more than 7 days, or if symptoms clear up and recur within a few days. It is important to keep the product out of reach of children, and in the event of ingestion, medical assistance or contact with a Poison Control Center should be sought immediately.

Drug Information (PDF)

This file contains official product information for Goodsense Cooling Pain Relief, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)