Astonea Cold Ice Analgesic Gel

Description

The product is a topical analgesic gel identified by SPL code 34089-3. It contains menthol as the active ingredient, providing analgesic properties. The gel is clear and colorless in appearance. Inactive ingredients include carbomer, triethanolamine, purified water, propylene glycol, methylparaben, propylparaben, and sodium hydroxide.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains in muscles and joints associated with various conditions, including simple backaches, strains, sprains, sports injuries, arthritis, and bruises.

There are no teratogenic or nonteratogenic effects mentioned in the available data.

Dosage and Administration

The affected area should be cleaned prior to the application of the product. For adults and children aged 2 years and older, the product may be applied to the affected area up to 3 to 4 times daily. It is important to ensure that the application does not exceed this frequency to maintain safety and efficacy.

Contraindications

Use of this product is contraindicated in the following situations:

Application in or near the eyes is prohibited due to the potential for irritation or injury. Additionally, the product should not be applied to wounds or damaged skin, as this may exacerbate the condition or hinder healing. It is also advised not to bandage the area tightly after application, as this could lead to increased pressure and potential adverse effects.

Warnings and Precautions

FOR EXTERNAL USE ONLY. This product is intended solely for topical application and should not be ingested. In the event of accidental ingestion, immediate medical assistance should be sought, or contact a Poison Control Center without delay.

The use of this product is contraindicated in conjunction with other topical pain relievers, as well as with heating pads or any heating devices, due to the potential for increased adverse effects.

General precautions must be observed to ensure safe use. This product should not be applied in or near the eyes, nor should it be used on wounds or damaged skin. Additionally, it is important to avoid tightly bandaging the area of application, as this may exacerbate irritation or other adverse reactions.

Healthcare professionals should advise patients to discontinue use and consult a physician if any of the following occur: the condition worsens, symptoms persist for more than 7 days, symptoms resolve and then recur within a few days, or if any redness or irritation develops at the site of application. Monitoring for these signs is essential to ensure patient safety and effective management of treatment.

Side Effects

Patients should be aware that the product is intended for external use only. It is contraindicated for use in conjunction with other topical pain relievers or with heating pads and heating devices, as these combinations may increase the risk of adverse reactions.

In clinical practice, patients are advised to discontinue use and consult a healthcare professional if any of the following occur: the condition worsens, symptoms persist for more than 7 days, symptoms resolve and then recur within a few days, or if redness or irritation develops at the application site. These recommendations are based on clinical observations and are intended to ensure patient safety and effective management of symptoms.

Drug Interactions

Co-administration of this medication with other topical pain relievers is contraindicated due to the potential for increased local irritation or adverse effects. It is advised to avoid the simultaneous use of heating pads or other heating devices, as this may enhance the risk of skin irritation or burns.

Healthcare professionals should monitor patients for any signs of adverse reactions when considering the use of this medication in conjunction with other topical agents or heat sources.

Packaging & NDC

Below are the non-prescription pack sizes of Astonea Cold Ice Analgesic Gel (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients 2 years of age and older are indicated for use of the product. The recommended application frequency is to the affected area no more than 3 to 4 times daily for both adults and children within this age range.

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

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 and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully considered in these populations to ensure the safety of both the mother and the fetus or infant.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding the excretion of this medication in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

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 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 the management of the overdose. Additionally, healthcare professionals should refer to local protocols and guidelines for the management of overdose situations, as these may provide specific recommendations based on the substance involved.

Documentation of the incident, including the amount and timing of the substance taken, 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 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 seek medical help or contact a Poison Control Center immediately if the product is swallowed. It is important to instruct patients not to use the product in or near the eyes, as this could lead to irritation or injury.

Patients should be informed that the product should not be applied to wounds or damaged skin, and they should avoid tightly bandaging the area where the product is applied. Providers should emphasize the importance of monitoring their condition and to stop using the product and consult a doctor if the condition worsens.

Additionally, patients should be counseled to discontinue use and seek medical advice if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. They should also be advised to stop use and consult a healthcare professional if any redness or irritation develops following application.

Storage and Handling

The product is supplied in a container that must be kept tightly closed to maintain its integrity. It should be stored at room temperature, away from direct light to prevent degradation. Once opened, the product should be discarded to ensure safety and efficacy.

Additional Clinical Information

The medication is administered topically and is indicated for use in adults and children aged 2 years and older. Patients should apply the treatment to the affected area no more than 3 to 4 times daily.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)