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Cvs

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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
November 25, 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
November 25, 2025
Manufacturer
CVS Pharmacy
Registration number
ANDA077511
NDC root
59779-523
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 cream designed to treat skin infections caused by fungi. It is particularly effective for curing most cases of jock itch (tinea cruris), a common condition that can cause discomfort, including itching, burning, cracking, and scaling of the skin.

This cream works by targeting the underlying fungal infection, providing relief from the uncomfortable symptoms associated with jock itch. It is comparable to the active ingredient found in Lamisil AT, offering full prescription strength in a convenient topical form.

Uses

If you're dealing with jock itch, also known as tinea cruris, this medication can help. It effectively cures most cases of this uncomfortable skin condition.

In addition to treating the infection, it also provides relief from the annoying symptoms that often come with jock itch, such as itching, burning, cracking, and scaling. You can expect to feel more comfortable as the treatment works to clear up the area.

Dosage and Administration

To use this medication effectively, start by breaking the seal on the tube using the tip of the cap. Before applying the medication, wash the affected area of skin with soap and water, then dry it completely. If you are treating jock itch, apply the medication once a day, either in the morning or at night, for one week, or follow your doctor's instructions. Remember to wash your hands thoroughly after each use to avoid spreading the medication.

If you are considering this treatment for a child under 12 years old, it’s important to consult a doctor first to ensure it’s safe and appropriate for them.

What to Avoid

It's important to use this product safely to avoid potential issues. You should not use it on your nails or scalp, in or near your mouth or eyes, or for treating vaginal yeast infections. If the product accidentally gets into your eyes, rinse them thoroughly with water right away.

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

Side Effects

This product is intended for external use only and should not be applied to nails, the scalp, or in areas near the mouth or eyes, including for vaginal yeast infections. It's important to avoid contact with your eyes; if this happens, rinse them thoroughly with water.

If you experience excessive irritation or if side effects occur, stop using the product and consult a doctor. You can report any side effects to the FDA at 1-800-FDA-1088. Additionally, if the product is swallowed, seek medical assistance or contact a poison control center immediately.

Warnings and Precautions

This product is 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 intended for treating vaginal yeast infections. If the product accidentally gets into your eyes, rinse them thoroughly with water.

While using this product, if you experience increased irritation or any side effects, stop using it and consult your doctor. You can also report side effects to the FDA at 1-800-FDA-1088. Keep this product out of reach of children, and 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 precautions regarding the use of terbinafine hydrochloride cream during pregnancy. This means that, based on the available information, it is generally considered safe to use this cream while you are pregnant. However, as with any medication, you should always consult your healthcare provider before starting treatment to ensure it is appropriate for your individual situation.

Lactation Use

If you are breastfeeding and considering using 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 cream passes into breast milk or if it poses any risk to your infant while you are lactating (breastfeeding).

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

Pediatric Use

If you are considering this medication for your child, it's important to know that it is intended for use in adults and children aged 12 years and older. For children under 12 years, you should consult a doctor before giving this medication. This ensures that your child receives the appropriate care and guidance tailored to their specific needs. Always prioritize your child's health by seeking professional advice when it comes to medications.

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, it’s important to consult with a healthcare provider for personalized advice. 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 there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations for the medication do not include special monitoring or safety considerations tailored for patients with renal impairment (kidney issues).

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

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 monitor your liver function and make any necessary adjustments to your care.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you. Always share your complete list of medications and any health conditions you have to receive the best care possible.

Storage and Handling

To ensure the 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°-25°C (68°-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 should apply this medication topically for jock itch once a day, either in the morning or at night, for one week or as directed by your doctor. 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 it is swallowed, seek medical help or contact a poison control center immediately. Additionally, if you notice any side effects, you can report them to the FDA at 1-800-FDA-1088.

FAQ

What is Terbinafine Hydrochloride Cream used for?

Terbinafine Hydrochloride Cream is an antifungal cream that cures most jock itch (tinea cruris) and relieves associated symptoms like itching, burning, cracking, and scaling.

How should I use Terbinafine Hydrochloride Cream?

For adults and children 12 years and older, apply the cream once a day for 1 week after washing and drying the affected area. Always wash your hands after use.

Can children under 12 use this cream?

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

What should I avoid while using this cream?

Do not use the cream on nails, scalp, in or near the mouth or eyes, or for vaginal yeast infections. Avoid getting it in your eyes; if contact occurs, rinse thoroughly with water.

What should I do if I experience irritation or side effects?

Stop using the cream and ask a doctor if irritation worsens or side effects occur. You can report side effects to the FDA at 1-800-FDA-1088.

Is it safe to use Terbinafine Hydrochloride Cream during pregnancy or while nursing?

The provided information does not mention specific warnings or precautions for using this cream during pregnancy or while nursing.

What should I do if I accidentally swallow the 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°-25°C (68°-77°F) and keep it out of reach of children.

Packaging Info

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

Packaging configurations for Cvs.
Details

Drug Information (PDF)

This file contains official product information for Cvs, 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 drug.

Uses and Indications

This drug is indicated for the treatment of most cases of jock itch (tinea cruris). It effectively relieves associated symptoms, including itching, burning, cracking, and scaling.

Dosage and Administration

Adults and children 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, followed by thorough drying. For the treatment of jock itch, the recommended application frequency is once daily, either in the morning or at night, for a duration of 1 week, or as directed by a healthcare professional. It is essential to wash hands after each use to prevent unintended spread of the medication.

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, as well as in or near the mouth or the eyes. It should not be used for vaginal yeast infections.

In addition, care should be taken to avoid contact with the eyes during application. In the event of eye contact, it is essential to rinse thoroughly with water.

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 indicated 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.

Healthcare professionals should advise patients to discontinue use and consult a physician if excessive irritation occurs or if side effects manifest. Side effects can be reported to the FDA at 1-800-FDA-1088.

This product must be kept out of reach of children. In the case of accidental ingestion, immediate medical assistance should be sought, or a poison control center should be contacted without delay.

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 the use of this product, patients must take care to avoid contact with the eyes. In the event of eye contact, it is advised to rinse thoroughly with water. Patients are also cautioned to discontinue use and consult a healthcare professional if excessive irritation occurs or worsens, or if any side effects manifest. Side effects may be reported to the FDA at 1-800-FDA-1088.

In cases where the product is ingested, immediate medical assistance should be sought, or contact with a poison control center is recommended.

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 necessary at this time.

Packaging & NDC

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

Packaging configurations for Cvs.
Details

Pediatric Use

Pediatric patients aged 12 years and older may use this medication as directed for adults. For children under 12 years of age, it is advised to consult a healthcare professional before use.

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, given the lack of targeted data for this population.

Pregnancy

There are no specific warnings or precautions regarding the use of terbinafine hydrochloride cream during pregnancy. However, healthcare professionals should consider the potential risks and benefits when prescribing this medication to pregnant patients. It is advisable to assess the necessity of treatment and to discuss any concerns with women of childbearing potential. As with any medication, careful consideration should be given to the individual circumstances of the patient.

Lactation

There are no specific warnings or recommendations regarding the use of terbinafine hydrochloride cream in nursing mothers. Additionally, there is no information available about the potential for excretion in breast milk or any associated risks to breastfed infants during the use of this product in 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 detailed guidance necessitates careful clinical judgment and monitoring of these patients.

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, 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 may vary depending on the specific substance involved, and monitoring for any adverse effects is essential.

Management of overdosage should include supportive care and symptomatic treatment as necessary. It is recommended that healthcare providers follow established protocols for the assessment and management of overdose cases, ensuring that appropriate measures are taken to mitigate potential risks to the patient.

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.

Postmarketing Experience

Postmarketing experience has indicated that side effects may occur following the use of the product. Healthcare professionals and patients are encouraged to report any adverse events to the FDA at 1-800-FDA-1088. Reports received are considered voluntary and contribute to ongoing surveillance efforts.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. Instruct patients that if the product is swallowed, they should seek medical help or contact a poison control center immediately.

It is important to inform patients that this product should not be used on nails or the scalp, and it should not be applied in or near the mouth or the eyes. Additionally, patients should be cautioned against using this product for vaginal yeast infections.

Patients should be instructed to discontinue use and consult a doctor if they experience excessive irritation or if the irritation worsens. They should also be made aware that if any side effects occur, they should stop using the product and seek medical advice. Patients can report side effects to the FDA at 1-800-FDA-1088.

When using this product, patients must be reminded to avoid contact with the eyes. In the event 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 before 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 of 20°-25°C (68°-77°F). For traceability, the lot number and expiration date can be found on the carton or the crimp of the tube. Proper handling and storage are crucial to ensure the integrity and efficacy of the product.

Additional Clinical Information

The medication is administered topically, specifically for the treatment of jock itch, with a recommended application frequency of once daily for one week, or as directed by a healthcare professional.

Clinicians should counsel patients to discontinue use and seek medical advice if excessive irritation occurs or worsens. Patients are also advised to report any side effects to the FDA at 1-800-FDA-1088. It is important to keep the product out of reach of children, and in the event of ingestion, medical assistance or contact with a poison control center should be sought immediately.

Drug Information (PDF)

This file contains official product information for Cvs, 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 Cvs, 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.