Xtracare Ice Cold Topical Analgesic Gel

Description

The drug is a sterile, non-pyrogenic, isotonic solution, identified by SPL code 34089-3. It contains sodium chloride and water for injection as its active components. The pH of the solution is adjusted using hydrochloric acid and/or sodium hydroxide. The solution is characterized by its clear and colorless appearance. It is supplied in a 500 mL flexible plastic container, which is constructed from a multi-layer film designed to protect the contents from moisture and light. Inactive ingredients consist of sodium chloride and water for injection.

Uses and Indications

XtraCare® Ice Cold Topical Analgesic Gel is indicated for topical analgesic use. This formulation is designed to provide localized relief from pain through its topical application.

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

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

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. Prior to use, it is imperative to consult a healthcare professional if the patient has a cough associated with smoking, excessive phlegm, asthma, emphysema, or a persistent or chronic cough.

During the application of this product, the following precautions must be observed: do not 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 directly on mucous membranes, taken by mouth, placed in nostrils, applied to wounds or damaged skin, or bandaged.

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.

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

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

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

There are no specific drug interactions identified for this medication. Additionally, no laboratory test interactions have been noted in the available data. 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 Xtracare Ice Cold Topical Analgesic Gel (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 2 years of age should consult a physician prior to use. For children aged 2 years and older, the recommended application is to the affected area not 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 therapeutic response, given the lack of targeted data for this population.

Pregnancy

There are no specific warnings, precautions, or contraindications regarding the use of XtraCare Ice Cold Topical Analgesic Gel during pregnancy. Available data do not indicate any known risks associated with the use of this product in pregnant patients. However, as with any medication, healthcare professionals should consider the potential benefits and risks when recommending this product to women of childbearing potential. It is advisable for pregnant patients to consult their healthcare provider before using this topical analgesic to ensure it aligns with their individual health needs and circumstances.

Lactation

There are no specific warnings or recommendations regarding the use of XtraCare Ice Cold Topical Analgesic Gel in lactating mothers. Additionally, there is no information available concerning the potential for excretion of the product 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 clinical trials for this medication. Consequently, there is no available information regarding 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 warranted based on clinical judgment.

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 amount and timing of the substance taken, is crucial for effective treatment 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 use of the compound in these contexts.

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 and well-being of both patients and their families.

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 integrity and efficacy. Proper storage conditions should be ensured to prevent exposure to extreme temperatures or humidity.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)