Eucalyptamint

Description

Eucalyptamint is an ointment formulated with 16% menthol, specifically designed for arthritis pain relief. The product is presented in a net weight of 2 fluid ounces (60 mL).

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains of muscles and joints associated with various conditions, including arthritis, sore muscles, simple backache, strains, and sprains.

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

Dosage and Administration

Adults and children aged 2 years and older should gently massage a conservative amount of the product into the affected area no more than 3 to 4 times daily. For children under 2 years of age, it is advised to consult a doctor prior to use.

In the event that the product thickens, it is recommended to warm the tube by holding it in the palm of the hand or by running it under warm water to restore its consistency before application.

Contraindications

Use of this product is contraindicated in the following situations:

• The product should only be used as directed; misuse may lead to adverse effects.

• Application with a heating pad or heating device is contraindicated due to the potential for increased absorption and risk of burns.

• Contact with the eyes must be avoided to prevent irritation or injury.

• Tight bandaging is contraindicated as it may restrict circulation and lead to complications.

• Application to wounds or damaged skin is not recommended, as it may exacerbate irritation or delay healing.

Warnings and Precautions

For external use only. This product should be utilized strictly as directed. It is contraindicated to use this product in conjunction with a heating pad or any heating device, as this may lead to adverse effects.

When using this product, it is imperative to avoid contact with the eyes. Additionally, users should refrain from applying the product to wounds or damaged skin and should not bandage the area tightly, as this may exacerbate irritation or other complications.

Healthcare professionals should advise patients to discontinue use and seek medical advice if the condition worsens, if symptoms persist beyond 7 days, or if symptoms resolve and then recur within a few days.

It is crucial to keep this product out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center should be made without delay.

Side Effects

Patients should be aware that this product is for external use only. It is imperative that the product is used strictly as directed and not in conjunction with any heating pads or heating devices.

While using this product, patients must avoid contact with the eyes and should not apply it to wounds or damaged skin. Additionally, bandaging should not be done tightly over the area of application.

Patients are advised to discontinue use and consult a healthcare professional if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days.

This product should be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center should be made without delay.

Drug Interactions

There are no reported drug interactions associated with the use of this medication. Additionally, no interactions with laboratory tests have been identified. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug interactions.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 2 years of age should consult a doctor prior to use. For children aged 2 years and older, the recommended application involves gently massaging a conservative amount into the affected area no more than 3 to 4 times daily.

Geriatric Use

Elderly patients may not have specific dosage adjustments, safety concerns, or special precautions outlined in the drug insert for Eucalyptamint (menthol ointment). As there is no available information regarding geriatric use, healthcare providers should exercise caution when prescribing this medication to patients aged 65 and older.

It is advisable for healthcare providers to monitor elderly patients closely for any potential adverse effects or unusual responses to treatment, given the lack of targeted data for this population.

Pregnancy

There is currently no information available regarding the use of Eucalyptamint (menthol ointment) during pregnancy, including safety concerns, dosage modifications, or any special precautions that should be taken. Healthcare professionals should exercise caution when considering the use of this product in pregnant patients due to the lack of data on potential fetal impacts and outcomes. It is advisable to weigh the potential benefits against any unknown risks when prescribing this medication to women of childbearing potential.

Lactation

There is no specific information available regarding the use of this medication in nursing mothers or lactation considerations. Healthcare professionals should exercise caution and consider the potential risks and benefits when prescribing this medication to lactating mothers. The effects on breastfed infants have not been established, and further research may be necessary to determine safety and efficacy in this population.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials for this medication. Consequently, there is no available information regarding dosage adjustments, special monitoring requirements, or precautions 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 warranted based on clinical judgment.

Overdosage

In the event of an overdosage, immediate medical intervention is crucial. If the substance is ingested, it is imperative to seek medical assistance or contact a Poison Control Center without delay.

Healthcare professionals should be aware that prompt action can significantly influence the outcome of an overdosage situation. Symptoms of overdosage may vary depending on the specific substance involved; therefore, a thorough assessment of the patient's condition is essential.

Management procedures should include supportive care and symptomatic treatment as necessary. Continuous monitoring of the patient's vital signs and clinical status is recommended to address any complications that may arise.

In all cases of suspected overdosage, the involvement of poison control experts can provide valuable guidance on the appropriate management strategies tailored to the specific circumstances of the case.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

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 to prevent accidental ingestion. Instruct patients that if the product is swallowed, they should seek medical help or contact a Poison Control Center immediately.

Patients should be informed to use the product only as directed and to avoid using it in conjunction with a heating pad or any heating device, as this may lead to adverse effects. It is important to counsel patients to 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.

Additionally, healthcare providers should emphasize the importance of avoiding contact with the eyes while using this product. Patients should also be cautioned against bandaging the area tightly and advised not to apply the product to wounds or damaged skin to ensure safe and effective use.

Storage and Handling

The product is supplied in various packaging configurations, with specific NDC numbers available for reference. It should be stored at room temperature to maintain its efficacy. For traceability, healthcare professionals are advised to check the box or the crimp of the tube for the lot number and expiration date. Proper handling and storage conditions are essential to ensure the integrity of the product throughout its shelf life.

Additional Clinical Information

The product is administered topically, with a recommended application frequency of 3 to 4 times daily for adults and children aged 2 years and older. A conservative amount should be gently massaged into the affected area. For children under 2 years of age, consultation with a doctor is advised prior to use.

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 Eucalyptamint, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)