Sunset Pain Relief - Cooling Relief

Description

The SUNSET COOLING RELIEF STICK is a topical formulation designed for pain relief, incorporating 500 mg of CBD oil. This product is presented in a stick dosage form, facilitating easy application to targeted areas. The effective date of this formulation is September 8, 2022. The product is visually represented in an image file labeled "SUNSET - PAIN RELIEF STICK COOLING 1oz.jpg," which is in JPEG format.

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

Adults and children over 12 years of age should apply a small amount of the product to the area intended for treatment. The application should be performed using 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.

The product is intended for topical application only.

Contraindications

Use of this product is contraindicated in the following situations:

Tight bandaging or the use of heating pads in conjunction with this product is not recommended, as it may lead to 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 potential for exacerbating the condition. Additionally, exposure of the treated area to heat or direct sunlight should be avoided to minimize the risk of adverse reactions.

Warnings and Precautions

For external use only. Healthcare professionals should advise patients to discontinue use and seek medical attention under the following circumstances:

• If the condition worsens despite treatment.

• If redness occurs at the application site.

• If any irritation develops.

• If symptoms persist for more than 7 days or if symptoms resolve and then recur within a few days.

• If patients experience signs of injury, including pain, swelling, or blistering at the site of application.

It is essential for healthcare providers to monitor patients for these adverse reactions and to ensure appropriate follow-up care is provided.

Side Effects

Patients should be aware that the product is intended for external use only. In the event of adverse reactions, it is advised to stop use and consult a healthcare professional if any of the following occur: worsening of the condition, presence of redness, development of irritation, persistence of symptoms for more than 7 days, or if symptoms clear up and then recur within a few days. Additionally, patients should seek medical advice if they experience signs of injury, which may include pain, swelling, or blistering at the site of application.

Drug Interactions

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

Packaging & NDC

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

Pediatric Use

Pediatric patients should be advised to keep this product out of reach of children. For adolescents aged 12 years and older, the recommended application involves using a small amount on the targeted area, massaging in a circular motion, and allowing it to set for a few seconds. This process may be repeated as necessary, but should not exceed 3 to 4 applications per day. Safety and efficacy in children under 12 years have not been established.

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 considered, 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 breastfeeding.

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 drug 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 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 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, as the clinical presentation can vary depending on the substance involved. Common symptoms of overdose may include, but are not limited to, altered mental status, cardiovascular instability, and respiratory distress.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs. The use of activated charcoal may be considered if the patient presents within a suitable timeframe and if the ingestion was recent.

Furthermore, it is crucial to consult local poison control centers or toxicology experts for guidance on specific management protocols and antidotes, if applicable. Continuous assessment and supportive measures are paramount in ensuring patient safety and optimizing outcomes in cases of suspected overdose.

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 keep the product out of reach of children to prevent accidental ingestion or misuse. Patients should be instructed to stop using the product and consult a doctor if their condition worsens, if redness or irritation develops, if symptoms persist for more than seven days, or if symptoms clear up only to recur within a few days. Additionally, patients should seek medical advice if they experience signs of injury, such as pain, swelling, or blistering at the application site.

It is important to emphasize that patients should use the product only as directed. They should be cautioned against bandaging the area tightly or using the product in conjunction with a heating pad. Patients must also be informed to avoid contact with eyes and mucous membranes, and 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 healthcare professional. Furthermore, patients should be advised to avoid exposing the treated area to heat or direct sunlight to prevent adverse effects.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product in a cool, dry place, away from any sources of fire or flame to ensure safety and integrity. Proper handling practices should be observed to maintain the quality of the product throughout its storage period.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)