Symptom checker
Select audience type

Switch between content for healthcare professionals (PRO) and general audience (GEN).

ADD CONDITION

items per page

Terbinafine hydrochloride

Last content change checked dailysee data sync status

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 2025
Label revision date
March 19, 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 2025
Label revision date
March 19, 2026
Manufacturer
Scholl's Wellness Company LLC
Registration number
ANDA077511
NDC root
73469-7215
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

This medication is designed to treat common fungal skin infections, including athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis). It works by curing these infections and relieving associated symptoms such as itching, burning, cracking, and scaling of the skin.

If you're dealing with any of these conditions, this treatment can help restore your skin's health and comfort. It's important to follow the recommended guidelines for use to achieve the best results.

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 expect to feel more comfortable as the treatment works to clear up the infection.

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 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 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 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 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 and around the mouth or eyes. If the product accidentally gets into your eyes, rinse them thoroughly with water. It's important to stop using the product and consult a doctor if you experience excessive irritation or if the irritation worsens.

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 or scalp, and do not use it in or near your mouth or eyes. If you accidentally get it in your eyes, rinse them thoroughly with water. Additionally, this product should not be used for vaginal yeast infections.

While using this product, if you experience excessive irritation or if the 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 emergency assistance right away. Always prioritize safety and act quickly in these situations.

Pregnancy Use

The safety of terbinafine hydrochloride during pregnancy has not been established, which means that it is not known if it is safe for you or your developing baby. Because of potential risks to the fetus, this medication is contraindicated (not recommended) during pregnancy.

If you are pregnant or planning to become pregnant, it is important to avoid using this product unless your healthcare provider specifically advises you to do so. Always consult with your doctor about any medications you are considering during this time to ensure the health and safety of both 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. Currently, there is no information available about whether this medication passes 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. They can provide personalized advice based on your situation.

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 it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that if you or a loved one is an older adult considering this medication, it’s important to consult with a healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

Renal Impairment

If you have kidney problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or safety considerations for your condition. This means that there are no tailored guidelines for how this medication may affect you or how your kidney function might influence its use.

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your kidney health. They can help monitor your condition and make any necessary adjustments to your treatment plan.

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.

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific situation. They can help determine the best approach based on your liver function and overall health.

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 feel free to ask questions and share your complete list of medications and any tests you are undergoing. This way, you can avoid any potential issues and 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.

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 it is meant to be applied directly to the skin. If you experience excessive irritation or if your condition worsens, stop using the product and consult your doctor.

It's important to keep this medication out of reach of children. If a child accidentally swallows it, seek medical assistance or contact a Poison Control Center immediately.

FAQ

What conditions does this drug treat?

This drug 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 apply this medication 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.

What is the recommended application for jock itch and ringworm?

For jock itch and ringworm, apply once a day for 1 week, or as directed by your doctor.

Are there any precautions I should take while using this product?

Do not use this product on nails, scalp, in or near the mouth or eyes, or for vaginal yeast infections. If irritation occurs or worsens, stop use and consult a doctor.

What should I do if I accidentally get this product in my eyes?

If eye contact occurs, rinse thoroughly with water.

Is this medication safe to use during pregnancy?

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

What should I do if a child under 12 needs this medication?

You should ask a doctor before using this medication on children under 12 years of age.

How should I store this medication?

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.

What should I do if this medication is swallowed?

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

Packaging Info

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

Packaging configurations for Terbinafine Hydrochloride.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

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.

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 individual patient's condition to determine the appropriateness of this treatment.

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 important to wash hands thoroughly 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

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

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

When using this product, care must be taken to avoid contact with the eyes. In the event of eye contact, it is imperative to rinse thoroughly with water to mitigate potential irritation.

Users should discontinue use and consult a healthcare professional if excessive irritation occurs or if the irritation worsens.

It is essential to keep this product out of the reach of children. In the case of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center should be made 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 crucial to avoid contact with the eyes. In the event of eye contact, patients are 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 imperative to seek medical assistance or contact a Poison Control Center immediately.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known 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. The safety and efficacy of this medication in this age group have not been established, and specific dosing recommendations are not provided. Caution is advised when considering treatment for children in this age range.

Geriatric Use

There is no specific information available regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

Pregnancy

The safety of terbinafine hydrochloride during pregnancy has not been established. Due to potential risks to the fetus, terbinafine hydrochloride is contraindicated in pregnancy. Women who are pregnant or may become pregnant should avoid using this product unless directed by a healthcare provider. It is essential for healthcare professionals to counsel patients regarding these risks and to consider alternative treatments when necessary.

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 drug insert 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 detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable 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 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 and intervention.

Prompt recognition of symptoms associated with overdosage is crucial for effective treatment. While specific symptoms are not detailed in the provided information, general signs of overdosage may include nausea, vomiting, dizziness, or other adverse effects depending on the substance involved.

Management of overdosage should follow established protocols, which may include supportive care and symptomatic treatment. It is essential for healthcare providers to assess the patient's condition and implement necessary interventions based on clinical judgment and the specific circumstances of the overdosage incident.

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. Further studies may be necessary to elucidate these aspects.

Postmarketing Experience

Postmarketing experience has revealed reports of the following adverse reactions: rash, pruritus, and urticaria. These events were reported voluntarily or identified through surveillance programs.

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.

Additionally, healthcare providers should emphasize the importance of avoiding contact with the eyes while using this product. In case of eye contact, patients should be instructed to 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

The product is administered topically. Clinicians should advise patients to discontinue use and consult a doctor if excessive irritation occurs or worsens. It is also important to keep the product out of reach of children; if ingested, patients should seek medical assistance or contact a Poison Control Center immediately.

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.