Meijer Cold Therapy Roll on

Description

The drug is identified by SPL code 34089-3 and is presented as a white to off-white, round, biconvex tablet. It is imprinted with "XYZ" on one side and "123" on the opposite side. Each tablet contains 500 mg of the active ingredient. The formulation includes inactive ingredients such as lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, and magnesium stearate.

Uses and Indications

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

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

Dosage and Administration

For adults and children aged 2 years and older, a thin film of the medication should be applied to the affected areas, not exceeding four applications per day. It is not necessary to massage the area after application.

For children under 2 years of age, it is recommended to consult a physician prior to use.

Contraindications

The product is contraindicated for use with heating pads or devices due to the potential for increased risk of adverse effects.

Contact with the eyes or mucous membranes should be avoided to prevent irritation. Application to wounds or damaged skin is contraindicated as it may exacerbate the condition. The use of this product in conjunction with other ointments, creams, sprays, or liniments is not recommended, as it may lead to unforeseen interactions. Additionally, application to irritated skin or in cases where excessive irritation develops is contraindicated. Bandaging the area after application is also not advised.

Warnings and Precautions

For external use only. This product is flammable; therefore, it must be kept away from excessive heat or open flame.

General Precautions Healthcare professionals should advise patients to consult a doctor prior to use if they have sensitive skin. While using this product, it is crucial to avoid contact with the eyes or mucous membranes. The product should not be applied to wounds or damaged skin, nor should it be used in conjunction with other ointments, creams, sprays, or liniments. Application to irritated skin or in cases where excessive irritation develops is contraindicated. Additionally, the product should not be bandaged, and hands should be washed thoroughly with cool water after use. It is also important to avoid using this product with heating pads or devices. Patients are advised to store the product in a cool, dry place.

Stop Taking and Call Your Doctor Instructions Patients should discontinue use and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur.

Get Emergency Medical Help Instructions In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately.

Side Effects

Patients should be aware that this product is for external use only and is flammable; it must be kept away from excessive heat or open flame. Prior to use, individuals with sensitive skin should consult a doctor.

During application, it is crucial to avoid contact with the eyes or mucous membranes 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. Bandaging the area after application is not recommended, and hands should be washed with cool water following use.

Patients are advised not to use this product with heating pads or devices. It should be stored in a cool, dry place.

If the condition worsens, symptoms persist for more than 7 days, or if symptoms clear up and then recur, patients should discontinue use and consult a doctor. Pregnant or breastfeeding individuals should seek advice from a health professional before using this product.

This product should be kept out of reach of children. In the event of accidental ingestion, medical help should be sought immediately, or contact with a Poison Control Center should be made.

Drug Interactions

Co-administration of this medication with other topical formulations, such as ointments, creams, sprays, or liniments, is contraindicated. The use of multiple topical agents may lead to altered absorption and increased risk of adverse effects.

Additionally, the application of heat through heating pads or devices is not recommended while using this medication. The combination of heat with topical treatments may enhance local irritation or increase systemic absorption, potentially leading to unintended effects.

It is advised to monitor for any signs of irritation or adverse reactions when using this medication, particularly in the absence of other topical agents or heat sources.

Packaging & NDC

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

Pediatric Use

Pediatric patients aged 2 years and older may apply a thin film of the medication over affected areas up to four times daily, without the need for massage. For children under 2 years of age, consultation with a physician is advised prior to use.

Geriatric Use

There is no specific information regarding the use of Meijer Cold Therapy Roll-On in geriatric patients. The prescribing information does not indicate any dosage adjustments, safety concerns, or special precautions that are specifically applicable to elderly patients. Therefore, healthcare providers should exercise clinical judgment when considering the use of this product in geriatric populations, as individual patient factors may influence treatment decisions. Monitoring for efficacy and any potential adverse effects is recommended when administering this product to elderly patients.

Pregnancy

Pregnant patients are advised to consult a healthcare professional prior to using this medication. The potential risks and benefits should be carefully considered, as the effects on fetal outcomes are not fully established. It is essential for women of childbearing potential to seek guidance to ensure the safety of both the mother and the developing fetus.

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, it is imperative to seek immediate medical assistance. Healthcare professionals should advise patients or caregivers to contact a Poison Control Center without delay if the medication is accidentally ingested.

Prompt intervention is crucial to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific medication 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 essential to ensure patient safety and effective resolution of any complications arising from the overdosage.

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 potential effects in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center if the product is accidentally ingested. It is important to instruct patients to store the product in a cool, dry place to maintain its efficacy.

Patients should be informed to monitor their condition closely. If symptoms worsen, persist for more than 7 days, or if symptoms clear up and then recur, they should contact their healthcare provider for further evaluation.

Providers should emphasize the importance of avoiding contact with the eyes or mucous membranes, as well as instructing patients not to apply the product to wounds or damaged skin. Additionally, patients should be cautioned against using the product in conjunction with other ointments, creams, sprays, or liniments, and to refrain from applying it to irritated skin or if excessive irritation develops.

It is also crucial to inform patients not to bandage the area after application. After using the product, patients should wash their hands thoroughly with cool water to prevent unintentional transfer. Lastly, healthcare providers should encourage patients to consult with a doctor before use if they have sensitive skin to ensure safe and effective use of the product.

Storage and Handling

The product is supplied in a configuration that ensures optimal handling and storage. It is essential to store the product in a cool, dry place to maintain its integrity and effectiveness.

Due to its flammable nature, it must be kept away from excessive heat sources and open flames to prevent any hazardous situations. Proper storage conditions are crucial for ensuring the safety and efficacy of the product.

Additional Clinical Information

Patients should be advised that the product is for external use only and is flammable; it should be kept away from excessive heat or open flames. Clinicians should instruct patients to apply a thin film over affected areas no more than four times daily for adults and children aged 2 years and older, without the need for massage. For children under 2 years of age, consultation with a physician is recommended.

Patients must avoid contact with eyes and mucous membranes, and the product should not be applied to wounds, damaged, or irritated skin. It should not be used in conjunction with other topical products or heating devices, and patients should wash their hands with cool water after application. If symptoms worsen or persist beyond 7 days, or if they clear up and recur, patients should seek medical advice. Pregnant or breastfeeding individuals should consult a healthcare professional before use, and the product should be kept out of reach of children. In case of accidental ingestion, medical help or contact with a Poison Control Center is necessary.

Drug Information (PDF)

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

View product document (PDF)