Astonea Green Gel

Description

The product is identified by the SPL code 34089-3. No specific description details are provided in the text.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with muscles and joints. Specifically, it is effective for conditions such as simple backache, arthritis, strains, bruises, and sprains.

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

Dosage and Administration

For adults and children aged 2 years and older, a thin film of the medication should be applied to the affected area no more than 3 to 4 times daily. It is important 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 recommended to consult a physician prior to use to ensure safety and appropriateness of treatment.

After application, healthcare professionals should advise patients to wash their hands thoroughly with cool water to prevent unintentional contact with other areas of the body or with other individuals.

Contraindications

The product is contraindicated in the following situations:

Application to wounds or damaged skin is prohibited due to the potential for adverse effects. Additionally, the product should not be applied to irritated skin or in cases where excessive irritation develops, as this may exacerbate the condition. Furthermore, tight bandaging or the use of heating pads or devices in conjunction with the product is contraindicated, as this may lead to increased risk of irritation or other complications.

Warnings and Precautions

For external use only, this product is flammable and should be kept away from excessive heat or open flame.

When utilizing this product, it is imperative to adhere strictly to the following precautions. Users must apply the product only as directed and should avoid contact with the eyes and mucous membranes. It is contraindicated to apply the product to wounds or damaged skin, as well as to irritated skin or areas where excessive irritation develops. Additionally, users should refrain from tightly bandaging the area of application or using the product in conjunction with heating pads or devices.

Users are advised to discontinue use and consult a healthcare professional if they experience any of the following: pain, swelling, or blistering of the skin; worsening of the condition; persistence of symptoms beyond 7 days; or recurrence of symptoms after a temporary improvement. Special caution is warranted for arthritis pain that persists for more than 10 days, the presence of redness, or in cases involving children under 12 years of age.

In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

Side Effects

Patients using this product should be aware that it is intended for external use only. It is crucial to avoid contact with the eyes and mucous membranes, as well as to refrain from applying the product to wounds, damaged skin, or irritated areas. Additionally, patients should not bandage the application site tightly or use it in conjunction with heating pads or devices.

In the event of adverse reactions, patients are advised to discontinue use and consult a healthcare professional if they experience pain, swelling, or blistering of the skin. Furthermore, if the condition worsens or symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days, medical advice should be sought. For arthritis pain, if symptoms persist for more than 10 days, or if redness is present, patients should also seek medical attention. This guidance is particularly important for conditions affecting children under 12 years of age.

Drug Interactions

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

Packaging & NDC

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

Pediatric Use

Pediatric patients under 2 years of age should consult a physician before use. For children aged 2 years and older, the recommended application is to rub a thin film over the affected area no more than 3 to 4 times daily.

It is important to note that any conditions affecting children under 12 years of age should be evaluated by a healthcare professional if arthritis pain persists for more than 10 days or if there is the presence of redness.

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 before using this medication. The safety of this drug during pregnancy has not been established, and potential risks to fetal outcomes are not fully known. Therefore, it is essential for women of childbearing potential to seek medical advice prior to use to ensure appropriate management and consideration of any potential risks.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data on the excretion of this drug 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 studied in relation to dosage adjustments, special monitoring, or safety considerations for this medication. As such, there is no available information regarding the use of this drug in individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing this medication to patients with renal impairment.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this medication. Consequently, there are no 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 prescribing information.

Overdosage

In the event of an overdosage, immediate medical assistance is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical help or contact a Poison Control Center without delay.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved; therefore, a thorough assessment by a medical professional is recommended to determine the appropriate course of action.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. It is imperative that healthcare providers remain vigilant and prepared to address any complications that may arise from an overdosage scenario.

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 seek immediate medical assistance or contact a Poison Control Center if the product is swallowed. Patients should be informed to monitor for any signs of pain, swelling, or blistering of the skin, and to report these symptoms promptly.

It is important to counsel patients that if their condition worsens, or if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days, they should consult their healthcare provider. Additionally, patients experiencing arthritis pain that lasts longer than 10 days, or those who notice redness, should also seek medical advice. Special attention should be given to conditions affecting children under 12 years of age, as these may require different management.

Patients must be instructed to use the product only as directed. They should be cautioned to avoid contact with the eyes and mucous membranes, and not to apply the product to wounds or damaged skin. It is also essential to inform patients not to apply the product to irritated skin or if excessive irritation develops. Furthermore, patients should be advised against tightly bandaging the area or using the product in conjunction with a heating pad or device.

Storage and Handling

The product is supplied in packaging that ensures its integrity and stability. It should be stored at a temperature range of 20˚-25˚C (68˚-77˚F) to maintain its efficacy. It is essential to keep the product in a cool, dry place, away from direct sunlight to prevent degradation. Proper storage conditions are crucial for preserving the quality of the product throughout its shelf life.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)