Painfix Relief

Description

PainFix-1 is presented in a media type of image/jpeg, with the image reference number 72749001-1.

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, cramps, strains, bruises, and sprains.

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

Dosage and Administration

For adults and children over 12 years of age, the recommended dosage involves applying the gel to the affected area(s) and gently massaging it into the skin until it is thoroughly absorbed. This application may be repeated up to 3 to 4 times per day, as needed. Following the application, it is essential to wash hands with soap and water to prevent unintentional contact with other areas of the body or surfaces.

For children 12 years and younger, it is advised to consult a healthcare professional for appropriate dosing and administration guidance.

Contraindications

Use is contraindicated in the event of accidental ingestion. If swallowed, seek medical assistance or contact a Poison Control Center immediately. No other contraindications are noted.

Warnings and Precautions

Direct contact with the eyes must be avoided when using this product, which is intended for external use only. Healthcare professionals should advise patients to adhere strictly to the usage instructions provided. It is imperative to avoid contact with the 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.

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 promptly.

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 without delay.

Side Effects

Patients using this product should be aware of several important warnings and precautions. Direct contact with the eyes must be avoided, and the product is intended for external use only. It is crucial that patients use the product only as directed, steering clear of contact with 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.

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 skin irritation develops or if they experience signs of skin injury, such as pain, swelling, or blistering at the site of application.

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

Drug Interactions

There are no reported drug interactions associated with the use of this medication. Additionally, no interactions with laboratory tests have been identified. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Painfix Relief (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 adults over 12 years, the recommended application involves applying the gel to the affected area(s) and gently massaging until fully absorbed into the skin. This can be repeated up to 3 to 4 times per day, as needed.

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. The potential risks and benefits must be carefully considered in these populations to ensure the safety of both the mother and the fetus or infant.

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

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 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 typically involves supportive care and symptomatic treatment. Healthcare providers should monitor the patient closely and implement appropriate measures based on the clinical presentation. It is crucial to follow established protocols for the specific substance involved to ensure optimal patient outcomes.

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 keep this 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 for ensuring 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

Patients aged 12 years and older should apply the gel to the affected area(s) and massage gently until it is thoroughly absorbed into the skin. This application can be repeated up to 3 to 4 times per day, as needed. There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)