Therapeutic Icy Cold

Description

ICY COLD Cool Pain Relief is presented as a continuous spray formulation designed for topical application. The product is formulated to provide localized pain relief. Specific details regarding the active ingredients, molecular weight, and chemical composition are not provided in the extracted facts. The appearance of the spray is consistent with typical aerosol formulations, allowing for easy application to affected areas.

Uses and Indications

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

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

Dosage and Administration

The formulation should be shaken gently before use. For adults and children aged 2 years and older, the product is to be sprayed onto the affected area. The recommended frequency of application is not more than 3 to 4 times daily. After spraying, the gel must be rubbed in thoroughly until fully absorbed.

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 use 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 should be aware of several important warnings and potential adverse reactions. This product is intended 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.

Additionally, the product should not be used in conjunction with heating pads or devices, nor should it be applied under bandages. It is contraindicated for use in pregnant or breastfeeding individuals; consultation with a physician is recommended prior to use in these populations. Furthermore, the product should not be applied to wounds or damaged skin.

Patients are advised to discontinue use and consult a doctor if irritation persists after application. 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 aged 2 years and older may use this product for external application. It is recommended to spray onto the affected area no more than 3 to 4 times daily. Care should be taken to keep the product out of reach of children to prevent accidental ingestion or misuse.

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. 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 healthcare providers to advise women of childbearing potential to consult their physician prior to use. The potential risks associated with the use of this medication during pregnancy or lactation have not been established, and caution is warranted to avoid any adverse fetal outcomes.

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 may not have specific dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. Therefore, healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the lack of detailed guidance necessitates careful clinical judgment and individualized patient assessment. Regular monitoring of renal function is advisable to ensure patient safety and therapeutic efficacy.

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 initiate supportive care, 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 further management and treatment options.

Documentation of the incident, including the substance involved, the amount taken, and the time of ingestion, 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 that patients consult their physician prior to use to ensure safety and appropriateness.

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 insert 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 safety in the home environment, particularly for households with young children.

In the event of accidental ingestion, healthcare providers should instruct patients to seek medical help or contact a poison control center immediately. Prompt action is essential to ensure the safety and well-being of the patient.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which are essential for identification and inventory management. It is recommended to store the product at room temperature to maintain its efficacy.

To ensure optimal preservation, the product must be protected from light exposure. Additionally, it is crucial to keep the container tightly closed when not in use to prevent contamination and degradation. Once opened, the product should be discarded after use to ensure safety and effectiveness.

Additional Clinical Information

The medication is administered topically, with a recommended application for adults and children aged 2 years and older. Patients should spray the product onto the affected area no more than 3 to 4 times daily, ensuring to rub it in thoroughly until the gel is fully absorbed.

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

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)