Pain Relieving Patch Ultra Strength

Description

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

Uses and Indications

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

Limitations of Use: There are no noted teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Open the pouch and remove the patch. If necessary, the patch may be cut to size before application. Peel off the protective backing and apply the sticky side of the patch to the affected area.

For adults and children aged 12 years and older, the patch may be applied to the affected area no more than 3 to 4 times daily. For children under 12 years of age, it is advised to consult a doctor prior to use.

For optimal results, ensure that the skin is clean and dry before applying the patch. After use, reseal the pouch to maintain the integrity of the remaining patches.

Contraindications

The product is contraindicated for use in the following situations:

• Application on wounds or damaged skin is prohibited due to the risk of exacerbating the condition.

• Concurrent use with a heating pad or other heating devices is not recommended, as this may lead to increased irritation or adverse effects.

• The product should not be used in children under 12 years of age with arthritis-like conditions, as safety and efficacy have not been established in this population.

Additionally, discontinue use if the condition worsens, excessive skin irritation or redness occurs, or if symptoms persist for more than 7 days or recur within a few days.

Avoid contact with eyes and mucous membranes, and do not apply tight bandages over the treated area. Pregnant or breastfeeding individuals should consult a healthcare professional prior to use.

Warnings and Precautions

For external use only. This product is contraindicated for application on wounds or damaged skin. It should not be used in conjunction with a heating pad. Additionally, it is not recommended for use in children under 12 years of age who present with arthritis-like conditions.

Healthcare professionals should advise patients to discontinue use and seek medical attention if any of the following occur: worsening of the condition, excessive skin irritation, presence of redness, or if symptoms persist for more than 7 days or resolve only to recur within a few days. Pregnant or breastfeeding individuals are encouraged to consult with a healthcare professional prior to using this product.

It is imperative to keep this product out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is advised.

Side Effects

For external use only. Patients should discontinue use of this product if the condition worsens, excessive skin irritation occurs, redness is present, or if symptoms persist for more than 7 days or clear up and then recur within a few days.

It is advised that patients consult a doctor before using this product if they have redness over the affected area or if they are pregnant or breastfeeding.

Drug Interactions

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

Packaging & NDC

Below are the non-prescription pack sizes of Pain Relieving Patch Ultra Strength (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age with arthritis-like conditions should not use this medication. For children in this age group, it is advised to consult a healthcare professional prior to use.

For adolescents and children aged 12 years and older, the recommended application is to the affected area no more than 3 to 4 times daily.

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.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional before using this medication. It is important for women of childbearing potential to discuss their pregnancy status with their healthcare provider prior to use to ensure safety for both the mother and the fetus. The potential risks and benefits should be carefully evaluated in these populations.

Lactation

Lactating mothers are advised to consult a healthcare professional prior to using this medication. There is limited information available regarding the excretion of this drug in human breast milk and its effects on breastfed infants. Therefore, it is essential for lactating mothers to seek medical advice to ensure safety for both themselves and their nursing infants.

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 to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring of these patients.

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 available information.

Overdosage

In the absence of specific information regarding overdosage in the provided sections of the Summary of Product Characteristics (SPL), healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdosage.

Recommended Actions In the event of an overdosage, it is essential for healthcare providers to assess the patient's clinical status and initiate appropriate supportive care. Monitoring of vital signs and symptomatic treatment should be implemented as necessary.

Potential Symptoms While specific symptoms of overdosage are not detailed, healthcare professionals should remain vigilant for any unusual or severe reactions that may arise, given the pharmacological profile of the medication.

Management Procedures In the absence of specific antidotes or treatment protocols, healthcare professionals should consult local poison control centers or toxicology experts for guidance on the management of overdosage cases. It is crucial to document the incident thoroughly and report any adverse effects to the relevant regulatory authorities as per local guidelines.

Overall, the lack of detailed overdosage information underscores the importance of careful dosing and monitoring of patients receiving this medication.

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 text.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children. In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately.

Patients who are pregnant or breastfeeding should be encouraged to consult a healthcare professional prior to using this product.

When using this product, it is important to instruct patients to avoid contact with the eyes and mucous membranes. They should also be informed not to bandage the area tightly and to refrain from using the product in conjunction with a heating pad or other heating devices.

Healthcare providers should recommend that patients consult a doctor before use if they have redness over the affected area or if they are pregnant or breastfeeding.

Patients should be instructed to discontinue use of the product if their condition worsens, if excessive skin irritation occurs, if redness is present, or if symptoms persist for more than 7 days or clear up and then recur within a few days.

Storage and Handling

The product is supplied in a pouch that should be resealed after opening to maintain its integrity. It is essential to store the product at room temperature. To ensure safety, the product must be kept out of reach of children. Any unused portion should be discarded after opening.

Additional Clinical Information

The medication is administered topically, with adults and children aged 12 years and older advised to apply it to the affected area no more than 3 to 4 times daily. For children under 12 years of age, consultation with a doctor is recommended prior to use. Clinicians should counsel patients to ensure that the skin is clean and dry before application to achieve optimal results.

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

Drug Information (PDF)

This file contains official product information for Pain Relieving Patch Ultra Strength, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)