Octagon Pain Relief

Description

OCTAGON is an extreme formula designed for the temporary relief of various types of pain, including joint pain, back pain, arthritis, and muscle pain. The product is available in a net weight of 3 oz (85 g).

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, and sprains.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

For adults and children aged 2 years and older, the recommended application is to roll the product onto the affected area no more than 3 to 4 times daily. Prior to application, it is essential to shake the container well to ensure proper mixing of the formulation.

For children under 2 years of age, it is advised to consult a physician before use to determine the appropriate course of action.

Contraindications

The product is contraindicated in the following situations:

Use is not recommended in conjunction with heating pads or devices, as this may lead to adverse effects. Additionally, the product should not be applied alongside ointments, creams, sprays, or liniments due to potential interactions that could compromise efficacy or safety. It is also contraindicated for use on wounds, damaged skin, or irritated skin, as this may exacerbate the condition or lead to further complications.

Warnings and Precautions

For external use only, this product is flammable and should be kept away from excessive heat or open flame to prevent fire hazards.

Healthcare professionals are advised to counsel patients to consult a doctor prior to use if they have sensitive skin or are pregnant or breastfeeding. These considerations are crucial to ensure the safety and appropriateness of the product for individual patients.

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

Patients should be instructed to discontinue use and consult a healthcare provider if their condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then reoccur within a few days. Additionally, if any irritation develops, it is imperative to stop use and seek medical advice.

Side Effects

Patients using this product should be aware of several important warnings and precautions. The product is intended for external use only and is flammable; therefore, it should be kept away from excessive heat or open flame. It is contraindicated for use with heating pads or devices, as well as with ointments, creams, sprays, or liniments. Additionally, it should not be applied to wounds, damaged skin, or irritated skin.

Before using this product, patients are advised to consult a healthcare professional if they have sensitive skin or are pregnant or breastfeeding. During use, it is crucial to avoid contact with the eyes or mucous membranes, and patients should refrain from tightly bandaging the area of application.

Patients should discontinue use and seek medical advice if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up only to reoccur within a few days. Development of irritation is also a reason to stop use and consult a healthcare provider.

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

Drug Interactions

The use of this medication is contraindicated with heating pads or devices, as well as with ointments, creams, sprays, or liniments. Co-administration with these products may lead to adverse effects or diminished therapeutic efficacy.

There are no specific laboratory test interactions reported for this medication. Therefore, routine monitoring of laboratory tests is not required in relation to this drug.

Packaging & NDC

Below are the non-prescription pack sizes of Octagon Pain Relief (menthol, unspecified form). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 2 years of age should consult a physician prior to use. For children aged 2 years and older, the recommended application is to roll on the affected area no more than 3 to 4 times daily.

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, given the lack of targeted data.

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 considered, 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 their healthcare provider to ensure safe use during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a healthcare professional 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, caution is recommended when considering the use of this medication during lactation.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this drug. 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 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.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

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 this product in conjunction with heating pads or devices, as well as not to combine it with ointments, creams, sprays, or liniments. It is important to emphasize that the product should not be applied to wounds, damaged skin, or areas of irritated skin.

Healthcare providers should counsel patients to discontinue use and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then reoccur within a few days. Additionally, patients should be advised to stop using the product and seek medical advice if they experience any irritation.

While using this product, patients should be cautioned to avoid contact with their eyes or mucous membranes. Furthermore, they should be instructed not to bandage the area tightly after application to ensure safety and effectiveness.

Storage and Handling

The product is supplied in a configuration that requires the cap to be replaced after each use to ensure proper sealing and integrity. It is essential to store the product in a cool, dry place to maintain its efficacy and stability.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)