Therapeutic Icy Cold

Description

ICY COLD Cooling Pain Relief Roll-On is a topical analgesic formulation designed for localized pain relief. The product is presented in a roll-on dosage form, facilitating easy application to affected areas. It is specifically formulated to provide a cooling sensation upon application, which may help alleviate discomfort associated with minor aches and pains. The formulation is intended for external use only.

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 or nonteratogenic effects associated with this drug.

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 completely 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, devices, or under bandages is strictly prohibited. Additionally, it is not recommended for use during pregnancy or breastfeeding; healthcare professionals should advise patients to 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 from a healthcare provider.

In the case of accidental ingestion, immediate medical assistance should be sought, or the individual should contact a poison control center without delay.

Side Effects

Patients using this product should be aware of several important warnings and precautions. The 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. These precautions are essential to ensure the safe and effective use of the product.

Drug Interactions

No specific drug interactions have been identified for this medication. 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 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 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 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 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, as the clinical presentation can vary depending on the substance involved. Common symptoms of overdose may include, but are not limited to, respiratory depression, altered mental status, cardiovascular instability, and gastrointestinal disturbances.

In the event of an overdose, immediate medical intervention is recommended. Healthcare providers should initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs. The use of activated charcoal may be considered if the patient presents within a suitable timeframe and if the ingestion was recent.

Furthermore, it is crucial to consult local poison control centers or toxicology experts for guidance on specific management protocols tailored to the substance involved. Continuous assessment and supportive measures should be prioritized to ensure patient safety and mitigate potential complications associated with overdose.

Nonclinical Toxicology

The use of this product is contraindicated in pregnant or breastfeeding individuals. It is essential to consult a 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 information.

Postmarketing Experience

No postmarketing experience details are available in the provided data.

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 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 a recommended application frequency of 3 to 4 times daily for adults and children aged 2 years and older. Patients should apply the gel to the affected area and rub it in thoroughly until 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)