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Athletes Foot

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Active ingredient
Terbinafine Hydrochloride 1 g/100 g
Other brand names
Drug class
Allylamine Antifungal
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2007
Label revision date
July 15, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Terbinafine Hydrochloride 1 g/100 g
Other brand names
Drug class
Allylamine Antifungal
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2007
Label revision date
July 15, 2025
Manufacturer
H E B
Registration number
ANDA077511
NDC root
37808-080
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

If you are a consumer or patient please visit this version.

Drug Overview

Terbinafine Hydrochloride Cream 1% is an antifungal medication designed to treat common skin infections caused by fungi. It effectively cures most cases of athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis). In addition to eliminating the fungal infection, this cream helps relieve uncomfortable symptoms such as itching, burning, cracking, and scaling associated with these conditions.

If you're dealing with any of these fungal skin issues, Terbinafine Hydrochloride Cream can provide relief and help restore your skin's health.

Uses

If you're dealing with athlete's foot, jock itch, or ringworm, this medication can help. It effectively cures most cases of athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis).

In addition to treating these fungal infections, it also provides relief from uncomfortable symptoms such as itching, burning, cracking, and scaling that often accompany these conditions. You can feel more comfortable and confident as you address these common skin issues.

Dosage and Administration

To use this medication effectively, start by breaking the seal on the tube with the tip of the cap. Before applying the medication, wash the affected area of your skin with soap and water, then dry it completely.

If you’re treating athlete's foot, it’s important to wear well-fitting, ventilated shoes and change your shoes and socks at least once a day. For application, if the infection is between your toes, apply the medication twice a day—once in the morning and once at night—for one week, or as your doctor advises. If the infection is on the bottom or sides of your foot, apply it twice a day for two weeks, or follow your doctor's instructions. For jock itch and ringworm, you should apply the medication once a day, either in the morning or at night, for one week, or as directed by your doctor. Remember to wash your hands after each use to prevent spreading the infection.

If you are considering this treatment for a child under 12 years old, please consult a doctor first.

What to Avoid

It's important to use this product safely and effectively. You should avoid applying it to your nails or scalp, and it should not be used in or near your mouth or eyes. Additionally, do not use this product for vaginal yeast infections, as it is not intended for that purpose.

While there are no specific contraindications or concerns about abuse, misuse, or dependence associated with this product, following these guidelines will help ensure your safety and the best possible results. Always prioritize your health and consult a healthcare professional if you have any questions or concerns.

Side Effects

When using this product, it's important to remember that it is for external use only. Avoid applying it to your nails, scalp, or in areas near your mouth or eyes, as well as for vaginal yeast infections. If the product accidentally gets into your eyes, rinse them thoroughly with water.

You should stop using the product and consult a doctor if you experience excessive irritation or if the irritation worsens. Additionally, keep this product out of reach of children, and if it is swallowed, seek medical help or contact a Poison Control Center immediately.

Warnings and Precautions

This product is intended for external use only, so please avoid applying it to your nails or scalp, and do not use it in or near your mouth or eyes, or for vaginal yeast infections. If the product accidentally gets into your eyes, rinse them thoroughly with water.

While using this product, if you experience excessive irritation or if your irritation worsens, stop using it and consult your doctor. It's also important to keep this product out of reach of children. If a child swallows it, seek medical help or contact a Poison Control Center immediately.

Overdose

If you or someone else has swallowed too much of a medication, it’s important to act quickly. You should seek medical help immediately or contact a Poison Control Center. They can provide guidance on what to do next.

Signs of an overdose can vary, but they may include unusual symptoms that are not typical for the medication. If you notice any concerning changes in behavior or health, don’t hesitate to reach out for help. Remember, it’s always better to be safe and get professional advice in these situations.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that there are no specific warnings or contraindications related to the use of terbinafine hydrochloride cream during pregnancy. The information available does not indicate any risks associated with its use, nor does it suggest any changes to the dosage for pregnant individuals.

While the insert does not mention any special precautions, it's always a good idea to consult with your healthcare provider before using any medication during pregnancy to ensure it is safe for you and your baby.

Lactation Use

If you are breastfeeding and considering using terbinafine hydrochloride cream, you can feel reassured that there are no specific warnings or recommendations against its use for nursing mothers. Currently, there is no information available about whether this cream passes into breast milk or if it poses any risk to your infant while you are lactating.

As always, it's a good idea to consult with your healthcare provider if you have any concerns or questions about using this product while breastfeeding.

Pediatric Use

If you are considering this medication for a child under 12 years old, it’s important to consult with a doctor first. This ensures that the treatment is safe and appropriate for their age and health needs. Always prioritize professional guidance when it comes to the health of your children.

Geriatric Use

When using Terbinafine Hydrochloride Cream, there is no specific information available about how it should be used by older adults. This means that there are no special dosage adjustments, safety concerns, or precautions outlined for elderly patients.

If you are caring for an older adult, it’s always a good idea to consult with a healthcare professional before starting any new medication, including topical treatments like this cream. They can provide guidance tailored to individual health needs and ensure safe use.

Renal Impairment

If you have kidney problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to change based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment is safe and effective, especially if you have any concerns about your kidney health.

Hepatic Impairment

If you have liver problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication should be used if you have hepatic impairment (liver issues).

Before starting any new medication, including this one, you should discuss your liver health with your healthcare provider. They can help determine the best approach for your treatment and ensure your safety.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. In this case, there are no specific drug interactions or laboratory test interactions noted, which is a positive sign. However, every individual is different, and your healthcare provider can help ensure that your treatment plan is safe and effective for you. Always feel free to ask questions and share any concerns you may have regarding your medications or health tests.

Storage and Handling

To ensure the safety and effectiveness of your product, it's important to store it properly. Keep it at a controlled room temperature between 20° to 25°C (68° to 77°F). Always check the seal on the tube before use; do not use the product if the seal is broken or not visible. Additionally, make sure to look for the lot number and expiration date, which can be found on the carton or the crimp of the tube, to confirm that the product is still valid for use.

Handling the product with care is essential for your safety. Always ensure that the storage conditions are met and that the seal is intact before using it. Following these guidelines will help you use the product safely and effectively.

Additional Information

You will apply this medication topically, which means you will apply it directly to the skin. There are no additional details available regarding laboratory tests, abuse potential, or patient counseling information.

FAQ

What is Terbinafine Hydrochloride Cream used for?

Terbinafine Hydrochloride Cream is used to cure most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis), while also relieving associated itching, burning, cracking, and scaling.

How should I apply Terbinafine Hydrochloride Cream?

For athlete's foot, apply twice a day for 1 week between the toes or for 2 weeks on the bottom or sides of the foot. For jock itch and ringworm, apply once a day for 1 week.

Are there any side effects of using Terbinafine Hydrochloride Cream?

For external use only, you should stop using the cream and consult a doctor if irritation occurs or worsens. Keep it out of reach of children.

Can I use Terbinafine Hydrochloride Cream during pregnancy?

There are no specific statements regarding the use of Terbinafine Hydrochloride Cream during pregnancy, and no teratogenic effects are mentioned.

What should I avoid while using Terbinafine Hydrochloride Cream?

Do not use the cream on nails, scalp, in or near the mouth or eyes, or for vaginal yeast infections. If the cream gets into your eyes, rinse thoroughly with water.

What should I do if I accidentally swallow Terbinafine Hydrochloride Cream?

If swallowed, seek medical help or contact a Poison Control Center immediately.

Is Terbinafine Hydrochloride Cream safe for children?

For children under 12 years, you should consult a doctor before use.

How should I store Terbinafine Hydrochloride Cream?

Store the cream at a controlled room temperature of 20° to 25°C (68° to 77°F) and do not use it if the seal on the tube is broken.

Packaging Info

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

Packaging configurations for Athletes Foot.
Details

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)

Description

Terbinafine Hydrochloride Cream 1% is an antifungal formulation indicated for the treatment of most cases of athlete's foot. This topical cream is designed to relieve associated symptoms, including itching, burning, cracking, and scaling of the affected area. The product is supplied in a net weight of 0.5 ounces (15 grams).

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.

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

Dosage and Administration

Adults and children aged 12 years and over 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 completely.

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 applied twice a day (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 be applied twice a day (morning and night) for 2 weeks, or as directed by a healthcare professional.

For the treatment of jock itch and ringworm, the medication should be applied once a day (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

The product is contraindicated for use on nails or the scalp. It should not be applied in or near the mouth or eyes. Additionally, the product is not indicated for the treatment of vaginal yeast infections.

Warnings and Precautions

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

Care should be taken to avoid contact with the eyes. In the event of accidental eye contact, it is imperative to rinse the eyes thoroughly with water. If irritation occurs or worsens during use, the patient should discontinue use immediately and consult a healthcare professional.

This product must be kept out of reach of children. In the case of ingestion, it is crucial to seek medical assistance or contact a Poison Control Center without delay.

Side Effects

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

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

Additionally, this product should be kept out of reach of children. If swallowed, 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 (terbinafine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Athletes Foot.
Details

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. The safety and efficacy of this medication in this age group have not been established, and specific dosing recommendations are not provided for children in this category.

Geriatric Use

There is no specific information regarding the use of Terbinafine Hydrochloride Cream in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as the absence of data necessitates careful consideration of individual patient factors and potential risks. Monitoring for any adverse effects is advisable, given the lack of established guidelines for 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 potential benefits against any unknown risks.

Lactation

There are no specific warnings or recommendations regarding the use of terbinafine hydrochloride cream in nursing mothers. Additionally, there is no information available about the potential for excretion in breast milk or any associated risks to breastfed infants from the use of this product during lactation.

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 may vary depending on the specific substance involved, and monitoring for any adverse effects is essential.

Management of overdosage should include supportive care and symptomatic treatment as necessary. Continuous assessment of the patient's condition is recommended to address any complications that may arise.

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 to keep the 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.

It is important to inform patients that the product should not be used on nails or the scalp, and they should avoid application in or near the mouth or eyes. Additionally, patients should be made aware that this product is not intended for the treatment of vaginal yeast infections.

Healthcare providers should counsel patients to discontinue use and consult a doctor if they experience excessive irritation or if the irritation worsens. Furthermore, patients should be cautioned to avoid contact with the eyes while using the product. In the event of eye contact, they should rinse thoroughly with water.

Storage and Handling

The product is supplied in a tube format, and it is essential to ensure that the seal on the tube is intact and visible before use. Any product with a broken seal should not be utilized.

Storage conditions require the product to be maintained at a controlled room temperature ranging from 20° to 25°C (68° to 77°F). For traceability, the lot number and expiration date can be found on the carton or the crimp of the tube. Proper handling and storage are crucial to ensure the product's efficacy and safety.

Additional Clinical Information

The route of administration for the medication is topical. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

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)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Athletes Foot, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

Learn more in our Editorial Policy

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Primary FDA sources:

Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.