Trurelief Rubiton Rub It Where It Hurts

Description

The product is a clear, colorless to pale yellow liquid. It contains the active ingredient: insert active ingredient name here. Inactive ingredients include: insert inactive ingredients here. The product is packaged in a insert packaging details here. The SPL Code for this product is 34089-3.

Uses and Indications

This drug is indicated for the temporary relief of minor pain associated with various conditions, including arthritis, simple backache, muscle strains, sprains, bruises, and cramps.

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 is to apply the product generously to the affected area. The application should be followed by a gentle massage into the painful area until the product is thoroughly absorbed into the skin. This process may be repeated as necessary, but should not exceed four applications within a 24-hour period.

For children aged 12 years or younger, it is advised to consult a physician before use.

Contraindications

Use is contraindicated in the following situations:

Pregnant or breastfeeding individuals should consult a healthcare professional prior to use. The product should be kept out of reach of children to prevent accidental ingestion. In the event of accidental swallowing, immediate medical assistance or contact with a Poison Control Center is necessary.

The product should not be applied with tight bandaging or in conjunction with a heating pad, as this may exacerbate adverse effects. Contact with eyes or mucous membranes must be avoided to prevent irritation. Additionally, the product is contraindicated for application on wounds or damaged skin to reduce the risk of complications.

Warnings and Precautions

For external use only. This product is not intended for internal use, and caution should be exercised to prevent accidental ingestion.

Pregnant or breastfeeding individuals should consult a healthcare professional prior to use to ensure safety for both mother and child. It is imperative to keep this product out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

Users are advised to discontinue use and consult a physician if any of the following occur: the condition worsens, symptoms persist for more than 7 days, symptoms resolve and then recur within a few days, redness appears, or irritation develops. These actions are crucial to ensure the safety and well-being of the patient.

In cases of ingestion, it is essential to seek emergency medical help or contact the Poison Control Center immediately to mitigate potential risks associated with accidental swallowing.

Side Effects

For external use only. Patients are advised to discontinue use and consult a healthcare professional if the condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. Additionally, individuals should seek medical advice if redness is present or if irritation develops during the course of treatment.

Drug Interactions

No drug interactions have been identified for the specified medication. Additionally, there are no interactions noted between the drug and laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the available data.

Packaging & NDC

Below are the non-prescription pack sizes of Trurelief Rubiton Rub It Where It Hurts (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients 12 years of age or younger should consult a healthcare professional before use. It is important to assess the appropriateness of treatment and dosage for this age group, as specific recommendations may vary based on individual health needs and conditions.

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. 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 regarding the excretion of this medication 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 may require dosage adjustments to ensure safety and efficacy. It is essential to monitor renal function tests in individuals with kidney problems to assess their renal status. Specifically, patients with reduced creatinine clearance may need a reduced dose to avoid potential adverse effects associated with inadequate clearance of the medication.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials for this medication. Consequently, there is no available information regarding dosage adjustments, special monitoring requirements, or precautions 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 warranted based on clinical judgment.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

Additionally, it is recommended to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols. The implementation of these measures is crucial to ensure patient safety and effective management of overdose situations.

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 consult a health professional if they are pregnant or breastfeeding before using this product. It is important to emphasize the necessity of keeping the product out of reach of children. In the event of accidental ingestion, patients should seek medical assistance or contact the Poison Control Center immediately.

Patients should be instructed 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. Additionally, they should stop using the product and seek medical advice if they notice any redness or if irritation develops.

When using this product, patients must be reminded to follow the directions provided and to avoid bandaging tightly or using it in conjunction with a heating pad. It is also crucial to instruct patients to avoid contact with the eyes and mucous membranes, and to refrain from applying the product to wounds or damaged skin.

Storage and Handling

The product is supplied in a tube format, with specific handling and storage requirements to ensure its integrity and efficacy. It should be stored at room temperature, away from direct light exposure. To maintain the product's quality, it is essential to keep the tube tightly closed when not in use. Additionally, the product should be discarded after opening to prevent any potential degradation or contamination.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Trurelief Rubiton Rub It Where It Hurts, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)