Zims Max Freeze

Description

ZIM'S™ MAX-FREEZE PRO FORMULA is a topical analgesic designed for deep penetrating pain relief. This fast-acting formulation provides long-lasting effects and features a cooling liquid that contains 16% menthol, enhancing its cold therapy properties. The product is presented in a 3 fl oz (89 mL) bottle, shaped for easy application, and is characterized by a vanishing scent, ensuring a discreet user experience.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains of muscles and joints associated with conditions such as simple backache, arthritis, strains, bruises, and sprains.

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

Dosage and Administration

For adults and children aged 12 years and over, the recommended dosage is to apply the medication to the affected area up to four times daily. It is important to ensure that the application does not exceed this frequency to avoid potential adverse effects.

For children under 12 years of age, it is advised to consult a healthcare professional prior to use to determine the appropriate course of action and dosage.

Contraindications

Use of this product is contraindicated in the following situations:

• Patients with a known allergy to any ingredient in this product.

• Application on open wounds, damaged, or irritated skin due to the risk of exacerbating the condition.

• Concurrent use with a heating pad or TENS device, as this may lead to adverse effects.

• Use after the expiration date, as efficacy and safety cannot be guaranteed.

• Tight bandaging is contraindicated to prevent potential complications.

• Use contrary to the provided directions is not recommended.

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

Warnings and Precautions

For external use only. This product is flammable; it must be kept away from fire, flames, and heated surfaces to prevent ignition.

The product should not be used in the following circumstances:

• In individuals with a known allergy to any ingredient contained in this formulation.

• On open wounds, damaged, or irritated skin, as this may exacerbate the condition.

• In conjunction with heating pads or TENS devices, as this may lead to adverse effects.

• After the expiration date, as efficacy and safety cannot be guaranteed.

Healthcare professionals should advise patients to discontinue use and seek medical advice if any of the following occur:

• The condition worsens despite treatment.

• There is the development of a rash, itching, redness, or excessive irritation of the skin.

• Symptoms persist for more than 7 days.

• Symptoms resolve and then recur within a few days.

In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

General precautions include consulting a healthcare professional prior to use if the patient is pregnant or breastfeeding. Additionally, it is imperative to keep this product out of the reach of children to prevent accidental ingestion or misuse.

Side Effects

Patients should be aware that this product is for external use only. It is contraindicated in individuals with known allergies to any ingredient in the formulation, and it should not be applied to open wounds, damaged, or irritated skin. The use of this product in conjunction with heating pads or TENS devices is also not recommended. Additionally, it should not be used after the expiration date.

During the application of this product, patients are advised to press the applicator gently against the skin to avoid excess application. Bandaging should not be done tightly, and the product should only be used as directed. Care should be taken to avoid contact with the eyes or mucous membranes.

Patients are instructed to discontinue use and consult a healthcare professional if any of the following occur: worsening of the condition, development of a rash, itching, redness, or excessive irritation of the skin, persistence of symptoms beyond 7 days, or if symptoms resolve and then recur within a few days.

For pregnant or breastfeeding individuals, it is recommended to seek advice from a healthcare professional prior to use. This product should be kept out of reach of children, and in the event of accidental ingestion, medical assistance should be sought immediately or contact with a Poison Control Center should be made.

Drug Interactions

The use of this medication is contraindicated with heating pads or transcutaneous electrical nerve stimulation (TENS) devices due to potential adverse effects. It is advised that patients refrain from using these devices concurrently to avoid complications.

No specific drug or laboratory test interactions have been identified. Therefore, routine monitoring or dosage adjustments related to other medications or laboratory tests are not necessary.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. For adolescents and adults aged 12 years and older, the recommended application is to the affected area no more than four times daily.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population, given the lack of targeted data.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to assess the potential risks and benefits associated with its use during pregnancy and lactation. The safety of this medication in pregnant women has not been established, and therefore, caution is advised.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data on the excretion of this drug 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 drug insert 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 the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

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 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 course of action.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. It is imperative that healthcare providers remain vigilant and prepared to address any complications that may arise from an overdosage scenario.

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 keep this product out of reach of children. In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately.

Patients should be informed not to use the product if they have a known allergy to any of its ingredients. It is also important to instruct patients to avoid applying the product on open wounds, damaged, or irritated skin. Additionally, patients should be cautioned against using the product in conjunction with heating pads or TENS devices.

Healthcare providers should emphasize the importance of adhering to the expiration date and not using the product after it has expired. Patients should be advised to discontinue use and consult a doctor if their condition worsens or if they experience a rash, itching, redness, or excessive irritation of the skin. Furthermore, patients should be instructed to seek medical advice if symptoms persist for more than seven days or if symptoms resolve and then recur within a few days.

When using the product, patients should be guided to apply it carefully by pressing the applicator gently against the skin to avoid excess application. They should also be reminded not to bandage the area tightly and to use the product only as directed. Lastly, patients should be cautioned to avoid contact with the eyes or mucous membranes during application.

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 place, away from direct sunlight, to maintain its efficacy. Additionally, the cap must be closed tightly to prevent contamination and preserve the product's quality. Proper adherence to these storage conditions is crucial for ensuring the product remains effective throughout its intended shelf life.

Additional Clinical Information

Patients aged 12 years and older are advised to apply the medication to the affected area no more than four times daily. For children under 12 years of age, consultation with a healthcare professional is recommended prior to use.

Clinicians should counsel patients to seek advice from a health professional if they are pregnant or breastfeeding. It is also important to instruct patients to keep the product out of reach of children and to seek immediate medical assistance or contact a Poison Control Center if the product is swallowed.

Drug Information (PDF)

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

View product document (PDF)