Ice Cold Analgesic

Description

The product is an ice cold analgesic gel, formulated for topical application. It is available in a new weight of 8 ounces (227 grams).

Uses and Indications

This drug is indicated for the temporary relief of minor 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 may be applied to the affected area up to 3 to 4 times daily. It is important to ensure that the application does not exceed this frequency to maintain safety and efficacy.

Contraindications

Use of this product is contraindicated in children due to the risk of accidental ingestion. In the event of swallowing, immediate medical assistance or contact with a poison control center is advised.

Warnings and Precautions

For external use only, this product should not be combined with other topical pain relievers or used in conjunction with heating pads or heating devices. It is imperative to avoid application in or near the eyes, as well as on wounds or damaged skin. Additionally, bandaging should not be done tightly to prevent complications.

Healthcare professionals should advise patients to discontinue use and seek medical advice if the condition worsens, if symptoms persist for more than a few days, or if symptoms resolve only to recur within a few days. The development of redness or irritation also necessitates consultation with a healthcare provider.

Pregnant or breastfeeding individuals are encouraged to consult a health professional prior to using this product to ensure safety for both mother and child.

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

Patients should be reminded to stop using the product and contact their doctor if any of the aforementioned conditions arise.

Side Effects

Patients should be aware that this product is for external use only and should not be used in conjunction with other topical pain relievers, heating pads, or heating devices. It is important to avoid application in or near the eyes, on wounds, or on damaged skin. Additionally, patients should not bandage the area tightly after application.

In the event that the condition worsens, symptoms persist for more than a few days, or if symptoms clear up and then recur within a few days, patients are advised to stop use and consult a healthcare professional. The development of redness or irritation also warrants discontinuation of use and a discussion with a doctor.

For pregnant or breastfeeding individuals, it is recommended to seek advice from a health professional prior to using this product.

Drug Interactions

Co-administration of this medication with other topical pain relievers is contraindicated. The use of multiple topical analgesics may increase the risk of adverse effects without providing additional therapeutic benefit.

Additionally, the application of heating pads or other heating devices in conjunction with this medication is not recommended. The combination may enhance the risk of skin irritation or burns due to increased absorption and localized heat effects.

It is advised to monitor for any signs of adverse reactions when using this medication, particularly in patients who may be using other topical treatments or heat sources.

Packaging & NDC

Below are the non-prescription pack sizes of Ice Cold Analgesic (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 dosing, the product is indicated for use in adults and children aged 2 years and older. It should be applied to the affected area no more than 3 to 4 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 efficacy, given the lack of targeted data for this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to assess the potential risks and benefits associated with the use of this drug during pregnancy and lactation. Healthcare providers can offer guidance based on individual circumstances and the latest clinical data.

Lactation

Lactating mothers are advised to consult a healthcare professional prior to using this medication. There is currently no available data regarding the excretion of this medication in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating mothers.

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 when administering the medication. It is essential to monitor patients closely for any signs of adverse effects or symptoms that may arise from excessive dosing.

In the event of suspected overdosage, immediate medical attention should be sought. Healthcare providers should implement supportive measures as necessary, which may include symptomatic treatment and monitoring of vital signs.

Due to the lack of detailed overdosage information, it is recommended that healthcare professionals refer to established clinical guidelines and protocols for managing overdose situations relevant to the specific medication in question. Additionally, contacting a poison control center may provide valuable assistance in the management of overdosage cases.

Continued vigilance and adherence to dosing recommendations are crucial to minimize the risk of overdosage and ensure 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 limits the assessment of potential risks associated with the compound in these areas.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. Instruct patients that if the medication is swallowed, they should seek medical help or contact a poison control center immediately. This precaution is essential to ensure the safety and well-being of children.

Storage and Handling

This 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 efficacy.

To ensure safety, the product must be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a poison control center is advised. Special handling precautions should be observed to prevent misuse or accidental exposure.

Additional Clinical Information

The product is administered topically and is indicated for use in adults and children aged 2 years and older, with a recommended application frequency of 3 to 4 times daily to the affected area. Clinicians should advise patients to keep the product out of reach of children and to seek medical assistance or contact a poison control center immediately if ingested. Additionally, patients who are pregnant or breastfeeding should consult a healthcare professional prior to use.

Drug Information (PDF)

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

View product document (PDF)