Icequake Coldn Hot Medicated Patch

Description

The product is identified by SPL code 34089-3 and is presented as a white to off-white, round, biconvex tablet, which is debossed with "A" on one side and "123" on the other. Each tablet contains 500 mg of Acetaminophen. The formulation includes the following inactive ingredients: microcrystalline cellulose, croscarmellose sodium, magnesium stearate, hypromellose, polyethylene glycol, titanium dioxide, iron oxide red, and iron oxide yellow.

Uses and Indications

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

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

Dosage and Administration

Adults and children over 12 years of age should store the product at room temperature.

For children under 12 years of age, the following administration guidelines should be adhered to: Carefully remove the backing film from the patch. Apply one patch to the affected area. Only one patch should be used at a time, and it may be applied once or twice daily, depending on the clinical need.

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.

• Contact with eyes and mucous membranes must be avoided.

• Application to wounds or damaged skin is prohibited.

Warnings and Precautions

For external use only. This product should be utilized strictly as directed to ensure safety and efficacy. It is imperative to avoid bandaging the area tightly and to refrain from using a heating pad in conjunction with this treatment. Care should be taken to prevent contact with the eyes and mucous membranes, as exposure may lead to irritation or injury. Application to wounds or damaged skin is contraindicated.

Healthcare professionals should advise patients who are pregnant or breastfeeding to consult with a qualified health professional prior to use. Additionally, this product must be kept out of reach of children to prevent accidental ingestion or misuse.

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

Patients are instructed to discontinue use and consult a physician if any of the following occur: the condition worsens, symptoms persist for more than 7 days, symptoms resolve and then recur within a few days, redness appears, or irritation develops. These precautions are essential to ensure the safe and effective use of the product.

Side Effects

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

Patients should not use this product if they are allergic to any of its ingredients. If any adverse reactions occur, it is advised to stop use and consult a healthcare professional if the condition worsens, if symptoms persist for more than 7 days, if redness is present, or if irritation develops.

In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately.

Drug Interactions

No drug interactions or drug and laboratory test interactions have been identified for this product. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Icequake Coldn Hot Medicated Patch (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Use is not recommended in pediatric patients under 12 years of age. For adolescents aged 12 years and older, the recommended dosage is to apply one patch to the affected area, utilizing one patch at a time, either once or twice daily.

Geriatric Use

There is no specific information 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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in 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 weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice 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 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 text. Therefore, healthcare professionals should exercise caution and consider individual patient factors when prescribing to this population. Regular assessment of renal function may be warranted to ensure safe and effective use of the medication in 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 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 assistance is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical help or contact a Poison Control Center without delay.

Prompt intervention 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.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and evaluation are advised to ensure patient safety and effective resolution of any complications arising from the overdosage.

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 assistance or contact a Poison Control Center if the product is swallowed. It is important for patients to consult with a healthcare professional before using the product if they are pregnant or breastfeeding.

Patients should be instructed to use the product only as directed and to avoid bandaging the area tightly. They should not use a heating pad in conjunction with the product. Additionally, patients must be cautioned to avoid contact with their eyes and mucous membranes, and to refrain from applying the product to wounds or damaged skin.

Healthcare providers should inform patients to discontinue use and consult a doctor if any of the following occur: the condition worsens, symptoms persist for more than 7 days or resolve and then recur within a few days, redness appears, or irritation develops. Patients should also be made aware that they should not use the product if they are allergic to any of its ingredients.

Storage and Handling

The product is supplied in a configuration suitable for both adults and children over 12 years of age, with instructions to use one patch at a time, either once or twice daily. Each patch must be applied after carefully removing the backing film.

Storage conditions require the product to be kept at room temperature. It is essential to ensure that the patches are stored out of reach of children to prevent accidental ingestion. In the event of accidental swallowing, immediate medical assistance should be sought, or contact with a Poison Control Center is advised.

Additional Clinical Information

The medication is administered topically, with a recommendation to use one patch at a time, either once or twice daily. Clinicians should advise patients who are pregnant or breastfeeding to consult a healthcare professional prior to use. No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)