Phizico Pain Relief

Description

No relevant information is available for SPL code 34089-3, and therefore, a detailed description cannot be provided.

Uses and Indications

This drug is indicated for the temporary relief of pain.

There are no teratogenic effects associated with this drug. Additionally, no nonteratogenic effects have been reported.

Dosage and Administration

For adults and children aged 2 years and older, the recommended application frequency is to apply the medication to the affected area no more than 3 to 4 times daily.

For children under 2 years of age, it is advised to consult a healthcare professional prior to use.

Contraindications

Use is contraindicated in the following situations:

Application on damaged or broken skin is prohibited due to the potential for adverse effects and impaired healing. Contact with the eyes must be avoided to prevent irritation or injury. Additionally, tight bandaging is contraindicated as it may lead to compromised circulation and increased risk of local tissue damage.

Warnings and Precautions

For external use only. This product should not be applied to damaged or broken skin, and contact with the eyes must be avoided. It is important to refrain from tightly bandaging the area where the product is applied.

Users are advised to discontinue use if a rash or irritation develops and persists. Additionally, if the condition worsens or if symptoms last longer than 7 days, or if symptoms resolve and then recur within a few days, the product should no longer be used.

In the event of accidental ingestion, immediate medical assistance should be sought, or the local Poison Control Center should be contacted without delay.

Pregnant or breastfeeding individuals are advised to consult a healthcare professional prior to using this product to ensure safety for both mother and child.

Side Effects

Patients using this product should be aware of several important safety considerations. This product is intended for external use only and should not be applied to damaged or broken skin. Care should be taken to avoid contact with the eyes, and it is advised not to bandage the area tightly after application.

In the event that a rash or irritation develops and persists, or if the condition worsens, patients are advised to discontinue use. Additionally, if symptoms do not improve within 7 days or if they resolve and then recur within a few days, patients should stop using the product.

It is crucial to keep this product out of reach of children. In the case of accidental ingestion, immediate medical assistance should be sought, or the local Poison Control Center should be contacted.

For pregnant or breastfeeding individuals, it is recommended to consult a health professional prior to use to ensure safety for both the mother and 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 Phizico Pain Relief (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 2 years and older may apply the medication to the affected area no more than 3 to 4 times daily. For children under 2 years of age, it is advised to consult a doctor prior to use. Additionally, the product should be kept out of reach of children to ensure safety.

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 on 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 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, immediate medical intervention is crucial. If the substance is ingested, it is imperative to seek medical assistance or contact a Poison Control Center without delay.

Healthcare professionals should be aware that prompt action can significantly influence the outcome of an overdosage situation. Symptoms of overdosage may vary depending on the specific substance involved; therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous evaluation and appropriate interventions should be implemented based on the clinical presentation and severity of symptoms.

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 the medication out of reach of children to prevent accidental ingestion. In the event that the medication is swallowed, patients should seek medical assistance or contact a Poison Control Center immediately.

Patients should be instructed not to use the medication on damaged or broken skin and to avoid contact with the eyes. It is important to inform patients that they should not bandage the area tightly after application.

Healthcare providers should also counsel patients to discontinue use if a rash or irritation develops and persists, if the condition worsens, or if symptoms do not improve within 7 days. Additionally, patients should be made aware that if symptoms clear up and then recur within a few days, they should stop using the medication and consult their healthcare provider.

Storage and Handling

The product is supplied in a container designed to safeguard its integrity. It is essential to protect the product from excessive heat and direct sunlight to maintain its efficacy and safety. Proper storage conditions should be observed to ensure optimal performance.

Additional Clinical Information

For patients aged 2 years and older, the medication should be applied to the affected area no more than 3 to 4 times daily. For children under 2 years of age, it is advised to consult a doctor prior to use. No further information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)