Dzul Fast Freeze

Description

DZUL FAST FREEZE INSTANT PAIN RELIEF is a product designed for effective pain relief. The formulation is intended for immediate application, providing rapid alleviation of discomfort. The product is represented visually in an image/jpeg format, with the reference value identified as DZUL FAST FREEZE INSTANT PAIN RELIEF.jpg. The effective time for this formulation is noted as 20250630, indicating its intended use within a specified timeframe.

Uses and Indications

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

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

Dosage and Administration

For adults and children over 12 years of age, the recommended dosage is to spray two to three pumps onto the affected area as necessary, not to exceed three to four applications per day.

In children under 12 years of age, the use of this product is not recommended without consulting a healthcare professional.

Contraindications

Use of this product is contraindicated in the following situations:

Tight bandaging should be avoided, as it may lead to compromised circulation. Contact with eyes and mucous membranes must be strictly avoided to prevent irritation or injury. Additionally, exposure of the treated area to heat or direct sunlight is contraindicated due to the potential for adverse reactions.

Warnings and Precautions

The product is intended for external use only. It is imperative that it not be applied to wounds or damaged skin, nor should it be used in conjunction with a heating pad. Additionally, this product is contraindicated for use on children under 12 years of age.

In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

Healthcare professionals should advise patients to discontinue use and consult a physician if any of the following occur: the condition worsens, redness develops, irritation arises, symptoms persist for more than 7 days, or if symptoms resolve only to recur within a few days. Furthermore, if any signs of injury are observed—such as pain, swelling, or blistering at the site of application—medical advice should be sought promptly.

Side Effects

Patients using this product may experience various adverse reactions. It is important to note that the product is intended for external use only and should not be applied to wounds or damaged skin. Additionally, it should not be used in children under 12 years of age.

In the event that a patient's condition worsens, or if redness, irritation, or any other concerning symptoms develop, it is advised to stop use and consult a healthcare professional. Patients should also seek medical advice if symptoms persist for more than 7 days, if they resolve and then recur within a few days, or if they experience signs of injury, such as pain, swelling, or blistering at the site of application.

These precautions are essential to ensure the safe use of the product and to mitigate the risk of serious adverse reactions.

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions between the drug and laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the current information.

Packaging & NDC

Below are the non-prescription pack sizes of Dzul Fast Freeze (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should not use this product. It is important to consult a healthcare professional for guidance in this age group. Additionally, the product should not be applied to wounds or damaged skin, nor should it be used in conjunction with a heating pad.

Geriatric Use

Geriatric patients may respond differently to treatment compared to younger populations; however, specific geriatric use information is not explicitly mentioned in the provided drug insert.

Healthcare providers should exercise caution when prescribing this medication to elderly patients, as they may have altered pharmacokinetics and pharmacodynamics. It is advisable to monitor these patients closely for any adverse effects and to consider potential dose adjustments based on individual patient factors, including renal and hepatic function, which may be more prevalent in this age group.

Due to the lack of specific data regarding geriatric use, clinical judgment should guide the treatment of elderly patients, ensuring that the benefits of therapy outweigh any potential risks.

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 regarding the excretion of this medication 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 substance, amount ingested, and time of exposure, is crucial for effective treatment and follow-up care.

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

Patients should be advised to seek immediate medical assistance or contact a Poison Control Center if the product is swallowed. It is important to instruct patients to discontinue use and consult a healthcare provider if their condition worsens, if redness occurs, or if any irritation develops. Patients should also be informed to stop using the product and seek medical advice if symptoms persist for more than 7 days or if symptoms clear up and then recur within a few days.

Healthcare providers should counsel patients to be vigilant for signs of injury, such as pain, swelling, or blistering at the site of application, and to report these symptoms promptly. Patients must be reminded to use the product only as directed and to avoid tightly bandaging the treated area.

Additionally, patients should be cautioned to avoid contact with eyes and mucous membranes. In the event of an allergic reaction, patients should discontinue use immediately and consult a healthcare professional. Lastly, it is essential to advise patients not to expose the treated area to heat or direct sunlight to prevent adverse effects.

Storage and Handling

The product is supplied in a tightly closed container to ensure its integrity. It should be stored in a dry place at a controlled room temperature, specifically between 59°F and 86°F (15°C to 30°C). It is essential to keep the product away from fire or flame to maintain safety and efficacy.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)