Painfix Restore

Description

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

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 patch application. The pouch should be opened to remove the patch, after which the protective backing must be peeled off. The sticky side of the patch should be carefully applied to the affected area. In cases where the affected area is large, multiple patches may be used to achieve optimal results. Each patch is designed for use for a maximum of 15 hours and should be replaced with a new patch daily. For smaller areas, the patch may be cut to fit appropriately. For enhanced effectiveness, it is recommended that the patch be used in conjunction with prescribed exercises.

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

Contraindications

Use is contraindicated in children due to the risk of accidental ingestion. In the event of accidental swallowing, immediate medical assistance or contact with a Poison Control Center is advised.

Warnings and Precautions

Direct contact with the eyes must be avoided, as this product is intended for external use only. Healthcare professionals should advise patients to use the product strictly as directed, ensuring that it does not come into contact with the eyes or mucous membranes. 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.

Patients should be instructed to discontinue use and consult a healthcare provider if the 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, medical advice should be sought.

For individuals who are pregnant or breastfeeding, it is essential to consult a healthcare professional prior to using this product.

This product should be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center should be made.

Side Effects

Patients using this product should be aware of several important warnings and precautions. Direct contact with the eyes must be avoided, as the product is intended for external use only. It is crucial that patients use the product strictly as directed, ensuring that it does not come into contact with eyes or mucous membranes. Additionally, patients should refrain from applying local heat to the area of use and should not apply the product to wounds, broken, damaged, or irritated skin.

In the event that a patient's condition worsens or symptoms persist for more than 7 days, it is advised to stop use and consult a healthcare professional. Patients should also discontinue use if they experience skin irritation or signs of skin injury, such as pain, swelling, or blistering at the site of application.

For pregnant or breastfeeding individuals, it is recommended to seek advice from a health professional prior to using this product.

Drug Interactions

There are no specific drug interactions identified for this medication. Additionally, no laboratory test interactions have been noted in the available data. 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 and younger should consult a healthcare professional before use. For adolescents and children over 12 years, each patch may be used for a maximum of 15 hours, with a new patch applied daily.

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, given the lack of targeted data.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is no specific data available regarding the excretion of this medication in 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 renal impairment, including dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of specific guidance when treating patients with renal impairment.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials for this medication. Consequently, there is no available information regarding dosage adjustments, special monitoring requirements, or precautions 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 warranted based on clinical judgment.

Overdosage

In the event of an overdosage, immediate medical intervention is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical assistance or contact a Poison Control Center without delay.

Prompt action is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved; therefore, a thorough assessment by a medical professional is recommended to determine the appropriate course of action and management strategies.

Healthcare providers should ensure that patients are aware of the importance of timely reporting of any suspected overdosage to facilitate effective treatment and minimize risks.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. It is important to emphasize that if the medication is swallowed, patients should seek medical help or contact a Poison Control Center immediately. This guidance is crucial to ensure the safety and well-being of patients and their families.

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 kept away 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 product is administered topically, with each patch intended for use for up to 15 hours. Patients should apply a new patch daily. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. Additionally, it is important to keep the patches out of reach of children; if a patch is swallowed, medical assistance or contact with a Poison Control Center is necessary.

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)