Arthritis Relief

Description

North Star Nutritionals Arthritis Relief Cream is a pain-relieving topical formulation designed to alleviate discomfort associated with arthritis. This cream is enriched with menthol, providing a cooling sensation upon application. The product is presented in a net weight of 2 oz (57 ml) and is formulated without parabens, ensuring a more skin-friendly option for users.

Uses and Indications

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

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 not more than 3 to 4 times daily. It is essential to ensure that the application is performed with clean hands and that the affected area is free from any other topical products prior to administration.

For children under 12 years of age, it is advised to consult a physician before use to determine the appropriate course of action and dosage.

Contraindications

The product is contraindicated for use on wounds or damaged skin. This restriction is in place to prevent potential complications and ensure patient safety.

Warnings and Precautions

For external use only. This product is contraindicated for application on wounds or damaged skin.

When utilizing this product, it is imperative to avoid contact with the eyes and mucous membranes. Additionally, it is advised not to apply a tight bandage over the treated area to prevent complications.

Healthcare professionals should instruct patients to discontinue use and seek medical advice if the condition worsens or if symptoms persist beyond 7 days. Furthermore, if symptoms resolve and then recur within a few days, medical consultation is recommended.

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

Side Effects

Patients should be aware that this product is for external use only and should not be applied to wounds or damaged skin. When using this product, it is important to avoid contact with the eyes or mucous membranes, and to refrain from bandaging tightly.

In the event that the condition worsens or symptoms persist for more than 7 days, patients are advised to stop use and consult a doctor. Additionally, if symptoms clear up and then recur within a few days, it is also recommended to seek medical advice.

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 Arthritis 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 adolescents and children aged 12 years and older, the recommended dosage is to apply the medication to the affected area no more than 3 to 4 times daily.

Geriatric Use

There is no specific information available 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.

Pregnancy

There is no specific information regarding the use of this medication during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients. It is advisable to weigh the potential benefits against any unknown risks to fetal outcomes. Women of childbearing potential should be counseled on the importance of effective contraception during treatment and the need to inform their healthcare provider if they become pregnant or plan to become pregnant while on this medication.

Lactation

There is no specific information regarding the use of Arthritis Relief menthol cream in lactating mothers or any lactation considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution and consider the lack of data when advising lactating mothers on the use of this product. The potential effects on breastfed infants have not been established.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the drug insert text regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals 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 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 consider the potential risks associated with excessive administration of the medication.

It is essential to monitor patients closely for any signs or symptoms that may arise from an overdose. Symptoms may vary depending on the medication's pharmacological profile and the individual patient's response.

In the event of suspected overdosage, immediate medical intervention is recommended. Healthcare providers should initiate supportive care and symptomatic treatment as necessary. It is also advisable to consult local poison control centers or relevant medical authorities for guidance on management protocols specific to the medication in question.

Documentation of the incident, including the amount ingested and the time of exposure, is crucial for effective management and follow-up care.

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 this product out of reach of children to prevent accidental ingestion. Instruct patients that if the product is swallowed, they should seek medical help or contact a Poison Control Center immediately.

Patients should be informed not to use the product on wounds or damaged skin. They should be counseled to stop using the product and consult a doctor if their condition worsens or if symptoms persist for more than 7 days. Additionally, patients should be advised to discontinue use and seek medical advice if symptoms resolve but then recur within a few days.

It is important to instruct patients to avoid contact with eyes or mucous membranes while using this product. Furthermore, they should be cautioned against bandaging the area tightly when applying the product to ensure proper use and minimize the risk of adverse effects.

Storage and Handling

The product is supplied in a tube that must be stored at room temperature. It is essential to protect the tube from light exposure to maintain product integrity. To ensure optimal conditions, the tube should be kept tightly closed when not in use. Additionally, any unused product should be discarded after opening if it is not utilized within the specified time frame.

Additional Clinical Information

For patients aged 12 years and older, the medication should be applied 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 regarding the appropriate use and administration. No further information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

Drug Information (PDF)

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

View product document (PDF)