Arthri-Support

Description

ARTHRI SUPPORT is a medicated cream formulated to support joint and muscle comfort. The product is manufactured by Pure Science International and is available in a net weight of 3.0 oz. (85 g).

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

For adults and children aged 12 years and older, the recommended application is to the affected area no more than 3 to 4 times daily. For children under 12 years of age, it is advised 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 particularly beneficial to apply the product before and after sports or exercise to help alleviate aching muscles, muscle strain, and stiffness. Applications may be repeated as needed, up to a maximum of four times per day.

Contraindications

Use is contraindicated in patients with open wounds or damaged skin due to the potential for adverse effects and impaired healing. No other contraindications have been specified.

Warnings and Precautions

For external use only, this product must be applied strictly as directed. It is imperative to avoid contact with the eyes and mucous membranes, as such contact may lead to irritation or adverse effects. The product should not be applied to open wounds or damaged skin to prevent further complications.

To ensure safety, this product should 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 irritation.

Prior to use, it is recommended that individuals consult a physician if they are considering application for children under 12 years of age, or if they are pregnant or nursing. Additionally, medical advice should be sought if the condition persists for more than seven days, if symptoms resolve and then recur within seven days, or if excessive skin irritation occurs. Caution is also advised for those with a known history of allergic reactions to salicylates, including aspirin.

Side Effects

Patients using this product should be aware of several important warnings and adverse reactions associated with its use. This product is intended for external use only and should be applied strictly as directed. It is crucial to avoid contact with the eyes and mucous membranes, as this may lead to irritation or other adverse effects.

In addition to the warnings, patients should not apply the product to open wounds or damaged skin, as this may exacerbate irritation or lead to further complications. It is advisable for patients to consult a physician prior to use if they are children under 12 years of age, pregnant, or nursing. Furthermore, individuals should seek medical advice if their condition persists for more than seven days, if it clears up and then returns within seven days, or if they experience excessive skin irritation.

Patients with a known history of allergic reactions to salicylates, including aspirin, should exercise caution and consult a healthcare professional before using this product. These considerations are essential to ensure safe and effective use while minimizing the risk of 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-Support (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

There is no specific information regarding the use of ARTHRI-SUPPORT menthol cream in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when considering this product for elderly patients, as the absence of data necessitates careful monitoring and assessment of individual patient needs and responses. It is advisable to evaluate the overall health status and any concurrent medications of geriatric patients prior to recommending this treatment.

Pregnancy

Pregnant patients and nursing mothers 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 provided 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 available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to 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 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 may vary depending on the specific substance involved, and monitoring for any adverse effects is essential.

Management of overdosage should include supportive care and symptomatic treatment as necessary. Continuous assessment of the patient's condition is recommended to address any complications that may arise.

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.

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. Additionally, patients should be informed to seek medical advice if their condition persists for more than seven days, or if the condition clears up and then returns within seven days.

Patients should also be counseled to consult a physician if they experience excessive skin irritation while using the product. Furthermore, those who are prone to allergic reactions to salicylates, including aspirin, should be advised to speak with their healthcare provider 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 efficacy and stability. Proper storage conditions must be adhered to, ensuring that the product is kept within the specified temperature limits to prevent degradation.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)