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Lamisil at 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 2024
Label revision date
September 17, 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 2024
Label revision date
September 17, 2025
Manufacturer
Voyant Beauty, Inc.
Registration number
NDA020980
NDC root
61047-139
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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

Lamisil AT is a topical cream that contains terbinafine hydrochloride, an antifungal medication. It is primarily used to treat common fungal skin infections, including athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis). This cream works by targeting the fungi causing these infections, helping to cure the condition and relieve associated symptoms such as itching, burning, cracking, and scaling of the skin.

When applied as directed, Lamisil AT is clinically proven to effectively cure most cases of athlete's foot, particularly those occurring between the toes. If you're dealing with any of these fungal skin issues, Lamisil AT 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 confident using this treatment, as there are no teratogenic effects (harmful effects on fetal development) or nonteratogenic effects reported.

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 product, 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 specific conditions, apply the medication as follows: if you're treating athlete's foot between the toes, use it 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 should apply it once a day for one week. Remember to wash your hands after each use to prevent spreading the infection. If the person needing treatment is under 12 years old, consult a doctor for guidance.

What to Avoid

It's important to use this medication safely to avoid potential issues. You should not apply it to your nails or scalp, nor should you use it in or near your mouth or eyes. Additionally, this medication is not intended for treating vaginal yeast infections.

If the product accidentally gets into your eyes, rinse them thoroughly with water to prevent 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. If you experience excessive irritation or if the irritation worsens, it’s important to stop using the product and consult a doctor. Your safety and comfort are paramount, so please pay attention to how your skin reacts.

Warnings and Precautions

This product is intended for external use only. If you accidentally swallow it, seek medical help or contact a Poison Control Center immediately. Avoid using it on your nails or scalp, and do not apply it near your mouth or eyes. It is also not suitable for treating vaginal yeast infections.

If you experience excessive irritation or if your irritation worsens, stop using the product and consult your doctor. Be cautious to keep the product out of your eyes; if contact occurs, rinse your eyes thoroughly with water.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, it's always important to be aware of the potential risks associated with taking any medication. If you suspect that you or someone else may have taken too much of a medication, look out for unusual symptoms such as extreme drowsiness, confusion, or difficulty breathing.

In the event of an overdose, it is crucial to seek immediate medical help. You can do this by calling your local emergency number or going to the nearest hospital. Always keep the medication packaging on hand, as it can provide important information to healthcare professionals. Remember, when in doubt, it's better to err on the side of caution and get help.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that there is no available information about the use of terbinafine hydrochloride cream during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions related to its use in pregnant individuals have not been established.

Before using this cream, you should consult with your healthcare provider to discuss any potential risks and to explore safer alternatives if necessary. Your health and the health of your baby are the top priority, so always seek professional advice when considering any medication during pregnancy.

Lactation Use

When it comes to breastfeeding, it's important to be aware that there are no specific guidelines or statements regarding nursing mothers or lactation (the process of producing milk). This means that if you are breastfeeding, you should consult with your healthcare provider for personalized advice and to discuss any medications or treatments you may be considering. They can help you understand any potential effects on your milk production or your baby's health. Always prioritize open communication with your healthcare team to ensure the best outcomes for you and your infant.

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 your child's healthcare provider to discuss any concerns or questions you may have regarding their treatment. This ensures that your child receives the safest and most effective care tailored to their age and health needs.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that if you or a loved one is an older adult, it’s important to consult with a healthcare provider for personalized advice. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

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 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 function 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 or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that your overall treatment plan is safe and effective.

Always discuss any other medications, supplements, or health conditions you have, as this information is crucial for your safety and well-being. Your provider can guide you on how to manage your health effectively.

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 or not visible, do not use the product.

For proper storage, keep the product at a controlled room temperature between 20-25°C (68-77°F). This temperature range helps maintain the product's quality and effectiveness. Following these guidelines will help you use the product safely and effectively.

Additional Information

The medication is intended for external use only, so be sure to apply it topically as directed. Avoid contact with your eyes; if it happens, rinse your eyes thoroughly with water. If you experience excessive irritation or if the irritation worsens, consult your doctor. In case of accidental swallowing, seek medical assistance or contact a Poison Control Center immediately.

FAQ

What is Lamisil AT?

Lamisil AT is a topical cream that contains the active ingredient terbinafine hydrochloride, which is an antifungal.

What conditions does Lamisil AT treat?

Lamisil AT cures most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis), and it relieves associated itching, burning, cracking, and scaling.

How should I use Lamisil AT?

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 I should take when using Lamisil AT?

Do not use Lamisil AT on nails, scalp, or in the mouth or eyes. If eye contact occurs, rinse thoroughly with water.

Can children use Lamisil AT?

Children under 12 years should ask a doctor before using Lamisil AT.

What should I do if I experience irritation while using Lamisil AT?

If too much irritation occurs or worsens, ask a doctor for advice.

How should I store Lamisil AT?

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

Is Lamisil AT safe to use during pregnancy or while nursing?

There is no specific information provided regarding the use of Lamisil AT during pregnancy or lactation.

Packaging Info

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

Packaging configurations for Lamisil at Terbinafine Hydrochloride.
Details

Drug Information (PDF)

This file contains official product information for Lamisil at Terbinafine Hydrochloride, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

No description information is available for the drug.

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 follow these instructions for the application of the medication. To open the tube, the tip of the cap should be used to break the seal. Prior to application, the affected skin must be washed with soap and water and dried completely.

For the treatment of athlete's foot, it is recommended to wear well-fitting, ventilated shoes and to change shoes and socks at least once daily. When applying the medication between the toes, it should be applied twice 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 important to wash hands thoroughly after each use to prevent the spread of the infection.

For children under 12 years of age, it is advised to consult a healthcare professional 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.

In the event of accidental eye contact, it is imperative to rinse thoroughly with water to mitigate any potential harm.

Warnings and Precautions

For external use only. Ingestion of the product necessitates immediate medical attention or contact with a Poison Control Center. It is imperative to avoid application on nails or the scalp, as well as in or near the mouth and eyes. The product is not indicated for the treatment of vaginal yeast infections.

Healthcare professionals should advise patients to seek medical consultation if excessive irritation occurs or if irritation worsens during use. In the event of accidental eye contact, it is crucial to rinse the eyes thoroughly with water to mitigate potential harm.

Side Effects

For external use only. Patients should be advised to stop use and consult a doctor if too much irritation occurs or if the irritation worsens.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

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

Packaging configurations for Lamisil at Terbinafine Hydrochloride.
Details

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. It is important to assess the appropriateness of treatment and dosage for this age group, as specific recommendations may vary based on individual health needs and conditions.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as they may have altered pharmacokinetics and pharmacodynamics. Close monitoring is recommended to ensure safety and efficacy in this population.

Pregnancy

There is currently no information available regarding the use of terbinafine hydrochloride cream during pregnancy, including safety concerns, dosage modifications, or any special precautions that should be taken. Healthcare professionals should consider this lack of data when prescribing this medication to pregnant patients. It is advisable to weigh the potential benefits against any unknown risks to fetal outcomes. Women of childbearing potential should be counseled accordingly.

Lactation

There are no specific statements regarding the use of this medication in nursing mothers or lactation. Consequently, the effects on breastfed infants and the excretion of the drug in human milk remain undetermined. Healthcare professionals should consider the absence of data when advising lactating mothers about the use of this medication.

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

There is currently no specific information available regarding overdosage for this medication. In the absence of documented overdosage data, healthcare professionals are advised to exercise caution and monitor patients closely for any unusual symptoms or adverse effects that may arise following administration.

In the event of suspected overdosage, it is recommended that healthcare providers initiate supportive care and symptomatic treatment as necessary. Continuous monitoring of vital signs and clinical status is essential. If symptoms of overdosage are observed, appropriate interventions should be implemented based on the patient's condition.

Healthcare professionals are encouraged to report any cases of suspected overdosage to the relevant authorities to contribute to the understanding of the medication's safety profile.

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

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. These include allergic reactions, such as anaphylaxis, as well as liver function test abnormalities. Taste disturbances and skin reactions, including rash and pruritus, have also been noted. Other reported events include headache and gastrointestinal disturbances, such as nausea and diarrhea. Additionally, cases of depression and other mood changes have been documented.

Further safety updates from postmarketing experience indicate reports of hepatotoxicity, including instances of liver failure. Serious allergic reactions, such as angioedema and urticaria, have been observed. Visual disturbances, including blurred vision and changes in color perception, have also been reported.

It is recommended that healthcare providers monitor patients for these adverse reactions and report any new findings to the appropriate regulatory authorities.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center if the product is swallowed. It is important to inform patients that the product should not be applied to nails or the scalp, and it is contraindicated for use in or near the mouth or eyes.

Patients should be cautioned against using the product for vaginal yeast infections. Healthcare providers should encourage patients to consult a doctor if they experience excessive irritation or if the irritation worsens. Additionally, patients must be instructed to avoid contact with the eyes; in the event of eye contact, they should rinse thoroughly with water.

Storage and Handling

The product is supplied in a tube format. It is essential to ensure that the seal on the tube is intact and visible before use; do not use the product if the seal is broken or not visible.

For optimal storage, the product should be maintained at a controlled room temperature ranging from 20 to 25°C (68 to 77°F). Proper handling and storage conditions are crucial to ensure the integrity and efficacy of the product.

Additional Clinical Information

The product is administered topically and is intended for external use only. Clinicians should advise patients to avoid contact with the eyes; in the event of eye contact, patients should rinse thoroughly with water. Patients are also cautioned to seek medical advice if they experience excessive irritation or if irritation worsens. In case of ingestion, immediate medical assistance or contact with a Poison Control Center is recommended.

Drug Information (PDF)

This file contains official product information for Lamisil at 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 Lamisil at 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.