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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
July 1, 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 2007
Label revision date
July 1, 2025
Manufacturer
Sun Pharmaceutical Industries, Inc.
Registration number
ANDA077511
NDC root
51672-2140
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 prescription-strength antifungal cream that is commonly used to treat various fungal skin infections. It is effective in curing most cases of athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis). This cream works by relieving the uncomfortable symptoms associated with these conditions, such as itching, burning, cracking, and scaling of the skin.

With a concentration of 1%, Terbinafine Hydrochloride provides targeted treatment to help you regain comfort and health in affected areas. If you're dealing with any of these fungal infections, this cream 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 confident using this treatment, as there are no teratogenic effects (harmful effects on fetal development) or other nonteratogenic effects reported.

Dosage and Administration

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

If you’re treating athlete's foot, it’s important to wear well-fitting, ventilated shoes and change your shoes and socks at least once a day. For application, if the infection is between your toes, apply the cream twice a day—once in the morning and once at night—for one week, or 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 cream once a day for one week. Remember to wash your hands after each use to avoid 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 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 treating 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 the irritation worsens, stop using it and consult a doctor. Additionally, keep this product out of reach of children. If swallowed, seek medical assistance 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, scalp, or in and around your mouth and 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 contact your doctor for advice. 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 the safety of terbinafine hydrochloride, a medication used to treat fungal infections, has not been established. In fact, it is contraindicated, meaning it should not be used during pregnancy due to potential risks to the fetus.

Before considering this medication, you should consult your healthcare provider to discuss any concerns and explore safer alternatives. Your health and the health of your baby are the top priority, so always seek professional advice when it comes to medication during pregnancy.

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 considerations mentioned for nursing mothers in the drug insert. This means that, based on the available information, it is generally considered safe to use this cream while breastfeeding.

However, as with any medication, it's always a good idea to consult with your healthcare provider to discuss your individual situation and any potential concerns. They can provide personalized advice to ensure both you and your baby remain healthy.

Pediatric Use

If you are considering using this medication for your child, it's important to know that children under 12 years old should consult a doctor before use. This ensures that the treatment is safe and appropriate for their age and health needs. Always prioritize your child's well-being by seeking professional advice when it comes to their medication.

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’s appropriate for your individual health needs and any other medications you may be taking.

Always keep in mind that older adults may have different responses to medications, so discussing any potential risks or side effects with a doctor is a wise step to take.

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 (issues with liver function).

Always consult your healthcare provider for personalized advice and to discuss any concerns regarding your liver health and medication use. They can help ensure that you receive the safest and most effective treatment based on your individual needs.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking. In this case, there are no specific drug interactions or laboratory test interactions noted, which means that the medication is generally considered safe to use with other drugs and tests. However, every individual is different, and your healthcare provider can help ensure that your treatment plan is safe and effective for you.

Always discuss any new medications or tests with your healthcare provider to avoid potential issues and to get the best care tailored to your needs.

Storage and Handling

To ensure the safety and effectiveness of your product, always check that the seal on the tube is intact and visible before use. If the seal is broken, do not use the product. For proper storage, keep the product at a controlled room temperature between 20° to 25°C (68° to 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 apply it directly to the skin. There are no additional details available regarding laboratory tests, abuse potential, or patient counseling information.

FAQ

What is Terbinafine Hydrochloride used for?

Terbinafine Hydrochloride is an antifungal cream that cures most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis).

How does Terbinafine Hydrochloride relieve symptoms?

It relieves itching, burning, cracking, and scaling associated with these fungal conditions.

What are the instructions for applying Terbinafine Hydrochloride?

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. For jock itch and ringworm, apply once a day for 1 week.

Are there any contraindications for using Terbinafine Hydrochloride?

Yes, do not use it on nails, scalp, in or near the mouth or eyes, or for vaginal yeast infections.

Is Terbinafine Hydrochloride safe to use during pregnancy?

The safety of Terbinafine Hydrochloride during pregnancy has not been established, and it is contraindicated in pregnancy due to potential risks to the fetus.

What should I do if I accidentally get Terbinafine Hydrochloride in my eyes?

If eye contact occurs, rinse thoroughly with water.

What should I do if I experience irritation while using Terbinafine Hydrochloride?

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

What precautions should I take when using Terbinafine Hydrochloride?

Keep it out of reach of children, and if swallowed, get medical help or contact a poison control center immediately.

Can children under 12 use Terbinafine Hydrochloride?

Children under 12 should ask a doctor before use.

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 cream formulated at a concentration of 1%. It is presented in a cream dosage form, with a net weight of ½ oz (15 g).

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, indicating a favorable safety profile for use in the indicated patient populations.

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 duration of 2 weeks, or as directed by a healthcare professional.

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

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

Contraindications

The product is contraindicated for use in the following situations:

  • Application on nails or scalp is not recommended.

  • Use in or near the mouth or eyes is contraindicated due to potential irritation or adverse effects.

  • The product should not be used 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.

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 to mitigate potential irritation.

Patients should be instructed to discontinue use and consult a healthcare provider if they experience excessive irritation or if the irritation worsens.

To ensure safety, this product must be kept out of reach of children. In cases of accidental 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. 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 a poison control center contacted without delay.

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions between the drug and 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 prior to use. It is important to assess the appropriateness of treatment in this age group to ensure safety and efficacy.

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. Further clinical judgment should guide the use of Terbinafine Hydrochloride cream in geriatric patients, taking into account their overall health status and any concomitant medications.

Pregnancy

The safety of terbinafine hydrochloride during pregnancy has not been established, and its use is contraindicated in pregnant patients. There may be potential risks to the fetus associated with the use of this medication during pregnancy. Therefore, it is essential for women of childbearing potential to consult a healthcare provider before using this medication if they are pregnant or planning to become pregnant.

Lactation

There are no specific warnings or considerations regarding the use of Terbinafine Hydrochloride cream in lactating mothers. The available data does not indicate any known effects on breastfed infants. Healthcare professionals may consider the use of this medication in nursing mothers, as no adverse effects have been documented in relation to lactation.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the prescribing information regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the absence of data limits the ability to make informed decisions about its use in this population. Regular monitoring of renal function may be warranted in these patients to ensure safety and efficacy.

Hepatic Impairment

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

Overdosage

In the event of an overdosage, it is imperative to keep the product out of reach of children. Should ingestion occur, immediate medical assistance is required. Healthcare professionals are advised to contact a poison control center without delay to ensure appropriate management.

Prompt action is crucial in mitigating potential adverse effects associated with overdosage. The healthcare provider should assess the situation and provide guidance based on the specific circumstances of the ingestion.

Nonclinical Toxicology

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

Postmarketing Experience

No postmarketing experience details are available in the extracted data.

Patient Counseling

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

Patients should be informed that this product is not intended for use on nails or the scalp, and it should not be applied in or near the mouth or the eyes. Additionally, it is important to communicate that this product is not indicated for the treatment of vaginal yeast infections.

Healthcare providers should instruct patients to discontinue use and consult a doctor if they experience excessive irritation or if the irritation worsens. Furthermore, patients should be cautioned to avoid contact with the eyes while using this product. In case of eye contact, they should rinse thoroughly with water.

Storage and Handling

The product is supplied in a tube format, and it is essential to ensure that the seal on the tube is intact and visible prior to 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 ranging from 20° to 25°C (68° to 77°F). For traceability, the lot number and expiration date can be found on the carton or the crimp of the tube.

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.

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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.