C. D. M. a Icy Cool

Description

Menthol is a topical analgesic formulated at a concentration of 10.5%. It is indicated for the relief of aches and pains associated with strains, sprains, simple backaches, bruises, and arthritis.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with sore muscles and joints, including those related to arthritis, backache, strains, and sprains. It provides relief from discomfort due to strains, sprains, simple backaches, bruises, and arthritis.

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

Dosage and Administration

Adults and children 12 years of age and older are instructed to apply the spray to the affected areas, with a maximum frequency of four times daily. It is not necessary to massage the area after application.

For children under 12 years of age, it is recommended to consult a physician prior to use to determine appropriate dosing and administration.

Contraindications

There are no specific contraindications listed for this product. However, it is advised to discontinue use and consult a healthcare professional if the condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then reoccur.

Warnings and Precautions

FOR EXTERNAL USE ONLY. This product is flammable; therefore, it must be kept away from excessive heat or open flame. The contents are under pressure, and it is imperative not to puncture or incinerate the container. Additionally, storage temperatures must not exceed 120°F to ensure safety.

General precautions should be observed to minimize the risk of adverse effects. Contact with eyes or mucous membranes should be avoided. The product must not be applied to wounds or damaged skin. It is contraindicated to use this product in conjunction with other sprays, ointments, creams, sprays, or liniments. Application to irritated skin or in cases where excessive irritation develops is also prohibited. Bandaging the area after application is not recommended. Healthcare professionals should advise patients to wash their hands with cold water after use and to refrain from using heating pads or devices concurrently.

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

Patients should be instructed to discontinue use and consult a healthcare provider if any of the following occur: the condition worsens, symptoms persist for more than 7 days, or if symptoms improve and then reoccur. These actions are crucial for ensuring patient safety and effective management of their condition.

Side Effects

Patients using this product should be aware of several important warnings and precautions. This product is for external use only and is flammable; it must be kept away from excessive heat or open flame. The contents are under pressure, and users should not puncture or incinerate the container. Additionally, it should not be stored at temperatures above 120°F.

When using this product, patients should avoid contact with the eyes or mucous membranes and should not apply it to wounds or damaged skin. It is advised not to use this product in conjunction with other sprays, ointments, creams, sprays, or liniments. Application to irritated skin should be avoided, and excessive irritation should be monitored closely. Bandaging the area after application is not recommended. Patients are also instructed to wash their hands with cold water after use and to refrain from using the product with heating pads or devices.

Patients should stop using the product and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms improve and then reoccur.

Drug Interactions

Co-administration of this product with other topical formulations, such as sprays, ointments, creams, or liniments, is contraindicated. The use of heating pads or devices in conjunction with this product is also not recommended, as it may lead to adverse effects.

There are no specific interactions identified with laboratory tests associated with this product. Therefore, no adjustments or special monitoring are required in this regard.

Packaging & NDC

Below are the non-prescription pack sizes of C. D. M. a Icy Cool (cold therapy muscle). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should consult a physician prior to use. For adolescents and children aged 12 years and older, the recommended dosage is to spray on the affected areas no more than four times daily.

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

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional before using this medication. It is essential to evaluate the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. Healthcare providers should consider individual circumstances and the specific needs of the patient when making recommendations.

Lactation

Lactating mothers are advised to consult a doctor before using this medication. There is no available data regarding the excretion of this drug in human breast milk or its effects on breastfed infants. Therefore, healthcare professionals should exercise caution and consider the potential risks and benefits when recommending this medication to lactating patients.

Renal Impairment

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

Hepatic Impairment

There is no available information regarding the use of this medication in patients with hepatic impairment. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions specified for individuals with compromised liver function. Healthcare professionals should exercise caution and consider the lack of data when prescribing this medication to patients with liver problems.

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, altered mental status, cardiovascular instability, and respiratory distress.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

Additionally, it is recommended to contact a poison control center or consult local guidelines for specific management protocols tailored to the substance involved. Prompt intervention and appropriate management strategies are crucial in mitigating the effects of an overdose and ensuring patient safety.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available for SPL code 90375-7.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. In the event that the medication is swallowed, patients should be instructed to seek medical help or contact a Poison Control Center immediately.

Additionally, healthcare providers should inform patients to stop using the medication and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms improve and then reoccur. This guidance is essential for ensuring patient safety and effective management of their condition.

Storage and Handling

The product is supplied in a configuration that ensures optimal performance and safety. It must be stored at temperatures below 120°F to maintain its integrity. Care should be taken to keep the product away from excessive heat and open flames, as these conditions may compromise its quality.

The contents are under pressure; therefore, it is critical to avoid puncturing or incinerating the container. Proper handling and storage are essential to ensure the safety and efficacy of the product.

Additional Clinical Information

The product is administered topically, with a recommended frequency of up to four times daily for adults and children aged 12 years and older. For children under 12 years, consultation with a physician is advised prior to use. Clinicians should inform patients that the product is for external use only and is flammable; it should be kept away from excessive heat or open flames.

Patients are cautioned to avoid contact with eyes and mucous membranes, and not to apply the product to wounds or damaged skin. It should not be used in conjunction with other topical products, nor applied to irritated skin. Patients should wash their hands with cold water after application and refrain from using heating pads or devices. They should discontinue use and consult a doctor if the condition worsens, symptoms persist beyond seven days, or if symptoms resolve and then reoccur. The product should be kept out of reach of children, and immediate medical assistance should be sought if ingested. Pregnant or breastfeeding patients should consult a physician before use.

Drug Information (PDF)

This file contains official product information for C. D. M. a Icy Cool, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)