Therapeutic Icy Cold

Description

ICY COLD Cooling Pain Relief is a topical gel formulated for the relief of pain. The product is designed to provide a cooling sensation upon application, which may help alleviate discomfort associated with various conditions. The gel's formulation is intended for external use only, and it is packaged in a convenient dosage form suitable for targeted application.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with arthritis, backache, and strains or sprains.

There are no teratogenic effects associated with this drug, and no nonteratogenic effects have been reported.

Dosage and Administration

For adults and children aged 2 years and older, the recommended dosage is to apply the gel to the affected area no more than 3 to 4 times daily. It is essential to rub the gel in thoroughly until it is fully absorbed into the skin. Care should be taken to ensure that the application is limited to the specified frequency to avoid potential overuse.

Contraindications

There are no specific contraindications listed for this product. However, in the event of accidental ingestion, it is imperative to seek medical assistance or contact a poison control center immediately.

Warnings and Precautions

For external use only. This product is contraindicated for application near the eyes, mouth, mucus membranes, cuts, rashes, and sores. In the event of contact with these areas, it is imperative to flush the affected area with cold water immediately.

The use of this product in conjunction with heating pads or devices, or under bandages, is strictly prohibited. Additionally, it is not recommended for use during pregnancy or while breastfeeding. Patients should consult their physician prior to use in these circumstances.

Application to wounds or damaged skin is not advised. Should irritation persist after use, it is essential to discontinue application and seek medical advice.

In the case of accidental ingestion, immediate medical assistance should be sought, or contact with a poison control center is recommended.

Side Effects

Patients using this product may experience various adverse reactions. It is important to note that this product is for external use only and should not be applied near the eyes, mouth, mucus membranes, cuts, rashes, or sores. In the event of contact with these areas, it is advised to flush with cold water immediately.

Serious warnings include the prohibition of use with heating pads or devices, or under bandages, as well as the recommendation against use during pregnancy or breastfeeding. Patients are strongly encouraged to consult their physician prior to use in these circumstances. Additionally, the product should not be applied to wounds or damaged skin.

If irritation persists after application, patients should discontinue use and seek medical advice. These precautions are essential to ensure the safe use of the product and to minimize the risk of adverse reactions.

Drug Interactions

There are no specific drug interactions identified for this medication. Additionally, no laboratory test interactions have been reported. 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 Therapeutic Icy Cold (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients should be advised to keep the medication out of reach of children. For children aged 2 years and older, the recommended application is to the affected area not more than 3 to 4 times daily.

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 adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

Pregnant patients and those who are breastfeeding should not use this medication. It is essential for women of childbearing potential to consult their physician prior to use to discuss potential risks and benefits. The safety of this medication during pregnancy and lactation has not been established, and its use is contraindicated in these populations.

Lactation

Lactating mothers are advised against the use of this medication while breastfeeding. It is important for lactating mothers to consult their physician prior to use to discuss potential risks and benefits. There is no available data on the excretion of this medication in breast milk or its effects on breastfed infants.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

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 maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

Additionally, it is recommended to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols and antidotes, if applicable.

Documentation of the incident, including the substance involved, estimated dose, and time of exposure, is crucial for effective management and follow-up care.

Nonclinical Toxicology

The use of this product is contraindicated in pregnant or breastfeeding individuals. It is imperative to consult a physician prior to use to ensure safety and mitigate potential risks.

No specific non-teratogenic effects have been identified in the available data. Additionally, there are no detailed findings regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current dataset.

Postmarketing Experience

No postmarketing experience details are available in the provided text.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. It is crucial to emphasize the importance of seeking medical help or contacting a poison control center immediately if the medication is accidentally ingested. This information is vital for ensuring patient safety and preventing potential harm.

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 direct light exposure to protect its quality. Once opened, the product should be discarded to ensure safety and efficacy.

Additional Clinical Information

The medication is administered topically, with the recommended application for adults and children aged 2 years and older being to the affected area no more than 3 to 4 times daily. Clinicians should instruct patients to rub the gel in thoroughly until it is fully absorbed.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)