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Lamisil at Cream

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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
January 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 2024
Label revision date
January 9, 2025
Manufacturer
Karo Healthcare Inc.
Registration number
NDA020980
NDC root
84485-3748
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

LAMISIL AT is a topical cream that contains terbinafine hydrochloride, an antifungal medication. It is primarily used to treat common fungal skin infections such as athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis). This cream works by curing these infections and relieving associated symptoms like itching, burning, cracking, and scaling of the skin.

Clinically proven to be effective, LAMISIL AT can cure most cases of athlete's foot, especially those occurring between the toes. If you're dealing with any of these fungal skin conditions, this cream may provide the relief you need.

Uses

If you're dealing with athlete's foot, jock itch, or ringworm, this treatment can help. It effectively cures most cases of athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis). You can also expect relief from uncomfortable symptoms like itching, burning, cracking, and scaling that often come with these conditions.

In fact, it's clinically proven to cure most athlete's foot infections, especially those that occur between the toes. So, if you're looking for a solution to these common fungal infections, this treatment may be just what you need.

Dosage and Administration

To use this medication effectively, start by breaking the seal on the tube with the tip of the cap. Before applying the cream, wash the affected area of your skin with soap and water, then dry it completely.

If you’re treating athlete's foot, it’s important to wear well-fitting, ventilated shoes and change your shoes and socks at least once a day. For application, if the infection is between your toes, apply the cream twice a day—once in the morning and once at night—for one week, or as your doctor advises. If the infection is on the bottom or sides of your foot, you should apply it twice a day for two weeks. For jock itch and ringworm, apply the cream 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. You should not apply it to your nails or scalp, and avoid using it in or near your mouth or eyes. Additionally, do not use it for treating vaginal yeast infections. Following these guidelines will help ensure your safety and the effectiveness of the product.

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 or contact a Poison Control Center immediately.

Warnings and Precautions

This product is intended for external use only, so please avoid applying it to your nails or scalp, and do not use it in or near your mouth or eyes. It is also not suitable 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 the irritation worsens, stop using it and consult your doctor. Keep this product out of reach of children, and if it is swallowed, seek medical help or contact a Poison Control Center immediately.

Overdose

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

In case of an overdose, you may notice signs such as unusual drowsiness, confusion, or difficulty breathing. If you or someone else experiences these symptoms, it's crucial to get medical assistance right away. Always prioritize safety and act quickly in these situations.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that there are no specific guidelines or safety concerns mentioned regarding the use of Lamisil AT Cream (terbinafine hydrochloride) during pregnancy. The information available does not indicate any contraindications or special precautions for pregnant individuals, nor does it suggest any changes to the dosage for those who are 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 using Lamisil AT Cream, it's important to consult your doctor first. This is because the active ingredient, terbinafine, may be present in your breast milk. The effects of terbinafine on nursing infants have not been thoroughly studied, so it's best to exercise caution. Always prioritize your health and your baby's well-being by discussing any medications with your healthcare provider.

Pediatric Use

If you have a child under 12 years old, it's important to consult a doctor before using this medication, as specific dosing instructions for younger children are not provided. For those aged 12 and older, you can use the medication as directed.

Always keep the medication out of reach of children. If your child accidentally swallows it, seek medical help immediately or contact a Poison Control Center. Your child's safety is a top priority, so don't hesitate to ask for guidance when it comes to their health.

Geriatric Use

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. Since older adults may have different health needs and may be taking multiple medications, it’s always a good idea to consult with a healthcare provider before starting any new medication. They can help ensure that the treatment is safe and appropriate for your individual health situation.

If you or a loved one is an older adult, be sure to discuss any concerns about potential side effects or interactions with other medications you may be taking. Your healthcare provider can provide guidance tailored to your specific needs.

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 there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations apply, but you should always consult your healthcare provider for personalized advice. They can help determine the best approach for your treatment and monitor your liver function as needed.

Make sure to keep your doctor informed about your liver health, as they may want to conduct regular liver function tests (which check how well your liver is working) to ensure your safety while using any medication.

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). This helps maintain its quality and performance. Following these guidelines will help you use the product safely and effectively.

Additional Information

No further information is available.

FAQ

What is LAMISIL AT?

LAMISIL AT is a cream containing terbinafine hydrochloride 1%, which is an antifungal medication.

What conditions does LAMISIL AT treat?

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

How should I use LAMISIL AT for athlete's foot?

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

Can children use LAMISIL AT?

Children under 12 years should consult a doctor before using LAMISIL AT.

Are there any warnings for using LAMISIL AT?

LAMISIL AT is for external use only. Avoid contact with eyes, and do not use on nails, scalp, or for vaginal yeast infections.

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

If you experience too much irritation or if it gets worse, stop using the product and ask a doctor.

Is LAMISIL AT safe to use during pregnancy?

The insert does not provide specific information regarding the use of LAMISIL AT during pregnancy, so consult a doctor.

Can nursing mothers use LAMISIL AT?

Nursing mothers should consult a doctor before using LAMISIL AT, as terbinafine may be excreted in breast milk.

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

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

How should I store LAMISIL AT?

Store LAMISIL AT at a controlled room temperature of 20-25°C (68-77°F).

Packaging Info

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

Packaging configurations for Lamisil at Cream.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

LAMISIL AT is a topical cream formulation containing 1% terbinafine hydrochloride, indicated for the treatment of athlete's foot. The product is presented in a net weight of 30 grams (1 ounce) and is packaged in a recyclable carton. LAMISIL AT is distributed by Karo Healthcare Inc., located in Morristown, NJ 07960, USA, and is manufactured in Canada. Trademarks associated with this product are owned or licensed by Karo Healthcare. ©2024 Karo Healthcare or licensor.

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 is clinically proven to effectively cure most instances of athlete's foot, particularly those occurring between the toes. Additionally, this drug provides relief from associated symptoms, including itching, burning, cracking, and scaling that accompany these dermatological conditions.

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 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 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 scalp, in or near the mouth or eyes, and for the treatment of vaginal yeast infections. These restrictions are in place to prevent potential adverse effects associated with inappropriate application.

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 eyes. Additionally, it is not intended for the treatment of vaginal yeast infections.

When using this product, care must be taken to avoid contact with the eyes. In the event of eye contact, it is imperative to rinse thoroughly with water.

Users should 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 advised.

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. It is also contraindicated for the treatment of vaginal yeast infections.

During the use of this product, it is imperative 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, it is crucial to seek medical assistance or contact a Poison Control Center immediately.

Drug Interactions

There are no reported drug interactions associated with the use of this medication. Additionally, no interactions with laboratory tests have been identified. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug interactions.

Packaging & NDC

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

Packaging configurations for Lamisil at Cream.
Details

Pediatric Use

Pediatric patients under 12 years of age should consult a doctor before use, as specific dosing instructions for this age group are not provided. For adolescents aged 12 years and older, the medication should be used as directed.

It is crucial to keep the medication out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any potential adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

There are no specific statements regarding the use of Lamisil AT Cream (terbinafine hydrochloride) during pregnancy. The prescribing information does not mention any safety concerns, contraindications, or special precautions related to the use of this product in pregnant patients. Additionally, no dosage modifications for pregnant individuals are provided. Healthcare professionals should consider the absence of data when advising women of childbearing potential regarding the use of this medication during pregnancy.

Lactation

Lactating mothers should consult a doctor before using Lamisil AT Cream. There is a potential for excretion of terbinafine in breast milk. The effects of terbinafine on a nursing infant are not well studied; therefore, caution is advised.

Renal Impairment

Patients with renal impairment may not have specific dosage adjustments, special monitoring, or safety considerations outlined in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of detailed information necessitates careful clinical judgment. Regular monitoring of renal function is advisable to ensure patient safety and therapeutic efficacy.

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, it is imperative to keep the product out of reach of children. Should ingestion occur, immediate medical assistance is required. Healthcare professionals should advise caregivers to contact a Poison Control Center without delay.

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

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the compound in these areas.

Postmarketing Experience

No postmarketing experience details have been reported for SPL code 90375-7.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children. In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately.

Patients should be informed that this product is not intended for use on nails or the scalp, and it should not be applied in or near the mouth or eyes. Additionally, it is important to clarify 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. Furthermore, patients should be cautioned to avoid contact with the eyes while using this product. 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.

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

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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