Nuturna Arthritis Intensive Concentrate for Pain Relief and Recovery

Description

The product is identified by the SPL code 34089-3. No specific description details are provided in the text.

Uses and Indications

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

Limitations of Use: There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Adults and children aged 2 years and older should apply the cream to the affected area no more than 3 to 4 times daily. For children under 2 years of age, it is advised to consult a doctor prior to use.

Prior to application, it is recommended to test a small amount of the cream on the skin to assess for any adverse reactions and to ensure comfort. If the initial test is well-tolerated, wait 15 minutes before proceeding to apply the cream to the affected area.

Contraindications

Use of this product is contraindicated in patients with damaged or broken skin due to the potential for adverse effects and compromised healing. No other contraindications have been specified.

Warnings and Precautions

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

When utilizing this product, it is imperative to avoid contact with the eyes. Additionally, users should refrain from applying tight bandages over the treated area to prevent complications.

In the event that a rash or irritation develops and persists, or if the condition worsens, it is essential to discontinue use and consult a healthcare professional. Users should also seek medical advice if symptoms do not improve within 7 days or if they resolve only to recur within a few days.

This product must be kept out of reach of children. In the case of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is advised.

For individuals who are pregnant or breastfeeding, it is recommended to consult a healthcare professional prior to use to ensure safety.

Side Effects

Patients using this product should be aware that it is intended for external use only and should not be applied to damaged or broken skin. During use, it is important to avoid contact with the eyes and to refrain from tightly bandaging the area of application.

In clinical practice, patients are advised to discontinue use and consult a healthcare professional if a rash or irritation develops and persists, if the condition worsens, or if symptoms do not improve after 7 days. Additionally, if symptoms resolve and then recur within a few days, medical advice should be sought.

This product should be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance or contact with a Poison Control Center is recommended.

For pregnant or breastfeeding individuals, it is advisable to consult a healthcare professional prior to use to ensure safety.

Drug Interactions

No drug interactions or drug and laboratory test interactions have been identified in the provided data. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Nuturna Arthritis Intensive Concentrate for Pain Relief and Recovery (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 2 years and older may apply the medication to the affected area no more than 3 to 4 times daily. For children under 2 years of age, it is advised to consult a doctor prior to use.

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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is essential to evaluate the potential risks and benefits associated with the use of this drug during pregnancy and lactation. The safety of this medication in pregnant women has not been established, and therefore, caution is advised.

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 medication in 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 no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. 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.

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, 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 based on the clinical presentation and severity of symptoms.

In all cases of suspected overdosage, the involvement of poison control and emergency medical services is recommended to ensure optimal patient care and safety.

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

No postmarketing experience details are provided in the insert.

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 not to apply the product on damaged or broken skin to prevent further complications.

Patients should be informed to discontinue use and consult a doctor if they experience a rash or irritation that develops and persists. Additionally, they should be cautioned to stop using the product and seek medical advice if their condition worsens, or if symptoms last longer than 7 days, or if symptoms clear up only to recur within a few days.

While using the product, patients must be reminded to avoid contact with the eyes to prevent irritation or injury. Furthermore, they should be advised against tightly bandaging the area where the product is applied, as this may lead to adverse effects.

Storage and Handling

The product is supplied in a container designed to safeguard its integrity. It is essential to protect the product from excessive heat and direct sunlight to maintain its efficacy and safety. Proper storage conditions should be observed to ensure optimal performance.

Additional Clinical Information

Patients aged 2 years and older are advised to apply the medication to the affected area no more than 3 to 4 times daily. For children under 2 years of age, consultation with a doctor is recommended prior to use.

Clinicians should counsel patients to perform a patch test by applying a small amount of cream to the skin and waiting 15 minutes to assess for any adverse skin reactions or discomfort before proceeding with application to the affected area.

Drug Information (PDF)

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

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