Xtracare Ice Cold Topical Analgesic Gel

Description

No relevant information is available for SPL code 34089-3.

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 gently and that the area is clean prior to use.

For children under 2 years of age, it is advised to consult a physician before administration to ensure safety and appropriateness of treatment.

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 for patients to consult a healthcare professional if they have 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 that may cause splattering, which could result in burns. The product should not be used in the eyes or applied directly to mucous membranes. It is contraindicated for oral ingestion or placement in the nostrils, and should not be applied to wounds or damaged skin. Additionally, bandaging the skin after application is not recommended.

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 local Poison Control Center should be contacted.

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 the nostrils, or applied to wounds or damaged skin. Bandaging the skin after application is also not recommended.

Patients are 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 use of the product and to minimize the risk of adverse reactions.

Drug Interactions

There are no specific drug interactions reported for this medication. Additionally, no laboratory test interactions have been identified 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 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 adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

The product has not been evaluated for safety during pregnancy. Therefore, it is contraindicated for use in pregnant patients or those planning to become pregnant without prior consultation with a healthcare provider. There are no specific studies available that address the risk to the fetus associated with this product. As such, healthcare professionals should exercise caution when considering this product for use in pregnant individuals. No specific dosage modifications are recommended for this population. It is essential for healthcare providers to discuss potential risks and benefits with patients who are pregnant or may become pregnant while using this product.

Lactation

There are no specific warnings or recommendations regarding the use of this product by 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 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 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 toxicology experts for guidance on specific management protocols tailored to the substance involved.

Documentation of the incident, including the amount and timing of the overdose, 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 provided in the insert for XtraCare Ice Cold Topical Analgesic Gel.

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 exposure in young children.

In the event of accidental ingestion, healthcare providers should instruct patients to seek professional assistance immediately or contact a Poison Control Center. Prompt action is crucial to ensure the safety and well-being of the patient.

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.

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)