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Terbinafine hydrochloride

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Active ingredient
Terbinafine Hydrochloride 1 g/100 g
Other brand names
Drug class
Allylamine Antifungal
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2023
Label revision date
July 10, 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 2023
Label revision date
July 10, 2025
Manufacturer
WALGREEN COMPANY
Registration number
ANDA077511
NDC root
0363-4502
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

If you are a consumer or patient please visit this version.

Drug Overview

Terbinafine Hydrochloride Cream 1% is an antifungal cream commonly used to treat skin infections such as athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis). This cream works by curing these fungal infections and relieving associated symptoms like itching, burning, cracking, and scaling of the skin.

With a net weight of 1 oz (30 g), this cream is designed to provide effective relief and promote healing for those suffering from these common skin conditions. If you're dealing with any of these issues, Terbinafine Hydrochloride Cream may be a helpful option for you.

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. With this treatment, you can expect to feel more comfortable and get back to your daily activities without the irritation caused by these skin issues.

Dosage and Administration

To use this medication effectively, start by breaking the seal on the tube using the tip of the cap. Before applying the medication, wash the affected area of 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 medication twice a day—once in the morning and once at night—for one week, or follow your doctor's instructions. 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 only need to apply the medication once a day for one week. Remember to wash your hands after each use to prevent spreading the infection. If the patient is a child under 12 years old, consult a doctor before use.

What to Avoid

It's important to use this product safely to avoid any potential issues. You should not apply it to your nails or scalp, and it should never be used in or near your mouth or eyes. Additionally, this product is not intended for treating vaginal yeast infections, so please refrain from using it for that purpose. Following these guidelines will help ensure your safety and the effectiveness of the product.

Side Effects

When using this product, it's important to remember that it is for external use only. Avoid applying it on nails, the scalp, or in and around the mouth and eyes, as well as for 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 this 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. Please avoid applying it on your nails or scalp, and do not use it in or near your mouth or eyes, or 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 your irritation worsens, stop using it and consult your doctor. It's also important to keep this product out of reach of children. If a child swallows it, 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 there are no specific guidelines or safety information regarding the use of Terbinafine Hydrochloride during pregnancy. This means that the drug insert does not provide details on whether you should adjust your dosage or take special precautions while using this medication.

Given the lack of information, it's crucial to consult with your healthcare provider before using Terbinafine Hydrochloride. They can help you weigh the potential risks and benefits based on your individual health needs and circumstances. Always prioritize open communication with your doctor about any medications you are considering during pregnancy.

Lactation Use

Currently, there is no specific information available about the use of Terbinafine Hydrochloride cream for nursing mothers or during lactation (the period of breastfeeding). This means that it’s unclear how this medication may affect you or your baby while you are breastfeeding.

If you are considering using this cream while nursing, it’s a good idea to consult with your healthcare provider to discuss any potential risks and to ensure the safety of both 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 using Terbinafine Hydrochloride Cream, there is no specific information available about how it should be used by older adults. This means that there are no special dosage adjustments, safety concerns, or precautions outlined for elderly patients.

If you are caring for an older adult, it’s always a good idea to consult with a healthcare professional before starting any new medication, including topical treatments like this cream. They can provide personalized advice based on individual health needs and conditions.

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 concerns about your kidney health. They can provide guidance based on your individual situation.

Hepatic Impairment

If you have liver problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or precautions related to your condition. This means that there are no tailored recommendations for how the medication may affect you differently due to your liver health.

It's always best to discuss your liver condition with your healthcare provider before starting any new medication. They can provide personalized advice and ensure that your treatment 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 known drug interactions or laboratory test interactions associated with them. This ensures that your treatment plan is safe and effective for your individual health needs.

Always feel free to ask questions and share any concerns you may have regarding your medications or tests. Your healthcare provider is there to help you understand how to manage your health safely.

Storage and Handling

To ensure the best quality 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 mindful of the tamper-evident seal; do not use it 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 will apply this medication topically, which means you will apply it directly to the skin. There are no additional details available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences related to this medication.

FAQ

What is Terbinafine Hydrochloride Cream used for?

Terbinafine Hydrochloride Cream is used to cure most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis).

How does Terbinafine Hydrochloride Cream work?

It is an antifungal cream that relieves itching, burning, cracking, and scaling associated with these conditions.

What are the instructions for applying the cream for athlete's foot?

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, after washing and drying the affected area.

Can children use Terbinafine Hydrochloride Cream?

Children under 12 years should ask a doctor before use.

Are there any areas where I should not apply this cream?

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

What should I do if I experience irritation while using the cream?

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

How should I store Terbinafine Hydrochloride Cream?

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

What should I do if the cream is swallowed?

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Packaging Info

Below are the non-prescription pack sizes of Terbinafine Hydrochloride. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Terbinafine Hydrochloride.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Terbinafine Hydrochloride Cream 1% is an antifungal formulation indicated for the treatment of athlete's foot. This cream is presented in a net weight of 1 ounce (30 grams). The active ingredient, terbinafine hydrochloride, functions by inhibiting the growth of fungi, thereby alleviating the symptoms associated with fungal infections.

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.

Limitations of Use: The efficacy of this drug may vary based on the severity and duration of the fungal infection. It is recommended that healthcare professionals assess the specific condition and patient history before prescribing this medication.

Dosage and Administration

Adults and children aged 12 years and older should begin treatment by using the tip of the cap to break the seal and open the tube. Prior to application, the affected skin must be washed with soap and water and dried thoroughly.

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

In cases of jock itch and ringworm, the medication should be applied once daily (either morning or night) for 1 week, or as directed by a healthcare professional. It is essential to wash hands thoroughly after each use to prevent the spread of infection.

For children under 12 years of age, it is advised to consult a doctor before use.

Contraindications

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 the case of ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

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, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

Drug Interactions

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

Packaging & NDC

Below are the non-prescription pack sizes of Terbinafine Hydrochloride. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Terbinafine Hydrochloride.
Details

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional 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 Terbinafine Hydrochloride Cream in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as the absence of data necessitates careful consideration of individual patient factors and potential risks. Monitoring for efficacy and adverse effects is recommended in this population, given the lack of established guidelines for geriatric use.

Pregnancy

There are no specific statements regarding the use of Terbinafine Hydrochloride during pregnancy, including safety concerns, dosage modifications, or special precautions. As such, the potential risks and benefits of using this medication in pregnant patients should be carefully considered. Healthcare professionals are advised to evaluate the necessity of treatment with Terbinafine Hydrochloride in women of childbearing potential and to discuss any potential risks to fetal outcomes with their patients.

Lactation

There is no specific information available regarding the use of Terbinafine Hydrochloride cream in nursing mothers or its effects on lactation. Consequently, the safety and efficacy of this medication in lactating mothers and its potential excretion in breast milk remain undetermined. Healthcare professionals should exercise caution when considering the use of this medication in breastfeeding individuals.

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 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 use of the compound in these contexts.

Postmarketing Experience

No postmarketing experience details are available in the provided data.

Patient Counseling

Healthcare providers should advise patients to keep the 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 to discontinue use and consult a doctor if they experience excessive irritation or if the irritation worsens during use.

It is important to instruct patients to avoid contact with the eyes while using the product. In case of eye contact, they should rinse the eyes thoroughly with water.

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.

For optimal storage, the product should be maintained at a controlled room temperature of 20° to 25°C (68° to 77°F). The lot number and expiration date can be found on the carton or crimp of the tube, ensuring proper tracking and usage within the designated timeframe.

Additional Clinical Information

The route of administration for the product is topical. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Terbinafine Hydrochloride, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

Learn more in our Editorial Policy

Last AI update:

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.