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Athletes Foot

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This product has been discontinued

Active ingredient
Terbinafine Hydrochloride 1 g/100 g
Other brand names
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
March 8, 2019
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Terbinafine Hydrochloride 1 g/100 g
Other brand names
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
March 8, 2019
Manufacturer
Topco Associates LLC
Registration number
ANDA077511
NDC root
36800-080
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 a topical medication commonly used to treat fungal skin infections, specifically athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis). This cream works by curing these infections and relieving associated symptoms such as itching, burning, cracking, and scaling of the skin.

As a full prescription strength product, Terbinafine Hydrochloride Cream is often recommended by pharmacists for effective treatment of these conditions. It comes in a convenient 0.5 oz (15 g) tube, making it easy to apply directly to the affected areas.

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 confident using this treatment, as there are no teratogenic effects (harmful effects on fetal development) or nonteratogenic effects noted.

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 cream, 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 cream 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, continue applying it twice a day for two weeks, or follow your doctor's instructions. For jock itch and ringworm, apply the cream 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, as well as in or near your mouth or eyes. Additionally, do not use this product for treating vaginal yeast infections. Following these guidelines will help ensure your safety and the best possible results.

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 treating 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 your symptoms worsen. 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 near your mouth or eyes. If you accidentally get the product in your eyes, rinse them thoroughly with water. It’s also important not to use this product for vaginal yeast infections.

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

Overdose

It's important to keep this medication out of reach of children. If a child accidentally swallows it, you should seek medical help or contact a Poison Control Center immediately.

In case of an overdose, you may notice symptoms such as unusual drowsiness, confusion, or difficulty breathing. If you or someone else experiences these signs, it's crucial to get emergency assistance right away. Always prioritize safety and act quickly 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 regarding the use of terbinafine hydrochloride cream during pregnancy. The information available does not indicate any risks to the fetus associated with this medication, and there are no recommended dosage changes for pregnant individuals. Additionally, no special precautions are noted for its use in pregnant patients.

As always, it's best 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 your child, it's important to know that it is not recommended for children under 12 years old without consulting a doctor first. Always reach out to a healthcare professional to discuss the best options for your child's specific needs and to ensure their safety.

Geriatric Use

While there is no specific information about the use of terbinafine hydrochloride cream in older adults, it’s important to approach any new medication with caution. Since the drug insert does not mention dosage adjustments or safety concerns for elderly patients, you should consult with a healthcare provider before starting this treatment. They can help ensure that it is appropriate for your individual health needs and circumstances. Always prioritize open communication with your doctor about any concerns or questions you may have regarding medications.

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 for your specific health needs. They can help determine the best approach for managing your condition while considering 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 (issues with liver function).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your liver health. They can help determine the best course of action based on your individual situation.

Drug Interactions

It's important to communicate openly with your healthcare provider about any medications you are taking. In this case, there are no reported interactions between this medication and other drugs or laboratory tests. This means that, as far as current knowledge goes, you can use this medication without worrying about it affecting other treatments or test results.

However, always keep in mind that individual responses can vary. Discussing your full list of medications and any lab tests with your healthcare provider ensures that you receive the safest and most effective care tailored to your needs.

Storage and Handling

To ensure the safety and effectiveness of your product, always check that the seal on the tube is intact and visible before use. If the seal is broken, do not use the product. For proper storage, keep the product at a controlled room temperature between 20° to 25°C (68° to 77°F). Additionally, you can find important information such as the lot number and expiration date on the carton or the crimp of the tube, so be sure to check these details before use.

Additional Information

You should apply this medication topically, depending on the condition you're treating. For athlete's foot, apply it twice a day (morning and night) for one week, or as your doctor advises. If you're treating the bottom or sides of your foot, continue applying it twice daily for two weeks. For jock itch and ringworm, use it once a day (morning or night) for one week, or follow your doctor's instructions. Always ensure to follow the recommended application schedule for the best results.

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 precautions for using this cream?

Do not use Terbinafine Hydrochloride Cream on nails, scalp, or in/near the mouth or eyes. If contact with eyes occurs, rinse thoroughly with water.

Can I use this cream if I am pregnant or nursing?

There are no specific warnings regarding the use of Terbinafine Hydrochloride Cream during pregnancy or lactation, but consult your doctor for personalized advice.

What should I do if I experience irritation?

If you experience too much irritation or if it worsens, stop using the cream and consult a doctor.

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.

What should I do if I accidentally swallow the cream?

Keep Terbinafine Hydrochloride Cream out of reach of children. If swallowed, seek medical help or contact a Poison Control Center immediately.

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

TopCare® health™ Athlete's Foot Cream contains Terbinafine Hydrochloride at a concentration of 1%, serving as a full prescription strength antifungal treatment. The product is formulated as a cream and is packaged 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, indicating a favorable safety profile for use in the indicated patient populations.

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 duration of 2 weeks, or as directed by a healthcare professional.

In cases 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 essential 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

This product is intended for external use only and should not be applied to nails or the scalp. It is contraindicated for use in or near the mouth or eyes, and it is not recommended for the treatment of vaginal yeast infections.

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

Additionally, this product must be kept out of reach of children. In cases of ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

Side Effects

Patients using this product should be aware that it 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, nor for the treatment of vaginal yeast infections.

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

Additionally, this 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 currently 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 or laboratory test interactions.

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

Elderly patients may not have specific information regarding the use of terbinafine hydrochloride cream, including dosage adjustments, safety concerns, or special precautions. As such, healthcare providers should exercise caution when prescribing this medication to geriatric patients.

Due to the absence of detailed data, it is advisable for clinicians to closely monitor elderly patients for any potential adverse effects or unusual responses to treatment. Individual patient factors, including comorbidities and concurrent medications, should be considered when evaluating the appropriateness of terbinafine hydrochloride cream for this population.

Pregnancy

There are no specific statements regarding the use of terbinafine hydrochloride cream during pregnancy. The available data does not indicate any contraindications or risks to the fetus associated with the use of this medication during pregnancy. Additionally, no dosage modifications for pregnant individuals are provided in the prescribing information. The insert does not include any special precautions regarding the use of this medication in pregnant patients. As with any medication, healthcare professionals should weigh the potential benefits against any unknown risks when considering the use of terbinafine hydrochloride cream in pregnant patients.

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 during the use of this product in 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 relation to the use of this medication. Consequently, there are no 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, it is imperative to keep the product out of reach of children. Should ingestion occur, immediate medical assistance is required. Healthcare professionals should advise caregivers to contact a Poison Control Center without delay.

Prompt action is crucial in managing potential overdosage situations to mitigate risks and ensure patient safety.

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 this product out of reach of children to prevent accidental ingestion. In the event of swallowing the product, patients should seek medical help or contact a Poison Control Center immediately.

Patients should be informed that this product is not intended for use on nails or the scalp, and it should not be applied in or near the mouth or eyes. Additionally, it is important to communicate that this product is not indicated for the treatment of vaginal yeast infections.

Healthcare providers should instruct patients to discontinue use and consult a doctor if they experience excessive irritation or if the irritation worsens. While using the product, patients must be cautioned to avoid contact with the eyes. In case of eye contact, they should rinse the eyes 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. If the seal is broken or not visible, the product should not be used.

Storage conditions require the product to be maintained at a controlled room temperature between 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.

Additional Clinical Information

The medication is administered topically, with specific application instructions based on the condition being treated. For athlete's foot, patients should apply the medication twice daily (morning and night) for one week, or as directed by a healthcare provider. When treating the bottom or sides of the foot, the same twice-daily application is recommended for two weeks. For jock itch and ringworm, the medication should be applied once daily (morning or night) for one week, or as directed by a clinician.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

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.

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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.