Owell Naturals Deep Penetrating Pain Relief

Description

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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. The formulation provides cooling pain relief to enhance comfort during use.

Limitations of Use: This drug is intended for temporary relief and should not be used as a substitute for more comprehensive treatment of underlying conditions.

Dosage and Administration

For adults and children aged 2 years and older, the recommended application frequency is to 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 healthcare professional prior to use.

Contraindications

Use is contraindicated on 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 using this product, it is imperative to avoid contact with the eyes; in the event of contact, rinse thoroughly with water. Additionally, do not apply a tight bandage over the treated area to prevent complications.

Users should 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 or if they resolve and then recur within a few days.

This product should be kept out of reach of children. In the case of accidental ingestion, immediate medical assistance should be sought, or contact a Poison Control Center without delay.

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

Side Effects

Patients using this product should be aware of several important safety considerations. The product is intended for external use only and should not be applied to damaged or broken skin. Care should be taken to avoid contact with the eyes; in the event of contact, the area should be rinsed with water immediately.

Patients are advised not to bandage the area tightly while using this product. If a rash or irritation develops and persists, or if the condition worsens, patients should discontinue use and consult a healthcare professional. Additionally, if symptoms do not improve within 7 days or if they clear up and then recur within a few days, medical advice should be sought.

It is crucial to keep this product out of reach of children. In the event of accidental ingestion, immediate medical assistance should be obtained, or contact with a Poison Control Center should be made without delay.

For pregnant or breastfeeding individuals, it is recommended to consult a healthcare professional prior to use to ensure safety for both the mother and child.

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 Owell Naturals Deep Penetrating Pain Relief (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 2 years of age should consult a doctor prior to use. For children aged 2 years and older, the recommended application is to the affected area not more than 3 to 4 times daily.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

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 weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use during pregnancy and lactation.

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 mothers.

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 medication. Consequently, there are no 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 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 compound in these areas.

Postmarketing Experience

No postmarketing experience details are provided in the insert.

Patient Counseling

Patients should be advised to seek immediate medical assistance or contact a Poison Control Center if the product is swallowed. It is important to inform patients that the product should not be applied to damaged or broken skin to avoid potential complications.

Healthcare providers should counsel patients to discontinue use and consult a doctor if a rash or irritation develops and persists. Additionally, patients should be instructed to stop using the product and seek medical advice if their condition worsens, or if symptoms last longer than 7 days, or if symptoms resolve and then recur within a few days.

While using the product, patients must be reminded to keep it away from the eyes and to rinse with water if contact occurs. Furthermore, it is essential to advise patients against tightly bandaging the area where the product is applied to ensure proper healing and avoid adverse effects.

Storage and Handling

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

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)