X-Treme Freeze

Description

The product is identified by the SPL code 34089-3. No additional specific description details are provided in the available data.

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 arthritis, backache, strains, and sprains.

Limitations of Use: There are no known teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

For adults and children aged 2 years and older, a thin film of the medication should be applied to the affected areas, not exceeding four applications per day. It is not necessary to massage the area after application.

For children under 2 years of age, it is essential to consult a physician prior to use to ensure safety and appropriateness of treatment.

Contraindications

The product is contraindicated in the following situations:

Application to wounds or damaged skin is prohibited due to the potential for adverse effects. The use of this product in conjunction with other ointments, creams, sprays, or liniments is not recommended, as it may lead to unpredictable interactions. It should not be applied to irritated skin or if excessive irritation develops, as this may exacerbate the condition. Bandaging the area after application is contraindicated to prevent occlusion and potential complications. Additionally, the use of heating pads or devices in conjunction with this product is not advised, as it may increase the risk of irritation or adverse reactions.

Warnings and Precautions

For external use only. This product is flammable; it must be kept away from excessive heat or open flame to prevent fire hazards.

Healthcare professionals should advise patients to consult a doctor prior to use if they have sensitive skin. During the application of this product, it is crucial to avoid contact with the eyes or mucous membranes. The product should not be applied to wounds or damaged skin, nor should it be used in conjunction with other ointments, creams, sprays, or liniments. Application to irritated skin is contraindicated, and if excessive irritation develops, use should be discontinued. Bandaging the area after application is not recommended. Patients should wash their hands thoroughly with cool water after use and should refrain from using the product in conjunction with heating pads or devices.

Patients are instructed to stop using the product and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days.

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

Side Effects

Patients using this product should be aware that it is for external use only. It is important to consult a healthcare professional prior to use if the patient has sensitive skin. During application, patients should avoid contact with the eyes or mucous membranes and refrain from applying the product to wounds or damaged skin. The product should not be used in conjunction with other ointments, creams, sprays, or liniments, nor should it be applied to irritated skin or if excessive irritation develops. Bandaging the area after application is not recommended, and patients should wash their hands with cool water following use. Additionally, the use of heating pads or devices in conjunction with this product should be avoided.

Patients are advised to discontinue use and consult a healthcare professional if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. For those who are pregnant or breastfeeding, it is recommended to seek advice from a health professional before using the product.

This product should be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought by contacting a physician or the Poison Control Center at 1-800-222-1222.

Drug Interactions

Co-administration of this medication with other topical formulations, such as ointments, creams, sprays, or liniments, is contraindicated. The use of multiple topical agents may lead to increased risk of adverse effects or reduced efficacy of the treatment.

Additionally, the application of this medication in conjunction with heating pads or devices is not recommended. The combination may enhance local irritation or alter the pharmacological effects of the medication.

Healthcare professionals should ensure that patients are advised against these combinations to maintain the safety and effectiveness of the treatment regimen.

Packaging & NDC

Below are the non-prescription pack sizes of X-Treme Freeze (cold therapy gel). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 2 years and older may apply a thin film of the medication over affected areas up to four times daily, without the need for massage. For children under 2 years of age, it is advised to consult a physician prior to use.

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 adverse effects or changes in therapeutic response, given the potential for altered pharmacokinetics and pharmacodynamics in this population.

Pregnancy

Pregnant patients should consult a healthcare professional prior to using this medication. The safety of this drug during pregnancy has not been established, and potential risks to fetal outcomes are not fully understood. It is essential for women of childbearing potential to discuss their individual circumstances with their healthcare provider to weigh the benefits and risks associated with the use of this medication during pregnancy.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. 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 individuals.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the drug insert text regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as there is no available data to guide treatment decisions in this population. Regular monitoring of renal function may be prudent in these patients, although specific recommendations are not provided.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to 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 prescribing information.

Overdosage

In the event of an overdosage, immediate medical assistance is crucial. If the substance is swallowed, it is imperative to seek medical help without delay. Healthcare professionals should contact a physician or the Poison Control Center at 1-800-222-1222 for guidance on appropriate management.

Prompt intervention 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, swift action and professional consultation are vital in cases of overdosage to ensure patient safety and effective treatment.

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 to seek immediate medical assistance if the product is swallowed, recommending that they contact a physician or the Poison Control Center at 1-800-222-1222 without delay.

Patients should be instructed to discontinue use and consult a doctor if their condition worsens or if symptoms persist for more than 7 days. Additionally, if symptoms resolve and then recur within a few days, patients should also stop using the product and seek medical advice.

When using this product, it is important to inform patients to avoid contact with the eyes and mucous membranes. They should not apply the product to wounds or damaged skin, nor should it be used in conjunction with other ointments, creams, sprays, or liniments. Patients should be cautioned against applying the product to irritated skin or if excessive irritation develops, and they should refrain from bandaging the area after application. It is also essential for patients to wash their hands with cool water after use and to avoid using the product with heating pads or devices.

Furthermore, healthcare providers should recommend that patients consult a doctor before using the product if they have sensitive skin.

Storage and Handling

The product is supplied in a tamper-evident container. It is essential to inspect the seal before use; do not use the product if the seal is damaged.

For optimal storage, the product should be kept in a cool, dry place, away from excessive heat or open flame. Proper handling and storage conditions are crucial to maintain the integrity and safety of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for X-Treme Freeze, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)