Cryofreeze Roll-on Regular Strength

Description

CRYOFREEZE™ HEMP PAIN RELIEF ROLL-ON is a topical formulation designed for pain relief, available in a regular strength dosage. Each container holds 3 fluid ounces (89 mL) of the product, which contains 150 mg of active ingredients. The roll-on application facilitates targeted delivery to affected areas, providing localized relief.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with sore muscles and joints, backache, and arthritis.

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

Dosage and Administration

The medication should be used only as directed by a healthcare professional. It is contraindicated for use in children under 12 years of age.

For adults and adolescents, the medication should be applied by rolling it onto the affected area. The application should not exceed four times daily. Care should be taken to ensure that the product is applied evenly and only to the specified area of concern.

Contraindications

Use is contraindicated in individuals with sensitive skin, as well as in pregnant or breastfeeding patients, or those currently taking any medications, due to potential adverse effects.

The product should not be used in conjunction with a heating pad, nor should it be bandaged. Following application, hands must be washed with cold water immediately, and contact with eyes or mucous membranes should be avoided to prevent irritation.

Warnings and Precautions

For external use only. This product is flammable; therefore, it should be kept out of reach of children to prevent accidental ingestion or misuse.

Healthcare professionals are advised to recommend that patients contact a doctor prior to use if they have sensitive skin, are pregnant, breastfeeding, or are currently taking any medications. This precaution is essential to ensure the safety and appropriateness of the product for individual patients.

In the event of accidental ingestion, it is critical to seek medical assistance immediately or contact a Poison Control Center. Prompt action is necessary to mitigate potential health risks associated with swallowing the product.

Patients should be instructed to discontinue use and consult a healthcare provider if any of the following occur: redness or irritation at the application site, worsening of the condition, or if pain persists for more than 7 days or resolves only to reoccur. Monitoring for these symptoms is important to ensure patient safety and effective management of any adverse reactions.

Side Effects

Patients should be aware that the product is for external use only and is flammable; therefore, it should be kept out of reach of children. It is advised that individuals contact a healthcare professional prior to use if they have sensitive skin, are pregnant, breastfeeding, or are currently taking any medications. In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center should be contacted.

Drug Interactions

The use of this medication is contraindicated with heating pads, as the combination may lead to adverse effects. It is essential to avoid concurrent use to ensure patient safety.

There are no specific laboratory test interactions associated with this medication. Therefore, routine laboratory monitoring is not required in relation to this drug.

Packaging & NDC

Below are the non-prescription pack sizes of Cryofreeze Roll-on Regular Strength (menthol, unspecified form). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should not be administered this medication. Safety and efficacy have not been established in this population, and use in this age group is contraindicated. Healthcare professionals are advised to consider alternative treatments for children in this age range.

Geriatric Use

Elderly patients should be carefully evaluated before initiating treatment, particularly those aged 65 years and older. Due to the potential for altered pharmacokinetics and pharmacodynamics in this population, it is essential to consider appropriate dosage adjustments and safety monitoring.

Clinical findings indicate that the use of this medication is not recommended for children under 12 years of age. Therefore, healthcare providers should ensure that treatment is only prescribed to eligible patients, taking into account the specific needs and health status of geriatric patients.

Close monitoring for adverse effects and therapeutic efficacy is advised, as elderly patients may exhibit increased sensitivity to medications.

Pregnancy

Pregnant patients should contact their healthcare provider before using this medication. It is important for women who are pregnant, breastfeeding, or taking any other medications to discuss potential risks and benefits with their doctor. The safety of this medication during pregnancy has not been established, and caution is advised to ensure the well-being of both the mother and the fetus.

Lactation

Lactating mothers are advised to contact a healthcare professional prior to using this medication while breastfeeding. 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 considering the use of this medication during lactation.

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 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 management strategy.

Healthcare providers should be prepared to implement supportive care and symptomatic treatment as necessary, based on the clinical presentation of the patient. Continuous monitoring and evaluation may be required to ensure patient safety and effective management of any complications arising from the overdosage.

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 that the product is flammable and must be kept out of reach of children to ensure safety. Patients should be instructed to contact their doctor prior to use if they have sensitive skin, are pregnant, breastfeeding, or are currently taking any medications.

In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately. It is important to inform patients that the product should not be used in conjunction with a heating pad and should not be bandaged after application.

Patients should be counseled to wash their hands with cold water immediately after using the product and to avoid touching their eyes or mucous membranes to prevent irritation. They should also be advised to discontinue use and consult a doctor if they experience redness or irritation, if their condition worsens, or if pain persists for more than 7 days or resolves only to reoccur.

Storage and Handling

The product is supplied in a container that must be stored in a cool, dry place. It is essential to ensure that the cap is tightly closed to maintain the integrity of the product. Proper storage conditions are crucial for preserving the quality and efficacy of the product.

Additional Clinical Information

The product is administered topically, with a recommended application of no more than four times daily to the affected area. Clinicians should advise patients to consult a doctor prior to use if they have sensitive skin, are pregnant, breastfeeding, or taking any medications. Patients are cautioned against using the product with a heating pad or bandaging the area. It is also important for patients to wash their hands with cold water immediately after application and to avoid contact with eyes or mucous membranes.

Patients should discontinue use and seek medical advice if they experience redness or irritation, if their condition worsens, or if pain persists for more than seven days or resolves only to reoccur.

Drug Information (PDF)

This file contains official product information for Cryofreeze Roll-on Regular Strength, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)