Meijer Cold Therapy Pain Relieving

Description

The drug is classified as a cold therapy product, designed for therapeutic applications. The effective date for this product is August 1, 2024. The package label features a principal display panel that includes an image reference for the product, ensuring clear identification and usage guidance.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various musculoskeletal conditions. Specifically, it is effective for the management of arthritis, simple backache, bursitis, tendonitis, muscle strains, muscle sprains, bruises, and cramps.

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

Dosage and Administration

Adults and children aged 12 years and older should first clean and dry the affected area, ensuring it is free of lotions, ointments, and creams. The backing of the patch should be carefully removed, and the sticky side of the patch should be applied directly to the affected area. It is important to note that no more than one patch should be used within an 8-hour period, and the application may be repeated as necessary, with a maximum of three patches permitted per day. Each patch is for single use only and should be discarded after application.

For children under 12 years of age, consultation with a physician is recommended prior to use.

Contraindications

Use is contraindicated in the following situations:

• Application on infants is prohibited due to the potential for adverse effects.

• Tight bandaging or concurrent use with heating pads is not recommended, as this may exacerbate local irritation or discomfort.

• Contact with eyes and mucous membranes must be avoided to prevent irritation or injury.

• Application to wounds or damaged skin is contraindicated to reduce the risk of systemic absorption and local irritation.

• Concurrent use with other topical analgesics is not advised, as this may increase the risk of adverse reactions.

Warnings and Precautions

For external use only, this product must be utilized strictly as directed to ensure safety and efficacy. Healthcare professionals should be aware that rare cases of serious burns have been reported with similar products. It is imperative to avoid tight bandaging and the simultaneous use of heating pads when applying this product. Additionally, contact with the eyes and mucous membranes should be strictly avoided, and the product must not be applied to wounds or damaged skin. Concurrent use with other topical analgesics is contraindicated.

Patients should be advised to discontinue use and consult a healthcare provider if any of the following occur: worsening of the condition, presence of redness, development of irritation, persistence of symptoms beyond 7 days, or recurrence of symptoms after initial improvement. Signs of skin injury, such as pain, swelling, or blistering at the application site, also warrant immediate medical consultation.

In the event of accidental ingestion, it is crucial to seek emergency medical assistance or contact a Poison Control Center at 1-800-222-1222 without delay.

Side Effects

Patients using this product should be aware that it is intended for external use only. Rare cases of serious burns have been reported with similar products, highlighting the importance of adhering to the recommended usage guidelines. It is crucial to avoid contact with the eyes and mucous membranes, and the product should not be applied to wounds or damaged skin. Additionally, concurrent use with other topical analgesics is not advised.

Patients are instructed to discontinue use and consult a healthcare professional if any of the following occur: worsening of the condition, presence of redness, development of irritation, persistence of symptoms for more than 7 days, or if symptoms clear up and then recur within a few days. Signs of skin injury, such as pain, swelling, or blistering at the application site, also warrant immediate medical consultation.

Drug Interactions

Concurrent use of this medication with other topical analgesics is contraindicated. The combination may increase the risk of adverse effects without providing additional therapeutic benefit. It is advised to avoid using multiple topical analgesics simultaneously to ensure patient safety and optimal therapeutic outcomes. Monitoring for any signs of increased local irritation or systemic effects is recommended if there is a concern about inadvertent overlap in therapy.

Packaging & NDC

Below are the non-prescription pack sizes of Meijer Cold Therapy Pain Relieving (menthol). 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. The product is not recommended for infants. It is essential to keep the product out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center (1-800-222-1222) should be contacted.

For children aged 12 years and older, the application instructions are as follows: the affected area should be cleaned and dried, ensuring it is free of lotions, ointments, and creams. The backing of the patch should be carefully removed, and the sticky side should be applied to the affected area. No more than one patch should be used in an 8-hour period, with a maximum of three patches allowed per day. Each patch is for single use only and should be discarded after application.

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. The potential risks and benefits must be carefully considered, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use during pregnancy and breastfeeding.

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 drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed 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 on managing the situation.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Healthcare providers should be prepared to assess the patient's condition and implement appropriate management strategies based on the severity of symptoms and the specific substance involved.

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

Rare cases of serious burns have been reported with products of this type. These events were identified through voluntary reporting and surveillance programs. The nature of these reports does not imply a causal relationship, and further investigation may be warranted to understand the context of these occurrences.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children and to avoid using it on infants. In the event of accidental ingestion, patients should seek medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Patients should be instructed to stop using the product and consult a doctor if any of the following occur: the condition worsens, redness develops, irritation occurs, symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. Additionally, patients should seek medical attention if they experience signs of skin injury, such as pain, swelling, or blistering at the site of application.

When using this product, patients must use it only as directed. It is important to inform them that rare cases of serious burns have been reported with similar products. Patients should be cautioned not to bandage the area tightly or use a heating pad in conjunction with the product. They should also avoid contact with the eyes and mucous membranes, refrain from applying the product to wounds or damaged skin, and not use it simultaneously with other topical analgesics.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at room temperature, ensuring that the temperature does not exceed 86°F (30°C). Proper storage conditions are crucial to maintain the integrity and efficacy of the product.

Additional Clinical Information

No further data are available.

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)