Zims Max Freeze

Description

ZIM'S™ MAX-FREEZE EXTRA STRENGTH is a professional formulation designed for effective pain relief. This product features a cooling gel base containing 7% menthol, providing both fast-acting and long-lasting relief. The formulation is characterized by its vanishing scent, enhancing user experience during application. The product is packaged in a net weight of 4 oz (113 g) and is specifically designed for cold therapy applications. The enhanced formula offers longer-lasting pain relief 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 apply the product to the affected area no more than four times daily. The application should involve massaging the painful area until the product is fully absorbed into the skin. It is essential 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 recommended 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.

• 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.

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

Additionally, while using this product, it is important to avoid bandaging tightly, using it in a manner other than as directed, and ensuring that it does not come into contact with the eyes or mucous membranes to prevent irritation or injury.

Warnings and Precautions

For external use only, this product has been associated with rare cases of burns. Healthcare professionals should advise patients to exercise caution and ensure that the product is kept away from fire, flames, and heated surfaces due to its flammable nature.

Patients should be instructed not to use this product if they have a known allergy to any of its ingredients. It is contraindicated for application on open wounds, damaged, or irritated skin. Additionally, the use of this product in conjunction with heating pads or TENS devices is not recommended.

The product should not be used after the expiration date. While a mild burning sensation may occur upon application, this sensation typically diminishes over time. Patients should be cautioned against tightly bandaging the area of application and should use the product strictly as directed.

Contact with eyes or mucous membranes should be avoided. If patients experience a burning sensation that is painful and persistent, or if their condition worsens, they should discontinue use and consult a healthcare professional. Furthermore, patients should seek medical advice if they develop a rash, itching, redness, or excessive irritation of the skin, or if symptoms persist for more than 7 days. If symptoms resolve and then recur within a few days, medical consultation is also advised.

This 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.

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.

Patients should not use this product if they are allergic to any ingredient in the formulation, on open wounds, damaged or irritated skin, in conjunction with a heating pad or TENS device, or after the expiration date.

While using this product, patients may experience a burning sensation at the application site, which is typically mild and tends to lessen over time. It is advised not to bandage the area tightly and to avoid using the product in any manner other than as directed. Additionally, contact with eyes or mucous membranes should be avoided.

Patients are instructed to stop use and consult a doctor if the burning sensation becomes painful and persistent, if the condition worsens, or if any rash, itching, redness, or excessive irritation of the skin develops. 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.

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

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 not more than 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 or unusual responses is advisable in 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 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.

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 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 help or contact a Poison Control Center immediately.

Patients should be informed not to use the product if they are allergic 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 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.

Patients should also 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 mild burning sensation at the application site, which typically diminishes over time. Providers should remind patients not to bandage the area tightly and to use the product only as directed. Furthermore, 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 ensure the product remains stable. Proper adherence to these storage conditions is crucial for the product's longevity and effectiveness.

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, ensuring to massage the painful area until fully absorbed into the skin. It is important for patients to wash their hands with cold water after each application. 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, patients should be instructed 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)