Avcoo Pain Relief

Description

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

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 simple backaches, arthritis, strains, bruises, and sprains.

Limitations of Use: There are no known teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

The recommended application involves rubbing a thin film of the product over the affected area, not exceeding 3 to 4 times daily. It is essential for healthcare professionals to advise patients to wash their hands thoroughly with cold water after each application to prevent unintentional contact with other areas of the body or with other individuals.

For pediatric patients, it is important to note that the product is not recommended for use in children under 12 years of age. In such cases, consultation with a healthcare provider is advised prior to use.

Contraindications

Use of this product is contraindicated in the following situations:

Patients with a known allergy to any of the listed ingredients should not use this product due to the risk of allergic reactions. Additionally, the product should not be used if the package is damaged or opened, as this may compromise safety and efficacy.

Concurrent use with other topical analgesics is contraindicated to avoid potential interactions and increased risk of adverse effects. Furthermore, application on mucous membranes, cuts, broken, swollen, or irritated skin is prohibited, as this may lead to increased irritation or systemic absorption.

Warnings and Precautions

Healthcare professionals are advised to adhere strictly to the following warnings and precautions when administering this product.

Warnings

It is imperative to read all directions and warnings thoroughly and to use the product only as directed. This formulation is intended for external use only. The product is flammable; therefore, it must be kept away from excessive heat and open flames. Heating or microwaving the product is contraindicated, as is adding it to hot water or any container with heated water, due to the risk of splattering that may result in burns. Bandaging should not be applied tightly, and contact with the eyes must be avoided. The product should not be applied to wounds or damaged skin.

General Precautions

The product should not be used by individuals who are allergic to any of the listed ingredients. Additionally, it should not be used if the package is damaged or opened. Concurrent use with other topical analgesics is not recommended. The product is contraindicated for application on mucous membranes, cuts, broken, swollen, or irritated skin.

Stop Use and Call Your Doctor

Healthcare professionals should instruct patients to discontinue use and consult a doctor if the condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. Patients should also be advised to seek medical attention if they experience any signs of deterioration or skin injury, including redness, irritation, swelling, or blistering.

Get Emergency Medical Help

In the event of accidental ingestion, it is crucial to seek emergency medical assistance or contact a Poison Control Center immediately.

Side Effects

Patients using this product should be aware of several important warnings and precautions. The product is intended for external use only and is flammable; therefore, it should be kept away from excessive heat and open flames. It is crucial not to heat or microwave the product, nor should it be added to hot water or any container with heated water, as this may cause splattering and result in burns. Additionally, patients should avoid bandaging the area tightly and should refrain from applying the product to wounds or damaged skin. Contact with the eyes must also be avoided.

Patients are advised to stop using the product 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. Signs of deterioration or skin injury, such as redness, irritation, swelling, and blistering, should also prompt immediate medical consultation.

Drug Interactions

Concurrent use of this medication with other topical analgesics is contraindicated due to the potential for additive effects, which may increase the risk of adverse reactions. It is advised to avoid simultaneous application to ensure patient safety and efficacy of treatment.

No specific interactions with laboratory tests have been identified for this medication. Therefore, routine monitoring of laboratory parameters is not necessary when this medication is administered.

Packaging & NDC

Below are the non-prescription pack sizes of Avcoo Pain Relief (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should not use this medication without consulting a healthcare professional. It is important for healthcare providers to evaluate the appropriateness of treatment in this age group, considering potential risks and the need for alternative therapies.

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. Consideration of individual patient factors, including comorbidities and concurrent medications, is essential in managing treatment effectively in elderly patients.

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 weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a healthcare 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

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

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 event of an overdosage, there is currently no specific information available regarding the effects or management of such an occurrence. Healthcare professionals are advised to monitor the patient closely for any unusual symptoms and to provide supportive care as necessary.

In the absence of detailed guidance, it is recommended that clinicians follow standard protocols for managing drug overdosage, which may include symptomatic treatment and supportive measures. Consultation with a poison control center or a medical toxicologist may also be beneficial in managing the situation effectively.

Nonclinical Toxicology

There is currently no available information regarding teratogenic or non-teratogenic effects associated with the compound. Additionally, no data has been provided concerning nonclinical toxicology, including animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children and pets to prevent accidental ingestion. Instruct patients that if the medication is swallowed, they should seek medical help or contact a Poison Control Center immediately. It is important for patients to understand the potential risks associated with improper use and to take necessary precautions to ensure safety.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which are essential for identification and inventory management. It is crucial to store the product in a dry environment, maintaining a temperature range of 20-25°C (77-86°F). Care should be taken to keep the product away from direct sunlight to ensure its integrity and efficacy.

Additional Clinical Information

Patients should apply a thin film of the medication over the affected area no more than 3-4 times daily. Clinicians are advised to counsel patients regarding the use of the medication during pregnancy or breastfeeding, recommending that they consult a healthcare professional before use. Additionally, it is important to inform patients that the medication is not recommended for children under 12 years of age without prior consultation with a doctor.

Drug Information (PDF)

This file contains official product information for Avcoo Pain Relief, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)