Ice Cold Analgesic

Description

The product is identified by the SPL code 34089-3. No additional specific description details are provided in the available data.

Uses and Indications

This drug is indicated for the management of musculoskeletal pain and discomfort. It is formulated as an Ice Cold Analgesic Gel, designed for topical application to provide localized relief. The product is also referred to as DT for your DailyTouch and Gel Frio Antimuscular.

There are no teratogenic or nonteratogenic effects associated with this drug, indicating a favorable safety profile for use in the indicated patient populations.

Dosage and Administration

For the temporary relief of minor muscle aches and pains, the product is indicated for use in adults and children aged 2 years and older. It is contraindicated for use in children under 2 years of age.

The recommended method of administration involves a topical application. Healthcare professionals should instruct patients to apply the gel liberally to the affected area and massage it into the skin until fully absorbed. This application may be repeated 3 to 4 times daily, as needed, to achieve the desired relief.

Contraindications

Use is contraindicated in children due to the risk of accidental ingestion. In the event of accidental ingestion, it is imperative to seek professional assistance or contact a Poison Control Center immediately.

Warnings and Precautions

For external use only; contact with eyes should be avoided. Healthcare professionals should advise patients to consult a doctor prior to use if they have a cough associated with smoking, excessive phlegm, asthma, emphysema, or a persistent or chronic cough.

When utilizing this product, it is imperative to avoid certain actions to ensure safety. Users should not heat, microwave, or add the product to hot water or any container that may cause splattering, which could result in burns. The product should not be applied to the eyes or directly on mucous membranes, nor should it be ingested or placed in the nostrils. Additionally, it should not be applied to wounds or damaged skin, and bandaging of the skin after application is not recommended.

Patients should be instructed to consult a healthcare professional and discontinue use if their condition worsens, persists for more than one week, or tends to recur.

It is essential to keep this product out of reach of children. In the event of accidental ingestion, immediate professional assistance should be sought, or the Poison Control Center should be contacted.

No specific laboratory tests are required for monitoring during the use of this product.

Side Effects

Patients should be aware that the product is for external use only and should avoid contact with the eyes. In the event that the condition worsens, persists for more than one week, or tends to recur, it is advised to consult a doctor and discontinue use. These precautions are important to ensure the safety and well-being of individuals using the product.

Drug Interactions

No specific drug interactions have been identified in the available data. 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 Ice Cold Analgesic (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 2 years of age should not use this medication. For children aged 2 years and older, the recommended application involves liberal use on the painful area, followed by gentle massage until the gel is fully absorbed into the skin. This process may be repeated 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 potential adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

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

Lactation

Lactating mothers are advised to consult a healthcare professional prior to using this product. There is a potential for excretion of the product in breast milk; however, the effects on breastfed infants are not known.

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.

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 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 patients closely for any signs or symptoms that may arise following an overdose. Common symptoms may include, but are not limited to, altered mental status, cardiovascular instability, and gastrointestinal disturbances.

In the event of an overdose, immediate medical attention should be sought. Supportive care is the cornerstone of management, which may involve the following steps:

1. Assessment: Conduct a thorough evaluation of the patient's clinical status, including vital signs and level of consciousness.

2. Supportive Care: Provide symptomatic treatment as necessary, which may include intravenous fluids, oxygen supplementation, or medications to stabilize the patient's condition.

3. Decontamination: If the overdose is recent and the patient is alert, activated charcoal may be administered to limit further absorption of the substance.

4. Consultation: Engage with a poison control center or toxicology specialist for guidance on specific antidotes or advanced interventions, if applicable.

Healthcare professionals should remain vigilant and prepared to implement these management strategies in the event of an overdose, despite the lack of specific information regarding the substance in question.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

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 important for patients to understand the potential risks associated with accidental ingestion. In such cases, they should be instructed to seek professional assistance or contact a Poison Control Center immediately. This information is crucial for ensuring the safety of both patients and their families.

Storage and Handling

The product is supplied in configurations that ensure optimal handling and storage. It should be stored at room temperature, away from direct sunlight and moisture. It is imperative to keep the product out of reach of children to prevent accidental ingestion.

Special handling precautions must be observed. The product should not be heated, microwaved, or added to hot water, nor should it be placed in any container that may cause heating water to splatter, as this could result in burns. Adhering to these guidelines will help maintain the integrity and safety of the product.

Additional Clinical Information

The medication is administered topically. For adults and children aged 2 years and older, it should be applied liberally to the painful area and massaged into the skin until absorbed. This application can be repeated 3 to 4 times daily. No further information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

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)