Personal Care Ice Cold

Description

The drug is classified as an analgesic, indicating its primary function in pain relief. The package label features a principal display panel, which provides essential information regarding the product. The effective date of the insert is June 7, 2010, marking the time from which the information is applicable.

Uses and Indications

This drug is indicated for the temporary relief of aches and pains in muscles and joints associated with various conditions, including simple backache, sports injuries, strains, arthritis, sprains, and bruises.

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

Dosage and Administration

The affected area should be cleaned prior to the application of the product. For adults and children aged 2 years and older, the product should be applied to the affected area no more than 3 to 4 times daily.

Contraindications

Use of this product is contraindicated in the following situations:

• Concurrent use with other topical pain relievers, as this may increase the risk of adverse effects.

• Application in or near the eyes, which may lead to irritation or injury.

• Application to wounds or damaged skin, due to the potential for exacerbating the condition or causing further harm.

• Use with heating pads or heating devices, as this may enhance absorption and increase the risk of skin irritation or burns.

• Tight bandaging of the area post-application, which may restrict blood flow and lead to complications.

If the condition worsens, persists beyond 7 days, or if redness or irritation develops, discontinue use and consult a healthcare professional.

Warnings and Precautions

For external use only. This product is intended solely for topical application and should not be ingested.

General precautions must be observed to ensure safe use. The product should not be used concurrently with other topical pain relievers, as this may increase the risk of adverse effects. Additionally, the application of heating pads or other heating devices in conjunction with this product is contraindicated, as it may lead to increased irritation or other complications.

Healthcare professionals should advise patients to discontinue use and seek medical advice 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, or if any redness or irritation develops at the application site.

In the event of accidental ingestion, it is imperative to seek emergency medical assistance or contact a poison control center immediately. Prompt action is essential to mitigate potential health risks associated with ingestion.

Side Effects

Patients should be aware that the product is intended for external use only.

In clinical practice, it is advised that patients discontinue use and consult a healthcare professional 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, or if redness or irritation develops. These reactions may indicate a need for further evaluation or a change in treatment strategy.

Drug Interactions

Co-administration of this medication with other topical pain relievers is contraindicated due to the potential for increased local irritation or adverse effects. It is advised to avoid the simultaneous use of heating pads or other heating devices, as this may enhance the risk of skin irritation or burns.

Monitoring for signs of adverse reactions is recommended when considering the use of this medication in conjunction with other topical agents or heat sources.

Packaging & NDC

Below are the non-prescription pack sizes of Personal Care Ice Cold (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients should be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance or contact with a poison control center is advised.

For children aged 2 years and older, the medication may be applied to the affected area no more than 3 to 4 times daily. Care should be taken to ensure that the application is appropriate for the child's age and condition.

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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

Pregnant patients should be aware that no specific information regarding the use of this product during pregnancy is provided in the drug insert. There are no statements indicating whether the product is contraindicated in pregnancy or any associated risks to the fetus. Additionally, there are no dosage modifications or special precautions regarding the use of this product during pregnancy. Healthcare professionals should consider the lack of data when advising women of childbearing potential and weigh the potential benefits against any unknown risks.

Lactation

There is no specific information available regarding the use of this medication in nursing mothers or its effects on lactation. Additionally, no data are provided concerning the excretion of the drug in breast milk or its potential effects on breastfed infants. Healthcare professionals should consider the lack of information when advising lactating mothers about the use of this medication.

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 of these patients.

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

Overdosage may lead to significant adverse effects that require prompt attention. Healthcare professionals should be aware that symptoms associated with overdosage can include severe skin irritation, as well as other systemic effects that may vary in severity.

In the event of an overdosage, it is imperative to seek immediate medical attention. Timely intervention is crucial to mitigate potential complications and ensure appropriate management of the patient's condition.

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 in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep the product out of reach of children to prevent accidental ingestion. In the event of swallowing the product, patients should seek medical help or contact a poison control center immediately.

Patients should be informed not to use this product in conjunction with other topical pain relievers, as this may increase the risk of adverse effects. Additionally, they should avoid using the product with heating pads or other heating devices, as this could lead to increased irritation or burns.

Patients are encouraged to monitor their condition closely. They should stop using the product and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. Furthermore, if patients experience any redness or irritation while using the product, they should discontinue use and seek medical advice.

It is important to instruct patients to avoid contact with the eyes when using this product. They should also refrain from applying it to wounds or damaged skin, and should not bandage the area tightly after application to prevent complications.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at room temperature to maintain its integrity. The container must be kept tightly closed to protect the contents from light exposure, which can compromise the product's effectiveness. Additionally, it is important to discard the product after opening to ensure safety and efficacy.

Additional Clinical Information

The medication is administered topically, with a recommended application frequency of no more than 3 to 4 times daily for adults and children aged 2 years and older. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)