Menthol, unspecified form

Description

SUNSET PAIN RELIEF +350 CBD ROLL-ON is presented in a roll-on dosage form, designed for topical application. The product is visually characterized by its gold packaging, which is depicted in the associated image file (FD-03019 SUNSET - PAIN FREEZE CBD ROLL-ON 72937-004-03.jpg). The formulation includes 350 mg of CBD, intended to provide localized relief.

Uses and Indications

This drug is indicated for the temporary local relief of minor pain in muscles or joints. It is intended for use in patients experiencing such discomfort, providing symptomatic relief to enhance daily activities.

Dosage and Administration

For adults and children over 12 years of age, a small amount of the product should be applied to the affected area. The application should be followed by a gentle massage in a circular motion, allowing the product to set for a few seconds. This process may be repeated as necessary, but should not exceed 3 to 4 applications per day.

For children under 12 years of age, the product is not recommended. Consultation with a healthcare professional is advised prior to use in this age group.

Contraindications

Use of this product is contraindicated in the following situations:

• Tight bandaging or application with a heating pad is not recommended, as it may exacerbate adverse effects.

• Contact with eyes and mucous membranes should be avoided to prevent irritation or injury.

• Application to wounds or damaged, broken, or irritated skin is contraindicated due to the risk of further skin damage or infection.

• Exposure of the treated area to heat or direct sunlight is not advised, as it may lead to increased irritation or adverse reactions.

Warnings and Precautions

For external use only. Healthcare professionals should advise patients to consult a physician prior to use if there is any redness present over the affected area.

In the event of accidental ingestion, it is imperative to seek emergency medical assistance immediately or contact a Poison Control Center.

Patients should be instructed to discontinue use and consult their healthcare provider if any of the following occur: the condition worsens, redness develops, irritation arises, symptoms persist for more than 7 days, or if symptoms resolve only to recur within a few days. Additionally, if patients experience signs of injury, such as pain, swelling, or blistering at the site of application, they must stop using the product and seek medical advice.

Side Effects

Patients using this product may experience various adverse reactions. It is important to note that the product is intended for external use only. Patients should consult a healthcare professional prior to use if there is any redness over the affected area.

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

Patients should also be vigilant for signs of injury, such as pain, swelling, or blistering at the site of application, and seek medical attention if these occur.

Drug Interactions

There are no specific drug interactions or laboratory test interactions identified in the available data. Therefore, no recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Menthol. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should not use this medication without consulting a doctor. Safety and efficacy have not been established in this age group, and appropriate dosing guidelines are not available. Healthcare professionals are advised to consider alternative treatments for pediatric patients in this age range.

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 potential adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

Pregnant patients should consult a healthcare professional before using this medication. The safety of this drug during pregnancy has not been established, and potential risks to fetal outcomes are not fully understood. It is essential for women of childbearing potential to discuss their individual circumstances with their healthcare provider to weigh the benefits and risks associated with the use of this medication during pregnancy.

Lactation

There are no specific warnings or recommendations regarding the use of this product by lactating mothers. Additionally, there is no information available about the potential for excretion in breast milk or any associated risks to breastfed infants.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution and consider individual patient factors when prescribing to patients with reduced kidney function, as the absence of specific guidance necessitates careful clinical judgment.

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 adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, the following management procedures should be considered:

1. Assessment: Conduct a thorough assessment of the patient's clinical status, including vital signs and level of consciousness.

2. Supportive Care: Provide supportive care as needed, which may include airway management, oxygen supplementation, and intravenous fluids.

3. Consultation: Engage with a poison control center or a medical toxicologist for guidance on specific interventions and antidotes, if applicable.

4. Documentation: Document all findings, interventions, and the patient's response to treatment meticulously.

Healthcare professionals should remain vigilant and prepared to implement appropriate measures based on the clinical presentation of the patient.

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 available in the insert text.

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 to stop using the product and consult a doctor if any of the following occur: the condition worsens, redness appears, irritation develops, symptoms persist for more than 7 days, or if symptoms clear up only to return within a few days. Patients should also be informed to watch for signs of injury, such as pain, swelling, or blistering at the application site.

Patients must be reminded to use the product only as directed and to avoid tightly bandaging the area or using it in conjunction with a heating pad. They should be cautioned against contact with the eyes and mucous membranes, and advised not to apply the product to wounds or any damaged, broken, or irritated skin.

In the event of an allergic reaction, patients should discontinue use immediately and consult a doctor. Additionally, it is essential to inform patients not to expose the treated area to heat or direct sunlight.

Storage and Handling

The product is supplied in a tightly closed container to ensure stability and integrity. It should be stored in a dry place at controlled room temperature, specifically between 59°-86° F (15°-30° C). Proper storage conditions are essential to maintain the product's efficacy and safety.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)