Truvitality Cbd Muscle Freeze 4% Menthol

Description

The provided data does not specify the chemical name, physical characteristics, or inactive ingredients of the drug. Therefore, a detailed description cannot be formulated based on the available information. Further details are required to create a comprehensive description.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with sore muscles and joints. Specifically, it is effective for conditions such as simple backache, strains, sprains, bruises, and cramps.

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

Dosage and Administration

For adults and children over 2 years of age, a thin film of the medication should be applied to the affected areas up to four times daily. It is important to ensure that the application is uniform and covers the entire affected area for optimal efficacy.

For children under 2 years of age, it is recommended to consult a physician prior to use to determine the appropriate course of action and to ensure safety.

Contraindications

There are no contraindications listed for this product.

However, it is advised to discontinue use and consult a healthcare professional if any of the following occur: worsening of the condition, development of irritation, persistence of symptoms beyond 7 days, or if symptoms resolve and then reoccur within a few days.

Warnings and Precautions

For external use only. This product must be utilized strictly as directed. It is imperative to avoid bandaging tightly, using heating pads or devices, and contact with the eyes and mucous membranes. Application to wounds or damaged, broken, or irritated skin is contraindicated. Additionally, this product should not be used in conjunction with other ointments.

This product is flammable; therefore, it should be kept away from excessive heat or open flame.

In the event of accidental ingestion, immediate medical assistance should be sought, or contact a Poison Control Center at 1-800-222-1222.

Healthcare professionals should advise patients to discontinue use and consult a physician if any of the following occur: the condition worsens, irritation develops, symptoms persist for more than 7 days, or if symptoms clear up and then reoccur within a few days.

Side Effects

Patients should be aware that this product is for external use only. It is imperative to use the product strictly as directed. Patients are advised against bandaging tightly, using heating pads or devices, and should avoid contact with the eyes and mucous membranes. The product should not be applied to wounds or damaged, broken, or irritated skin, nor should it be used in conjunction with other ointments. Additionally, the product is flammable and should be kept away from excessive heat or flame.

In the event that a patient's condition worsens, irritation develops, symptoms persist for more than 7 days, or symptoms clear up and then reoccur within a few days, it is recommended that the patient stop use and consult a doctor.

Drug Interactions

No drug interactions or drug and laboratory test interactions have been identified for this product. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Truvitality Cbd Muscle Freeze 4% Menthol (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients over 2 years of age may apply a thin film of the product over affected areas up to four times daily. For children under 2 years, it is advised to consult a physician prior to use.

It is important to keep the product out of reach of children. In the event of accidental ingestion, medical assistance should be sought immediately, or contact a Poison Control Center at 1-800-222-1222.

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 healthcare professional prior to using this medication. The potential risks and benefits must be carefully weighed, 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 lactation.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data on the excretion of this drug 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 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 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, immediate medical attention should be sought. Healthcare providers should initiate supportive care, which may include maintaining airway patency, ensuring adequate ventilation, and monitoring vital signs.

If available, the use of specific antidotes or treatments should be considered based on the substance involved and the clinical presentation. Consultation with a poison control center or a medical toxicologist may provide additional guidance on the management of overdose cases.

Documentation of the incident, including the amount and timing of the substance taken, is crucial for effective treatment and follow-up care.

Nonclinical Toxicology

If pregnant or breast-feeding, it is advised to consult a health professional before use. No non-teratogenic effects have been specified. Additionally, there are no details provided regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children. In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately at 1-800-222-1222.

Patients should be instructed to stop using the medication and consult a doctor if their condition worsens, if irritation develops, or if symptoms persist for more than 7 days. Additionally, patients should be informed to seek medical advice if symptoms clear up and then reoccur within a few days.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which are essential for identification and inventory management. It is crucial to store the product in a cool place to maintain its integrity and effectiveness.

To ensure optimal conditions, the product must not be frozen. Additionally, it is important to keep the lid tightly closed when the product is not in use to prevent contamination and preserve its quality. Proper handling and storage practices are essential for maintaining the product's efficacy.

Additional Clinical Information

Adults and children over 2 years of age are instructed to apply a thin film of the product to the affected areas up to four times daily. For children under 2 years, consultation with a physician is recommended prior to use.

Clinicians should advise patients to keep the product out of reach of children and to seek medical assistance or contact a Poison Control Center immediately at 1-800-222-1222 if ingested. Pregnant or breastfeeding patients should consult a healthcare professional before use. The product should not be frozen, and the lid should be kept tightly closed when not in use, with storage in a cool place recommended.

Drug Information (PDF)

This file contains official product information for Truvitality Cbd Muscle Freeze 4% Menthol, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)