Ice Cold Topical Analgesic Gel

Description

The product is a topical gel formulation identified by SPL Code 34089-3. It contains menthol as the active ingredient. The gel is characterized by its clear and colorless appearance. Inactive ingredients include carbomer, ethanol, glycerin, and purified water.

Uses and Indications

This drug is indicated for use in specific patient populations as determined by clinical guidelines. Currently, there are no specific indications or usage information provided. Healthcare professionals are advised to refer to the latest clinical data and guidelines for appropriate prescribing information. There are no known teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

For adults and children aged 2 years and older, the recommended application frequency is to apply the medication to the affected area no more than 3 to 4 times daily. It is essential to ensure that the application is limited to the specified frequency to avoid potential adverse effects.

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

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 strictly avoided. Prior to use, it is imperative to consult a healthcare professional if the patient has a cough associated with any of the following conditions: smoking, excessive phlegm, asthma, emphysema, or a persistent or chronic cough.

During the application of this product, it is essential 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 lead to splattering and potential burns. Additionally, the product should not be applied to the eyes or directly on mucous membranes, ingested, or placed in the nostrils. It is also contraindicated to apply the product to wounds or damaged skin, or to bandage the skin after 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 using this product should be aware of several important warnings and precautions. This product is intended for external use only and should not come into contact with the eyes. Prior to use, patients are advised to consult a doctor if they have a cough associated with smoking, excessive phlegm, asthma, emphysema, or a persistent or chronic cough.

While using this product, patients must avoid certain actions to prevent adverse reactions. It should 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 to the eyes or directly on mucous membranes, taken by mouth, placed in nostrils, applied to wounds or damaged skin, or bandaged.

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. These precautions are essential to ensure the safe and effective use of the product.

Drug Interactions

No drug interactions or drug and laboratory test interactions have been identified in the available data. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

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 to prevent accidental ingestion. 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. However, for children under 2 years of age, consultation with a physician is recommended prior to use.

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. It is advisable to monitor these patients closely for any potential adverse effects or changes in efficacy.

Pregnancy

Pregnant patients may use this product as no specific information regarding its use during pregnancy is provided in the prescribing information. There are no contraindications noted for use in pregnancy, nor are there any associated risks to the fetus identified in the available data. Additionally, no dosage modifications or special precautions are recommended for pregnant patients. Healthcare professionals should consider the absence of data when advising women of childbearing potential regarding the use of this product during pregnancy.

Lactation

There are no specific warnings or recommendations regarding the use of this product by lactating mothers. Additionally, there is no information available about the potential for excretion in breast milk or any associated risks to breastfed infants.

Renal Impairment

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in 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 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 initiate supportive care, which may include monitoring vital signs, providing symptomatic treatment, and ensuring the patient's safety.

If available, consultation with a poison control center or a medical toxicologist is recommended to guide further management and treatment options.

Documentation of the incident, including the substance involved, the amount taken, and the time of ingestion, is crucial for effective management and follow-up care.

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 the medication out of reach of children to prevent accidental ingestion. It is important for patients to understand the potential risks associated with the medication and to take necessary precautions to ensure safety.

In the event of accidental ingestion, healthcare providers should instruct patients to seek professional assistance or contact a Poison Control Center immediately. Emphasizing the importance of prompt action in such situations can help mitigate potential risks and ensure appropriate care.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It should be stored at a controlled room temperature of 20°C to 25°C (68°F to 77°F). Care should be taken to ensure that the product is kept within this temperature range to maintain its integrity and efficacy.

Additional Clinical Information

The medication is administered topically, with the recommended application frequency for adults and children aged 2 years and older being 3 to 4 times daily to the affected area. For children under 2 years of age, it is advised to consult a physician prior to use. There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

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)