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Cvs Pharmacy

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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
September 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
September 25, 2025
Manufacturer
CVS Pharmacy
Registration number
ANDA077511
NDC root
59779-080
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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

Drug Overview

Terbinafine Hydrochloride Cream, 1% is an antifungal medication that is used to treat various skin infections caused by fungi. It is clinically proven to effectively cure most cases of athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis). In addition to treating these infections, the cream also helps relieve uncomfortable symptoms such as itching, burning, cracking, and scaling associated with these conditions.

This cream is available in a 15 g tube and is considered full prescription strength, making it a reliable option for those seeking relief from fungal skin infections. If you're dealing with any of these issues, Terbinafine Hydrochloride Cream may be a suitable choice to help restore your skin's health.

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 fungal infections, it also provides relief from uncomfortable symptoms such as itching, burning, cracking, and scaling that often accompany these conditions. Clinical studies have shown that it can successfully cure most athlete's foot, especially between the toes, helping you feel more comfortable and confident.

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, 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 to prevent spreading the infection.

If the person needing treatment is under 12 years old, be sure to 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 or eyes. Additionally, do not use this product for 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 apply it only to the skin and avoid areas such as the nails, scalp, mouth, eyes, and vaginal area. 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.

Keep this product out of reach of children. If 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, or for vaginal yeast infections. If the product accidentally gets into your eyes, rinse them thoroughly with water.

While using this product, if you experience excessive irritation or if your irritation worsens, stop using it and 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

If you or someone else has swallowed too much of this 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.

Signs of an overdose may include unusual symptoms, but specific details about these symptoms are not provided here. Always err on the side of caution and get help if you suspect an overdose has occurred. Your health and safety 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, a medication used to treat fungal infections, 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 considering using terbinafine while pregnant, your healthcare provider can help you understand the potential benefits and risks. They may also recommend dosage modifications tailored to your situation. Always discuss any medications with your healthcare provider to ensure the best care for you and your baby.

Lactation Use

If you are breastfeeding, it's important to know that terbinafine, a medication, can be found in breast milk. This means that there is a possibility that your nursing infant could be exposed to it. Because of this potential risk, you should exercise caution when considering the use of this medication while nursing. Always consult with your healthcare provider to discuss the benefits and risks, ensuring the safety of both you and your baby.

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

While there is no specific information about the use of Terbinafine hydrochloride cream in older adults, it’s important to approach any new medication with caution. Since the drug insert does not mention dosage adjustments or safety concerns for elderly patients, you should consult with a healthcare professional before starting this treatment. They can provide personalized advice based on your health status and any other medications you may be taking.

Always keep in mind that older adults may have different needs and considerations when it comes to medications, so discussing any potential risks or benefits with a doctor is a wise step.

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 be adjusted 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 condition. They can help monitor your kidney health and make any necessary changes to your medications.

Hepatic Impairment

If you have liver problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication may affect you 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 condition and the use of this medication. They can help ensure that you receive the safest and most effective treatment.

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 might be undergoing. This way, you can avoid any potential issues and ensure the best possible care for your health.

Storage and Handling

To ensure the safety and effectiveness 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.

Always handle the product with care. If you notice that the seal on the tube is punctured or not visible, do not use the product, as this indicates it may have been tampered with. Following these guidelines will help you use the product safely and effectively.

Additional Information

You should apply the medication for athlete's foot between your toes twice a day, in the morning and at night, for one week, or as your doctor advises. If you have athlete's foot on the bottom or sides of your foot, use it twice daily for two weeks. For jock itch and ringworm, apply the medication once a day, either in the morning or at night, for one week, or follow your doctor's instructions.

FAQ

What is Terbinafine Hydrochloride Cream used for?

Terbinafine Hydrochloride Cream is an antifungal medication used to cure most athlete's foot, jock itch, and ringworm, while also relieving associated itching, burning, cracking, and scaling.

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

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

Can children use Terbinafine Hydrochloride Cream?

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

Are there any precautions I should take when using this cream?

Yes, do not use Terbinafine Hydrochloride Cream on nails, scalp, or in/near the mouth or eyes. If contact with eyes occurs, rinse thoroughly with water.

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

If you experience too much irritation or if it gets worse, stop using the cream and consult your 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. Consult your healthcare provider for guidance.

What should nursing mothers know about using this cream?

Nursing mothers should be cautious as terbinafine may be excreted in breast milk, and they should discuss its use with their healthcare provider.

How should I store Terbinafine Hydrochloride Cream?

Store the cream at 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 Cvs Pharmacy (terbinafine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Cvs Pharmacy.
Details

Drug Information (PDF)

This file contains official product information for Cvs Pharmacy, 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 superficial fungal infections, specifically athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis). It is clinically proven to cure most cases of athlete's foot, particularly those affecting the areas between the toes.

In addition to its antifungal properties, this drug provides relief from associated symptoms, including itching, burning, cracking, and scaling that accompany these conditions.

Limitations of Use: The efficacy of this drug may vary based on the severity and extent 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.

  • For application between the toes, the product should be applied 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 product should be applied twice daily (morning and night) for a duration of 2 weeks, or as directed by a healthcare professional.

For the treatment of jock itch and ringworm, the product should be applied once daily (morning or 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 the spread of infection.

For children under 12 years of age, consultation with a healthcare professional is advised before use.

Contraindications

Use of this product is contraindicated in the following situations:

  • Application on nails or scalp is prohibited due to potential adverse effects.

  • Use in or near the mouth or eyes is contraindicated to prevent irritation or injury.

  • The product should not be used for the treatment of vaginal yeast infections, as it is not indicated for this condition.

Warnings and Precautions

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

Healthcare professionals should advise patients to avoid contact with the eyes during use. In the event of accidental eye contact, it is imperative to rinse the eyes thoroughly with water. Should excessive irritation occur or if the irritation worsens, patients are instructed to discontinue use and consult a healthcare provider.

It is crucial to keep this product out of reach of children. In the case of ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

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 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. 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 crucial to seek medical assistance or contact a Poison Control Center immediately.

Drug Interactions

There are currently no documented drug interactions associated with the use of this medication. Additionally, there is no information available regarding 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 Cvs Pharmacy (terbinafine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Cvs Pharmacy.
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

Elderly patients may not have specific dosage adjustments, safety concerns, or special precautions outlined in the prescribing information for Terbinafine hydrochloride cream. As there is no available data regarding the use of this medication in geriatric populations, healthcare providers should exercise caution when prescribing to elderly patients.

It is advisable to monitor these patients closely for any potential adverse effects, given the lack of targeted clinical findings for this demographic. Individual patient factors, including comorbidities and concurrent medications, should be considered when determining the appropriateness of Terbinafine hydrochloride cream for elderly patients.

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 this medication during pregnancy; therefore, it is essential for healthcare providers to be consulted for further information regarding these risks.

Dosage modifications may be necessary for pregnant individuals, and healthcare providers should be consulted for appropriate guidance. Pregnant women are advised to discuss the use of this medication with their healthcare provider to carefully weigh the potential benefits against the risks involved.

Lactation

Nursing mothers should be aware of the potential for excretion of terbinafine in breast milk. Caution is advised when administering this medication to nursing mothers due to the potential risk to the infant.

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 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 prescribing information.

Overdosage

In the event of an overdosage, immediate medical assistance is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical help or contact a Poison Control Center without delay.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and evaluation are recommended to ensure patient safety and effective resolution of any complications arising from the overdosage.

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 question. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

Postmarketing Experience

No postmarketing experience details are available in the provided data.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children. Instruct patients that if the product is swallowed, they should seek medical help 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.

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

Storage and Handling

The product is supplied in a tube format, with specific lot numbers and expiration dates indicated on the carton or tube crimp. It is essential to store the product at a controlled room temperature ranging from 20° to 25°C (68° to 77°F) to maintain its efficacy.

Special handling precautions must be observed, as the product features a tamper-evident seal. It should not be used if the seal on the tube is punctured or not visible, ensuring the integrity and safety of the product for healthcare professionals and patients alike.

Additional Clinical Information

For the treatment of athlete's foot, patients should apply the medication twice daily (morning and night) for one week when the infection is located between the toes, or for two weeks when it affects the bottom or sides of the foot, unless otherwise directed by a clinician. For jock itch and ringworm, the recommended application is once daily (morning or night) for one week, or as directed by a healthcare provider.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

Drug Information (PDF)

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