Painfix Restore

Description

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

Uses and Indications

This drug is indicated for the temporary relief of aches and pains in joints and muscles associated with various conditions, including backache, arthritis, bursitis, tendonitis, cramps, strains, bruises, and sprains.

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

Dosage and Administration

Adults and children over 12 years of age should follow these instructions for application. Open the pouch and remove the patch. Peel off the protective backing and carefully apply the sticky side of the patch to the affected area. If the affected area is large, it is recommended to use more than one patch to achieve optimal results. Each patch may be used for a maximum duration of 15 hours. A new patch should be applied each day. To enhance adherence, the provided adhesive plasters may be utilized to keep the patch securely in place. For best therapeutic outcomes, it is advisable to combine patch use with the recommended exercises.

For children 12 years and younger, consultation with a healthcare professional is required prior to use.

Contraindications

The application of this product is contraindicated in the following situations:

Local heat should not be applied to the area of use, as this may exacerbate adverse effects. Additionally, the product must not be applied to wounds, broken, damaged, or irritated skin due to the potential for increased irritation or adverse reactions.

Warnings and Precautions

Direct contact with the eyes must be avoided, as the product is intended for external use only. Healthcare professionals should ensure that patients are instructed to use the product strictly as directed to minimize the risk of adverse effects.

It is imperative to avoid contact with eyes and mucous membranes during application. Additionally, local heat should not be applied to the area of use, and the product should not be applied to wounds, broken, damaged, or irritated skin to prevent further complications.

Patients should be advised to discontinue use and seek medical attention if their condition worsens or if symptoms persist for more than 7 days. Furthermore, if skin irritation occurs or if signs of skin injury—such as pain, swelling, or blistering—develop at the site of application, immediate consultation with a healthcare provider is recommended.

In the event of accidental ingestion, patients should seek emergency medical assistance or contact a Poison Control Center without delay.

Side Effects

Patients using this product should be aware of several important safety considerations. Direct contact with the eyes must be avoided, and the product is intended for external use only. It is crucial to use the product strictly as directed and to refrain from applying it to wounds, broken, damaged, or irritated skin. Additionally, local heat should not be applied to the area of use.

In clinical practice, patients are advised to discontinue use and consult a healthcare professional if their condition worsens or if symptoms persist for more than 7 days. Signs of skin irritation, such as pain, swelling, or blistering at the application site, warrant immediate medical attention.

Furthermore, this product should be kept out of reach of children. In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center without delay. Pregnant or breastfeeding individuals are encouraged to consult a healthcare professional prior to using this product to ensure safety for both themselves and their child.

Drug Interactions

No specific drug interactions have been identified for this medication. Additionally, there are no reported interactions with laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Painfix Restore (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients 12 years of age and younger should consult a healthcare professional before use. It is important to assess the appropriateness of treatment and dosage for this age group, as specific recommendations may vary based on individual health needs and conditions.

Geriatric Use

There is no specific information 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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. Healthcare providers should consider individual circumstances and the specific needs of the patient when making recommendations.

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 medication in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

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 substance has been ingested.

Symptoms of overdosage may vary depending on the specific substance involved; therefore, a thorough assessment of the patient's condition is essential. Prompt recognition of symptoms can facilitate timely intervention and management.

Management of overdosage should be guided by the clinical presentation and may include supportive care and symptomatic treatment. Continuous monitoring of the patient's vital signs and overall status is recommended to ensure appropriate responses to any emerging complications.

In all cases of suspected overdosage, the involvement of medical professionals is crucial to determine the best course of action and to mitigate potential risks associated with the incident.

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 seek immediate medical assistance or contact a Poison Control Center if the product is swallowed. It is important to instruct patients to discontinue use and consult a doctor if their condition worsens or if symptoms persist for more than 7 days.

Patients should also be informed to stop using the product and seek medical advice if they experience any skin irritation or signs of skin injury, such as pain, swelling, or blistering at the application site. Emphasize the necessity of using the product only as directed to ensure safety and efficacy.

Providers should caution patients to avoid contact with the eyes and mucous membranes, as this could lead to adverse effects. Additionally, patients should be advised against applying local heat to the area where the product is used, as this may exacerbate any potential side effects.

Finally, it is crucial to inform patients not to apply the product to wounds, broken, damaged, or irritated skin to prevent further complications.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product in a cool, dry place, ensuring it is protected from direct sunlight to maintain its integrity and efficacy. Proper storage conditions are crucial for preserving the quality of the product throughout its shelf life.

Additional Clinical Information

The medication is administered topically, with each patch intended for use for up to 15 hours. Patients are advised to apply a new patch daily. Clinicians should counsel patients to consult a health professional if they are pregnant or breastfeeding before using the product. No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Painfix Restore, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)