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Terbinafine hydrochloride

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This product has been discontinued

Active ingredient
Terbinafine Hydrochloride 1 g/100 g
Other brand names
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2007
Label revision date
July 17, 2017
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Terbinafine Hydrochloride 1 g/100 g
Other brand names
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2007
Label revision date
July 17, 2017
Manufacturer
Walgreen Company
Registration number
ANDA077511
NDC root
0363-2083
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 is a topical antifungal cream used to treat jock itch, a common skin condition caused by a fungal infection known as tinea cruris. This cream works by targeting the fungus responsible for the infection, helping to cure the condition and relieve associated symptoms such as itching, burning, cracking, and scaling of the skin.

Typically available in a 1% concentration, Terbinafine Hydrochloride cream is applied directly to the affected area to provide relief and promote healing. If you're dealing with jock itch, this medication can be an effective option to help you feel more comfortable.

Uses

If you're dealing with jock itch, also known as tinea cruris, this treatment can help cure the infection effectively. Jock itch is a common fungal infection that can cause discomfort in the groin area.

In addition to treating the infection, this medication also provides relief from the annoying symptoms that often accompany it, such as itching, burning, cracking, and scaling. With proper use, you can expect to feel more comfortable and get back to your daily activities without the irritation caused by this condition.

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 are treating jock itch, 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 thoroughly after each use to prevent spreading the medication.

If you are considering this treatment for a child under 12 years old, it’s important to consult a doctor first to ensure it’s safe and appropriate for them.

What to Avoid

It's important to use this product safely and effectively. You should avoid applying it to your nails or scalp, as well as in or near your mouth and eyes. Additionally, do not use this product for 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 areas near the mouth or eyes. If the product accidentally gets into your eyes, rinse them thoroughly with water.

While using this product, if you experience excessive irritation or if side effects develop, it’s important to stop using it and consult a doctor. You can also report any side effects to the FDA at 1-800-FDA-1088.

Warnings and Precautions

This product is intended for external use only, so please avoid applying it to your nails, scalp, or in and around your mouth and eyes. If the product accidentally gets into your eyes, rinse them thoroughly with water. It is also not suitable for treating vaginal yeast infections.

While using this product, if you experience increased irritation or any side effects, stop using it and consult your doctor. You can report side effects to the FDA at 1-800-FDA-1088. Always keep this product out of reach of children, and if it is swallowed, seek medical help or contact a poison control center immediately.

Overdose

If you or someone else has swallowed too much of a medication, it’s important to seek medical help immediately. You can do this by contacting a poison control center or going to the nearest emergency room. Acting quickly can make a significant difference in the outcome.

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

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 during pregnancy. The information available does not indicate any contraindications (situations where the drug should not be used) or special precautions for pregnant individuals. Additionally, there are no recommended changes to the dosage for those who are pregnant.

As always, it's best to consult with your healthcare provider before starting any new medication, including Terbinafine Hydrochloride, to ensure it is safe for you and your baby.

Lactation Use

If you are breastfeeding and considering the use of Terbinafine Hydrochloride cream, you can feel reassured as there are no specific warnings or recommendations regarding its use for nursing mothers. Additionally, the information provided does not mention any particular considerations or precautions related to breastfeeding.

As always, it's a good idea to consult with your healthcare provider if you have any concerns or questions about using medications while nursing. They can provide personalized advice based on your situation.

Pediatric Use

If you are considering using this product for your child, it's important to note that it is not recommended for children under 12 years old without consulting a doctor first. For those aged 12 and older, you can use the product as directed.

When treating jock itch, apply the product once a day, either in the morning or at night, for one week, or follow your doctor's instructions. Always keep the product out of reach of children, and if it is accidentally swallowed, seek medical help or contact a poison control center immediately.

Geriatric Use

While there is no specific information about the use of Terbinafine Hydrochloride cream in older adults, it’s important to approach any new medication with caution. Since the drug insert does not mention dosage adjustments or safety concerns for elderly patients, you should consult with a healthcare professional before starting this treatment. They can provide personalized advice based on your health status and any other medications you may be taking.

Always keep in mind that older adults may have different responses to medications, so monitoring for any unusual side effects is essential. If you or a loved one experiences any unexpected reactions while using this cream, reach out to a healthcare provider promptly.

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 plan is safe and effective for your specific situation. They can help monitor your kidney health and make any necessary adjustments to your medications.

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 (issues with liver function).

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 specific drug interactions or laboratory test interactions noted, which is a positive sign. However, every individual is different, and your healthcare provider can help ensure that your treatment plan is safe and effective for you. Always feel free to ask questions and share any concerns you may have regarding your medications or health tests.

Storage and Handling

To ensure the safety and effectiveness of your product, always check that the seal on the tube is intact and visible before use. If the seal is broken, do not use the product. For proper storage, keep it at a controlled room temperature between 20°-25°C (68°-77°F). Additionally, you can find important information such as the lot number and expiration date on the carton or the crimp of the tube, so be sure to check these details before use.

Additional Information

You will apply this medication topically, which means you will put it directly on the skin. For treating jock itch, apply it once a day, either in the morning or at night, for one week, or follow your doctor's instructions if they differ. Make sure to use it consistently for the best results.

FAQ

What is Terbinafine Hydrochloride used for?

Terbinafine Hydrochloride is used to cure most cases of jock itch (tinea cruris) and relieve associated symptoms like itching, burning, cracking, and scaling.

How should I apply Terbinafine Hydrochloride?

For adults and children 12 years and older, apply the cream once a day for 1 week or as directed by a doctor. Make sure to wash the affected area and dry it completely before application.

Are there any precautions for using this cream?

Yes, do not use Terbinafine Hydrochloride 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 get the cream in my eyes?

If the cream gets into your eyes, rinse thoroughly with water.

What should I do if I experience irritation or side effects?

Stop using the cream and ask a doctor if irritation worsens or side effects occur. You can report side effects to the FDA at 1-800-FDA-1088.

Is Terbinafine Hydrochloride safe to use during pregnancy or while nursing?

The provided information does not mention specific safety concerns or recommendations for use during pregnancy or lactation. Consult your doctor for personalized advice.

What is the storage requirement for Terbinafine Hydrochloride?

Store the cream 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.

What should I do if I swallow Terbinafine Hydrochloride?

Keep the cream out of reach of children. If swallowed, seek medical help or contact a poison control center immediately.

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

Jock Itch Cream contains Terbinafine Hydrochloride as its active ingredient, formulated as a 1% cream. This product is classified as an antifungal agent, designed for topical application. Each container has a net weight of 0.5 oz (15 g).

Uses and Indications

This drug is indicated for the treatment of most cases of jock itch (tinea cruris). It effectively relieves associated symptoms, including itching, burning, cracking, and scaling.

There are no teratogenic or nonteratogenic effects mentioned in the available data.

Dosage and Administration

Adults and children 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, followed by thorough drying. For the treatment of jock itch, the recommended application frequency is once daily, either in the morning or at night, for a duration of 1 week, or as directed by a healthcare professional. It is essential to wash hands after each use to prevent unintended spread of the medication.

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 the 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 the eyes. Additionally, this product is not indicated for the treatment of vaginal yeast infections.

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

Users are advised to discontinue use and consult a healthcare professional if excessive irritation occurs or if side effects manifest. Side effects may be reported to the FDA at 1-800-FDA-1088.

This product should be stored out of reach of children. In the case of ingestion, immediate medical assistance should be sought, or contact with a poison control center is recommended.

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

During the use of this product, it is crucial to avoid contact with the eyes. In the event of eye contact, patients should rinse thoroughly with water.

Patients are advised to discontinue use and consult a healthcare professional if they experience excessive irritation or if side effects occur. Side effects may be reported to the FDA at 1-800-FDA-1088.

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 before use. For patients aged 12 years and older, the product may be used as directed.

In the treatment of jock itch, the recommended application is once daily, either in the morning or at night, for a duration of 1 week, or as directed by a healthcare provider.

It is important to keep the product 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 advised.

Geriatric Use

Elderly patients may use Terbinafine Hydrochloride cream; however, the prescribing information does not provide specific guidance regarding geriatric use, dosage adjustments, safety concerns, or special precautions for this population.

Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. Monitoring for efficacy and potential adverse effects is advisable, given the lack of targeted data for this demographic.

Pregnancy

There are no specific statements regarding the use of Terbinafine Hydrochloride during pregnancy. The available prescribing information does not mention any safety concerns, contraindications, or special precautions associated with the use of this medication in pregnant patients. Additionally, no dosage modifications for pregnant individuals are provided. Healthcare professionals should consider the absence of data when prescribing Terbinafine Hydrochloride to women of childbearing potential and weigh the potential benefits against any unknown risks to fetal outcomes.

Lactation

There are no specific warnings or recommendations regarding the use of Terbinafine Hydrochloride cream in lactating mothers. Additionally, there are no specific considerations or precautions related to lactation mentioned in the provided text. Therefore, healthcare professionals may consider the use of this medication in nursing mothers without specific concerns related to breastfeeding.

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 this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the prescribing information.

Overdosage

In the event of an overdosage, immediate medical intervention is crucial. If the substance is ingested, it is imperative to seek medical assistance or contact a poison control center without delay.

Healthcare professionals should be aware that prompt action can significantly influence the outcome of an overdosage situation. Symptoms may vary depending on the specific substance involved, and monitoring for any adverse effects is essential.

Management of overdosage should include supportive care and symptomatic treatment as necessary. It is recommended that healthcare providers follow established protocols for the assessment and management of overdose cases, ensuring that appropriate measures are taken to mitigate potential risks to the patient.

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 understanding of the compound's potential effects in these areas.

Postmarketing Experience

Postmarketing experience has indicated that side effects may occur following the use of the product. Healthcare professionals and patients are encouraged to report any adverse events to the FDA at 1-800-FDA-1088. Reports received are considered voluntary and contribute to ongoing surveillance efforts.

Patient Counseling

Healthcare providers should advise patients to keep the product out of reach of children. Instruct patients that if the product is swallowed, they should seek medical help or contact a poison control center immediately.

It is important to inform patients that the product should not be used on nails or the scalp, and they should avoid application in or near the mouth or eyes. Additionally, patients should be made aware that this product is not intended for the treatment of vaginal yeast infections.

Patients should be counseled to discontinue use and consult a doctor if they experience excessive irritation or if the irritation worsens. They should also be informed to stop using the product and seek medical advice if any side effects occur. Patients may report side effects to the FDA at 1-800-FDA-1088.

When using the product, patients must be cautioned 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, 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 of 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 medication is administered topically. For the treatment of jock itch, it should be applied once daily, either in the morning or at night, for a duration of one week, or as directed by a healthcare professional.

No additional information is available regarding laboratory tests, abuse potential, 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.