Mineral Ice

Description

NDC 0316-0226-08 identifies Mineral Ice®, a menthol pain relieving gel formulated for therapeutic use. This product features DEEPCOLD® Pain Reliever technology, providing a greaseless application. The gel is packaged in a net weight of 8 oz (226.8 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 arthritis, simple backache, strains, bruises, and sprains. It provides cooling, penetrating relief to alleviate discomfort associated with these conditions.

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

Dosage and Administration

The affected area should be cleaned prior to the application of the product. For adults and children aged 2 years and older, the product may be applied to the affected area up to 3 to 4 times daily. For children under 2 years of age, it is recommended to consult a physician before use.

Contraindications

Use of this product is contraindicated in the following situations:

• Co-administration with other topical pain relievers, as this may increase the risk of adverse effects.

• Application in or near the eyes, due to potential for irritation or injury.

• Use on wounds or damaged skin, as this may exacerbate irritation or delay healing.

• Application with heating pads or heating devices, which may lead to increased absorption and risk of burns.

• Tight bandaging of the area post-application, as this may restrict circulation and increase the risk of local adverse reactions.

Warnings and Precautions

For external use only. This product is contraindicated for use in conjunction with other topical pain relievers, as this may increase the risk of adverse effects. Additionally, it should not be used with heating pads or other heating devices, as this may exacerbate skin irritation or lead to burns.

When utilizing this product, it is imperative to avoid contact with the eyes. Application should not occur on wounds or damaged skin, and the area should not be tightly bandaged after application to prevent restricted blood flow and potential skin damage.

Healthcare professionals should advise patients to discontinue use and seek medical advice if the condition worsens, if symptoms persist beyond 7 days, or if symptoms resolve and then recur within a few days.

It is crucial to keep this product 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 without delay.

Side Effects

Patients should be aware that this product is for external use only. It is contraindicated for use with other topical pain relievers and should not be used in conjunction with heating pads or heating devices.

When using this product, patients are advised to avoid application in or near the eyes, on wounds, or on damaged skin. Additionally, it is important not to bandage the area tightly after application.

Patients should discontinue use and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days.

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

Drug Interactions

Co-administration of this medication with other topical pain relievers is contraindicated due to the potential for increased local irritation or adverse effects. It is essential to avoid the simultaneous use of heating pads or other heating devices, as this may enhance the risk of skin irritation or burns.

Healthcare professionals should monitor patients for any signs of adverse reactions when considering the use of this medication in conjunction with other topical agents or heat sources.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 2 years of age should consult a healthcare professional before use. For children aged 2 years and older, the recommended application is to the affected area no more than 3 to 4 times daily.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, 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. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing infant.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data on 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 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 absence of guidance 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 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 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 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 to prevent accidental ingestion. In the event of swallowing the product, patients should seek medical help or contact a Poison Control Center immediately.

Patients should be informed not to use this product in conjunction with other topical pain relievers, as this may increase the risk of adverse effects. Additionally, they should avoid using heating pads or other heating devices while using this product, as this could lead to increased irritation or burns.

Healthcare providers should instruct patients to discontinue use and consult a doctor if their condition worsens or if symptoms persist for more than 7 days. Patients should also be advised to seek medical advice if their symptoms improve and then recur within a few days.

It is important to inform patients that this product should not be applied in or near the eyes, on wounds, or on damaged skin. Furthermore, patients should be cautioned against tightly bandaging the area where the product is applied, as this may exacerbate irritation.

For patients who are pregnant or breastfeeding, healthcare providers should recommend consulting a health professional before using this product to ensure safety for both the patient and the child.

Storage and Handling

The product is supplied in a tightly closed container and should be stored at a temperature range of 20°C to 25°C (68°F to 77°F), in accordance with USP Controlled Room Temperature guidelines. It is essential to keep the product in a cool place and to avoid exposure to heat or open flame. Care should be taken to prevent any spillage or improper handling during storage.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)