Joint-Ritis Pain Relieving Roll-on

Description

The drug is formulated as a roll-on dosage form, facilitating targeted application. The packaging features a media reference for an accompanying image (8362316102-1.jpg). The effective date of the insert is September 27, 2023.

Uses and Indications

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

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

Dosage and Administration

For adults and children aged 12 years and older, a small amount of the product should be applied gently to the affected area. This application may be performed up to three to four times daily, as needed. It is essential to shake the product well before each use to ensure proper mixing.

For children under 12 years of age, the product is not recommended for use. Consultation with a healthcare professional is advised prior to administration in this age group.

Contraindications

There are no specific contraindications listed for this product. However, it is essential to keep the product out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact a Poison Control Center without delay.

Warnings and Precautions

For external use only. Healthcare professionals should advise patients to avoid contact with the eyes or mucous membranes. In the event of contact with the eyes, it is imperative to rinse thoroughly with water. The product should not be applied to wounds or damaged skin, and it is essential to avoid tight bandaging of the area where the product is applied. Additionally, the use of electric heating pads in conjunction with this product is contraindicated.

Patients should be instructed to discontinue use and consult a healthcare provider if the condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. The development of a rash or irritation also necessitates medical consultation.

For individuals who are pregnant or breastfeeding, it is crucial to seek advice from a healthcare professional prior to use.

This product should 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 should be made without delay.

Side Effects

Patients should be aware that this product is for external use only. When using this product, it is important to avoid contact with the eyes or mucous membranes; in the event of contact, the affected area should be rinsed thoroughly with water. The product should not be applied to wounds or damaged skin, and it is advised not to bandage the area tightly or use it in conjunction with electric heating pads.

In clinical practice, 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, if a rash or irritation develops, it is recommended to stop use and seek medical advice.

For pregnant or breastfeeding individuals, it is essential to consult a healthcare professional prior to using this product to ensure safety for both the patient and the child.

Drug Interactions

There are no documented drug interactions associated with this medication. Additionally, there are no known interactions with laboratory tests. Therefore, no specific dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Joint-Ritis Pain Relieving Roll-on (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should not use this medication without consulting a healthcare professional. For adolescents and adults aged 12 years and older, the recommended application is a small amount gently applied to the affected area no more than three to four 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, 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 no specific data available regarding 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 data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

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, 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 as necessary to ensure patient safety and recovery.

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

Serious side effects have been reported voluntarily or through surveillance programs. Healthcare professionals and patients are encouraged to report any adverse events to the designated phone number for further evaluation and monitoring.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. It is important to emphasize that if the medication is swallowed, patients should seek medical help or contact a Poison Control Center immediately. This guidance is crucial for ensuring patient safety and minimizing potential risks associated with accidental exposure.

Storage and Handling

The product is supplied in a configuration that ensures optimal quality and efficacy. Due to its all-natural composition, the consistency of the product may vary with temperature fluctuations. In the event of thickening, it is recommended to run the bottle under warm water or to warm it in the palms of the hands to restore its original texture.

For storage, the product should be kept at room temperature, away from direct light and heat sources, to maintain its integrity and effectiveness. Proper handling and storage conditions are essential to ensure the product remains in optimal condition for use.

Additional Clinical Information

The medication is administered topically, with a recommended application of a small amount to the affected area for adults and children aged 12 years and older, not exceeding three to four times daily. 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 Joint-Ritis Pain Relieving Roll-on, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)