Large Medicated Pain Relief Patches

Description

This product is distributed by Meijer Distribution, Inc., located in Grand Rapids, MI 49544. It is packaged in a box containing 60 units. The product should be stored in a clean, dry place, away from direct sunlight, and protected from excessive moisture to maintain its integrity.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains.

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

Dosage and Administration

For adults and children aged 12 years and over, the affected area should be cleaned and dried prior to application. The patch should be removed from its protective film and applied to the affected area. It is recommended that the patch be applied no more than 3 to 4 times daily. Each patch should be removed from the skin after a maximum application duration of 8 hours.

For children under 12 years of age, it is advised to consult a physician before use.

Contraindications

Use of this product is contraindicated in individuals with a known allergy to any of its ingredients.

Application on wounds or damaged skin is prohibited due to the potential for adverse reactions. The use of a heating pad concurrently with this product is also contraindicated, as it may increase the risk of skin irritation or burns.

Additionally, contact with the eyes, mucous membranes, or rashes should be avoided to prevent irritation. Tight bandaging is not recommended, and concurrent use with other topical analgesics is contraindicated to avoid potential interactions and increased side effects.

Warnings and Precautions

For external use only. Healthcare professionals should advise patients to consult a doctor prior to use if they have a known allergy to aspirin or salicylates, as this product may provoke an allergic reaction in susceptible individuals.

It is imperative to exercise caution when using this product. Patients should be instructed not to apply it to wounds or damaged skin, as this may exacerbate irritation or lead to adverse effects. Additionally, the use of heating pads in conjunction with this product is contraindicated, as it may increase the risk of skin irritation or burns. Patients with known allergies to any of the product's ingredients should refrain from use.

Patients should be advised to discontinue use and seek medical attention if they experience any rash, itching, or excessive skin irritation. Furthermore, if the condition being treated worsens or if symptoms persist beyond 7 days, or if symptoms resolve and then recur within a few days, patients should contact their healthcare provider for further evaluation.

In the event of accidental ingestion, immediate medical assistance should be sought, or the patient should contact a Poison Control Center without delay.

Side Effects

Patients should be aware of the potential for allergic reactions, particularly those with a known sensitivity to aspirin or salicylates. It is advised that such individuals consult a healthcare professional prior to use.

In clinical practice, patients are instructed to discontinue use and seek medical advice if they experience any of the following: rash, itching, or excessive skin irritation. Additionally, if the condition being treated worsens or if symptoms persist for more than seven days, or if they resolve and then recur within a few days, patients should also consult a doctor. These recommendations are crucial for ensuring patient safety and effective management of adverse reactions.

Drug Interactions

Concurrent use of this medication with other topical analgesics is contraindicated due to the potential for additive effects, which may increase the risk of adverse reactions. It is advised to avoid simultaneous application to ensure patient safety and efficacy of treatment.

No specific interactions with laboratory tests have been identified. Therefore, routine monitoring of laboratory parameters is not necessary when this medication is administered.

Packaging & NDC

Below are the non-prescription pack sizes of Large Medicated Pain Relief Patches (camphor, menthol, methyl salicylate). 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. It is essential to keep the product out of reach of children, as used patches still contain the drug and can pose serious risks if chewed or ingested. In the event of accidental ingestion, immediate medical assistance or contact with a Poison Control Center is advised.

For patients aged 12 years and older, the recommended application involves cleaning and drying the affected area before applying the patch. The patch should be applied to the affected area no more than 3 to 4 times daily and must be removed after a maximum of 8 hours. Proper disposal of used patches is crucial to prevent accidental exposure to children and pets.

Geriatric Use

There is no specific information available regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

The safety of this product during pregnancy has not been established. Pregnant patients or those planning to become pregnant should consult a physician before use. There may be potential risks to the fetus; however, specific studies or data regarding these risks are not provided in the prescribing information.

Healthcare professionals are advised to use this product only if clearly needed, weighing the potential risks against the benefits. No specific dosage modifications for pregnant individuals are mentioned in the available data.

Lactation

There are no specific warnings or recommendations regarding the use of this product by lactating mothers. Additionally, there are no statements concerning the potential for excretion in breast milk or any associated risks to breastfed infants during the use of this product.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

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 context of overdosage, it is important to note that there are currently no relevant details available regarding the overdosage of this medication (SPL code 34088-5). Healthcare professionals are advised to monitor patients closely for any unusual symptoms or adverse effects that may arise.

In the absence of specific overdosage information, standard supportive care measures should be implemented. This includes ensuring the patient's safety, providing symptomatic treatment, and considering the use of activated charcoal if the ingestion occurred within a suitable timeframe.

Healthcare providers should remain vigilant and report any observed adverse reactions to the appropriate regulatory authorities to contribute to the ongoing assessment of the medication's safety profile.

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

Postmarketing experience has identified the potential for serious adverse effects in cases where a child or pet chews or ingests a used patch, as these patches may still contain the drug product. This information has been reported voluntarily and through surveillance programs, highlighting the importance of proper disposal and storage of used patches to mitigate risks.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center if the product is swallowed. It is important to instruct patients not to apply the product on wounds or damaged skin, and to avoid using it in conjunction with a heating pad.

Patients should be informed that they must not use the product if they have a known allergy to any of its ingredients. They should be counseled to discontinue use and consult a doctor if they experience rash, itching, or excessive skin irritation. Additionally, patients should be advised to stop using the product and seek medical advice if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days.

When using the product, patients should be reminded to follow the directions carefully. They should avoid contact with the eyes, mucous membranes, or any rashes. It is also essential to inform patients not to bandage the area tightly and to refrain from using other topical analgesics simultaneously.

Finally, healthcare providers should emphasize the importance of proper disposal of used patches, ensuring that they are kept out of reach of children and pets, as these patches may still contain active drug substances that could lead to serious adverse effects if ingested.

Storage and Handling

The product is supplied in a clean, dry package designed to protect it from direct sunlight and excessive moisture. It is essential to store the product in a location that maintains these conditions to ensure its integrity and effectiveness.

After use, the patch must be disposed of properly to prevent access by children and pets, ensuring safety in the environment.

Additional Clinical Information

The route of administration for the product is topical. For adults and children aged 12 years and older, the affected area should be cleaned and dried before applying the patch, which can be used no more than 3 to 4 times daily. The patch should be removed after a maximum application time of 8 hours. For children under 12 years of age, consultation with a physician is advised.

Clinicians should counsel patients on several important safety measures. Individuals with a history of allergic reactions to aspirin or salicylates should consult a doctor prior to use. Used patches must be disposed of properly to prevent access by children and pets, as they still contain active drug that could lead to serious adverse effects if ingested. Patients should discontinue use and seek medical advice if they experience rash, itching, excessive skin irritation, worsening of their condition, or if symptoms persist beyond 7 days or recur shortly after resolution. Additionally, the product should be kept out of reach of children, and immediate medical assistance should be sought if swallowed.

Drug Information (PDF)

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

View product document (PDF)