Meijer Roll-on Cold Therapy Pain Relieving

Description

Meijer® ROLL-ON Cold Therapy Pain Relieving Gel is a topical analgesic formulation designed to provide relief from pain associated with arthritis, back pain, and sore muscles and joints. The active ingredient, menthol, is present at a concentration of 4%. This product features a hands-free roll-on applicator for ease of use and is formulated without parabens. Each container holds 2.5 fluid ounces (74 mL) of the gel. This formulation is comparable to Biofreeze® Roll-On Pain Relief.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains.

Limitations of Use: 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, to prevent exacerbation of the condition. Additionally, tight bandaging is contraindicated, as it may restrict circulation. The use of heating pads or heating devices in conjunction with this product is also contraindicated due to the risk of increased irritation or burns.

Warnings and Precautions

For external use only. Prior to application, individuals with sensitive skin should consult a healthcare professional.

When utilizing this product, it is imperative to avoid contact with the eyes. The product must 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 is contraindicated, and if excessive irritation develops, use should be discontinued. Additionally, the product should not be bandaged tightly, and hands should be washed thoroughly with cool water following application. The use of heating pads or heating devices in conjunction with this product is not recommended.

Patients should cease use and seek medical advice if the 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 should be kept away from excessive heat and open flames. It is essential to keep this product out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact a Poison Control Center at 1-800-222-1222.

Side Effects

Patients using this product should be aware of several important safety warnings and potential adverse reactions. This product is intended for external use only and should not come into contact with the eyes. It is contraindicated for application on wounds or damaged skin, and should not be used in conjunction with other ointments, creams, sprays, or liniments. Additionally, patients should avoid applying the product to irritated skin or if excessive irritation develops. Bandaging should not be done tightly, and hands should be washed with cool water after application. The use of heating pads or heating devices in conjunction with this product is also not recommended.

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.

It is important to note that the product is flammable; therefore, it should be kept away from excessive heat or open 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 related to laboratory tests are necessary.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 6 years of age should not use this medication. For children aged 6 years and older, the recommended application is to the affected area not more than 3-4 times daily.

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. 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 medication 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 lack of data 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 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 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. Contacting a Poison Control Center at 1-800-222-1222 is recommended for further guidance and support.

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

There is currently no available information regarding teratogenic effects. Additionally, no data has been provided concerning non-teratogenic effects. The nonclinical toxicology section does not contain any relevant information at this time. Furthermore, there is no information available related to 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 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.

It is important to communicate that the product is flammable and should be kept away from excessive heat or open flames.

When using this product, patients should be cautioned to avoid contact with the eyes and not to apply it to wounds or damaged skin. They should not use the product in conjunction with other ointments, creams, sprays, or liniments, and should refrain from applying it to irritated skin or if excessive irritation develops. Additionally, patients should be advised not to bandage the area tightly and to wash their hands with cool water after use. They should also be informed not to use the product with heating pads or heating devices.

Finally, healthcare providers should recommend that patients 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. It is for external use only, and patients should consult a doctor prior to use if they have sensitive skin. Pregnant or breastfeeding individuals should seek advice from a health professional before use.

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 recur within a few days. The medication should be kept out of reach of children, and immediate medical help should be sought if swallowed. Contact with the eyes should be avoided, and the medication should not be applied to wounds, damaged, or irritated skin. It should not be used in conjunction with other ointments, creams, sprays, or liniments, nor should it be bandaged tightly or used with heating pads or devices. Patients are also advised to wash their hands with cool water after application.

Drug Information (PDF)

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

View product document (PDF)