Muscle Freeze Relief

Description

Muscle Freeze Relief Gel is a topical formulation designed for the relief of muscle discomfort. The product is packaged in a net weight of 3 oz. (85 g).

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 medication to the affected area no more than four times a day. 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, due to the risk of allergic reactions.

• Application on open wounds, damaged, or irritated skin, as this may exacerbate the condition or lead to further irritation.

• Concurrent use with a heating pad or TENS device, as this may increase the risk of adverse effects.

• Use after the expiration date, as the safety and efficacy of the product cannot be guaranteed beyond this date.

Warnings and Precautions

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

Individuals with known allergies to any ingredient in this product should refrain from use. It is contraindicated for application on open wounds, damaged, or irritated skin. Additionally, the product should not be used in conjunction with heating pads or TENS devices, as this may lead to adverse effects.

Users must ensure that the product is not applied after the expiration date. When utilizing this product, it is important to avoid tight bandaging and to follow the directions provided. Contact with eyes or mucous membranes should be strictly avoided to prevent irritation.

In the event that the condition worsens, or if a rash, itching, redness, or excessive irritation of the skin develops, users should discontinue use and consult a healthcare professional. If symptoms persist for more than 7 days or if symptoms resolve and then recur within a few days, it is advisable to seek medical advice.

This product should be kept out of reach of children. In the case of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center should be made without delay.

Side Effects

Patients using this product should be aware of several important warnings and precautions. This product is for external use only and is flammable; therefore, it should be kept away from fire, flame, and heated surfaces.

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

While using this product, patients are advised not to bandage tightly and to use it only as directed. Care should be taken to avoid contact with the eyes or mucous membranes.

Patients should discontinue use and consult a healthcare professional if any of the following occur: the condition worsens, a rash, itching, redness, or excessive irritation of the skin develops, symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days.

For pregnant or breastfeeding patients, it is recommended to consult a health professional before use.

This product should be kept out of reach of children. In the event of accidental ingestion, medical help should be sought immediately, or the Poison Control Center should be contacted.

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 healthcare professionals avoid co-administration of these therapies to prevent complications.

No specific drug or laboratory test interactions have been identified with this medication. Therefore, routine monitoring or dosage adjustments related to drug interactions are not necessary.

Packaging & NDC

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

Pediatric Use

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

Geriatric Use

There is no specific information available 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. It is advisable to monitor these patients closely for any 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, as the effects on fetal outcomes and breastfeeding infants are not fully established. It is essential for women of childbearing potential to discuss their individual circumstances with a healthcare provider 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 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 patients with reduced kidney function, as the lack of data necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients, although specific recommendations are not provided.

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, healthcare professionals should advise patients or caregivers to seek medical assistance or contact the Poison Control Center without delay.

Prompt action 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 and management procedures.

Healthcare providers should ensure that patients are monitored closely for any signs of toxicity and that supportive care is initiated as necessary.

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

No postmarketing experience details are provided in the insert.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. In the event of swallowing the product, patients should seek medical help or contact the 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 a heating pad or TENS device.

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 stop using the product 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 7 days or if symptoms resolve and then recur within a few days.

When using the product, patients should be reminded not to bandage the area tightly and to use the product only as directed. It is also crucial to advise patients to avoid contact with their 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 environment, away from direct sunlight, to maintain its efficacy. Additionally, the cap must be closed tightly to prevent contamination and ensure the product remains in optimal condition. Proper adherence to these storage conditions is crucial for the product's stability and effectiveness.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)