ADD CONDITION

items per page

Equate

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)
Marketed in the U.S.
Since 2007
Label revision date
August 14, 2025
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
Marketed in the U.S.
Since 2007
Label revision date
August 14, 2025
Manufacturer
Wal-Mart Stores Inc
Registration number
ANDA077511
NDC root
49035-080

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 common skin infections caused by fungi, such as athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis). This cream works by curing these infections and relieving associated symptoms like itching, burning, cracking, and scaling of the skin.

If you're dealing with any of these fungal skin conditions, Terbinafine Hydrochloride can help restore your skin's health and comfort. It is available in a full prescription strength and is comparable to other antifungal treatments like Lamisil AT®.

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 nonteratogenic effects noted.

Dosage and Administration

To use this medication effectively, start by preparing the tube. Unscrew the cap, pull the tab to remove the foil seal, and then screw the cap back onto the tube. Before applying the medication, wash the affected area of your skin with soap and water, and make sure to 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, 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, and 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

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

You should stop using the product and consult a doctor if you experience excessive irritation or if the irritation worsens. Additionally, keep 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, so please avoid applying it to your nails or scalp, and do not use it in or near your mouth or eyes. If the product accidentally gets into your eyes, rinse them thoroughly with water. It is also not suitable for treating vaginal yeast infections.

While using this product, if you experience excessive irritation or if the irritation worsens, stop using it and consult your doctor. Always keep this product out of reach of children. If it is swallowed, seek medical help or contact a Poison Control Center immediately.

Overdose

If you or someone else has swallowed too much of a medication, it’s important to seek medical help immediately. You can do this by contacting a Poison Control Center or going to the nearest emergency room. Acting quickly can make a significant difference in the outcome.

Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms, don’t hesitate to get help right away. Remember, it’s always better to be safe and seek assistance if you suspect an overdose.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that there are no specific warnings or contraindications related to the use of terbinafine hydrochloride cream during pregnancy. The information available does not indicate any risks associated with its use, nor does it suggest any changes to the dosage for pregnant individuals.

While the absence of specific guidelines may seem reassuring, it's always 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 precautions related to its use for nursing mothers. Currently, there is no information available about whether this medication passes into breast milk or any potential risks 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 healthcare providers may not have tailored guidelines for elderly patients, which can be important given the unique health considerations that often come with aging.

If you or a loved one is an older adult considering this medication, it’s essential to discuss any potential risks and benefits with your healthcare provider. They can help determine the best approach based on individual health needs and circumstances.

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 for your specific condition. They can help you understand any necessary precautions or adjustments based on your kidney health.

Hepatic Impairment

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

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver function and how it relates to your treatment. They can help ensure that your medication is safe and effective for you.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. In this case, there are no known drug interactions or laboratory test interactions associated with the medication. However, always ensure that your healthcare provider is aware of all the medications you are using, as this helps them provide the best care tailored to your needs.

By discussing your full medical history and any other treatments, you can help prevent potential issues and ensure your safety.

Storage and Handling

To ensure the best performance of your product, store it at a controlled room temperature between 20° and 25°C (68° and 77°F). It's important to keep it in a stable environment, away from extreme temperatures. Always check the carton or tube crimp for the lot number and expiration date to ensure you are using a product that is still safe and effective.

When handling the product, make sure to do so with clean hands and in a clean environment to maintain its integrity. Following these guidelines will help you use the product safely and effectively.

Additional Information

The medication is administered topically, meaning it is applied directly to the skin. There are no additional details available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences. If you have any specific questions about how to use this medication or its effects, be sure to consult your healthcare provider for more information.

FAQ

What is Terbinafine Hydrochloride?

Terbinafine Hydrochloride is a 1% antifungal cream used to treat skin infections such as athlete's foot, jock itch, and ringworm.

How does Terbinafine Hydrochloride work?

It cures most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis), while relieving associated symptoms like itching, burning, cracking, and scaling.

What are the instructions for using 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 this cream?

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

What should I do if I experience irritation?

Stop using the product and consult a doctor if irritation occurs or worsens.

Is Terbinafine Hydrochloride safe to use during pregnancy?

The insert does not mention any specific risks or contraindications for use during pregnancy.

Can nursing mothers use Terbinafine Hydrochloride?

There are no specific warnings or precautions mentioned for nursing mothers regarding the use of this cream.

What should I do if the cream gets into my eyes?

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

How should I store Terbinafine Hydrochloride?

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

What should I do if the cream is swallowed?

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

Packaging Info

Below are the non-prescription pack sizes of Equate (terbinafine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Equate.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

This product, identified by NDC 49035-080-03, is an antifungal cream formulated with 1% Terbinafine Hydrochloride as the active ingredient. It is marketed under the equate™ brand and is comparable to Lamisil AT®. The cream is packaged in a net weight of 1 ounce (30 grams).

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 follow the preparation and application instructions carefully. To open the product, unscrew the cap, pull the tab to remove the foil seal, and then screw the cap back onto the tube. Prior to application, the affected skin must be washed with soap and water and dried completely.

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 applied twice a day (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 be applied twice a day (morning and night) for 2 weeks, or as directed by a healthcare professional.

For the treatment of jock itch and ringworm, the medication should be applied once a day (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 on nails or the scalp. It should not be applied in or near the mouth or the 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 the eyes. Additionally, it is not intended for the treatment of vaginal yeast infections.

Care should be taken to avoid contact with the eyes. In the event of eye contact, it is imperative to rinse thoroughly with water.

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

This product must 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 advised.

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 the eyes, nor is it indicated for 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. Should excessive irritation occur or worsen, patients are instructed to discontinue use and consult a healthcare professional.

Additionally, this product should be kept out of reach of children. If ingested, it is crucial to seek medical assistance or contact a Poison Control Center immediately.

Drug Interactions

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

Packaging & NDC

Below are the non-prescription pack sizes of Equate (terbinafine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Equate.
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 for children in this category.

Geriatric Use

There is no specific information 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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

There are no specific statements regarding the use of terbinafine hydrochloride cream during pregnancy. The available prescribing information does not mention any contraindications or risks associated with the use of this product in pregnant patients. Additionally, no dosage modifications for pregnant individuals are provided. The insert also does not include any special precautions regarding the use of this product during pregnancy. Healthcare professionals should consider the absence of data when advising women of childbearing potential and weigh the benefits against any potential risks.

Lactation

There are no specific warnings or precautions 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 may not have specific dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment and monitoring of these patients.

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, immediate medical intervention is crucial. If the substance is ingested, it is imperative to seek medical assistance or contact a Poison Control Center without delay.

Healthcare professionals should be aware that prompt action can significantly influence the outcome of an overdosage situation. Symptoms of overdosage 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. Continuous evaluation of the patient's condition is recommended to address any complications that may arise.

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 specific postmarketing experience details have been reported. As such, there are no additional adverse events or rare case reports to summarize at this time.

Patient Counseling

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

Patients should be informed that the 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 the 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 the product. In case of eye contact, they should rinse thoroughly with water.

Storage and Handling

The product is supplied in various packaging configurations, with specific NDC numbers available for identification. It should be stored at a controlled room temperature ranging from 20° to 25°C (68° to 77°F) to ensure optimal stability and efficacy.

Healthcare professionals are advised to check the carton or tube crimp for the lot number and expiration date, which are essential for tracking and quality assurance. Proper handling and storage conditions are crucial to maintain the integrity of the product.

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 Equate, 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 Equate, 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.