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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
January 17, 2025
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
January 17, 2025
Manufacturer
Safeway Inc.
Registration number
ANDA077511
NDC root
21130-080
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 cream designed to treat various fungal skin infections. It is effective in curing most cases of athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis). In addition to treating these conditions, the cream helps relieve associated symptoms such as itching, burning, cracking, and scaling.

This cream is available in a full prescription strength and is comparable to Lamisil AT®. It comes in a 1 oz (30 g) tube, making it easy to apply directly to the affected areas for relief and healing.

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 expect to feel more comfortable as the treatment works to clear up the infection.

Dosage and Administration

If you are an adult or a child aged 12 years and older, you can use this medication to treat skin conditions like athlete's foot, jock itch, and ringworm. To start, use the tip of the cap to break the seal and open the tube. Before applying the medication, wash the affected area of skin with soap and water, then dry it completely.

For athlete's foot, it's important to wear well-fitting, ventilated shoes and change your shoes and socks at least once a day. 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. For jock itch and ringworm, you only need to apply the medication once a day, either in the morning or at night, for one week. Remember to wash your hands after each use, and if you are caring for a child under 12, consult a doctor before use.

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 and 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 and 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 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 for external use only, so please avoid applying it to your nails, scalp, or in and around your mouth and eyes. If the product accidentally gets into your eyes, rinse them thoroughly with water.

While using this product, if you experience excessive irritation or if the 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 seek medical help immediately. You can do this by contacting a poison control center or going to the nearest emergency room. Acting quickly can make a significant difference in the outcome.

Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms, don’t hesitate to get help right away. Remember, it’s always better to be safe and get checked by a medical professional.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that there are no specific statements about the use of terbinafine hydrochloride cream during pregnancy. The information available does not highlight any safety concerns, contraindications (situations where the product should not be used), or special precautions related to its use while pregnant.

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 the use of terbinafine hydrochloride cream, you can feel reassured that there are no specific warnings or recommendations regarding its use for nursing mothers. Additionally, there is no information available about whether this cream is passed into breast milk or if it poses any risk to your infant.

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 health and safety.

Geriatric Use

When it comes to 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 who may need this treatment, it’s always a good idea to consult with a healthcare professional. They can provide personalized advice and ensure that the cream is used safely and effectively.

Renal Impairment

If you have kidney problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or safety considerations for your condition. This means that there are no tailored guidelines for how this medication may affect you if you have renal impairment (kidney issues).

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

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 have open conversations with your healthcare provider about any medications you are taking, even if there are no specific drug interactions or laboratory test interactions noted for your treatment. This ensures that your healthcare team can provide the best care tailored to your needs.

Always inform your doctor about all the medications, supplements, and over-the-counter products you use. This helps them monitor your health effectively and make informed decisions about your treatment plan. Your safety and well-being are the top priority, so don't hesitate to ask questions or express any concerns you may have.

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 it at a controlled room temperature between 20°-25°C (68°-77°F). This helps maintain its quality. 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 will use this medication topically, which means you apply it directly to the skin. If you are treating athlete's foot, it's important to wear well-fitting, ventilated shoes and to change your shoes and socks at least once a day. Remember to wash your hands after each use to prevent spreading the infection. If the patient is a child under 12 years old, consult a doctor before use.

FAQ

What is Terbinafine Hydrochloride Cream used for?

Terbinafine Hydrochloride Cream is an antifungal cream that cures most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis).

How do I apply Terbinafine Hydrochloride Cream?

Wash the affected skin with soap and water, dry completely, and apply the cream as directed. For athlete's foot, apply twice a day for 1-2 weeks; 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, and you should stop use and ask a doctor if irritation occurs or worsens. Keep out of reach of children.

Can I use Terbinafine Hydrochloride Cream if I am pregnant or nursing?

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

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. Avoid getting it in your eyes.

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

If swallowed, get medical help or contact a poison control center immediately.

Who should not use Terbinafine Hydrochloride Cream?

Children under 12 years should ask a doctor before use. There are no other specific contraindications mentioned.

How should I store Terbinafine Hydrochloride Cream?

Store the cream at a controlled room temperature of 20°-25°C (68°-77°F) and do not use 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

Signature™ care Quality Guaranteed is an antifungal cream formulated with 1% terbinafine hydrochloride as the active ingredient. This product is classified as a full prescription strength athlete's foot cream, designed to cure most cases of athlete's foot while providing relief from associated itching and burning sensations. The net weight of the cream is 1 ounce (30 grams). The product is comparable to Lamisil AT®.

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 older are advised to follow the specified dosage and administration guidelines. Prior to application, the affected skin should be washed with soap and water, then dried completely. To open the tube, the tip of the cap should be used to break the seal.

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 essential to wash hands thoroughly after each use to prevent the spread of infection.

For children under 12 years of age, consultation with a healthcare professional is recommended prior to use.

Contraindications

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

Care should be taken to avoid contact with the eyes. In the event of eye contact, it is imperative to rinse thoroughly with water.

Users are advised to discontinue use and consult a healthcare professional if excessive irritation occurs or if irritation worsens.

This product should be kept out of reach of children. In the case of accidental 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 the eyes, nor is it indicated for vaginal yeast infections.

During the use of this product, 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 the case of accidental ingestion, it is crucial to seek medical assistance or contact a poison control center immediately.

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 indicate any safety concerns, contraindications, or special precautions for pregnant patients. As such, healthcare professionals should consider the lack of data when prescribing this medication to women of childbearing potential and weigh the potential benefits against any unknown risks to fetal outcomes.

Lactation

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

Renal Impairment

Patients with renal impairment have not been specifically addressed in the drug insert text 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 data necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients, although specific recommendations are not provided.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to 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 prescribing information.

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 and monitoring of the patient are essential.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous evaluation and appropriate interventions should be implemented based on the clinical presentation and severity of symptoms.

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 question.

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 the 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 this product, patients must be cautioned to avoid contact with the eyes. In case 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. 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°-25°C (68°-77°F). It is important to check the carton or the tube crimp for the lot number and expiration date to ensure the product's validity and safety.

Additional Clinical Information

The route of administration for the medication is topical. Clinicians should advise patients with athlete's foot to wear well-fitting, ventilated shoes and to change shoes and socks at least once daily. It is also important for patients to wash their hands after each use of the medication. For children under 12 years of age, it is recommended to consult a doctor before use. No additional information is available regarding laboratory tests, abuse potential, 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.

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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.