Mountain Ice

Description

No description information is available for the drug.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with muscles and joints in patients suffering from osteoarthritis, rheumatoid arthritis, muscle strains, and sprains.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

For adults and children aged 2 years and older, the recommended dosage is to apply the product topically by rubbing it evenly on the affected area. This application should not exceed four times within a 24-hour period.

For children under 2 years of age, it is advised to consult with a healthcare professional prior to use to determine the appropriate course of action.

Contraindications

The product is contraindicated in the following situations:

Application is not recommended on wounds, damaged skin, or irritated skin due to the potential for adverse reactions. Additionally, concurrent use with other creams, ointments, sprays, or liniments is contraindicated to avoid possible interactions and diminished efficacy.

Warnings and Precautions

For external use only. This product is flammable; therefore, it must be kept away from excessive heat or open flame. Care should be taken to avoid contact with the eyes or mucous membranes.

Application of this product is contraindicated on wounds, damaged skin, or areas of irritation. It is also advised not to use this product in conjunction with other creams, ointments, sprays, or liniments, as this may lead to adverse effects.

Healthcare professionals should instruct patients to discontinue use and seek medical advice if any of the following occur: worsening of conditions, development of skin irritation, or lack of improvement after 7 days of use.

In the event of accidental ingestion, immediate medical attention should be sought, or the Poison Control Center should be contacted without delay.

Side Effects

Patients using this product should be aware of several important warnings and precautions. The product is intended for external use only and is flammable; therefore, it should be kept away from excessive heat or open flame. Contact with eyes or mucous membranes should be avoided to prevent irritation.

When using this product, it is crucial not to apply it to wounds, damaged skin, or irritated skin. Additionally, it should not be used in conjunction with other creams, ointments, sprays, or liniments, as this may lead to adverse effects. Patients are advised to discontinue use and consult a healthcare professional if conditions worsen, if skin irritation develops, or if the condition does not improve after 7 days of use.

Furthermore, this product should be kept out of the reach of children. In the event of accidental ingestion, immediate medical attention should be sought, or the Poison Control Center should be contacted without delay.

Drug Interactions

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

Packaging & NDC

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

Pediatric Use

Pediatric patients under 2 years of age should consult with a healthcare professional prior to use. For adults and children aged 2 years and older, the product should be applied evenly to the affected area no more than four times daily.

It is important to keep this product out of the reach of children. In the event of accidental ingestion, immediate medical attention should be sought, or the Poison Control Center should be contacted without delay.

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 potential adverse effects or changes in efficacy.

Pregnancy

The safety of this product during pregnancy has not been established. There are no adequate and well-controlled studies in pregnant women; therefore, it should be used only if clearly needed. Pregnant patients or those planning to become pregnant are advised to consult a healthcare provider before use.

Given the lack of definitive safety data, potential risks to the fetus must be carefully considered. Healthcare professionals should weigh the potential risks against the benefits when recommending this product to women of childbearing potential. Caution is advised in the use of this product during pregnancy.

Lactation

There are no specific warnings or recommendations regarding nursing mothers. Additionally, there are no specific considerations or precautions mentioned related to lactation. Therefore, healthcare professionals may consider the use of this medication in lactating mothers without specific concerns based on the available data.

Renal Impairment

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of 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 event of accidental ingestion, it is imperative to seek medical attention immediately. Healthcare professionals should advise patients or caregivers to contact the Poison Control Center without delay. Prompt action is crucial to ensure appropriate management and intervention.

Potential symptoms of overdosage may vary depending on the specific substance involved; therefore, a thorough assessment by a medical professional is essential. Management procedures will be guided by the clinical presentation and may include supportive care and symptomatic treatment as necessary.

Healthcare providers are encouraged to remain vigilant and prepared to implement appropriate protocols in cases of suspected overdosage to mitigate risks and ensure patient safety.

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 use of the compound in these contexts.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical attention or contact the Poison Control Center if the product is accidentally swallowed.

Patients should be instructed not to apply the product to wounds, damaged skin, or areas of irritated skin to avoid potential complications. It is also important to inform patients that the product should not be used in conjunction with other creams, ointments, sprays, or liniments, as this may lead to adverse effects.

Additionally, healthcare providers should counsel patients to discontinue use and consult a doctor if any of the following occur: the condition worsens, skin irritation develops, or if there is no improvement after 7 days of use. This guidance is essential for ensuring patient safety and effective treatment outcomes.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It should be stored at room temperature, ensuring that it is protected from excessive heat and open flame.

To maintain safety, the product must be kept out of reach of children. In the event of accidental ingestion, it is imperative to seek medical attention immediately or contact the Poison Control Center without delay.

Additional Clinical Information

The medication is administered topically, with the recommended application for adults and children aged 2 years and older being to rub the product evenly on the affected area no more than four times daily. For children under 2 years of age, it is advised to consult a healthcare provider prior to use.

There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

Drug Information (PDF)

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

View product document (PDF)