Cryofreeze Sport

Description

CRYOFREEZE™ SPORT ICY COLD ROLL-ON is presented in a dosage form of a roll-on solution, contained in a 3 fluid ounce (89 mL) bottle. This formulation is designed for topical application, providing a cooling sensation to the skin.

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 strictly as directed. It is contraindicated for use in children under 12 years of age. For adults and adolescents, the product 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 is contraindicated in individuals with sensitive skin, those who are pregnant or breastfeeding, and patients currently on any medication, due to potential adverse reactions.

The product should not be used in conjunction with a heating pad or bandaged, as these practices may exacerbate side effects. Additionally, it is essential to wash hands with cold water immediately after use and avoid contact with eyes or mucous membranes to prevent irritation.

Warnings and Precautions

For external use only. This product is flammable and 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 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. Prior to use, individuals are advised to contact a healthcare professional if they have sensitive skin, are pregnant, breastfeeding, or are currently taking any medications. In the event of accidental ingestion, it is crucial to seek medical assistance or contact a Poison Control Center immediately.

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.

There are no specific laboratory test interactions identified for this medication. However, it remains important for healthcare providers to consider the overall medication regimen of the patient when interpreting laboratory results. Regular monitoring and communication with healthcare professionals are recommended to manage any potential interactions effectively.

Packaging & NDC

Below are the non-prescription pack sizes of Cryofreeze Sport (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 when considering the use of this medication. It is important to note that this medication is not indicated for use in children under 12 years of age.

Healthcare providers should exercise caution and consider potential differences in pharmacokinetics and pharmacodynamics in geriatric patients. Monitoring for efficacy and safety is recommended, as elderly patients may have altered responses to treatment.

Dosage adjustments may be necessary based on individual patient factors, including renal and hepatic function, which can be affected by age. Regular assessment of the patient's condition and response to therapy is advised to ensure optimal outcomes in this population.

Pregnancy

Pregnant patients should contact their healthcare provider before using this medication. It is essential to evaluate the potential risks and benefits, as well as any available data regarding fetal outcomes. Healthcare professionals are advised to consider the individual circumstances of pregnant patients when making treatment decisions.

Lactation

Lactating mothers are advised to contact a healthcare professional before 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. Caution is recommended when administering this medication to lactating mothers, and healthcare providers should be consulted to ensure safety for both the mother and the nursing infant.

Renal Impairment

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

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 without delay. It is recommended to contact a Poison Control Center for guidance on the appropriate steps to take.

Prompt action is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

In summary, the key steps in managing an overdosage include:

1. Immediate Medical Attention: Patients should seek medical help or contact a Poison Control Center as soon as possible if an overdosage is suspected.

2. Symptom Assessment: Healthcare professionals should evaluate the patient for any symptoms that may arise from the overdosage and provide appropriate management based on clinical findings.

Timely intervention can significantly impact the outcome in cases of 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 use of the compound in these contexts.

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 before using the product 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.

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 wash their hands with cold water immediately and avoid touching their eyes or mucous membranes to prevent irritation.

Patients should be counseled 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. This guidance is essential for ensuring safe and effective use of the product.

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 place, ensuring that the cap is tightly closed to prevent contamination and maintain efficacy. Proper storage conditions are critical for the product's stability and longevity.

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 contact a doctor prior to use if they have sensitive skin, are pregnant, breastfeeding, or taking any medications. It is important to instruct patients not to use the product with a heating pad or to bandage the area after application. Patients should wash their hands with cold water immediately after use and avoid contact with eyes or mucous membranes.

Patients are also 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 seven days or resolves only to reoccur.

Drug Information (PDF)

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

View product document (PDF)