Ice Quake

Description

ICEQUAKE is a pain-relieving gel formulated with menthol as the active ingredient, present at a concentration of 15%. The product is designed for topical application and is packaged in a net weight of 4 ounces (113 grams).

Uses and Indications

This drug is indicated for the temporary relief of minor pain associated with various conditions, including arthritis, simple backache, muscle strains, sprains, bruises, and cramps.

There are no teratogenic or nonteratogenic effects mentioned in the available data.

Dosage and Administration

For adults and children over 18 years of age, ICEQUAKE should be applied directly to the affected area. The desired amount of gel should be squeezed onto the site of pain. It is important to massage the dispensed gel into the painful area until it is thoroughly absorbed. This application may be repeated as necessary, but should not exceed 3 to 4 times daily.

The route of administration is topical, specifically targeting the affected area, with a maximum frequency of application set at 3 to 4 times per day.

Contraindications

The product should not be used in the following situations:

Tight bandaging or the use of heating pads in conjunction with the product is contraindicated, as this may exacerbate adverse effects. Contact with eyes or mucous membranes must be avoided to prevent irritation or injury. Application to wounds or damaged, broken, or irritated skin is contraindicated due to the risk of further skin damage or infection. Additionally, exposure of the treated area to heat or direct sunlight should be avoided to prevent potential complications.

Warnings and Precautions

The product is intended for external use only. Healthcare professionals should advise patients to use the product strictly as directed. It is imperative to avoid bandaging the area tightly or using it in conjunction with a heating pad, as this may exacerbate adverse effects. Contact with the eyes or mucous membranes must be avoided to prevent irritation. The product should not be applied to wounds or any skin that is damaged, broken, or irritated.

In the event of a severe burning sensation, patients should discontinue use immediately. Additionally, it is crucial to instruct patients not to expose the treated area to heat or direct sunlight, as this may lead to further complications.

Patients are advised to stop using the product and consult a healthcare professional if their condition worsens, if redness develops, or if any irritation occurs.

In cases of ingestion, immediate medical assistance should be sought, or the patient should contact a Poison Control Center without delay.

Side Effects

Patients should be aware that this product is for external use only. It is essential to use the product only as directed and to avoid bandaging tightly or using it in conjunction with a heating pad. Contact with eyes or mucous membranes should be avoided, and the product should not be applied to wounds or damaged, broken, or irritated skin.

In clinical use, if a severe burning sensation occurs, patients are advised to discontinue use immediately. Additionally, the treated area should not be exposed to heat or direct sunlight.

Patients should stop using the product and consult a healthcare professional if the condition worsens, if redness is present, or if irritation develops.

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

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions with laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

Packaging & NDC

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

Pediatric Use

Pediatric patients 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 is advised.

For application, the product is indicated for adults and children over 18 years, with specific directions to apply to the affected area. There are no established dosing guidelines for pediatric patients under 18 years.

Geriatric Use

There is no specific information regarding the use of Ice Quake (menthol gel) in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when administering this product to elderly patients, as the absence of data necessitates careful monitoring for any potential adverse effects or unique responses in this population. It is advisable to consider the overall health status and comorbidities of geriatric patients when determining the appropriateness of treatment with Ice Quake.

Pregnancy

Pregnant patients should be aware that no specific information regarding the use of this product during pregnancy is provided in the prescribing information. There are no statements indicating whether the product is contraindicated in pregnancy or any associated risks to the fetus. Additionally, there are no dosage modifications or special precautions regarding the use of this product during pregnancy. Healthcare professionals should consider the lack of data when advising women of childbearing potential and weigh the potential benefits against any unknown risks.

Lactation

Lactating mothers should consult a healthcare professional before using this product. There is a potential for excretion in breast milk, and caution is advised when using this product while breastfeeding.

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 relation to the use of 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 available 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 a 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 strategies.

Healthcare providers should ensure that patients are aware of the importance of timely reporting of any suspected overdosage to facilitate effective treatment and minimize risks.

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 available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this product out of the reach of children to prevent accidental ingestion. 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 stop using the product and consult a doctor if their condition worsens, if redness is present, or if irritation develops. It is essential to emphasize that the product should be used only as directed. Patients should be cautioned against bandaging the area tightly or using the product in conjunction with a heating pad.

Healthcare providers should also instruct patients to avoid contact with the eyes or mucous membranes and to refrain from applying the product to wounds or damaged, broken, or irritated skin. If patients experience a severe burning sensation, they should discontinue use immediately. Additionally, patients should be advised not to expose the treated area to heat or direct sunlight.

Storage and Handling

The product is supplied in a container that must be kept tightly closed to maintain its integrity. It should be stored at room temperature, away from light, to ensure optimal stability and efficacy. Freezing the product is strictly prohibited, as it may compromise its quality. After opening, the product should be discarded to prevent any potential degradation or contamination.

Additional Clinical Information

Patients should be advised that the product is for external use only. When using the topical formulation, it is important to apply it as directed, avoiding tight bandaging or the use of heating pads. Contact with eyes or mucous membranes should be avoided, and the product should not be applied to wounds or damaged skin. If a severe burning sensation occurs, use should be discontinued immediately. Patients should also refrain from exposing the treated area to heat or direct sunlight.

Clinicians should instruct patients to stop use and consult a doctor if the condition worsens, if redness develops, or if irritation occurs. Additionally, the product should be kept out of the reach of children, and in the event of ingestion, medical assistance or contact with a Poison Control Center is necessary. For adults and children over 18 years, the recommended administration involves applying the gel to the affected area, massaging it in until fully absorbed, and repeating this process no more than 3 to 4 times daily.

Drug Information (PDF)

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

View product document (PDF)