Ice Cold Topical Analgesic Gel

Description

The product is a topical gel formulation identified by SPL code 34089-3. It contains the active ingredient Ice Gel and is characterized by its clear appearance and slight odor. The formulation includes the following inactive ingredients: water, glycerin, carbomer, triethanolamine, and menthol.

Uses and Indications

This drug is indicated for use in patients as determined by the prescribing healthcare professional. Currently, there are no specific indications or usage details provided.

There are no known teratogenic or nonteratogenic effects associated with this drug. Healthcare professionals should consider the overall clinical context when prescribing this medication.

Dosage and Administration

For adults and children aged 2 years and older, the recommended application is to the affected area not more than 3 to 4 times daily. It is important to ensure that the application is performed with clean hands and that the affected area is properly prepared prior to administration.

For children under 2 years of age, it is advised to consult a physician before use to determine the appropriate course of action.

Contraindications

There are no specific contraindications listed for this product. However, 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 strictly avoided. Prior to use, it is essential for patients to consult a healthcare professional if they have a cough associated with any of the following conditions: smoking, excessive phlegm, asthma, emphysema, or a persistent or chronic cough.

While using this product, it is imperative to adhere to the following precautions to ensure safety and efficacy. The product must not be heated, microwaved, or added to hot water, as these actions may cause splattering and result in burns. Additionally, the product should not be applied in or around the eyes, directly on mucous membranes, or taken orally. It is also contraindicated to apply the product to wounds or damaged skin, or to bandage the area of application.

Patients should be advised to consult a healthcare provider and discontinue use if their condition worsens, persists for more than one week, or tends to recur. In the event of accidental ingestion, immediate professional assistance should be sought, or the individual should contact a Poison Control Center without delay.

Side Effects

Patients should be aware that this product is for external use only and must avoid contact with the eyes. Prior to use, individuals should consult a doctor if they have a cough associated with smoking, excessive phlegm, asthma, emphysema, or a persistent or chronic cough.

When using this product, patients should adhere to specific precautions to ensure safety. It is important not to heat, microwave, or add the product to hot water or any container where heating may cause splattering, which could result in burns. The product should not be used in the eyes or applied directly to mucous membranes, nor should it be taken by mouth or placed in the nostrils. Additionally, it should not be applied to wounds or damaged skin, nor should it be bandaged.

Patients are advised to consult a doctor and discontinue use if their condition worsens, persists for more than one week, or tends to recur.

Drug Interactions

There are currently no specific drug interactions identified for the medication. Additionally, no interactions with laboratory tests have been reported. Therefore, no dosage adjustments or monitoring recommendations are necessary at this time. It is advisable for healthcare professionals to remain vigilant and consult updated resources as new data may emerge.

Packaging & NDC

Below are the non-prescription pack sizes of Ice Cold Topical Analgesic Gel (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, it is crucial to seek professional assistance or contact a Poison Control Center immediately.

For dosing, adults and children aged 2 years and older may apply the medication to the affected area no more than 3 to 4 times daily. For children under 2 years of age, consultation with a physician is recommended prior to use.

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 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 physician prior to using this product. Currently, there is no specific information available regarding the potential for excretion of this product in breast milk or any associated risks to breastfed infants.

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

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 from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

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

Additionally, it is recommended to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols and antidotes, if applicable.

Documentation of the incident, including the substance involved, estimated dose, and time of ingestion, is crucial for effective management and treatment planning.

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 medication out of reach of children to prevent accidental ingestion. It is important to emphasize the potential risks associated with unintentional consumption. In the event of accidental ingestion, patients should be instructed to seek professional assistance or contact a Poison Control Center immediately for guidance on appropriate actions to take.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a controlled temperature range of 20°C to 25°C (68°F to 77°F) to maintain its efficacy and stability. Proper container requirements must be adhered to, ensuring that the product is kept in its original packaging to prevent exposure to environmental factors. Special handling needs should be observed to avoid any conditions that may compromise the integrity of the product.

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. For children under 2 years of age, consultation with a physician is advised prior to use.

Clinicians should counsel patients to keep the product out of reach of children and to seek professional assistance or contact a Poison Control Center immediately in the event of accidental ingestion. Patients are also advised to consult a doctor and discontinue use if their condition worsens, persists for more than one week, or tends to recur.

Drug Information (PDF)

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

View product document (PDF)