Meijer Small Cold-Hot Medicated Patches

Description

This product is distributed by Meijer Distribution, Inc., located in Grand Rapids, MI 49544.

Uses and Indications

This drug is indicated for the temporary relief of minor pain associated with various musculoskeletal conditions, including 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 over 12 years of age should carefully remove the backing from the patch and apply the sticky side directly to the affected area. Each patch may be worn for a maximum of 8 hours. If necessary, the application may be repeated, but no more than four patches should be applied in a 24-hour period. After opening, the pouch should be resealed to maintain the integrity of the remaining patches.

For children 12 years of age or younger, it is recommended to consult a physician prior to use.

Contraindications

Use of this product is contraindicated in the following situations:

• Tight bandaging or application with a heating pad is not recommended, as this may lead to adverse effects.

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

• Application to wounds or damaged skin is contraindicated due to the risk of exacerbating the condition or causing further harm.

Warnings and Precautions

For external use only. Healthcare professionals should advise patients to discontinue use and consult a physician under the following circumstances: if the condition worsens, if redness occurs, if irritation develops, or if symptoms persist for more than 7 days or resolve only to recur within a few days.

In the event of accidental ingestion, it is imperative to seek emergency medical assistance or contact a Poison Control Center immediately.

Side Effects

Patients should be aware that the product is intended for external use only. In the event of worsening conditions, the presence of redness, the development of irritation, or if symptoms persist for more than 7 days or resolve and then recur within a few days, it is advised to stop use and consult a healthcare professional. These reactions warrant careful monitoring to ensure patient safety and effective management of any adverse effects.

Drug Interactions

No drug interactions or drug and laboratory test interactions have been identified in the available data. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Meijer Small Cold-Hot Medicated Patches (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients 12 years of age or younger should consult a physician prior to use. It is essential for healthcare professionals to evaluate the appropriateness of treatment in this age group, considering potential differences in dosage and safety profiles compared to older populations.

Geriatric Use

Elderly patients may not have specific dosage adjustments, safety concerns, or special precautions outlined in the drug insert for Meijer Small Cold-Hot Medicated Patches. As such, healthcare providers should exercise caution when recommending this product to geriatric patients, considering the lack of targeted clinical data for this population.

It is advisable for healthcare providers to monitor elderly patients closely for any adverse effects or unusual responses when using this product, given the absence of established guidelines for geriatric use.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional before using this medication. The potential risks and benefits must be carefully considered in these populations to ensure the safety of both the mother and the fetus or infant.

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 prescribing information. Therefore, healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the lack of detailed guidance necessitates careful clinical judgment and individualized patient assessment. Regular monitoring of renal function is advisable to ensure patient safety and therapeutic efficacy.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of 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 available information.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise, as the clinical presentation can vary depending on the substance involved and the individual patient's response. Common symptoms of overdose may include, but are not limited to, altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs. The use of activated charcoal may be considered if the patient presents within a suitable timeframe and if the ingestion was recent.

Furthermore, specific antidotes or treatments may be indicated based on the substance involved in the overdose. Consultation with a poison control center or a medical toxicologist is recommended to guide the management of the patient effectively.

Overall, vigilance and prompt intervention are critical in managing cases of suspected overdose, even in the absence of detailed information regarding specific overdosage effects.

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 compound in these areas.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to use the medication only as directed. It is important to emphasize that patients should not bandage the area tightly or use a heating pad in conjunction with the treatment, as this may lead to adverse effects.

Patients should be informed to avoid contact with the eyes and mucous membranes to prevent irritation or injury. Additionally, healthcare providers should instruct patients not to apply the medication to wounds or damaged skin, as this could compromise healing or exacerbate the condition.

Storage and Handling

The product is supplied in a resealable pouch, which should be securely resealed after each use to maintain product integrity. It is essential to keep the product out of reach of children to ensure safety during storage and handling.

Additional Clinical Information

The route of administration for the medication is topical. For adults and children over 12 years, the patch should be applied by carefully removing the backing and placing the sticky side on the affected area. Each patch can be worn for up to 8 hours, with a maximum of 4 applications per day. For children aged 12 years or younger, consultation with a physician is recommended prior to use.

Clinicians should counsel patients to use the medication only as directed. It is important to avoid tight bandaging or the use of heating pads in conjunction with the patch. Patients should also be advised to keep the patch away from eyes and mucous membranes, and not to apply it to wounds or damaged skin. Pregnant or breastfeeding patients should seek advice from a health professional before using the product.

Drug Information (PDF)

This file contains official product information for Meijer Small Cold-Hot Medicated Patches, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)