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Terbinafine hydrochloride

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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 2023
Label revision date
July 21, 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 2023
Label revision date
July 21, 2025
Manufacturer
STRATEGIC SOURCING SERVICES LLC
Registration number
ANDA077511
NDC root
70677-1003
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 marketed under the product name Foster & Thrive™ and comes in a 1-ounce (30 g) tube. If you're dealing with any of these fungal infections, 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. With this treatment, you can expect to feel more comfortable and get back to your daily activities without the irritation caused by these skin issues.

Dosage and Administration

To use this medication effectively, start by breaking the seal on the tube using 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, you should apply it twice a day for two weeks. For jock itch and ringworm, apply the medication once a day for one week. 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

This product is intended for external use only and should not be applied to nails, the scalp, or in and around the mouth or eyes. If the product accidentally gets into your eyes, rinse them thoroughly with water.

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

Warnings and Precautions

This product is intended for external use only. Please avoid applying it on your nails or scalp, and do not use it in or near your mouth or eyes, or for treating 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 or contact a Poison Control Center immediately. Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing.

Don't wait for symptoms to worsen; getting prompt assistance can be crucial. Always keep emergency contact numbers handy and be aware of the signs of overdose to ensure safety.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that there are no specific guidelines or safety concerns mentioned regarding the use of Terbinafine Hydrochloride Cream during pregnancy. This means that the information available does not provide clear recommendations on dosage adjustments or special precautions for pregnant individuals.

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. They can provide personalized advice based on your health needs.

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 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.

As always, it's a good idea to consult with your healthcare provider if you have any concerns or questions about using this medication while breastfeeding. Your health and the well-being of your baby are important, and your provider can help you make the best decision for both of you.

Pediatric Use

If you are considering this medication for your child, it's important to know that children under 12 years old should consult a doctor before use. This ensures that the treatment is safe and appropriate for their specific age and health needs. Always prioritize your child's well-being by seeking professional advice when it comes to their medication.

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 personalized advice based on individual health needs and conditions.

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 condition. They can help determine the best approach for managing your health, especially if you have concerns about your kidneys.

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 may affect you differently due to your liver health.

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver condition and how it relates to your treatment. They can help ensure that your medication is safe and effective for you.

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, store it at a controlled room temperature between 20° to 25°C (68° to 77°F). Always check the carton or tube crimp for the lot number and expiration date to confirm its validity.

It's important to note that the product is tamper evident, meaning you should not use it if the seal on the tube is punctured or not visible. This helps ensure that the product remains safe for 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 an antifungal cream that cures most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis).

How does Terbinafine Hydrochloride Cream relieve symptoms?

It relieves itching, burning, cracking, and scaling associated with these fungal conditions.

What is the recommended application for athlete's foot?

For athlete's foot, apply the cream twice a day for 1 week between the toes, or twice a day for 2 weeks on the bottom or sides of the foot, or as directed by a doctor.

How should I apply the cream for jock itch and ringworm?

For jock itch and ringworm, apply the cream once a day for 1 week, or as directed by a doctor.

Are there any precautions I should take when using this cream?

Do not use Terbinafine Hydrochloride Cream on nails, scalp, in or near the mouth or eyes, or for vaginal yeast infections. It is for external use only.

What should I do if I experience irritation?

Stop using the cream and ask a doctor if too much irritation occurs or gets worse.

What should I do if the cream is swallowed?

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

What is the storage requirement for this cream?

Store Terbinafine Hydrochloride Cream at controlled room temperature between 20° to 25°C (68° to 77°F).

Is there any information regarding use in children?

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

Can nursing mothers use Terbinafine Hydrochloride Cream?

There are no specific warnings or recommendations regarding the use of this cream in nursing mothers.

Packaging Info

Below are the non-prescription pack sizes of Terbinafine Hydrochloride. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Terbinafine Hydrochloride.
Details

Drug Information (PDF)

This file contains official product information for Terbinafine Hydrochloride, 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 designed for topical application. Each tube contains a net weight of 1 ounce (30 grams) of the cream. The active ingredient, terbinafine hydrochloride, is effective in treating various fungal infections.

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 specific condition and patient history before prescribing this medication.

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 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 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.

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

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 to mitigate potential irritation.

Patients should be instructed to discontinue use and consult a healthcare provider if they experience excessive irritation or if the irritation worsens.

To ensure safety, this product must be kept out of reach of children. In cases of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

Side Effects

Patients should be aware that this product is 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, or for vaginal yeast infections.

During use, it is important to avoid contact with the eyes. In the event of eye contact, patients should rinse thoroughly with water. If excessive irritation occurs or worsens, patients are 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 Terbinafine Hydrochloride. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Terbinafine Hydrochloride.
Details

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional prior to use. It is important for caregivers to seek medical advice to ensure the safety and appropriateness of treatment for this age group.

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 in this population, given the lack of established guidelines for geriatric use.

Pregnancy

There are no specific statements regarding the use of Terbinafine Hydrochloride Cream during pregnancy, including safety concerns, dosage modifications, or special precautions. As such, the potential risks and benefits of using this medication in pregnant patients should be carefully considered. Healthcare professionals are advised to evaluate the necessity of treatment with Terbinafine Hydrochloride Cream in women of childbearing potential and to discuss any potential risks to fetal outcomes. Given the absence of data, caution is recommended when prescribing this medication to pregnant patients.

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 Hydrochloride in breast milk or any associated risks to breastfed infants.

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 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 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 medical personnel 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 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 for SPL code 90375-7.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. In the event that the medication is swallowed, patients should be instructed to seek medical help or contact a Poison Control Center immediately.

Patients should also be cautioned against getting the medication into their eyes. If eye contact occurs, they should rinse their eyes thoroughly with water and seek medical attention if necessary.

Additionally, healthcare providers should inform patients to discontinue use and consult a doctor if they experience excessive irritation or if their symptoms worsen. This guidance is essential for ensuring patient safety and effective use of the medication.

Storage and Handling

The product is supplied in a tube format, with specific lot numbers and expiration dates indicated on the carton or tube crimp. It is essential to store the product at a controlled room temperature ranging from 20° to 25°C (68° to 77°F) to maintain its efficacy.

Special handling precautions must be observed, as the product features a tamper-evident seal. It should not be used if the seal on the tube is punctured or not visible, ensuring the integrity and safety of the product for healthcare professionals and patients alike.

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 Terbinafine Hydrochloride, 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 Terbinafine Hydrochloride, 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.