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Curist

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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 2024
Label revision date
June 15, 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 2024
Label revision date
June 15, 2025
Manufacturer
Little Pharma, Inc.
Registration number
ANDA077511
NDC root
72559-035
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

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

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

Drug Overview

Terbinafine Hydrochloride Cream 1% is an antifungal medication designed to provide relief from common 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 conditions, the cream helps relieve associated symptoms such as itching, burning, cracking, and scaling of the skin.

This cream is available in a 1-ounce (30 g) tube, making it easy to apply directly to the affected areas. If you're dealing with any of these fungal skin infections, Terbinafine Hydrochloride Cream can be a helpful option for restoring your skin's health and comfort.

Uses

If you're dealing with athlete's foot, jock itch, or ringworm, this treatment 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 conditions, it also provides relief from uncomfortable symptoms such as itching, burning, cracking, and scaling. You can expect to feel more comfortable as the treatment works to clear up these common skin issues.

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 prevent spreading the infection.

If you’re considering this treatment for a child under 12 years old, be sure to 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, and it should not be used in or near your mouth or eyes. Additionally, do not use this product for vaginal yeast infections, as it is not intended for that purpose. Following these guidelines will help ensure your safety and the best results from your treatment.

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. 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. It is also not suitable for treating vaginal yeast infections. If you accidentally get the product in 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 your doctor. Always keep this product out of reach of children. If a child swallows it, 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 act quickly. You should seek medical help or contact a poison control center immediately. Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing.

Don’t wait for symptoms to appear; getting prompt assistance can be crucial. Always keep emergency contact numbers handy and be aware of the steps to take in case of an overdose. Your safety and well-being are the top priority.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the safety of terbinafine hydrochloride has not been established. This medication is contraindicated during pregnancy, meaning it should not be used due to potential risks to your developing baby. There may be specific risks associated with its use, so it's crucial to consult your healthcare provider for more information.

If you are prescribed terbinafine while pregnant, special precautions or dosage adjustments may be necessary. Always discuss any medications with your healthcare professional before taking them, and avoid using this product unless directed by them. Your health and the health of your baby are the top priority.

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 a child under 12 years old, it’s important to consult with a doctor first. This ensures that the treatment is safe and appropriate for their age and health needs. Always prioritize professional guidance when it comes to the health of your children.

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. If you or a loved one is an older adult, it’s wise to discuss any potential risks or benefits with your healthcare provider. They can help determine the best approach, considering any unique health needs or conditions.

Always keep in mind that older adults may have different responses to medications, so regular check-ins with your doctor can ensure safety and effectiveness. If you notice any unusual side effects or changes in health, be sure to report these to your healthcare team promptly.

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 there are no specific guidelines, dosage adjustments, or special monitoring instructions provided for your condition in the available information. This means that the medication may not have been studied in depth for its effects on individuals with liver impairment.

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver health and medication use. They can help ensure that your treatment is safe and effective based on your individual health needs.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking, even if there are no known drug interactions or laboratory test interactions associated with them. This ensures that your treatment plan is safe and effective for your specific health needs.

Always keep your healthcare team informed about all the medications and supplements you use, as well as any lab tests you may undergo. This way, they can provide the best care tailored to you.

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 will apply this medication topically, which means you will apply it directly to the skin. There are no additional details available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences related to this medication.

FAQ

What is Terbinafine Hydrochloride Cream used for?

Terbinafine Hydrochloride Cream is an antifungal medication that cures most athlete's foot, jock itch, and ringworm, while relieving associated symptoms like itching, burning, cracking, and scaling.

How should I apply Terbinafine Hydrochloride Cream for athlete's foot?

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

Can children use Terbinafine Hydrochloride Cream?

Children under 12 years should consult a doctor before using Terbinafine Hydrochloride Cream.

Are there any warnings associated with Terbinafine Hydrochloride Cream?

Yes, it is for external use only, and you should avoid contact with eyes, mouth, and do not use it for vaginal yeast infections.

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

If you experience too much irritation or if it gets worse, stop using the cream and consult a doctor.

Is Terbinafine Hydrochloride Cream safe to use during pregnancy?

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

What should I do if I accidentally swallow Terbinafine Hydrochloride Cream?

If swallowed, seek medical help or contact a poison control center immediately.

How should I store Terbinafine Hydrochloride Cream?

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

Packaging Info

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

Packaging configurations for Curist.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Curist Antifungal Relief is formulated with Terbinafine Hydrochloride at a concentration of 1%. This topical antifungal cream is designed for the treatment of fungal infections. The product is presented 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.

Limitations of Use: There are no known 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 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.

When using this product, it is imperative to avoid contact with the eyes. In the event of eye contact, the affected area should be rinsed thoroughly with water to mitigate potential irritation.

Users are advised to discontinue use and consult a healthcare professional if excessive irritation occurs or if the condition 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 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 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, it is crucial to seek medical assistance or contact a poison control center immediately.

Drug Interactions

No specific drug interactions have been identified for this medication. Additionally, there are no reported interactions with laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

Packaging & NDC

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

Packaging configurations for Curist.
Details

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. The safety and efficacy of the 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 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, and its use is contraindicated due to potential risks to the fetus. There may be associated risks with the use of terbinafine during pregnancy; therefore, it is essential for healthcare providers to be consulted for further information regarding these risks.

Pregnant patients should avoid using this product unless specifically directed by a healthcare professional. Special precautions or dosage modifications may be necessary for individuals who are pregnant, underscoring the importance of professional guidance in managing treatment during this period.

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

There is no information available regarding the use of this medication in patients with hepatic impairment. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions specified for individuals with compromised liver function. Healthcare professionals should exercise caution and consider the lack of data when prescribing this medication to patients with liver problems.

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

Postmarketing experience has identified the following adverse reactions reported voluntarily or through surveillance programs: skin irritation, allergic reactions, and other hypersensitivity reactions. These events have been documented in the context of routine pharmacovigilance activities.

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 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 Curist, 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 Curist, 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

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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.