Medicated Pain Relief Patches

Description

This product is identified by the National Drug Code (NDC) 55301-907-60 and is packaged in a box containing 60 units. It is manufactured for Your Military Exchangers by Veridian Healthcare, located in Gurnee, IL 60031.

For optimal storage, it is recommended to keep the product in a clean, dry place, away from direct sunlight and protected from excessive moisture.

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

Adults and children 12 years of age and over should begin by cleaning and drying the affected area thoroughly. The patch should then be removed from its protective film and applied directly to the affected area. It is recommended that the patch be applied no more than 3 to 4 times daily. Each application should not exceed 8 hours; the patch must be removed from the skin after this duration.

For children under 12 years of age, it is advised to consult a physician prior to use to determine appropriate treatment and dosage.

Contraindications

Use of this product is contraindicated in the following situations:

• Application on wounds or damaged skin is prohibited due to the potential for irritation and adverse effects.

• Concurrent use with a heating pad is not recommended, as it may increase the risk of skin burns or other complications.

• Individuals with known allergies to any ingredients in this product should refrain from use to prevent allergic reactions.

• Contact with eyes, mucous membranes, or rashes must be avoided to prevent irritation or adverse reactions.

• Tight bandaging is contraindicated, as it may lead to compromised circulation or increased local irritation.

• Simultaneous use with other topical analgesics is not advised, as it may enhance the risk of systemic absorption and potential side effects.

Warnings and Precautions

For external use only. Individuals with a known allergy to aspirin or salicylates should consult a healthcare professional prior to use to assess the risk of an allergic reaction.

It is imperative to avoid application on wounds or damaged skin, as this may exacerbate irritation or lead to adverse effects. The use of this product in conjunction with a heating pad is contraindicated, as it may increase the risk of skin irritation or burns. Additionally, individuals who are allergic to any of the product's ingredients should refrain from using it.

In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is advised.

Users should discontinue use and consult a healthcare provider if any of the following occur: the development of a rash, itching, or excessive skin irritation; worsening of the condition; or if symptoms persist for more than 7 days or resolve only to recur within a few days.

Side Effects

Patients should be aware of the potential for allergic reactions when using this medication, particularly if they have a history of sensitivity to aspirin or salicylates. It is advisable for these individuals to consult a healthcare professional prior to use.

In the event that patients experience a rash, itching, or excessive skin irritation, they should discontinue use and seek medical advice. Additionally, if the condition worsens or if symptoms persist for more than 7 days, or if symptoms resolve only to recur within a few days, it is important to consult a doctor for further evaluation and management.

Drug Interactions

Concurrent use of this medication with other topical analgesics is contraindicated. The combination may increase the risk of adverse effects without providing additional therapeutic benefit. It is advised to avoid using multiple topical analgesics simultaneously to ensure patient safety and optimal therapeutic outcomes. Monitoring for any signs of increased local irritation or systemic effects is recommended if there is a concern for inadvertent overlap in therapy.

Packaging & NDC

Below are the non-prescription pack sizes of 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. For adolescents aged 12 years and older, the recommended application involves cleaning and drying the affected area, followed by the removal of the patch from its film and application to the affected area. The patch may be applied no more than 3 to 4 times daily, with a maximum wear time of 8 hours per application.

It is crucial to dispose of used patches in a manner that prevents access by children and pets, as they still contain the drug product, which can lead to serious adverse effects if ingested. Additionally, the product should be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance or contact with a Poison Control Center is advised.

Geriatric Use

Geriatric patients have not been specifically addressed in the provided text. There are no recommended age considerations, dosage adjustments, safety concerns, or special precautions outlined for this population. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. Monitoring for efficacy and safety is advised, given the potential for altered pharmacokinetics and increased sensitivity in this demographic.

Pregnancy

The safety of this product during pregnancy has not been established. Pregnant patients or those planning to become pregnant should consult a healthcare provider before use. Potential risks to the fetus are not clearly defined; therefore, caution is advised. There are no specific dosage modifications for pregnant individuals; it is recommended that healthcare professionals be consulted for guidance. This product should only be used if clearly needed and after a thorough discussion with a healthcare professional regarding the potential risks and benefits.

Lactation

Lactating mothers should consult a doctor before using this product. There is a potential for excretion in breast milk, and the safety of this product during lactation has not been established. Caution is advised when using this product while breastfeeding.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the absence of detailed information necessitates careful clinical judgment and monitoring.

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 from excessive dosing. Symptoms of overdosage can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include monitoring vital signs, providing symptomatic treatment, and ensuring the patient's safety.

If available, consultation with a poison control center or a medical toxicologist is recommended to guide the management of the overdose. Additionally, healthcare professionals should refer to local protocols and guidelines for the management of overdose situations, as these may provide specific recommendations based on the substance involved.

Overall, vigilance and prompt intervention are critical in managing any case of suspected 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 question.

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 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 eyes, mucous membranes, or rashes, and should not bandage the area tightly. It is also crucial to inform patients not to use the product simultaneously with other topical analgesics.

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 used patches still contain the drug product that can 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 meets these conditions to maintain its integrity and effectiveness.

Healthcare professionals are advised to ensure that used patches are disposed of properly. It is crucial to keep used patches out of reach of children and pets, as they may still contain active drug components that could lead to serious adverse effects if ingested or chewed.

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. Patients 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 cause 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 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 Medicated Pain Relief Patches, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)