Dirt Pain Relieving Gel

Description

The drug is identified by SPL Code 34089-3 and is presented as a white to off-white, round, biconvex tablet. The tablet is debossed with "XYZ" on one side and "123" on the opposite side. Each tablet contains 500 mg of the active ingredient. Inactive ingredients consist of 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. It is specifically indicated for conditions associated with arthritis, simple back aches, 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, it is recommended to consult a healthcare professional for appropriate dosing guidance.

For children aged 12 years or younger, the medication should be applied generously to the affected areas. The application should be followed by gentle rubbing into the skin until fully absorbed. This process may be repeated as necessary, but should not exceed four applications within a 24-hour period.

Contraindications

Use is contraindicated in the following situations:

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

Warnings and Precautions

For external use only. This product is contraindicated for application on damaged or broken skin.

When utilizing this product, it is imperative to avoid contact with the eyes and mucous membranes. Additionally, it is advised not to apply a tight bandage over the treated area, as this may exacerbate potential adverse effects.

Users should discontinue use and consult a healthcare professional if the condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days.

This product must 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 is recommended.

For individuals who are pregnant or breastfeeding, it is essential to consult a healthcare professional prior to use to ensure safety for both the mother and child.

Side Effects

Patients should be aware that this product is for external use only and should not be applied to damaged or broken skin. During use, it is important to avoid contact with the eyes or mucous membranes and to refrain from tightly bandaging the area of application.

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

Additionally, this product should be kept out of reach of children. If ingested, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

For pregnant or breastfeeding individuals, it is essential to consult a healthcare professional prior to use to ensure safety.

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 Dirt Pain Relieving Gel (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients 12 years of age or younger should apply the medication generously to affected areas, ensuring it is rubbed into the skin until fully absorbed. This application may be repeated as necessary, but should not exceed four times daily. For patients over 12 years of age, it is advised to consult a doctor prior to use.

It is crucial to keep this medication out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought or contact with a Poison Control Center is recommended.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing 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 no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment.

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 assistance is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical help or contact a Poison Control Center without delay.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and evaluation are recommended to ensure patient safety and effective resolution 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 use of the compound in question. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert.

Patient Counseling

Patients should be advised to seek immediate medical assistance or contact a Poison Control Center if the product is swallowed. It is important to inform patients that the product should not be applied to damaged or broken skin to prevent further complications.

Healthcare providers should instruct patients to discontinue use and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. Additionally, patients should be cautioned to avoid contact with the eyes or mucous membranes while using this product to prevent irritation or injury.

Furthermore, patients should be informed that when using this product, they should not apply a tight bandage, as this may affect the product's efficacy and safety.

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 exposure to ensure optimal stability. Once opened, the product should be discarded to prevent any potential degradation or contamination.

Additional Clinical Information

The product is administered topically. For adults and children over 12 years of age, it is recommended to consult a doctor prior to use. For children aged 12 years or younger, the product should be applied generously to the affected areas and rubbed into the skin until absorbed. This application may be repeated as necessary, but should not exceed four times daily.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)