Meijer Cold Therapy Pain Relieving

Description

This product, identified by NDC 79481-0087-1, is a pain-relieving gel marketed under the meijer® brand, formulated for cold therapy. It contains menthol as the active ingredient at a concentration of 4%, serving as a topical analgesic. The gel is indicated for the relief of backache, muscle pain, and joint pain, providing a cooling sensation upon application. The product is available in a dosage form of 3 fluid ounces (89 mL) and is comparable to Biofreeze® Pain Relief Gel.

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 simple backache, arthritis, strains, bruises, and sprains. It is specifically indicated for the management of backache, muscle pain, and joint pain.

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

Dosage and Administration

For adults and children aged 6 years and older, the recommended application is to the affected area not more than 3 to 4 times daily. It is not necessary to massage the area after application.

The product is contraindicated for use in children under 6 years of age.

Contraindications

The product is contraindicated in the following situations:

Application to wounds or damaged skin is prohibited due to the potential for adverse effects. The use of this product in conjunction with other ointments, creams, sprays, or liniments is not recommended, as it may lead to unpredictable interactions. It should not be applied to irritated skin or if excessive irritation develops, as this may exacerbate the condition. Additionally, tight bandaging is contraindicated to prevent complications. The use of heating pads or heating devices in conjunction with this product is also not advised, as it may increase the risk of adverse reactions.

Warnings and Precautions

For external use only. Healthcare professionals should advise patients to consult a physician prior to use if they have sensitive skin.

When utilizing this product, it is imperative to avoid contact with the eyes. The application should not occur on wounds or damaged skin, and it is contraindicated to use this product in conjunction with other ointments, creams, sprays, or liniments. Patients should refrain from applying the product to irritated skin or if excessive irritation develops. Additionally, tight bandaging of the area post-application is not recommended. It is essential for users to wash their hands thoroughly with cool water after application and to avoid the use of heating pads or heating devices concurrently.

Patients should be instructed to discontinue use and seek medical advice if their condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days.

This product is flammable; therefore, it must be kept away from fire or flame. It is crucial to keep this product out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center (1-800-222-1222) is advised.

For individuals who are pregnant or breastfeeding, consultation with a healthcare professional is recommended prior to use.

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 and to refrain from applying the product to wounds or damaged skin. The product should not be used in conjunction with other ointments, creams, sprays, or liniments, nor should it be applied to irritated skin or if excessive irritation develops. Additionally, patients are advised not to bandage the area tightly and to wash their hands with cool water after application. The use of heating pads or heating devices in conjunction with this product is also not recommended.

Patients should 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.

For individuals who are pregnant or breastfeeding, it is advisable to seek guidance from a health professional prior to use. The product should be kept out of reach of children, and in the event of accidental ingestion, medical assistance should be sought immediately or contact with a Poison Control Center (1-800-222-1222) should be made. It is also important to note that the product is flammable and should be kept away from fire or flame.

Drug Interactions

Co-administration of this medication with other topical formulations, such as ointments, creams, sprays, or liniments, is contraindicated. The use of heating pads or other heating devices in conjunction with this medication is also not recommended, as it may lead to adverse effects.

There are no specific interactions identified with laboratory tests associated with this medication. Therefore, no adjustments or special monitoring are required in this context.

Packaging & NDC

Below are the non-prescription pack sizes of Meijer Cold Therapy Pain Relieving (menthol, unspecified form). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 6 years and older may apply the medication to the affected area up to 3-4 times daily, without the need for massage. The safety and efficacy of this medication have not been established in children under 6 years of age; therefore, its use is not recommended in this population.

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 evaluate the potential risks and benefits associated with the use of this drug during pregnancy and lactation. Healthcare providers should consider the available data and individual patient circumstances when advising on the use of this medication in these populations.

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 no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to 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 prescribing information.

Overdosage

In the event of an overdosage, immediate medical assistance is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical help without delay. It is recommended to contact a Poison Control Center at 1-800-222-1222 for expert guidance.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and evaluation are recommended to ensure patient safety and effective recovery.

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 these contexts.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children. Instruct patients that if the product is swallowed, they should seek medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Patients should be informed to stop using the product and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days.

When using this product, patients should be cautioned to avoid contact with the eyes and not to apply it to wounds or damaged skin. It is important to inform patients that they should not use the product in conjunction with other ointments, creams, sprays, or liniments. Additionally, patients should refrain from applying the product to irritated skin or if excessive irritation develops. They should also be advised against tightly bandaging the area after application.

Patients should wash their hands with cool water after using the product and should not use it with heating pads or heating devices. Furthermore, healthcare providers should encourage patients to ask a doctor before use if they have sensitive skin.

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

Patients aged 6 years and older are advised to apply the medication to the affected area no more than 3-4 times daily, without the need for massage. The product is not recommended for children under 6 years of age.

Clinicians should counsel patients that the medication is for external use only. Patients should consult a doctor prior to use if they have sensitive skin, are pregnant, or are breastfeeding. It is important to avoid contact with the eyes and not to apply the product to wounds, damaged, or irritated skin. Patients should refrain from using other ointments, creams, sprays, or liniments concurrently, and should not bandage the area tightly. After application, hands should be washed with cool water, and the use of heating pads or devices should be avoided. Patients should discontinue use and seek medical advice if their condition worsens, symptoms persist beyond 7 days, or if symptoms recur shortly after resolution. The product should be kept away from fire or flame and out of reach of children. In case of ingestion, immediate medical assistance or contact with a Poison Control Center is necessary.

Drug Information (PDF)

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

View product document (PDF)