Freeze It Menthol Roll on

Description

Freeze It is presented in a 3-ounce dosage form. The product dimensions are 3 inches by 4.75 inches, with an expiration date of October 25, 2024.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with muscles and joints. Specifically, it is effective for 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 older, a thin film of the medication should be applied to the affected area no more than 3 to 4 times daily. It is important to ensure that the application is limited to this frequency to avoid potential adverse effects.

For children under 2 years of age, it is recommended to consult a physician prior to use to ensure safety and appropriateness of treatment.

After application, hands should be washed thoroughly with cool water to prevent unintentional contact with other areas of the body or with other individuals.

Contraindications

The product is contraindicated in the following situations:

Application to wounds or damaged skin is prohibited due to the potential for adverse effects. Additionally, the product should not be applied to irritated skin or in cases where excessive irritation develops, as this may exacerbate the condition. It is also contraindicated to bandage tightly or use in conjunction with a heating pad or device, as this may lead to increased risk of irritation or other complications.

Warnings and Precautions

This product is intended for external use only. It is imperative to keep the product away from excessive heat and open flames, as it is flammable. In the event of accidental ingestion, immediate medical assistance should be sought, or the local 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: pain, swelling, or blistering of the skin; worsening of the condition; or if symptoms persist for more than 7 days. Additionally, if symptoms resolve and then recur within a few days, medical advice should be sought. For patients experiencing arthritic pain, if symptoms persist for more than 10 days, or if redness is observed, a healthcare provider should be consulted. Special caution is warranted for use in children under 12 years of age, and any concerns should be addressed with a physician.

Side Effects

Patients should be aware that the product is for external use only and is flammable; it should be kept away from excessive heat or open flame.

In clinical practice, patients are advised to discontinue use and consult a healthcare professional if they experience any of the following adverse reactions: pain, swelling, or blistering of the skin. Additionally, if the condition worsens, or if symptoms persist for more than 7 days or resolve and then recur within a few days, medical advice should be sought.

For those experiencing arthritic pain, it is recommended to stop use and seek medical attention if the pain persists for more than 10 days, if redness is present, or if the product is being used in children under 12 years of age.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

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

Pediatric Use

For external use only. Pediatric patients should be kept out of reach of children. In the event of ingestion, medical assistance or contact with a Poison Control Center is advised immediately.

For dosing, adults and children aged 12 years and older may apply a thin film over the affected area no more than 3 to 4 times daily. For children under 2 years of age, consultation with a physician is required prior to use.

It is important to note that this product should not be used in conditions affecting children under 12 years of age.

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.

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 mothers.

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 clinical trials for this medication. Consequently, there is no available information regarding dosage adjustments, special monitoring requirements, or precautions 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 warranted based on clinical judgment.

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, as the clinical presentation can vary depending on the substance involved and the individual patient's response. Common symptoms of overdose may include, but are not limited to, altered mental status, cardiovascular instability, and respiratory distress.

In the event of an overdose, immediate medical intervention is recommended. Healthcare providers should initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs. The use of activated charcoal may be considered if the patient presents within a suitable timeframe and if the ingestion was recent.

Furthermore, it is crucial to consult local poison control centers or toxicology experts for guidance on specific management protocols and antidotes, if applicable. Continuous assessment and supportive measures should be prioritized until the patient stabilizes or further treatment is determined.

Documentation of the incident, including the substance involved, estimated dose, and time of exposure, is vital for ongoing management and potential reporting requirements.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

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. Instruct patients that if the product is swallowed, they should seek medical help or contact a Poison Control Center immediately.

Patients should be informed to discontinue use and consult a doctor if they experience any pain, swelling, or blistering of the skin. Additionally, they should be advised to stop using the product and seek medical advice if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days.

For those experiencing arthritic pain, it is important to inform them to stop use and consult a doctor if the pain persists for more than 10 days, if redness is present, or if the product is being used on children under 12 years of age.

When using this product, patients should be instructed to use it only as directed. They should avoid contact with the eyes and mucous membranes, and should not apply the product to wounds or damaged skin. Patients should also be cautioned against applying it to irritated skin or if excessive irritation develops. Furthermore, they should not bandage the area tightly or use it in conjunction with a heating pad or device.

Storage and Handling

The product is supplied in packaging that ensures its integrity and stability. It should be stored at a temperature range of 20–25ºC (68–77ºF) and kept in a cool, dry place, away from direct sunlight. Proper storage conditions are essential to maintain the product's efficacy and safety.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)