Cold Therapy Pain Relief

Description

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

Uses and Indications

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

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

Dosage and Administration

For adults and children aged 12 years and older, the recommended application is to the affected areas not more than 3 to 4 times daily. It is important to ensure that the application is performed with clean hands and that the affected area is clean and dry prior to application.

For children under 12 years of age, it is advised to consult a physician before use to determine the appropriate dosage and administration guidelines tailored to the child's specific needs.

Contraindications

Use is contraindicated in children due to the risk of accidental ingestion. In the event of accidental ingestion, it is imperative to seek medical assistance or contact a Poison Control Center immediately.

Warnings and Precautions

For external use only. Healthcare professionals should advise patients to avoid contact with the eyes or mucous membranes when using this product. It is imperative that the product is not applied to wounds, damaged skin, or irritated skin. If excessive irritation develops, the application should be discontinued. Additionally, patients should be instructed not to bandage the area after application and to refrain from using the product in conjunction with heating pads or devices.

Patients must be informed to stop use and consult a healthcare provider if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. Special consideration should be given to pregnant or breastfeeding individuals, who should seek advice from a health professional prior to use.

General precautions include keeping the product out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

In summary, healthcare professionals should ensure that patients are aware of these warnings and precautions to promote safe and effective use of the product.

Side Effects

Patients using this product should be aware that it is for external use only. It is important to avoid contact with the eyes or mucous membranes, and the product should not be applied to wounds, damaged skin, or irritated skin. If excessive irritation develops, application should be discontinued. Additionally, the product should not be bandaged or used in conjunction with heating pads or devices.

In the event that the condition worsens, or if symptoms persist for more than 7 days, or clear up and then recur within a few days, patients are advised to stop use and consult a healthcare professional. Furthermore, pregnant or breastfeeding individuals should seek guidance from a health professional prior to using this product.

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 Cold Therapy Pain Relief (menthol 4%). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should consult a physician prior to use. For adolescents and children aged 12 years and older, the recommended application is to the affected areas not more than 3-4 times daily.

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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and breastfeeding safety. Healthcare providers should consider individual circumstances and the specific needs of the patient when making recommendations.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding the excretion of this drug in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the lack of specific guidance necessitates careful clinical judgment and monitoring of these patients.

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 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, as the clinical presentation can vary depending on the substance involved and the individual patient's response. Common symptoms of overdose may include, but are not limited to, altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

In the event of an overdose, immediate medical intervention is recommended. Healthcare providers should initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and ensuring adequate circulation. The use of activated charcoal may be considered if the patient presents within a suitable timeframe and is deemed appropriate based on clinical judgment.

Additionally, it is crucial to consult local poison control centers or toxicology experts for guidance on specific management protocols and antidotes, if applicable. Continuous monitoring and supportive care should be maintained until the patient stabilizes or further treatment is determined.

In summary, while specific overdosage information is not available, healthcare professionals should remain vigilant and prepared to implement standard overdose management strategies in any suspected cases.

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 provided in the insert.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. It is important to emphasize the potential risks associated with accidental ingestion. In such cases, patients should be instructed to seek medical help or contact a Poison Control Center immediately. This guidance is crucial for ensuring patient safety and minimizing the risk of harm.

Storage and Handling

The product is supplied in a configuration that ensures optimal preservation of its integrity. It is essential to store the product in a cool, dry place, ensuring that the lid is closed tightly to prevent contamination and maintain efficacy. Proper storage conditions are critical for the product's stability and longevity.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)