Novarnica Sport

Description

Novarnica Sport is a pain-relieving cream formulated with natural ingredients designed for deep penetration to provide relief from various conditions. This specialized formulation is indicated for the alleviation of pain associated with sports injuries, sore muscles, and sprains or strains. The product is available in a 113g (4 oz) tube, with the National Drug Code (NDC) 61871-012-15.

Uses and Indications

This drug is indicated for the fast and soothing relief of minor aches and pains of muscles and joints associated with conditions such as simple backache, arthritis, strains, bruises, and sprains. It features a special formula designed for deep penetrating relief specifically targeting sports injuries, sore muscles, sprains, and strains.

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 apply the cream generously to the affected area and rub it in until fully absorbed through the skin. This process may be repeated as necessary, with a maximum frequency of up to four times daily.

Contraindications

There are no specific contraindications listed for this product. However, it is essential to keep the product safely out of reach of children to prevent accidental ingestion. In the event of an overdose or accidental ingestion, it is imperative to contact a poison control center immediately for guidance.

Warnings and Precautions

The use of this product necessitates careful consideration of the following warnings and precautions to ensure patient safety and efficacy.

Allergy Alert This product is contraindicated in individuals with a known allergy to the Asteraceae or Compositae (daisy) family, as well as to any other ingredients contained within the formulation.

Usage Guidelines This product is intended for external use only. It is imperative to discontinue use immediately if any signs of rash, irritation, reddening, dermatitis, or eczema occur. Application on open wounds is strictly prohibited.

Application Precautions Care should be taken to avoid contact with the eyes and mucous membranes. Additionally, the application of bandages or heat sources, such as heating pads, on the affected area is not recommended.

Consultation Recommendations Healthcare practitioners should be consulted prior to use in pregnant or breastfeeding individuals to assess potential risks and benefits.

Inhalation and Ingestion Warning Inhalation or ingestion of this product is contraindicated.

Child Safety This product must be kept securely out of reach of children. In the event of an overdose or accidental ingestion, it is crucial to contact a poison control center immediately for guidance.

Side Effects

Patients should be aware of the potential for serious allergic reactions associated with this product. It is contraindicated in individuals with known allergies to the Asteraceae or Compositae (daisy) family, as well as to any other ingredients contained in the formulation.

The product is intended for external use only. Patients are advised to discontinue use immediately if they experience any signs of rash, irritation, reddening, dermatitis, or eczema. It is important to avoid applying the product on open wounds and to prevent contact with the eyes and mucous membranes. Additionally, patients should not apply a bandage or heat, such as a heating pad, to the affected area.

For pregnant or breastfeeding individuals, consultation with a healthcare practitioner is recommended prior to use. Inhalation or ingestion of the product should be strictly avoided to prevent adverse effects.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

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

Pediatric Use

Pediatric patients aged 12 years and older may use the cream by applying it generously and rubbing it on the affected area until fully absorbed through the skin. It is important to keep the product safely out of reach of younger children. In the event of an overdose or accidental ingestion, it is crucial to contact a poison control center immediately for assistance.

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. 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 practitioner prior to using this medication. The potential risks and benefits must be carefully weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to discuss their individual circumstances with a healthcare provider to ensure safe use during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a healthcare practitioner 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 lactating 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 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 event of an overdose or accidental ingestion, it is imperative to contact a poison control center without delay. Prompt action is crucial to ensure the safety and well-being of the patient.

Healthcare professionals should be aware that symptoms of overdose may vary depending on the substance involved. Monitoring the patient for any adverse effects is essential, as timely intervention can significantly impact outcomes.

Management of an overdose should be guided by the specific circumstances and the substance involved. Supportive care and symptomatic treatment may be necessary, and healthcare providers should follow established protocols for overdose management.

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 provided in the insert.

Patient Counseling

Healthcare providers should advise patients to keep the medication safely out of reach of children to prevent accidental ingestion. It is important to emphasize the potential risks associated with overdose or accidental ingestion. Patients should be instructed to call a poison control center immediately in such events to ensure prompt and appropriate care.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at room temperature to maintain its integrity. Additionally, the product must be protected from light exposure to prevent degradation.

When not in use, the container should be kept tightly closed to ensure the product remains uncontaminated. It is important to note that the product should be discarded after opening to ensure safety and efficacy.

Additional Clinical Information

For patients aged 12 years and older, the recommended administration involves applying the cream generously to the affected area and rubbing it in until fully absorbed. This process may be repeated as needed, up to four times daily.

Clinicians should advise patients to consult a healthcare practitioner before use if they are pregnant or breastfeeding. It is important to instruct patients not to inhale or swallow the product and to keep it out of reach of children. In the event of an overdose or accidental ingestion, patients should contact a poison control center immediately.

Drug Information (PDF)

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

View product document (PDF)