Cold Therapy Pain Relief Roll-on

Description

No relevant information is available for SPL code 34089-3.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains of muscles and joints associated with 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 essential to ensure that the application is performed gently and that the affected areas are clean and dry prior to use.

For children under 12 years of age, it is advised to consult a physician before administration to determine the appropriate course of action.

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, this product must be applied with caution to ensure safety and efficacy. Healthcare professionals should advise patients to avoid contact with the eyes and mucous membranes. It is imperative that the product is not applied to wounds, damaged skin, or areas of irritation. In addition, patients should be instructed not to bandage the area after application and to refrain from using the product in conjunction with heating pads or other heating devices.

Patients should be closely monitored for any signs of worsening conditions or persistent symptoms. If symptoms do not improve within 7 days, or if they resolve and then recur within a few days, it is essential to discontinue use and consult a healthcare provider. Special consideration should be given to pregnant or breastfeeding individuals, who should seek advice from a health professional prior to use.

In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay. It is crucial for healthcare providers to emphasize these warnings to ensure patient safety and to facilitate appropriate medical intervention when necessary.

Side Effects

Patients using this product should be aware that it is for external use only. It is crucial to avoid contact with the eyes or mucous membranes, and the product should not be applied to wounds, damaged skin, or irritated areas. Additionally, patients should refrain from bandaging the area after application and should not use the product in conjunction with heating pads or devices.

In clinical practice, patients are advised to discontinue use and consult a healthcare professional if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. Furthermore, it is recommended that individuals who are pregnant or breastfeeding seek guidance from a health professional prior to using this product.

Drug Interactions

There are no documented drug interactions associated with this medication. Additionally, there are no known interactions with laboratory tests. Therefore, no specific 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 Roll-on (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. 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

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 can offer guidance tailored to individual circumstances, ensuring the health and safety of both the patient and the fetus or infant.

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

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 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 from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

Additionally, it is recommended to consult local poison control centers or toxicology experts for guidance on specific management protocols and interventions tailored to the substance involved.

Documentation of the incident, including the amount ingested and the time of exposure, is crucial for effective treatment and follow-up care.

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 compound in these areas.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. In the event of accidental ingestion, patients should be instructed to seek medical help or contact a Poison Control Center immediately. It is essential for patients to understand the importance of these precautions to ensure their safety and the safety of others.

Storage and Handling

The product is supplied in a container that must be stored in a cool, dry place. It is essential to ensure that the lid is closed tightly to maintain the integrity of the product. Proper storage conditions are crucial for preserving the quality and efficacy of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)