Arthri-Zen Relief

Description

This product is a soothing and medicated analgesic rub specifically formulated for the relief of aching joints and muscles. It is designed to provide deep penetrating therapeutic pain relief and is effective for pre-exercise warm-up. The formulation includes skin moisturizing conditioners such as aloe, shea butter, avocado, and grape seed oil, enhancing its soothing properties. Additionally, it contains Arthri-Zen Relief’s clinically tested herbal formula, ensuring a comprehensive approach to pain management. This product is manufactured exclusively for RZN Nutraceuticals, Inc., located in Miami, FL 33186.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with arthritis, backaches, sprains, bruises, strains, and stiffness.

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

Dosage and Administration

Adults and children aged 12 years and older should apply the product to the affected area no more than 3 to 4 times daily. For children under 12 years of age, it is recommended to consult a physician prior to use.

The product should be applied generously to the affected areas and massaged in until completely absorbed. It is advisable to apply the product before and after sports or exercise to help soothe aching muscles, muscle strain, and stiffness. Applications may be repeated as needed, up to a maximum of four times per day.

Contraindications

The product is contraindicated for application to open wounds or damaged skin due to the potential for irritation and adverse reactions. No other contraindications have been specified.

Warnings and Precautions

This product is intended for external use only and should be utilized strictly as directed. It is imperative to avoid contact with the eyes and mucous membranes, as such exposure may lead to irritation or adverse effects. The application of this product is contraindicated on open wounds or damaged skin to prevent further complications.

To ensure safety, this product must be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or a poison center should be contacted without delay.

Users are advised against tightly bandaging the area of application or using heating pads concurrently, as these practices may exacerbate potential side effects or lead to skin damage.

Prior to use, it is recommended that individuals consult a physician if they are children under the age of 12, pregnant, or nursing. Additionally, medical advice should be sought if the condition persists for more than seven days, if the condition resolves and then recurs within seven days, or if excessive skin irritation occurs. Those with a known sensitivity or allergic reactions to salicylates, including aspirin, should also seek medical consultation before use.

Side Effects

Patients using this product should be aware of several important warnings and precautions. The product is intended for external use only and should be applied strictly as directed. Care should be taken to avoid contact with the eyes and mucous membranes. It is contraindicated for application on open wounds or damaged skin.

In the context of over-the-counter (OTC) use, patients are advised to consult a physician prior to use if they are children under 12 years of age, pregnant, or nursing. Additionally, medical advice should be sought if the condition persists for more than seven days, if the condition resolves and then returns within seven days, if excessive skin irritation occurs, or if there is a known allergy to salicylates, including aspirin.

In the event of accidental ingestion, patients should seek medical assistance or contact a poison center immediately. Furthermore, it is important not to bandage the area tightly or use heating pads in conjunction with this product, as these practices may exacerbate adverse reactions.

Drug Interactions

There are no reported drug interactions associated with the use of this medication. Additionally, no interactions with laboratory tests have been identified. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Arthri-Zen Relief (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should consult a physician prior to use. For both adults and children aged 12 years and older, the recommended application is to the affected area no more than 3 to 4 times daily. Caution is advised when considering treatment for pediatric patients, and professional guidance is essential for those under the age of 12.

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 potential adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

Pregnant patients and those who are nursing should consult a physician prior to using this medication. The safety of this drug during pregnancy has not been established, and potential risks to fetal outcomes are not fully understood. Therefore, healthcare professionals are advised to carefully evaluate the benefits and risks when considering this medication for women of childbearing potential.

Lactation

Lactating mothers are advised to consult a physician prior to using this medication if they are breastfeeding. There is no specific data available regarding the excretion of this medication in breast milk or its effects on breastfed infants. Therefore, healthcare professionals should consider the potential risks and benefits when recommending this medication to nursing mothers.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the drug insert 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 data necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients, although specific recommendations are not provided.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this drug. 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, immediate medical intervention is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical assistance or contact a 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 ensure that patients are aware of the importance of timely reporting of any overdosage incidents to facilitate effective treatment and minimize risks.

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 keep the medication out of reach of children to prevent accidental ingestion. Patients should be instructed not to apply the medication to open wounds or damaged skin, as this may lead to adverse effects.

It is important for healthcare providers to recommend that patients consult a physician before using the medication if they are children under 12 years of age, or if they are pregnant or nursing. Patients should also be informed to seek medical advice if their condition persists for more than seven days, or if the condition improves and then returns within seven days.

Additionally, healthcare providers should counsel patients to consult a physician if they experience excessive skin irritation while using the product. Patients with a history of allergic reactions to salicylates, including aspirin, should also be advised to speak with their physician prior to use.

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 at a controlled temperature range of 20º to 25º C (68º to 77º F) to maintain its integrity and efficacy. Proper storage conditions must be adhered to, ensuring that the product is kept in a suitable container that protects it from environmental factors. Special handling requirements should be observed to prevent any compromise to the product's quality.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Arthri-Zen Relief, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)