Dzul Arthritis Pain Relief

Description

DZUL Arthritis Pain Relief Cream is a topical formulation designed for the relief of arthritis-related discomfort. The product is characterized by its effective time, which is set for April 20, 2024. The cream is intended for application to affected areas to provide localized relief from pain associated with arthritis.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains of muscles and joints associated with arthritis.

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

Dosage and Administration

For adults and children over 12 years of age, a small amount of the product should be applied to the affected area. The application should be followed by a gentle massage in a circular motion, allowing the product to set for a few seconds. This process may be repeated as necessary, but should not exceed 3 to 4 applications per day.

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

Contraindications

The product is contraindicated in the following situations:

Application to wounds or damaged skin is prohibited due to the potential for adverse effects. It should not be applied to irritated skin or in cases where excessive irritation develops, as this may exacerbate the condition. Additionally, tight bandaging is contraindicated to prevent complications related to circulation. The use of heating pads or devices in conjunction with the product is also contraindicated, as this may lead to increased risk of irritation or burns.

Warnings and Precautions

For external use only. Prior to application, it is essential for healthcare professionals to advise patients to consult a physician if there is any redness present over the affected area.

General precautions must be observed to ensure safe use. Contact with the eyes or mucous membranes should be strictly avoided. The product should not be applied to wounds or damaged skin, nor should it be used on irritated skin or if excessive irritation develops. It is important to avoid tight bandaging of the area where the product is applied. Additionally, the use of heating pads or devices in conjunction with this product is contraindicated.

In the event of accidental ingestion, immediate medical assistance should be sought, or the local Poison Control Center should be contacted without delay.

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.

Side Effects

Patients should be aware that the product is intended for external use only. It is important for individuals to consult a healthcare professional prior to use if there is any redness present over the affected area.

No additional adverse reactions have been reported in clinical trials or postmarketing experiences.

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 Dzul Arthritis Pain Relief (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. The safety and efficacy of this treatment have not been established in this age group, and appropriate dosing guidelines are not available. It is essential for healthcare providers to evaluate the risks and benefits before prescribing this medication to pediatric patients.

Geriatric Use

Elderly patients may not have specific dosage adjustments, safety concerns, or special precautions outlined in the drug insert. As such, healthcare providers should exercise caution when prescribing this medication to geriatric patients, considering the potential for altered pharmacokinetics and increased sensitivity to medications in this population.

It is advisable for healthcare providers to monitor elderly patients closely for any adverse effects or changes in therapeutic response, given the lack of specific data regarding geriatric use. Individualized treatment plans should be considered to ensure the safety and efficacy of the medication in this demographic.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully considered in these populations to ensure the safety of both the mother and the fetus or 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

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in this patient population.

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 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, as the clinical presentation can vary depending on the substance involved and the individual patient's response. Common symptoms of overdose may include, but are not limited to, altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

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 ensuring adequate circulation. The use of activated charcoal may be considered if the patient presents within a suitable timeframe and is deemed appropriate based on clinical judgment.

Furthermore, it is crucial to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols and antidotes, if applicable. Continuous monitoring and supportive care remain the cornerstone of managing overdose situations until the patient stabilizes or further interventions are deemed necessary.

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 text.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center if the product is swallowed. It is important to instruct patients to avoid contact with the eyes and mucous membranes to prevent irritation or injury.

Patients should be cautioned against applying the product to wounds or damaged skin, as well as to any areas of irritated skin. If excessive irritation develops, they should discontinue use and consult a healthcare professional.

Additionally, patients should be informed not to bandage the area tightly after application and to avoid using the product in conjunction with heating pads or devices, as this may lead to adverse effects.

Healthcare providers should emphasize the importance of stopping use and consulting a doctor if the condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days.

Storage and Handling

The product is supplied in a tightly closed container to ensure stability and integrity. It should be stored in a dry place at controlled room temperature, specifically between 59°F and 86°F (15°C to 30°C). Proper storage conditions are essential to maintain the product's efficacy and safety.

Additional Clinical Information

The product is intended for topical administration. For adults and children over 12 years, a small amount should be applied to the affected area and massaged in circular motions, with a maximum frequency of 3 to 4 times daily. Use is not recommended for children under 12 years without consulting a doctor.

Clinicians should counsel patients that the product is for external use only. Patients should be advised to consult a doctor if there is redness over the affected area, and to avoid contact with eyes or mucous membranes. It should not be applied to wounds, damaged, or irritated skin, and should not be bandaged tightly or used with heating devices. Patients should discontinue use and seek medical advice if the condition worsens, symptoms persist beyond 7 days, or if symptoms recur shortly after resolution. Pregnant or breastfeeding individuals should consult a health professional before use. In case of ingestion, immediate medical assistance or contact with a Poison Control Center is necessary.

Drug Information (PDF)

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

View product document (PDF)