The Skateboarding Pain Relieving Liniment

Description

The drug is identified by the SPL code 34089-3. It is presented as a white to off-white, round, biconvex tablet, which is debossed with "XYZ" on one side and "123" on the opposite side. Each tablet contains 500 mg of the active ingredient. The formulation includes inactive ingredients such as lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, and magnesium stearate.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains of muscles and joints associated with simple backache, strains, bruises, and sprains.

Limitations of Use: This medication is intended for short-term use and should not be used for chronic pain conditions without consulting a healthcare professional.

Dosage and Administration

For adults and children aged 2 years and older, the recommended application is to the affected area not more than 3 to 4 times daily. It is important to ensure that the application is limited to the specified frequency to avoid potential adverse effects.

For children under 2 years of age, it is advised to consult a healthcare professional prior to use to determine the appropriate course of action.

Contraindications

The product should not be applied to wounds or damaged skin due to the potential for irritation or adverse reactions. Additionally, it is contraindicated to bandage tightly, as this may compromise circulation and lead to further complications.

Warnings and Precautions

For external use only. It is imperative that the product is utilized strictly as directed to ensure safety and efficacy. Healthcare professionals should advise patients to avoid contact with the eyes, as this may lead to irritation or injury. Additionally, the product should not be applied to wounds or damaged skin, as this could exacerbate the condition or lead to adverse effects. Bandaging should be done loosely; tight bandages may impede circulation and cause further complications.

Patients should be instructed to discontinue use and seek medical advice if their condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. These signs may indicate a need for further evaluation or a change in treatment strategy.

In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay. Prompt action is crucial to mitigate potential health risks associated with ingestion.

Side Effects

Patients using this product should be aware that it is intended for external use only. It is crucial to use the product strictly as directed and to avoid contact with the eyes. The product should not be applied to wounds or damaged skin, and tight bandaging is not recommended.

In the event that the condition worsens, or if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days, patients are advised to stop use and consult a doctor.

Additionally, this product should be kept out of reach of children. If swallowed, it is imperative to seek medical assistance or contact the Poison Control Center immediately.

Drug Interactions

There are no specific drug interactions identified for this medication. Additionally, no laboratory test interactions have been reported. 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 The Skateboarding Pain Relieving Liniment (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 2 years of age should consult a doctor prior to use. For children aged 2 years and older, the recommended application is to the affected area not more than 3 to 4 times 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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

Pregnancy

There is no information available regarding the use of The Skateboarding Pain Relieving Liniment during pregnancy. As such, the potential risks and effects on fetal outcomes remain undetermined. Healthcare professionals are advised to exercise caution when prescribing this product to pregnant patients, considering the lack of data on its safety and efficacy in this population. Women of childbearing potential should be informed of the absence of pregnancy-related information and encouraged to discuss any concerns with their healthcare provider.

Lactation

There is no specific information available regarding the use of this medication in nursing mothers or its effects on lactation. Additionally, no data are provided concerning the excretion of this medication in breast milk or its potential effects on breastfed infants. Healthcare professionals should consider the lack of information when advising lactating mothers about the use of this medication.

Renal Impairment

Patients with renal impairment may not have specific dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment and monitoring of these patients.

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, immediate medical intervention is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical assistance or contact the 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 be prepared to implement supportive care and symptomatic treatment as necessary, based on the clinical presentation of the patient. Continuous monitoring and evaluation may be required to ensure patient safety and effective management of any complications arising from the overdosage.

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 the 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, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days.

When using this product, patients should be reminded to use it only as directed. They should be cautioned to avoid contact with the eyes and to refrain from applying the product to wounds or damaged skin. Additionally, patients should be informed not to bandage the area tightly after application.

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 controlled environment, maintaining a temperature below 86°F (30°C) to ensure its stability and efficacy. Proper storage conditions are crucial for preserving the integrity of the product throughout its shelf life.

Additional Clinical Information

The medication is administered topically, with a recommended application frequency of 3 to 4 times daily for adults and children aged 2 years and older. For children under 2 years of age, consultation with a doctor is advised prior to use. 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 The Skateboarding Pain Relieving Liniment, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)