Sports Pain Relief Cream

Description

Hemp Fusion Sports Pain Relief Cream is formulated with 1.75% menthol and includes capsicum, hemp extract containing naturally occurring cannabidiol (CBD) at a concentration of 90 mg per bottle, and terpenes derived from black pepper and clove at 85 mg per bottle. The cream incorporates various natural skin moisturizers and is suitable for all skin types. It is certified by the U.S. Hemp Authority and is non-GMO. The product is presented in a 50 mL (1.69 fl oz) dosage form.

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, bruises, and sprains.

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 the affected area not more than 3 to 4 times daily. It is important to ensure that the application is performed with clean hands and that the affected area is clean and dry prior to application.

For children under 12 years of age, it is advised to consult a healthcare professional for appropriate dosing and administration guidance.

Contraindications

Use of this product is contraindicated in the following situations:

Tight bandaging is not recommended, as it may lead to compromised circulation. Additionally, the application of this product to wounds or damaged skin is contraindicated due to the potential for irritation or adverse reactions.

Warnings and Precautions

For external use only. Healthcare professionals should advise patients to adhere strictly to this guideline to prevent unintended ingestion or systemic absorption.

When utilizing this product, it is essential to observe the following precautions to ensure safe application. Patients should avoid contact with the eyes to prevent irritation or injury. Additionally, it is advised not to bandage the area tightly, as this may lead to increased local irritation or adverse effects. The product should not be applied to wounds or damaged skin, as this could exacerbate the condition or lead to complications.

Patients are instructed to discontinue use and consult a healthcare provider if any of the following occur: worsening of the condition, onset of irritation, or if symptoms persist for more than 7 days. If symptoms resolve and then recur within a few days, medical advice should also be sought.

It is critical to keep this product out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended to ensure appropriate management.

Side Effects

Patients using this product should be aware that it is intended for external use only. It is important to avoid contact with the eyes and to refrain from bandaging tightly over the application site. Additionally, the product should not be applied to wounds or damaged skin.

In clinical practice, patients are advised to discontinue use and consult a healthcare professional if their condition worsens, if irritation occurs, or if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days.

For pregnant or breastfeeding individuals, it is recommended to seek advice from a healthcare professional prior to use.

Furthermore, 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 without delay.

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 Sports Pain Relief Cream (menthol 1.75%). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should consult a doctor before use. For adolescents and adults aged 12 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 considered in these populations to ensure the safety of both the mother and the fetus or infant.

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 individuals.

Renal Impairment

Patients with renal impairment may not have specific dosage adjustments, special monitoring, or safety considerations outlined in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment and monitoring of these patients.

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 assistance is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical help or contact a Poison Control Center without delay.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved; therefore, a thorough assessment by a medical professional is recommended to determine the appropriate course of action.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. It is imperative that healthcare providers remain vigilant and prepared to address any complications that may arise from an overdosage scenario.

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 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. In the event that the product is swallowed, patients should seek medical help or contact a Poison Control Center immediately.

Patients should be instructed to discontinue use and consult a doctor if their condition worsens, if irritation occurs, or if symptoms persist for more than 7 days. Additionally, if symptoms clear up and then recur within a few days, patients should also stop use and seek medical advice.

While using this product, it is important to avoid contact with the eyes. Patients should be cautioned against bandaging the area tightly and should not apply the product to wounds or damaged skin.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product in a cool, dry place, ensuring it is protected from light exposure to maintain its integrity and efficacy. Proper storage conditions are crucial for preserving the quality of the product throughout its shelf life.

Additional Clinical Information

The medication is administered topically, with a recommended application frequency of 3 to 4 times daily for adults and children aged 12 years and older. For children under 12 years of age, it is advised to consult a doctor prior to use. There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

Drug Information (PDF)

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

View product document (PDF)