Athletes Foot

Description

Athlete's foot cream is a topical formulation indicated for the treatment of athlete's foot. The product is presented in a cream dosage form, designed for external application. The effective date of this formulation is August 19, 2009. An image of the carton is available for reference, identified by the media type image/jpeg and the carton image reference c0a03ab1-3a10-4e10-85af-c3a8b28bca6e-03.jpg.

Uses and Indications

This drug is indicated for the treatment of most cases of athlete’s foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis). It effectively cures these fungal infections and provides relief from associated symptoms, including itching, burning, cracking, and scaling.

Limitations of Use: The efficacy of this drug may vary based on the severity and duration of the fungal infection. It is recommended that healthcare professionals assess the individual patient's condition to determine the appropriateness of this treatment.

Dosage and Administration

Adults and children aged 12 years and older should begin treatment by using the tip of the cap to break the seal and open the tube. Prior to application, the affected skin must be washed with soap and water and dried thoroughly.

For the treatment of athlete’s foot, it is recommended to wear well-fitting, ventilated shoes and to change shoes and socks at least once daily. When applying the medication between the toes, it should be administered twice daily (morning and night) for a duration of 1 week, or as directed by a healthcare professional. For application on the bottom or sides of the foot, the medication should also be applied twice daily (morning and night) but for a period of 2 weeks, or as directed by a healthcare professional.

In the case of jock itch and ringworm, the medication should be applied once daily (either morning or night) for 1 week, or as directed by a healthcare professional. It is important to wash hands thoroughly after each use to prevent the spread of infection.

For children under 12 years of age, it is advised to consult a doctor before use.

Contraindications

Use of this product is contraindicated in the following situations:

Application on nails or scalp is prohibited due to potential adverse effects. The product should not be applied in or near the mouth or eyes, as this may lead to irritation or injury. Additionally, it is contraindicated for the treatment of vaginal yeast infections, as it is not indicated for this condition.

In the event of accidental eye contact, it is essential to rinse thoroughly with water. Furthermore, the product should not be used if the seal on the tube is broken or not visible, as this may indicate compromised integrity and safety.

Warnings and Precautions

This product is intended for external use only. It is contraindicated for application on nails or the scalp, and it should not be used in or near the mouth or eyes. Additionally, this product is not indicated for the treatment of vaginal yeast infections.

Healthcare professionals should advise patients to avoid contact with the eyes during use. In the event of accidental eye contact, it is imperative to rinse the eyes thoroughly with water. Should excessive irritation occur or if irritation worsens, patients are instructed to discontinue use and consult a healthcare provider.

It is essential to keep this product out of reach of children. In cases of ingestion, immediate medical assistance should be sought, or the local poison control center should be contacted without delay.

Side Effects

Patients should be aware that the product is intended for external use only and should not be applied to nails or the scalp, nor should it be used in or near the mouth or eyes. It is also contraindicated for the treatment of vaginal yeast infections.

During use, patients must avoid contact with the eyes. In the event of eye contact, it is imperative to rinse thoroughly with water. If significant irritation occurs or worsens, patients are advised to discontinue use and consult a healthcare professional.

Additionally, the product should be kept out of reach of children. In cases of accidental ingestion, immediate medical assistance should be sought, or contact with a poison control center is recommended.

Drug Interactions

There are no specific drug interactions identified in the available data. Additionally, no laboratory test interactions have been reported. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the current information.

Packaging & NDC

Below are the non-prescription pack sizes of Athletes Foot (terbinafin hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. It is important to assess the appropriateness of treatment and dosage for this age group, as specific recommendations may vary based on individual health needs and conditions.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

There are no specific statements regarding the use of terbinafine hydrochloride cream during pregnancy. The available prescribing information does not mention any contraindications or risks associated with the use of this product in pregnant patients. Additionally, no dosage modifications for pregnant individuals are provided. The insert also does not include any special precautions regarding the use of this product during pregnancy. Healthcare professionals should consider the absence of data when advising women of childbearing potential and weigh the benefits against any potential risks.

Lactation

There are no specific statements regarding the use of this medication in lactating mothers or its effects on breastfed infants. Healthcare professionals should consider the absence of data when advising lactating mothers about the use of this medication.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data 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 lack of information necessitates careful clinical judgment and monitoring.

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. 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 use of the compound in these contexts.

Postmarketing Experience

No postmarketing experience details are available in the provided data.

Patient Counseling

Healthcare providers should advise patients that this product is for external use only and should not be applied to nails or the scalp. Patients must be informed not to use the product in or near the mouth or eyes, and it is not intended for the treatment of vaginal yeast infections.

When using the product, patients should be cautioned to avoid contact with the eyes. In the event of eye contact, they should rinse thoroughly with water. Patients should be instructed to stop using the product and consult a doctor if they experience excessive irritation or if the irritation worsens.

It is essential to keep the product out of reach of children. Patients should be informed that if the product is swallowed, they should seek medical help or contact a poison control center immediately.

Before applying the product, patients should wash the affected skin with soap and water and ensure it is completely dry. For athlete’s foot, they should wear well-fitting, ventilated shoes and change shoes and socks at least once daily. The application regimen varies: for athlete’s foot, patients should apply the product twice a day (morning and night) for one week between the toes or as directed by a doctor; for the bottom or sides of the foot, the application should also be twice a day for two weeks or as directed by a doctor. For jock itch and ringworm, the product should be applied once a day (morning or night) for one week or as directed by a doctor.

Patients should be reminded to wash their hands after each use. For children under 12 years of age, they should consult a doctor before use. The product should be stored at a controlled room temperature of 20-25°C (68-77°F) and should not be used if the seal on the tube is broken or not visible.

For any questions, patients can be directed to call 1-800-452-0051, which is available 24 hours a day, 7 days a week.

Storage and Handling

The product is supplied in a configuration that includes a crimped tube, which contains essential information such as the lot number and expiration date. It is crucial to store the product at a controlled room temperature ranging from 20 to 25°C (68 to 77°F) to ensure its stability and efficacy.

Healthcare professionals should inspect the tube prior to use; the product must not be utilized if the seal on the tube is broken or not visible, as this may compromise the integrity of the product.

Additional Clinical Information

The product is administered topically. Clinicians should advise patients to discontinue use and consult a doctor if excessive irritation occurs or worsens. It is also important to keep the product out of reach of children; if ingested, patients should seek medical assistance or contact a poison control center immediately.

Drug Information (PDF)

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

View product document (PDF)