Astonea Cold Therapy

Description

The product is a cold therapy gel designed for topical application. It is packaged in a 4 oz container, providing a convenient dosage form for use.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with sore muscles and joints. Specifically, it is effective for conditions such as arthritis, backache, strains, 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 areas once daily. It is not necessary to massage the area after application.

For children under 2 years of age, it is recommended to consult a physician prior to use.

Contraindications

The product is contraindicated in the following situations:

Application to wounds or damaged skin is prohibited due to the potential for adverse effects. The use of this product in conjunction with other ointments, creams, sprays, or liniments is not recommended, as it may lead to unpredictable interactions. Application to irritated skin or in cases where excessive irritation develops is contraindicated to prevent further skin damage. Bandaging the area after application is not advised, as it may alter the product's effectiveness. Additionally, the use of heating pads or devices in conjunction with this product is contraindicated due to the risk of increased irritation or adverse reactions.

Warnings and Precautions

For external use only. This product is flammable; therefore, it must be kept away from excessive heat or open flame.

Healthcare professionals should advise patients to consult a doctor prior to use if they have sensitive skin. During the application of this product, it is crucial to avoid contact with the eyes and mucous membranes. The product should not be applied to wounds or damaged skin, nor should it be used in conjunction with other ointments, creams, sprays, or liniments. Patients should refrain from applying the product to irritated skin or if excessive irritation develops. Additionally, bandaging the area after application is not recommended. It is important for users to wash their hands with cool water after use and to avoid using the product with heating pads or devices.

For individuals who are pregnant or breastfeeding, consultation with a healthcare professional is advised before use.

In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a poison control center should be made at 1-800-222-1222.

Patients should discontinue use and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days.

Side Effects

Patients using this product should be aware that it is for external use only and is flammable; therefore, it should be kept away from excessive heat or open flame. Prior to use, patients with sensitive skin are advised to consult a doctor.

In the event that the condition worsens or symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days, patients should discontinue use and seek medical advice. While using this product, it is important to avoid contact with the eyes or mucous membranes, and it should not be applied to wounds or damaged skin. Additionally, patients should refrain from using this product in conjunction with other ointments, creams, sprays, or liniments, and it should not be applied to irritated skin or if excessive irritation develops. Bandaging the area after application is not recommended, and hands should be washed with cool water after use. The product should not be used with heating pads or devices.

For pregnant or breastfeeding individuals, it is essential to consult a health professional before use. This product should be kept out of reach of children. In the case of accidental ingestion, medical help should be sought immediately, or contact a poison control center at 1-800-222-1222.

Drug Interactions

Co-administration of this medication with other topical formulations, such as ointments, creams, sprays, or liniments, is contraindicated. The use of heating pads or devices in conjunction with this medication is also not recommended, as it may lead to adverse effects.

There are no specific interactions identified between this medication and laboratory tests. Therefore, no adjustments or special monitoring related to laboratory tests are necessary.

Packaging & NDC

Below are the non-prescription pack sizes of Astonea Cold Therapy (menthol 4%). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 2 years and older may apply a thin film of the product over affected areas once daily, without the need for massage. For children under 2 years of age, consultation with a physician is advised prior to use.

It is important 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 at 1-800-222-1222.

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, as the effects on fetal outcomes and breastfeeding infants are not fully established. It is essential for women of childbearing potential to discuss their individual circumstances with a healthcare provider to ensure safe use during pregnancy and lactation.

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 drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

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, it is imperative to keep the product out of reach of children. Accidental ingestion may occur, necessitating immediate medical assistance. Healthcare professionals should advise caregivers to seek medical help or contact a poison control center without delay. The national poison control hotline can be reached at 1-800-222-1222 for guidance.

Prompt action is crucial in managing potential overdosage situations to mitigate risks and ensure patient safety.

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 question. Further studies may be necessary to fully evaluate the nonclinical toxicology profile.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children. In the event of accidental ingestion, patients should seek medical help or contact Poison Control immediately at 1-800-222-1222.

When using this product, patients should be instructed to avoid contact with the eyes and mucous membranes. It is important to inform patients not to apply the product to wounds or damaged skin, and to refrain from using it in conjunction with other ointments, creams, sprays, or liniments. Patients should also be cautioned against applying the product to irritated skin or if excessive irritation develops. Bandaging the area after application is not recommended. Patients should wash their hands with cool water after use and should not use the product with a heating pad or any heating device.

Patients should be encouraged to consult a doctor before using the product if they have sensitive skin. Additionally, they should be advised to stop use and seek medical advice 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.

Storage and Handling

The product is classified as flammable and must be kept away from excessive heat or open flame to ensure safety. It should be stored at room temperature to maintain its integrity and effectiveness. Proper handling and storage conditions are essential to prevent any hazards associated with its flammable nature.

Additional Clinical Information

Patients aged 2 years and older are advised to apply a thin film of the product over the affected areas no more than once daily, without the need for massage. For children under 2 years of age, consultation with a physician is recommended prior to use.

Clinicians should counsel patients to seek advice from a health professional if they are pregnant or breastfeeding. It is crucial 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 at 1-800-222-1222.

Drug Information (PDF)

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

View product document (PDF)