Zims Max Freeze

Description

ZIM'S™ MAX-FREEZE PRO FORMULA is a cold therapy cooling roll-on formulation containing 7% menthol. This product is designed for topical application and is presented in a net weight of 3 ounces (85 grams). The formulation provides a cooling sensation intended for relief in targeted areas.

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 should apply the product to the affected area using the roller ball applicator, not exceeding four applications per day. After application, the painful area should be gently massaged until the product is fully absorbed into the skin. It is important to wash hands thoroughly with cold water after each use to prevent accidental contact with sensitive areas.

For children under 12 years of age, it is advised to consult a doctor prior to use to ensure safety and appropriateness of treatment.

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, as this may lead to severe allergic reactions. Application on open wounds, damaged, or irritated skin is contraindicated due to the risk of exacerbating the condition or causing further injury. The use of this product in conjunction with a heating pad or TENS device is not recommended, as it may lead to increased irritation or adverse effects. Additionally, the product should not be used after the expiration date, as efficacy and safety cannot be guaranteed.

Tight bandaging is contraindicated, as it may restrict circulation and lead to complications. The product should only be used as directed; misuse may result in unintended effects. Contact with eyes or mucous membranes should be avoided to prevent irritation or injury.

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 care, as it is flammable; therefore, it should be kept away from fire, flames, and heated surfaces.

Patients should exercise caution and refrain from using this product if they have a known allergy to any of its ingredients. The product should not be applied to open wounds, damaged, or irritated skin. Additionally, it is contraindicated to use this product in conjunction with heating pads or TENS devices. Users must also ensure that the product is not used past its expiration date.

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

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

Side Effects

Patients using this product should be aware that it is for external use only. Rare cases of burns have been reported with similar products, highlighting the importance of adhering to usage guidelines. The product should not be applied to open wounds, damaged, or irritated skin, nor should it be used in conjunction with heating pads or TENS devices. Additionally, it should not be used after the expiration date.

During application, patients may experience a burning sensation at the site of use, which is typically mild and tends to lessen over time. It is advised that patients do not bandage the area tightly and avoid using the product in any manner other than as directed. Care should also be taken to prevent contact with the eyes or mucous membranes.

Patients are instructed to stop using the product 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. Furthermore, if symptoms persist for more than 7 days or if symptoms clear up and then recur within a few days, medical advice should be sought.

Additional considerations include consulting a healthcare professional if pregnant or breastfeeding. The product should be kept out of reach of children, and in the event of accidental ingestion, immediate medical assistance or contact with a Poison Control Center is recommended.

Drug Interactions

There are no specific drug interactions or laboratory test interactions identified in the available data. Therefore, no recommendations for dosage adjustments or monitoring are necessary at this time.

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 doctor before use. For adolescents and adults aged 12 years and older, the recommended application is to the affected area using a roller ball, not exceeding four times daily.

Geriatric Use

There is no specific information regarding the use of ZIM'S™ MAX FREEZE PRO FORMULA in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this product to elderly patients, as the absence of data necessitates careful consideration of individual patient factors and potential risks. Monitoring for any adverse effects is advisable in this population, given the lack of established guidelines for geriatric use.

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 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. 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 drug. 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 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 of overdosage may vary depending on the specific substance involved; therefore, a thorough assessment and monitoring of the patient are essential.

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

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

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 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.

Patients must be reminded to check the expiration date and not to use the product after it has expired. They should be advised to discontinue use and consult a doctor if they experience a painful and persistent burning sensation, if their condition worsens, or if they develop 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.

While using the product, patients may experience a burning sensation at the application site, which is typically mild and diminishes over time. It is essential to advise patients not to bandage the area tightly and to use the product only as directed. Lastly, patients should be cautioned to avoid contact with their eyes or mucous membranes.

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 location, 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 shelf life.

Additional Clinical Information

Adults and children aged 12 years and older should apply the product to the affected area using a roller ball, not exceeding four applications per day. Clinicians advise massaging the painful area until the product is fully absorbed into the skin and recommend washing hands with cold water after each use. For children under 12 years of age, consultation with a doctor is necessary prior to use.

Patients who are pregnant or breastfeeding should seek advice from a health professional before using the product. It is important to keep the product out of reach of children; if ingested, medical assistance should be sought immediately or contact a Poison Control Center.

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.

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