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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 29, 2020
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 29, 2020
Manufacturer
Taro Pharmaceuticals U. S. A. , Inc.
Registration number
ANDA077511
NDC root
51672-2083
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 1% antifungal cream used to treat jock itch, a common skin condition caused by a fungal infection. This medication works by curing the infection and relieving uncomfortable symptoms such as itching, burning, cracking, and scaling associated with jock itch.

As a full prescription-strength treatment, Terbinafine Hydrochloride is designed to effectively address the discomfort and irritation caused by this condition, helping you feel more comfortable and confident.

Uses

If you're dealing with jock itch, also known as tinea cruris, this medication can help. It effectively cures most cases of this uncomfortable skin condition, which often affects the groin area.

In addition to treating the infection, it also provides relief from the bothersome symptoms that come with jock itch, such as itching, burning, cracking, and scaling of the skin. With this treatment, you can expect to feel more comfortable and get back to your daily activities without the irritation.

Dosage and Administration

To use this medication, 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. You should apply the medication once a day, either in the morning or at night, for one week, unless your doctor advises otherwise. After applying the medication, make sure to wash your hands to avoid spreading it to other areas.

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 or 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

When using this product, it's important to remember that it is for external use only. Avoid applying it to your nails, scalp, or in areas near your mouth or eyes, as well as for treating vaginal yeast infections. If the product accidentally gets into your eyes, rinse them thoroughly with water.

You should stop using the product and consult a doctor if you experience excessive irritation or if the irritation worsens. Additionally, keep the product out of reach of children, and if it is 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. 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 excessive irritation or if your irritation worsens, stop using it and consult your doctor. Always keep this product out of reach of children. 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 symptoms such as unusual drowsiness, confusion, or difficulty breathing. If you or someone else experiences these signs, 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 the information available about Terbinafine Hydrochloride does not include specific warnings or precautions for its use during pregnancy. The insert does not state whether this medication is contraindicated (not recommended) for pregnant individuals or if there are any potential risks to the developing fetus.

Additionally, there are no dosage adjustments or special precautions mentioned for those who are pregnant. However, it's always best to consult with your healthcare provider before starting any new medication 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 that there are no specific warnings or recommendations against its use for nursing mothers. The information available does not indicate any concerns about the cream being passed into breast milk or any associated risks for your infant.

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

Pediatric Use

If you have a child under 12 years old, it's important to consult a doctor before using this medication. For those aged 12 and older, you can use the product by breaking the seal with the tip of the cap and applying it once a day, either in the morning or at night, for one week or as directed by your doctor.

Always keep this medication out of reach of children. If your child accidentally swallows it, 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 provider before starting this treatment. They can help ensure that it is appropriate for your needs and monitor for any potential side effects. Always prioritize open communication with your healthcare team to address any questions or concerns you may have.

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. They can provide the necessary guidance based on your individual situation.

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 you are taking, even if there are no specific drug interactions or laboratory test interactions noted for your treatment. This ensures that your healthcare team can provide the best care tailored to your needs.

Always feel free to ask questions about how different medications might affect each other or any tests you may undergo. Your health and safety are the top priority, and discussing these details can help prevent any potential issues.

Storage and Handling

To ensure the best performance and safety of your product, store it at a controlled room temperature between 20° to 25°C (68° to 77°F). It's important to check the carton or tube crimp for the lot number and expiration date to confirm its validity.

When handling the product, be cautious of the tamper-evident seal; do not use the product if the seal on the tube is punctured or not visible, as this could indicate that the product has been compromised. Following these guidelines will help you use the product safely and effectively.

Additional Information

You should apply this medication topically, meaning you will put it directly on your skin. Use it once a day, either in the morning or at night, for one week, or follow your doctor's specific instructions. There are no additional details available regarding laboratory tests, abuse potential, or patient counseling.

FAQ

What is Terbinafine Hydrochloride?

Terbinafine Hydrochloride is a 1% antifungal cream used to cure most jock itch (tinea cruris) and relieve associated symptoms like itching, burning, cracking, and scaling.

How do I use Terbinafine Hydrochloride?

For adults and children 12 years and over, apply the cream once a day for 1 week after washing and drying the affected area. Use the tip of the cap to break the seal and wash your hands after each use.

Can children under 12 use this cream?

Children under 12 years should ask a doctor before using Terbinafine Hydrochloride.

Are there any contraindications for using this cream?

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

What should I do if I get this cream in my eyes?

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

What should I do if I experience irritation?

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

Is Terbinafine Hydrochloride safe during pregnancy?

The insert does not provide specific warnings or contraindications regarding the use of Terbinafine Hydrochloride during pregnancy.

Can nursing mothers use this cream?

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

How should I store Terbinafine Hydrochloride?

Store the cream at controlled room temperature between 20° to 25°C (68° to 77°F) and do not use it if the seal on the tube is punctured or not visible.

What should I do if the cream is swallowed?

Keep Terbinafine Hydrochloride 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 is an antifungal agent formulated as a cream with a concentration of 1%. Each tube contains a net weight of 0.42 oz (12 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.

Dosage and Administration

For adults and children aged 12 years and over, the recommended dosage involves the following steps:

The seal of the tube should be broken using the tip of the cap to facilitate opening. Prior to application, the affected skin must be thoroughly washed with soap and water, followed by complete drying. The product should then be applied once daily, either in the morning or at night, for a duration of one week, or as directed by a healthcare professional. It is essential to wash hands after each application to prevent unintentional contact with other areas of the body or with other individuals.

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

Contraindications

The product is contraindicated for use on nails or the scalp. It should not be applied in or near the mouth or eyes. Additionally, the product is not indicated for the treatment of vaginal yeast infections.

Warnings and Precautions

This product is intended for external use only. It is contraindicated for application on nails or the scalp, and it should not be used in or near the mouth or eyes. Additionally, this product is not indicated for the treatment of vaginal yeast infections.

Healthcare professionals should advise patients to avoid contact with the eyes during use. In the event of accidental eye contact, it is imperative to rinse the eyes thoroughly with water. Should excessive irritation occur or if the irritation worsens, patients are instructed to discontinue use and consult a healthcare provider.

It is crucial to keep this product out of reach of children. In cases of ingestion, immediate medical assistance should be sought, or the local Poison Control Center should be contacted without delay.

Side Effects

Patients using this product should be aware that it 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, nor for the treatment of vaginal yeast infections.

During use, patients must take care to avoid contact with the eyes. In the event of eye contact, it is advised to rinse thoroughly with water. If excessive irritation occurs or worsens, patients should 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

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions with laboratory tests. 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 adolescents aged 12 years and older, the recommended application involves using the tip of the cap to break the seal and opening the tube, followed by a once-daily application for one week or as directed by a healthcare provider.

It is essential 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 not have specific dosage adjustments, safety concerns, or special precautions outlined in the prescribing information for Terbinafine Hydrochloride cream. As there is no dedicated information regarding geriatric use, healthcare providers should exercise caution when prescribing this medication to elderly patients.

It is advisable to monitor these patients closely for any potential adverse effects, given the general considerations for increased sensitivity to medications in this population. Individual patient factors, including comorbidities and concurrent medications, should be taken into account when determining the appropriateness of Terbinafine Hydrochloride cream for geriatric patients.

Pregnancy

There are no specific warnings or precautions regarding the use of Terbinafine Hydrochloride during pregnancy. The available data does not indicate whether the drug is contraindicated in pregnant patients or if there are any associated risks to the fetus. Additionally, no dosage modifications or special precautions for individuals who are pregnant have been provided in the prescribing information. Healthcare professionals should consider the lack of specific data when prescribing this medication to women of childbearing potential and weigh the potential benefits against any unknown risks.

Lactation

There are no specific warnings or recommendations regarding the use of Terbinafine Hydrochloride cream in lactating mothers. Additionally, there is no information available about the potential for excretion of Terbinafine Hydrochloride in breast milk or any associated risks to breastfed infants.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the 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 intervention is crucial to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved, and healthcare providers should be prepared to assess and manage any clinical manifestations that arise.

Management procedures should include a thorough evaluation of the patient's condition, supportive care as necessary, and consideration of specific antidotes or treatments based on the substance involved. Continuous monitoring and follow-up care may also be warranted to ensure patient safety and recovery.

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

Postmarketing Experience

No postmarketing experience details are available in the provided text.

Patient Counseling

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

Additionally, healthcare providers should inform patients to avoid contact with the eyes while using this product. If eye contact occurs, it is important to rinse the eyes thoroughly with water to mitigate any potential irritation or harm.

Storage and Handling

The product is supplied in a tamper-evident tube. It is essential to inspect the seal on the tube; do not use the product if the seal is punctured or not visible.

Storage conditions require the product to be maintained at a controlled room temperature of 20° to 25°C (68° to 77°F). For traceability, the lot number and expiration date can be found on the carton or crimp of the tube.

Additional Clinical Information

The medication is administered topically, with a recommended application frequency of once daily, either in the morning or at night, for a duration of one week or as directed by a healthcare professional. 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.