Uriflex Fast Acting Analgesic Pain Relief

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 minor aches and pains associated with simple backache, arthritis, bruises, sprains, and strains.

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

Dosage and Administration

The medication should be applied directly to the affected area. Healthcare professionals are advised to ensure that the application does not exceed four times per day. Care should be taken to follow the recommended frequency to avoid potential adverse effects.

Contraindications

The product is contraindicated for application on open wounds or damaged skin. If symptoms persist for more than seven days, discontinue use and consult a physician.

Warnings and Precautions

For external use only; this product should not come into contact with the eyes. It is imperative to avoid application on open wounds or damaged skin. Should symptoms persist for more than seven days, the user is advised to discontinue use and consult a physician for further evaluation.

This product must be kept out of reach of children. In the event of accidental ingestion, it is essential to seek medical advice immediately. Additionally, users should refrain from applying tight bandages over the treated area.

Pregnant or breastfeeding individuals are strongly encouraged to consult a physician prior to using this product to ensure safety for both the mother and child.

Side Effects

Patients should be aware of the following warnings and precautions associated with the use of this product. It is intended for external use only, and contact with the eyes should be avoided. The product should not be applied to open wounds or damaged skin. If symptoms persist for more than seven days, patients are advised to discontinue use and consult a physician.

Additionally, it is important to keep the product out of reach of children. In the event of accidental ingestion, patients should seek medical advice immediately. The product should not be bandaged tightly.

For pregnant or breastfeeding individuals, it is recommended to contact a physician prior to use to ensure safety for both the patient and the child.

Drug Interactions

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

Packaging & NDC

Below are the non-prescription pack sizes of Uriflex Fast Acting Analgesic Pain Relief (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients should be advised to keep this medication out of reach of children. In the event of accidental ingestion, it is important to consult a physician immediately.

Geriatric Use

There is no specific information regarding the use of URIFLEX Fast Acting Analgesic Pain Relief in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as the absence of data necessitates careful consideration of individual patient factors and potential risks. Monitoring for efficacy and adverse effects is recommended in this population, given the variability in pharmacokinetics and pharmacodynamics that may occur with aging.

Pregnancy

Pregnant patients and those who are breastfeeding should contact their physician prior to using this medication. It is essential to evaluate the potential risks and benefits in these populations, as the effects on fetal outcomes and lactation are not fully established. Healthcare professionals are advised to consider alternative treatments or closely monitor the patient if use is deemed necessary.

Lactation

Lactating mothers are advised to contact their physician prior to using this medication. There is no available data regarding the excretion of this drug in human breast milk or its effects on breastfed infants. Therefore, healthcare professionals should exercise caution and consider the potential risks and benefits when prescribing this medication to lactating patients.

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 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 prescribing information.

Overdosage

In the event of an overdosage, it is imperative to seek immediate medical attention. Healthcare professionals should advise patients or caregivers to consult a physician if the product is ingested.

It is crucial to avoid tightly bandaging any affected areas, as this may exacerbate potential complications. Monitoring for symptoms associated with overdosage is essential, although specific symptoms were not detailed in the provided information.

Management of overdosage should be guided by clinical judgment and may involve supportive care and symptomatic treatment as necessary. Prompt intervention can mitigate risks and improve 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 understanding of the compound's potential effects in these areas.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to consult a physician immediately if the product is swallowed. It is important to inform patients not to bandage the area tightly after application.

Patients should be instructed to avoid applying the product to open wounds or damaged skin. Additionally, if symptoms persist for more than seven days, they should discontinue use and seek guidance from a physician.

Storage and Handling

The product is supplied in a container that must be kept tightly closed to maintain its integrity. It should be stored at room temperature, away from direct light to prevent degradation. Once opened, the product should be discarded to ensure safety and efficacy.

Additional Clinical Information

The medication is administered topically, applied directly to the affected area, and should not be used more than four times per day. Clinicians should advise patients that the product is for external use only and to avoid contact with the eyes. It is contraindicated for application on open wounds or damaged skin. Patients are instructed to discontinue use and consult a physician if symptoms persist for more than seven days.

Additionally, it is important to keep the product out of reach of children, and if swallowed, patients should seek medical advice. Patients who are pregnant or breastfeeding should contact their physician prior to use. Tight bandaging of the area where the medication is applied is not recommended.

Drug Information (PDF)

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

View product document (PDF)