Zims Max Freeze

Description

ZIM'S™ MAX-FREEZE PRO FORMULA is an extra strength topical analgesic designed for fast-acting and long-lasting pain relief. The formulation features a continuous multi-way spray mechanism, delivering a cooling effect enhanced by 16% menthol. The product is presented in a net weight of 3.4 oz (96 g) and is characterized by a vanishing scent, ensuring a discreet application. The pain relief provided by this formulation is longer lasting compared to the original version.

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

Adults and children 12 years of age and over are instructed to spray the affected area up to four times daily. It is important to note that there is no need to rub the area after application. Following each use, individuals should wash their hands thoroughly with cold water to prevent any unintended contact with other areas of the body or surfaces.

For children under 12 years of age, it is recommended to consult a healthcare professional before use to determine the appropriate course of action.

Contraindications

Use of this product is contraindicated in the following situations:

Patients with a known allergy to any ingredient in this product should not use it due to the risk of allergic reactions. Application on open wounds, damaged, or irritated skin is contraindicated to prevent further injury or infection. The use of this product in conjunction with a heating pad or TENS device is not recommended, as it may lead to adverse effects. Application near the face is contraindicated to avoid potential irritation or injury. Additionally, the product should not be used after the expiration date, as efficacy and safety cannot be guaranteed.

It is also advised to avoid bandaging tightly, using the product in a manner other than directed, and to prevent contact with eyes or mucous membranes, as well as inhalation.

Warnings and Precautions

For external use only. There have been rare reports of burns associated with the use of products of this type. It is imperative to handle the product with caution due to its flammable nature. Users should keep the product away from fire, flames, and heated surfaces. Additionally, it should not be used near sparks or while smoking, and should not be utilized in small or confined spaces. Long-term storage should be avoided at temperatures exceeding 104°F (40°C), and the product must not be punctured or incinerated, as it contains pressurized contents. Exposure to temperatures above 119°F (48°C) should also be avoided.

General precautions must be observed. The product should not be used by individuals who are allergic to any of its ingredients. It is contraindicated for application on open wounds, damaged, or irritated skin. The use of this product in conjunction with heating pads or TENS devices is not recommended. Additionally, it should not be applied near the face, and usage after the expiration date is strictly prohibited.

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

Users are instructed to discontinue use and consult a physician if any of the following occur: a burning sensation that is painful and persistent, 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.

Side Effects

Patients using this product may experience a burning sensation at the site of application, which is typically mild and tends to diminish over time. However, in rare instances, more serious adverse reactions have been reported, including burns associated with the use of similar products.

It is important for patients to adhere strictly to the usage instructions provided. The product is intended for external use only, and patients should avoid tight bandaging, contact with eyes or mucous membranes, and inhalation of the product.

Patients are advised to discontinue use and consult a healthcare professional if they experience a burning sensation that is painful and persistent, if their condition worsens, or if they develop a rash, itching, redness, or excessive irritation of the skin. Additionally, if symptoms persist for more than 7 days or if symptoms resolve and then recur within a few days, medical advice should be sought.

The product should not be used by individuals who are allergic to any of its ingredients, on open wounds or damaged skin, in conjunction with heating pads or TENS devices, or near the face. It is also crucial to avoid using the product after its expiration date.

Furthermore, the product should be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought 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.

There are no specific interactions identified with laboratory tests associated with this medication. Therefore, routine laboratory monitoring does not require any adjustments or special considerations related to this drug.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 12 years of age should consult a doctor prior to use. For adolescents and adults aged 12 years and older, the recommended dosage is to spray the affected area no more than four times daily.

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 potential adverse effects or changes in efficacy, given the lack of targeted data for this population.

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 considered in these populations to ensure the safety of both the mother and the fetus or infant.

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 no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this medication. Consequently, there are no 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 intervention is crucial. If the substance is ingested, it is imperative to seek medical assistance or contact a Poison Control Center without delay.

Healthcare professionals should be aware that prompt action can significantly influence the outcome of an overdosage situation. Symptoms may vary depending on the specific substance involved, and monitoring for any adverse effects is essential.

Management of overdosage should include supportive care and symptomatic treatment as necessary. Continuous assessment of the patient's condition is recommended to address any complications that may arise.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

Rare cases of burns have been reported in association with the use of products of this type. These events were identified through voluntary reporting and surveillance programs.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. It is important to emphasize that if the medication is swallowed, patients should seek medical help or contact a Poison Control Center immediately. This guidance is crucial for ensuring patient safety and minimizing potential risks associated with accidental exposure.

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 environment, away from direct sunlight, to maintain its efficacy. Additionally, the cap must be locked tightly to prevent contamination and ensure the product remains secure during storage. Proper adherence to these storage conditions is crucial for the product's stability and effectiveness.

Additional Clinical Information

The product is administered topically, with a recommended frequency of up to four times daily for adults and children aged 12 years and older. There is no need to rub the area after application, but it is advised to wash hands with cold water following each use. For children under 12 years of age, consultation with a doctor is recommended prior to use.

Clinicians should counsel patients to seek advice from a health professional if they are pregnant or breastfeeding. Additionally, it is important to keep the product out of reach of children, and in the event of ingestion, medical assistance or contact with a Poison Control Center should be sought immediately.

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)