Cryofreeze Roll-on Extra Strength

Description

CRYOFREEZE™ is a hemp-based pain relief roll-on formulation designed for extra strength efficacy. Each 3 fl oz (89 mL) container contains 500 mg of active ingredients. The product is intended for topical application to provide targeted relief from discomfort.

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 to the affected area by rolling it on, with a maximum frequency of four applications per day. Care should be taken to ensure that the application does not exceed this recommended limit.

Contraindications

Use of this product is contraindicated in the following situations:

• Application with a heating pad is not recommended due to the potential for increased local temperature and risk of skin irritation.

• Bandaging the area where the product is applied is contraindicated, as it may alter the intended effect and increase the risk of adverse reactions.

• Contact with eyes or mucous membranes should be avoided to prevent irritation and potential injury.

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 should advise patients to 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 circumstances.

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 ingestion.

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. These symptoms may indicate an adverse reaction or the need for a different therapeutic approach.

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

Patients are advised to consult a healthcare professional prior to initiating treatment if they are currently taking any medications. This precaution is essential to ensure safety and efficacy, as potential drug interactions may occur.

Regarding laboratory test interactions, there are no specific interactions identified that would affect laboratory test results. However, it remains important for healthcare providers to consider the overall clinical context when interpreting test outcomes in patients receiving treatment.

Packaging & NDC

Below are the non-prescription pack sizes of Cryofreeze Roll-on Extra 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 considered when prescribing this medication. The use of this medication is contraindicated in children under 12 years of age; however, specific data regarding dosage adjustments or safety considerations for geriatric patients have not been provided.

Healthcare providers are advised to monitor elderly patients closely for any adverse effects or complications that may arise during treatment. It is essential to evaluate the overall health status and comorbidities of geriatric patients, as these factors may influence the medication's safety and efficacy.

Due to the lack of specific recommendations for dosage adjustments in this population, clinicians should exercise caution and consider starting at lower doses, if applicable, while closely observing the patient's response to therapy.

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 before using this medication if they are breastfeeding or taking any other medications. 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 considering the use of this medication during lactation.

Renal Impairment

There is no information available regarding renal impairment, including dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of specific guidance when treating patients with renal impairment.

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

Prompt action 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 prevent accidental ingestion or exposure. 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 help or contact a Poison Control Center immediately.

Patients should be informed not to use the product in conjunction with a heating pad and to avoid bandaging the area after application. It is essential for patients to wash their hands with cold water immediately after use and to refrain from touching their eyes or mucous membranes to prevent irritation.

Healthcare providers should counsel patients 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 also instructed to 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. It is important for patients to wash their hands with cold water immediately after application and to avoid contact with eyes or mucous membranes.

Drug Information (PDF)

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

View product document (PDF)