Icequake Cold Hot

Description

Southern Sales Services Inc, located in Pembroke Pines, FL 33332, is a company engaged in the distribution and marketing of pharmaceutical products.

Uses and Indications

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

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

Dosage and Administration

Adults and children 12 years of age and over should carefully remove the backing from the patch and apply one patch to the affected area. This application may be repeated as necessary, but should not exceed four times daily.

For children under 12 years of age, it is advised to consult a doctor before use.

Contraindications

Use of this product is contraindicated in individuals with a known allergy to any of its ingredients.

Additionally, the following precautions should be observed:

• Tight bandaging is not recommended.

• The application of a heating pad is contraindicated.

• This product should not be applied to wounds or damaged skin.

• Contact with eyes and mucous membranes must be avoided.

Warnings and Precautions

For external use only. Healthcare professionals should advise patients to seek emergency medical assistance immediately if the product is ingested. In such cases, contacting a Poison Control Center is strongly recommended.

Patients should be instructed to discontinue use and consult their healthcare provider under the following circumstances: if the condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. Additionally, patients should be advised to stop using the product if any redness or irritation develops. Monitoring for these signs is essential to ensure patient safety and effective management of their condition.

Side Effects

For external use only. Patients are advised to stop use and consult a doctor if the condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then occur again within a few days. Additionally, individuals should seek medical advice if redness is present or if irritation develops.

Drug Interactions

There are no specific drug interactions reported for this medication. Additionally, no laboratory test interactions have been identified in the available data. 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 Icequake Cold Hot (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. The safety and efficacy of this medication in this age group have not been established, and specific dosing recommendations are not provided for children in this age range. Caution is advised when considering treatment for pediatric patients.

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 potential 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 safety of this drug during pregnancy has not been established, and potential risks to fetal outcomes are not fully understood. Therefore, it is essential for women of childbearing potential to seek medical advice to weigh the benefits and risks associated with the use of this medication 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 medication 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 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 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 from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include monitoring vital signs, providing symptomatic treatment, and ensuring the patient's safety.

If available, consultation with a poison control center or a medical toxicologist is recommended to guide the management of the overdose effectively.

Documentation of the incident, including the substance involved, the amount taken, and the time of ingestion, is crucial for appropriate treatment and follow-up care.

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 question. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Patients should be advised to seek medical help or contact a Poison Control Center immediately if the product is swallowed. It is important to inform patients that they should discontinue use and consult a doctor if their condition worsens. Additionally, patients should be instructed to stop using the product and seek medical advice if symptoms persist for more than 7 days or if symptoms clear up and then recur within a few days.

Healthcare providers should emphasize the importance of discontinuing use and consulting a doctor if any redness or irritation develops. Patients must be reminded to use the product only as directed and to avoid bandaging the area tightly. They should also be cautioned against using a heating pad in conjunction with the product.

Patients should be informed to avoid contact with the eyes and mucous membranes and to refrain from applying the product to wounds or damaged skin. Finally, it is crucial to advise patients not to use the product if they are allergic to any of its ingredients.

Storage and Handling

The product is supplied in configurations that ensure optimal use and safety. It is essential to store the product at room temperature, away from direct sunlight and moisture. To maintain safety, the product should be kept out of reach of children.

When handling the product, it is important to avoid bandaging tightly and to refrain from using a heating pad. Care should be taken to prevent contact with eyes and mucous membranes. Additionally, the product should not be applied to wounds or damaged skin to ensure proper efficacy and safety.

Additional Clinical Information

The product is administered topically, with specific instructions for different age groups. For adults and children aged 12 years and older, one patch should be applied to the affected area, with a maximum of four applications per day as needed. For children under 12 years of age, consultation with a doctor is advised prior to use.

Clinicians should counsel patients to use the product only as directed, avoiding tight bandaging and the use of heating pads. Patients should be instructed to keep the product away from eyes and mucous membranes, and not to apply it to wounds or damaged skin. It is crucial to avoid use in individuals with known allergies to any ingredients in the product. Patients should discontinue use and seek medical advice if their condition worsens, if symptoms persist beyond seven days, if symptoms recur after clearing, if redness occurs, or if irritation develops. In case of ingestion, immediate medical assistance or contact with a Poison Control Center is recommended. Pregnant or breastfeeding patients should consult a healthcare professional before use.

Drug Information (PDF)

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

View product document (PDF)