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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 2018
Label revision date
July 9, 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 2018
Label revision date
July 9, 2025
Manufacturer
Cardinal Health, 110 dba LEADER
Registration number
ANDA077511
NDC root
70000-0338
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 common skin infections caused by fungi. 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 infections, the cream helps relieve uncomfortable symptoms such as itching, burning, cracking, and scaling associated with these conditions.

This cream is available in full prescription strength and is comparable to the active ingredient found in LAMISIL AT®. If you're dealing with any of these fungal skin issues, Terbinafine Hydrochloride Cream may provide the relief you need.

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 using the tip of the cap. Before applying the medication, wash the affected area of 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, continue the twice-daily application for two weeks. For jock itch and ringworm, apply the medication once a day, either in the morning or at night, for one week, or follow your doctor's instructions. 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 to avoid potential issues. You should not apply it to your nails or scalp, and it should never be used in or near your mouth or eyes. Additionally, this product is not intended for treating vaginal yeast infections.

While using this product, be cautious to prevent it from getting into your eyes. If it does come into contact with your eyes, rinse them thoroughly with water to avoid irritation. Always follow these guidelines to ensure your safety and the effectiveness of the treatment.

Side Effects

This product is intended for external use only, so it's important to avoid applying it to your nails or scalp, and you should not use it 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 a doctor. Additionally, keep this product out of reach of children. If swallowed, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

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 contact your doctor. It's also important to keep this product out of reach of children. If a child swallows it, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

Overdose

If you or someone else has swallowed too much of this medication, it’s important to seek medical help immediately. You can contact a Poison Control Center at 1-800-222-1222 for guidance.

Signs of an overdose may include unusual symptoms, but specific details on these symptoms are not provided here. If you notice anything concerning, don’t hesitate to reach out for help. Remember, acting quickly can make a significant difference in ensuring safety and health.

Pregnancy Use

Currently, there is no specific information available about the use of Terbinafine Hydrochloride during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions for pregnant individuals have not been clearly defined. If you are pregnant or planning to become pregnant, it is essential to discuss any medications with your healthcare provider to ensure the best care for you and your baby. Always prioritize open communication with your doctor regarding any treatments you may be considering.

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 medications while breastfeeding.

Pediatric Use

If you are considering using 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 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 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).

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 you understand how to manage your treatment effectively.

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 known drug interactions or laboratory test interactions associated with the medication. However, your healthcare provider can help ensure that your overall treatment plan is safe and effective, taking into account all the medications and tests you may be using. Always feel free to ask questions and share your complete health history to get the best care possible.

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°-25°C (68°-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

The medication is administered topically, meaning it is applied directly to the skin. There are no additional details available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences. If you have any specific questions or concerns about using this medication, it's best to consult with your healthcare provider.

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 work?

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

What are the instructions for using this 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 warnings for using Terbinafine Hydrochloride Cream?

This cream is for external use only. Do not use it on nails, scalp, in or near the mouth or eyes, or for vaginal yeast infections.

What should I do if I experience irritation?

Stop use and ask a doctor if too much irritation occurs or gets worse.

Is it safe to use during pregnancy or while nursing?

There is no specific information regarding the use of Terbinafine Hydrochloride Cream during pregnancy or lactation.

What should I do if the cream gets into my eyes?

If eye contact occurs, rinse thoroughly with water.

How should I store Terbinafine Hydrochloride Cream?

Store at controlled room temperature between 20°-25°C (68°-77°F).

What should I do if the seal on the tube is broken?

Do not use the cream if the seal on the tube is broken or not visible.

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 right away.

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 cream indicated for the treatment of athlete's foot. This formulation contains terbinafine hydrochloride as the active ingredient and is available in a full prescription strength. The product is packaged under the National Drug Code (NDC) 70000-0338-1 and has a net weight of ½ oz (15 g). It is designed for topical application and is comparable to the active ingredient found in 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 should begin treatment by using the tip of the cap to break the seal and open the tube. Prior to application, the affected skin must be washed with soap and water and dried thoroughly.

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

In 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

Use of this product is contraindicated in the following situations:

Application on nails or scalp is not recommended. The product should not be used in or near the mouth or eyes due to the potential for irritation or adverse effects. Additionally, it is contraindicated 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 essential to rinse thoroughly with water.

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. In the event of accidental eye contact, it is imperative to rinse the eyes thoroughly with water.

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

It is crucial to keep this product out of the reach of children. In the case of ingestion, immediate medical assistance should be sought, or the Poison Control Center should be contacted at 1-800-222-1222.

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 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, patients are advised to discontinue use and consult a healthcare professional.

Additionally, this product should be kept out of reach of children. In the case of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center should be contacted at 1-800-222-1222.

Drug Interactions

No drug interactions or drug and laboratory test interactions have been identified in the available data. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

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 or unusual responses is advisable in this population.

Pregnancy

There is no specific information available regarding the use of Terbinafine Hydrochloride during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients. The potential risks and benefits should be carefully evaluated, and alternative treatments may be considered in consultation with the patient. Women of childbearing potential should be advised to inform their healthcare provider if they are pregnant or plan to become pregnant while using this medication.

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 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 available information.

Overdosage

In the event of an overdosage, immediate medical assistance is crucial. If the product is swallowed, healthcare professionals should advise patients or caregivers to seek medical help without delay. Contacting a Poison Control Center is recommended, with the national hotline available at 1-800-222-1222.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Healthcare providers should be prepared to assess the patient's condition and initiate appropriate management procedures based on the severity of symptoms presented.

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 compound in these areas.

Postmarketing Experience

Postmarketing experience has revealed rare cases of serious liver injury, including instances that required liver transplantation. Additionally, there have been reports of serious skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis. Other reported events include cases of anaphylaxis and angioedema.

Further postmarketing reports indicate occurrences of taste disturbances, including loss of taste (dysgeusia) and taste perversion. Rare cases of depression and other mood changes have also been documented. Furthermore, there have been reports of renal impairment, including cases of acute renal failure.

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 assistance or contact a Poison Control Center immediately at 1-800-222-1222.

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 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 product integrity and safety.

Additional Clinical Information

The route of administration for the product 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 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.

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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.