Meijer Cold Therapy Pain Relief 360

Description

This formulation contains 85 grams of a topical analgesic designed for cold therapy pain relief, identified by NDC 52313-1112-1. The active ingredient, soothing menthol, is present at a concentration of 10.5%. The product is paraben-free and is indicated for the relief of arthritis, sore muscles, back pain, and joint discomfort. It features a vanishing scent and can be applied as a spray from any angle, enhancing ease of use.

Uses and Indications

This drug is indicated for the relief of pain associated with cold therapy in patients experiencing arthritis, sore muscles, back pain, and joint discomfort.

Pregnant or breastfeeding individuals are advised to consult a healthcare professional prior to use to assess potential teratogenic effects. No nonteratogenic effects have been mentioned.

Dosage and Administration

For adults and children aged 12 years and older, the recommended dosage is to spray the medication on the affected areas up to four times daily. It is not necessary to massage the area after application.

For children under 12 years of age, it is advised to consult a healthcare professional for appropriate dosing recommendations.

Contraindications

Use of this product is contraindicated in the following situations:

• The product should be kept out of reach of children to prevent accidental ingestion.

• In the event of accidental ingestion, immediate medical assistance or contact with a Poison Control Center is required.

Warnings and Precautions

For external use only, this product is flammable and should be kept away from excessive heat or open flame. It is important to note that the contents are under pressure; therefore, storage at temperatures exceeding 120ºF is strictly prohibited to prevent potential hazards.

To ensure the product's integrity and safety, it should be stored in a cool, dry place with the lid tightly closed. This precaution helps maintain the efficacy of the product and minimizes risks associated with improper storage.

In the event of accidental ingestion, immediate medical assistance is required. Healthcare professionals should advise patients to seek emergency medical help or contact a Poison Control Center without delay.

No specific laboratory tests are recommended for monitoring the use of this product, and there are no additional instructions regarding discontinuation or further consultation with a healthcare provider.

Side Effects

Patients should be aware that the product is for external use only and is flammable. It is essential to keep the product away from excessive heat or open flame, as the contents are under pressure. Additionally, the product should not be stored at temperatures exceeding 120ºF.

To ensure optimal safety and efficacy, it is recommended that the product be stored in a cool, dry place with the lid closed tightly. These precautions are critical to prevent adverse reactions associated with improper storage and handling.

Drug Interactions

No drug interactions or drug and laboratory test interactions have been identified for this product. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Meijer Cold Therapy Pain Relief 360 (cold therapy muscle). 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 dosage is to spray on the affected areas no more than four times daily; massage is not necessary.

It is important to keep this product out of reach of children. In the event of accidental ingestion, medical assistance should be sought immediately, or contact a Poison Control Center.

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 and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is essential to evaluate the potential risks and benefits associated with the use of this drug during pregnancy and lactation. The safety profile in these populations has not been fully established, and healthcare providers should consider individual circumstances when advising patients.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data on 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 information available regarding renal impairment, including dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function. Healthcare professionals should exercise caution and consider individual patient factors when treating patients with renal impairment, as specific recommendations are not provided.

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 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 initiate supportive care, which may include maintaining airway patency, ensuring adequate ventilation, and monitoring vital signs.

If available, the use of specific antidotes or treatments should be considered based on the clinical scenario and the substance involved. Consultation with a poison control center or a medical toxicologist may provide additional guidance on the management of overdose cases.

Documentation of the incident, including the amount and timing of the substance taken, is crucial for effective treatment and follow-up care.

Nonclinical Toxicology

There is no information available regarding teratogenic effects. For individuals who are pregnant or breastfeeding, it is advised to consult a health professional prior to use. Additionally, there is no information provided concerning nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of the reach of children to prevent accidental ingestion. It is important for patients to understand the potential risks associated with accidental ingestion. In the event that the medication is ingested, patients should be instructed to seek medical help or contact a Poison Control Center immediately. This information is crucial for ensuring patient safety and promoting appropriate responses in emergency situations.

Storage and Handling

The product is supplied in a container that must be stored in a cool, dry place with the lid closed tightly to maintain its integrity. It is essential to avoid temperatures exceeding 120ºF, as higher temperatures may compromise the product's quality. Additionally, the product should be kept away from excessive heat sources or open flames due to the contents being under pressure. Proper handling and storage conditions are crucial to ensure safety and efficacy.

Additional Clinical Information

The product is administered topically, with a recommended application of no more than four times daily. Massage of the affected areas is not necessary. Clinicians should advise patients that the product is for external use only and is flammable; it should be kept away from excessive heat or open flames. Patients must avoid contact with the eyes and mucous membranes, and should not apply it to wounds, damaged, or irritated skin. Bandaging the area is not recommended, nor should it be used in conjunction with heating pads or devices.

Patients are counseled to discontinue use and consult a healthcare professional if their condition worsens, if symptoms persist for more than seven days, or if symptoms resolve and then recur within a few days. Pregnant or breastfeeding individuals should seek advice from a health professional before use. The product should be kept out of reach of children, and in the event of accidental ingestion, medical assistance or contact with a Poison Control Center is advised.

Drug Information (PDF)

This file contains official product information for Meijer Cold Therapy Pain Relief 360, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)