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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 2007
Label revision date
February 20, 2026
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 2007
Label revision date
February 20, 2026
Manufacturer
Sun Pharmaceutical Industries, Inc.
Registration number
ANDA077511
NDC root
51672-2080
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (7 NDCs)
Packaging & NDC Codes (7)

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 various skin infections caused by fungi. It is effective in curing most cases of athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis). In addition to treating these infections, it helps relieve associated symptoms such as itching, burning, cracking, and scaling of the skin.

This medication works by targeting the fungi responsible for these conditions, helping to restore your skin's health and comfort. If you're dealing with any of these fungal infections, Terbinafine Hydrochloride may be a suitable option to consider for relief and recovery.

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 more comfortable and confident as you address these common 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, make sure 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 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 medication 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 to avoid potential issues. You should not use it on your nails or scalp, 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 right away.

Always remember to follow these guidelines to ensure your safety and the effectiveness of the product. If you have any questions or concerns about its use, please consult a healthcare professional.

Side Effects

This product is intended for external use only, so be sure to avoid applying it to your nails or scalp, and do not use it in or 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. 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 immediately or contact a Poison Control Center.

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 concerns mentioned regarding the use of terbinafine hydrochloride cream during pregnancy. The information available does not indicate any contraindications (situations where the medication should not be used) or special precautions for pregnant individuals. Additionally, there are no recommended dosage modifications 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 the use of terbinafine hydrochloride cream, you can feel reassured that there are no specific warnings or recommendations regarding its use for nursing mothers. Additionally, there is no information available about whether this medication is passed into breast milk or if it poses any risk to your infant.

As always, it's a good idea to consult with your healthcare provider if you have any concerns or questions about using medications while breastfeeding.

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

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 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 may affect you if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to discuss any concerns regarding your liver health and how it may relate to your treatment. They can help ensure that you receive the safest and most effective care.

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 everything you are taking works well together and is safe for you. Always share your complete list of medications and any health conditions you have to receive the best care possible.

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.

Always inspect the seal on the tube before use; do not use the product if the seal is punctured or not visible, as this indicates it may have been tampered with. Following these guidelines will help you handle the product safely and effectively.

Additional Information

You should apply this medication according to the following guidelines: For athlete's foot between the toes, use it twice a day (morning and night) for 1 week, or as your doctor advises. If you're treating athlete's foot on the bottom or sides of your foot, apply it twice a day for 2 weeks, or follow your doctor's instructions. For jock itch and ringworm, apply the medication once a day (morning or night) for 1 week, or as directed by your healthcare provider. Always consult your doctor if you have any questions about your treatment.

FAQ

What is Terbinafine Hydrochloride?

Terbinafine Hydrochloride is a 1% antifungal cream used to treat skin infections.

What conditions does Terbinafine Hydrochloride treat?

It 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 Terbinafine Hydrochloride for athlete's foot?

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

How should I use Terbinafine Hydrochloride for jock itch and ringworm?

Apply Terbinafine Hydrochloride once a day for 1 week, or as directed by a doctor.

Are there any precautions for using Terbinafine Hydrochloride?

Do not use it on nails, scalp, in or near the mouth or eyes, or for vaginal yeast infections. If eye contact occurs, rinse thoroughly with water.

What should I do if I experience irritation while using this product?

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

Is Terbinafine Hydrochloride safe to use during pregnancy?

The insert does not mention any specific safety concerns or precautions regarding the use of Terbinafine Hydrochloride during pregnancy.

Can I use Terbinafine Hydrochloride if I am nursing?

There are no specific warnings or recommendations regarding its use in nursing mothers mentioned in the insert.

What should I do if Terbinafine Hydrochloride is swallowed?

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

How should I store Terbinafine Hydrochloride?

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

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

No description information is available for the specified 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.

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 thoroughly dried.

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.

  • For application between the toes, the product 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 product should be applied twice daily (morning and night) for a duration of 2 weeks, or as directed by a healthcare professional.

For the treatment of jock itch and ringworm, the product should be applied once daily (morning or 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 the spread of infection.

For children under 12 years of age, consultation with a healthcare professional is advised prior to use.

Contraindications

Use of this product is contraindicated in the following situations:

The product should not be applied to nails or the scalp, nor should it be used in or near the mouth or eyes due to the potential for irritation or adverse reactions. 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

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 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 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, immediate medical assistance should be sought, or the local Poison Control Center should be contacted without delay.

Drug Interactions

There are currently no documented drug interactions associated with the use of 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 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

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 adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

There are no specific statements regarding the use of terbinafine hydrochloride cream during pregnancy. The prescribing information does not mention any safety concerns, contraindications, or precautions related to pregnancy. Additionally, no dosage modifications for pregnant individuals are provided. Furthermore, the insert does not include any special precautions regarding the use of this medication during pregnancy. Healthcare professionals should consider the absence of data when prescribing this medication to pregnant patients 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 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 clinical trials for this medication. Consequently, there is no available information regarding dosage adjustments, special monitoring requirements, or precautions 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 warranted based on clinical judgment.

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 are advised to contact a Poison Control Center without delay to ensure appropriate management and intervention.

Prompt action is crucial in mitigating potential adverse effects associated with overdosage. The symptoms may vary depending on the specific substance involved; therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures should include supportive care and symptomatic treatment as necessary. It is recommended that healthcare providers follow established protocols for the specific substance to guide treatment decisions effectively.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

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 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 this product. Should eye contact occur, 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.

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

Patients aged 12 years and older are advised to apply the medication twice daily, in the morning and at night, for athlete's foot between the toes for a duration of one week, or as directed by a healthcare professional. For application on the bottom or sides of the foot, the treatment should also be administered twice daily for two weeks, unless otherwise instructed by a clinician. In cases of jock itch and ringworm, the recommended application is once daily, either in the morning or at night, for one week or as directed by a healthcare provider.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

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.