Meijer Cold Therapy Pain Relief

Description

The product is identified by the SPL code 34089-3. No additional specific description details are provided in the available text.

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.

Limitations of Use: There are no reported 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

Use of this product is contraindicated in the following situations:

The product should not be used in conjunction with heating pads or devices due to the potential for increased risk of burns or skin irritation.

Contact with the eyes or mucous membranes must be avoided to prevent irritation or injury. Application to wounds or damaged skin is contraindicated as it may exacerbate the condition or lead to infection.

The use of this product with other ointments, creams, sprays, or liniments is not recommended, as it may lead to adverse reactions or reduced efficacy. Additionally, application to irritated skin or in cases where excessive irritation develops is contraindicated.

Bandaging the area after application is also not advised, as it may trap heat and moisture, increasing the risk of skin irritation.

Warnings and Precautions

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

Healthcare professionals should advise patients to consult a doctor prior to use if they have sensitive skin. During the application of 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. Additionally, it is important to refrain from applying the product to irritated skin or if excessive irritation develops. Bandaging the area after application is not recommended. Patients should wash their hands with cool water after use to prevent unintended contact with other areas of the body.

In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center should be contacted.

Patients are advised to 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. No specific laboratory tests are required for the safe use of this product.

Side Effects

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

While using this product, it is important to avoid contact with the eyes or mucous membranes and not to apply it 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 after use.

Patients should refrain from using this product with heating pads or devices and should store it 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 are advised to stop use and consult a doctor.

For pregnant or breastfeeding individuals, it is recommended to seek advice from a health professional before use. Additionally, 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 is advised.

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 this medication in conjunction with heating pads or devices is not recommended. The use of heat may enhance the absorption of the medication, potentially leading to increased systemic exposure and heightened risk of side effects.

Healthcare professionals should ensure that patients are advised against these combinations to maintain safety and efficacy.

Packaging & NDC

Below are the non-prescription pack sizes of Meijer Cold Therapy Pain Relief (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 product 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.

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

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 before using this medication. The safety of this drug during pregnancy has not been established, and potential risks to fetal outcomes are not fully known. Therefore, it is essential for women of childbearing potential to seek medical advice prior to use to ensure appropriate management and consideration of any potential risks.

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 may not have specific dosage adjustments, special monitoring, or safety considerations outlined in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of detailed information necessitates careful clinical judgment. Regular monitoring of renal function may be advisable to ensure patient safety and therapeutic 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 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.

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 not to use the product in conjunction with heating pads or devices, as this may lead to adverse effects.

Patients should be informed to store the product in a cool, dry place to maintain its efficacy. They should be cautioned to 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.

When using this product, healthcare providers should emphasize the importance of avoiding contact with the eyes and mucous membranes. Patients should not apply the product to wounds or damaged skin, nor should they use it alongside other ointments, creams, sprays, or liniments. It is also crucial to advise against applying the product to irritated skin or if excessive irritation develops. Patients should refrain from bandaging the area after application and should wash their hands with cool water after use.

Additionally, healthcare providers should recommend that patients consult a doctor before using the product if they have sensitive skin, to ensure safe and effective use.

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

The medication is administered topically, with a recommended application of a thin film over affected areas for adults and children aged 2 years and older, not exceeding four times daily. Massage of the area is not necessary. For children under 2 years of age, consultation with a physician is advised prior to use.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)