Auvon Pain Relief

Description

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

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with sore muscles and joints.

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

Dosage and Administration

The patch should be applied to a clean and dry area of skin, ensuring that the site is free from wounds or hair. To apply the patch, the healthcare professional should first pull to separate the film, then peel off one side of the film and apply the exposed patch to the skin. After positioning the patch, the other side of the film should be peeled off, and the patch must be pressed firmly against the skin to ensure proper adhesion.

It is important to avoid repeated use or reapplication of the patch as much as possible. If the patch is to be applied over joints, it should be cut prior to application to ensure proper fit and adherence. The patch may be used in the affected area no more than four times daily. After the application, hands should be washed with cool water to maintain hygiene.

Contraindications

Use of this product is contraindicated in the following situations:

• Patients with a known allergy to any of the listed ingredients.

• Pregnant or breastfeeding individuals, due to potential risks to the fetus or infant.

• Children under 12 years of age, as safety and efficacy have not been established in this population.

• Application on wounds, cuts, or any damaged, broken, or irritated skin, as this may exacerbate irritation or lead to adverse effects.

• Contact with eyes or mucous membranes, which may result in significant irritation or injury.

• Concurrent use with heating pads or devices, or when wrapped with a bandage, as this may increase absorption and risk of adverse reactions.

• Co-administration with other topical analgesics, which may lead to increased side effects or diminished therapeutic effect.

• If the package is received damaged or opened, as this may compromise product integrity and safety.

Warnings and Precautions

For external use only. This product is contraindicated in individuals with known allergies to any of the listed ingredients. It should not be used by pregnant or breastfeeding individuals, or by those under 12 years of age. Application is not recommended on wounds, cuts, or any damaged, broken, or irritated skin. Care should be taken to avoid contact with the eyes or mucous membranes. The use of heating pads or devices, as well as wrapping the area with a bandage, is prohibited while using this product. Additionally, it should not be used concurrently with other topical analgesics. If the package is received damaged or opened, it should not be used.

Patients should discontinue use and consult a healthcare professional if they experience pain, swelling, or blistering. The presence of redness or the development of irritation warrants immediate medical advice. If symptoms persist for more than 7 days, or if they resolve and then recur within a few days, a healthcare provider should be consulted.

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

Side Effects

Patients should be aware that this product is for external use only. It is contraindicated in individuals who are allergic to any of the listed ingredients, as well as in those who are pregnant or breastfeeding. The product should not be used in patients under 12 years of age, on wounds, cuts, or damaged, broken, or irritated skin, and it should not come into contact with the eyes or mucous membranes. Additionally, the product should not be used in conjunction with heating pads or devices, wrapped with a bandage, or combined with other topical analgesics. Patients should also refrain from using the product if the package is damaged or opened upon receipt.

While using this product, it is crucial to adhere strictly to the directions provided on the label. Patients are advised to stop use and consult a healthcare professional if they experience pain, swelling, or blistering, if redness or irritation develops, or if symptoms persist for more than 7 days or resolve only to recur within a few days.

This product should be kept out of reach of children and pets. In the event of ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

Drug Interactions

The use of this medication is contraindicated in conjunction with other topical analgesics, as this may lead to an increased risk of adverse effects without providing additional therapeutic benefit.

There are no specific laboratory test interactions associated with this medication, indicating that it does not interfere with the results of laboratory tests. Therefore, routine monitoring of laboratory parameters is not required when this medication is administered.

Packaging & NDC

Below are the non-prescription pack sizes of Auvon 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. Safety and efficacy have not been established in this age group, and appropriate dosing guidelines are not available. Healthcare professionals are advised to consider alternative treatments for pediatric patients within this age range.

Geriatric Use

Elderly patients should be carefully evaluated before initiating treatment, particularly those aged 65 years and older. Due to the lack of specific data regarding the safety and efficacy of this medication in geriatric populations, caution is advised.

It is important to note that this medication is contraindicated in individuals under 12 years of age. Therefore, healthcare providers should ensure that patients meet the appropriate age criteria prior to prescribing.

Ongoing monitoring for adverse effects and therapeutic efficacy is recommended in elderly patients, as they may have altered pharmacokinetics and pharmacodynamics that could influence treatment outcomes. Adjustments to dosage may be necessary based on individual patient assessments and clinical judgment.

Pregnancy

Pregnant patients and those who are breastfeeding should not use this medication. The potential risks associated with the use of this drug during pregnancy have not been established, and its safety profile in lactating women is also unclear. Healthcare professionals are advised to consider alternative treatments for women who are pregnant or breastfeeding to avoid any potential adverse effects on fetal outcomes or infant health.

Lactation

Lactating mothers are advised against the use of this medication while breastfeeding. There is no available data on the excretion of this drug in human breast milk or its effects on breastfed infants. Therefore, caution is warranted, and alternative treatments should be considered for lactating mothers.

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 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, immediate medical assistance is crucial. Healthcare professionals are advised to seek medical help or contact a Poison Control Center without delay if the substance has been ingested.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and evaluation are recommended to ensure patient safety and effective resolution of any complications arising from the overdosage.

Nonclinical Toxicology

Pregnant or breastfeeding individuals should exercise caution, as teratogenic effects may be a concern. The product is contraindicated for individuals with known allergies to any of the listed ingredients. Additionally, it is not recommended for use in individuals under 12 years of age. The product should not be applied to wounds, cuts, or any damaged, broken, or irritated skin. It is also advised against using the product on the eyes or mucous membranes. The use of heating pads or devices in conjunction with the product is prohibited, as is wrapping the area with a bandage. Furthermore, the product should not be used alongside other topical analgesics.

No relevant information regarding carcinogenicity, mutagenicity, or animal pharmacology and toxicology is available.

Postmarketing Experience

No postmarketing experience details are available in the insert.

Patient Counseling

Healthcare providers should advise patients to keep the product out of reach of children and pets to prevent accidental ingestion. In the event of ingestion, patients should seek medical help or contact a Poison Control Center immediately.

Patients should be informed not to use the product if they are allergic to any of the listed ingredients. Additionally, it is important to counsel patients against using the product if they are pregnant or breastfeeding, or if they are under 12 years of age.

Healthcare providers should emphasize that the product should not be applied to wounds, cuts, damaged, broken, or irritated skin, nor should it be used on the eyes or mucous membranes. Patients should also be cautioned against using the product in conjunction with heating pads or devices, or wrapping it with a bandage. Furthermore, the product should not be used alongside other topical analgesics.

Patients should be instructed to avoid using the product if the package is damaged or opened. They should be advised to stop use and consult a doctor if they experience pain, swelling, or blistering, or if redness or irritation develops. If symptoms persist for more than 7 days or if they clear up and then recur within a few days, patients should also seek medical advice.

Finally, healthcare providers should remind patients to use the product only as directed and to read and follow all directions and warnings on the label carefully.

Storage and Handling

The patches are supplied in a manner that ensures optimal preservation of their efficacy. It is essential to avoid storing the patches in direct sunlight, as exposure to light can compromise their integrity. Additionally, the patches must be protected from excessive moisture to maintain their quality and effectiveness.

For best results, it is recommended to store the patches in a cool, dry place, away from sources of heat and humidity. Proper handling and storage conditions are crucial to ensure the patches remain effective throughout their shelf life.

Additional Clinical Information

The medication is administered topically and should be applied to the affected area no more than four times daily. Clinicians should advise patients to keep the product out of reach of children and pets. In the event of ingestion, patients should seek medical assistance or contact a Poison Control Center immediately.

Drug Information (PDF)

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

View product document (PDF)