Cold Leaf Nutrition Muscle and Joint Pain Relief

Description

This formulation is designed for muscle and joint pain relief and contains a blend of active ingredients including aloe, arnica, vitamin E, and tea tree oil. The product is presented in a roll-on dosage form, which is characterized by its greaseless texture and vanishing scent. It is free from parabens, synthetic fragrances, sulfates, paraffins, DEA, petrolatum, and mineral oil. Additionally, the product has not been tested on animals. The total volume of the formulation is 89 mL (3 fl oz).

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

Adults and children 12 years and older are instructed to apply the product to the affected painful joints and/or muscles. The application should be accompanied by gentle massage to enhance absorption. This process may be repeated as needed, but should not exceed four applications in a 24-hour period.

After each use, it is essential to wash hands thoroughly with cold water to prevent accidental contact with sensitive areas.

Contraindications

The product is contraindicated in the following situations:

• Use with other topical products is not recommended, as this may lead to adverse interactions.

• Application in conjunction with heating devices is contraindicated due to the potential for increased absorption and risk of skin irritation.

• The product should not be applied to open wounds, damaged, or irritated skin to prevent exacerbation of the condition and ensure safety.

• Exposure to excessive heat or open flame is contraindicated, as it may pose a risk of fire or thermal injury.

Warnings and Precautions

Use of this product should be strictly in accordance with the provided directions. It is intended for external use only. In the event that the condition worsens, or if symptoms persist beyond 7 days or resolve only to recur within a few days, the product should be discontinued, and a physician should be consulted.

Care should be taken to avoid contact with the eyes or mucous membranes. For individuals who are pregnant or breastfeeding, it is advisable to consult a physician prior to use. The product should not be used concurrently with other topical products or heating devices, as this may lead to adverse effects.

This product is contraindicated for application on open wounds, damaged, or irritated skin. Additionally, it should be stored away from excessive heat or open flames to prevent degradation or potential hazards.

It is imperative to keep this and all medications out of the reach of children. In the case of accidental ingestion, immediate professional assistance should be sought, and Poison Control should be contacted without delay.

Side Effects

Patients using this product may experience adverse reactions, which can vary in seriousness. It is important to note that this product is for external use only. In the event that the condition worsens, or if symptoms persist for more than 7 days or resolve and then recur within a few days, patients should discontinue use and consult a physician.

Patients are advised to avoid contact with eyes or mucous membranes to prevent irritation. Additionally, the product should not be used in conjunction with other topical products or heating devices, nor should it be applied to open wounds, damaged, or irritated skin. It is also recommended to keep the product away from excessive heat or open flame.

For pregnant or breastfeeding patients, it is essential to consult a physician before use.

To ensure safety, this product should be kept out of reach of children. In the case of accidental ingestion, it is crucial to seek professional help and contact Poison Control immediately.

Drug Interactions

Co-administration of this product with other topical products is contraindicated due to the potential for increased irritation or altered efficacy. Additionally, the use of heating devices in conjunction with this product is not recommended, as it may lead to enhanced absorption and increased risk of adverse effects.

Healthcare professionals should advise patients to avoid these combinations to ensure optimal safety and effectiveness of the treatment. Monitoring for any signs of irritation or adverse reactions is advisable if accidental co-use occurs.

Packaging & NDC

Below are the non-prescription pack sizes of Cold Leaf Nutrition Muscle and Joint Pain Relief (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 12 years and older may apply and gently massage the medication onto painful joints and/or muscles. It is important to keep this and all medications out of reach of children to ensure safety.

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 efficacy, given the lack of targeted data for this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a physician prior to using this medication. The potential risks associated with the use of this drug during pregnancy and lactation have not been fully established. Therefore, healthcare professionals are advised to weigh the benefits against any potential risks when considering treatment options for women of childbearing potential.

Lactation

Lactating mothers are advised to consult a physician 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 administering this medication to lactating mothers.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the prescribing information 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 and monitoring of these patients.

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, it is crucial to seek professional medical assistance promptly. Healthcare professionals should be alerted to any accidental ingestion of the medication. Immediate contact with Poison Control is recommended to ensure appropriate management and intervention.

Symptoms of overdosage may vary depending on the specific medication involved; therefore, a thorough assessment of the patient's condition is essential. Healthcare providers should monitor for any adverse effects and be prepared to implement supportive care as necessary.

Management procedures may include symptomatic treatment and monitoring of vital signs. It is important to follow established protocols for the specific substance involved in the overdosage to mitigate potential risks and complications effectively.

Nonclinical Toxicology

No specific information regarding teratogenic or non-teratogenic effects is available. Additionally, there are no details provided concerning nonclinical toxicology, animal pharmacology, or toxicology. As such, a comprehensive assessment of these aspects cannot be made at this time.

Postmarketing Experience

No postmarketing experience details are provided in the insert.

Patient Counseling

Healthcare providers should advise patients to keep this medication and all other medicines out of reach of children to prevent accidental ingestion. It is crucial to emphasize the importance of safeguarding medications to avoid potential harm to young children.

In the event of accidental ingestion, healthcare providers should instruct patients to seek professional help immediately and contact Poison Control. Prompt action is essential to ensure the safety and well-being of the individual involved.

Storage and Handling

The product is supplied in a configuration that ensures optimal preservation of its integrity. It is essential to store the product in a cool, dry area to maintain its efficacy. Additionally, the cap must be closed tightly after each use to prevent contamination and ensure the product remains in optimal condition.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)