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Terbinafine hydrochloride

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This product has been discontinued

Active ingredient
Terbinafine Hydrochloride 1 g/100 g
Other brand names
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
May 10, 2017
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Terbinafine Hydrochloride 1 g/100 g
Other brand names
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
May 10, 2017
Manufacturer
Pharmacy Value Alliance LLC
Registration number
ANDA077511
NDC root
68016-080
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 various fungal skin infections. 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.

This cream comes in a 1-ounce (30 g) tube and has been independently tested to ensure its effectiveness. If you're dealing with any of these fungal infections, Terbinafine Hydrochloride Cream may provide the relief you need.

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 breaking the seal on the tube with the tip of the cap. Before applying the medication, wash the affected area of your skin with soap and water, then dry it completely.

If you’re treating athlete's foot, it’s important to wear well-fitting, ventilated shoes and change your shoes and socks at least once a day. For application, if the infection is between your toes, apply the medication twice a day—once in the morning and once at night—for one week, or as your doctor advises. If the infection is on the bottom or sides of your foot, you should apply it twice a day for two weeks. For jock itch and ringworm, apply the medication once a day for one week. Remember to wash your hands after each use to prevent spreading the infection.

If 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 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

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 the product accidentally gets into 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. Keep this product out of reach of children, and if it is swallowed, seek medical help or contact a poison control center immediately.

Overdose

It's important to keep this medication out of reach of children. If a child accidentally swallows it, you should seek medical help or contact a poison control center immediately.

Signs of an overdose can vary, but if you suspect that someone has taken too much, it's crucial to act quickly. Always prioritize safety and don't hesitate to reach out for professional assistance.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that there is no specific information available about the use of Terbinafine Hydrochloride during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions related to its use in pregnant individuals have not been established.

Before taking this medication, you should discuss it with your healthcare provider to understand any potential risks and to ensure the best care for you and your baby. Always prioritize open communication with your doctor regarding any medications you may be considering during pregnancy.

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 regarding its use for nursing mothers. Additionally, there is no information available about whether this cream is passed 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.

Pediatric Use

If your child is under 12 years old, it's important to consult a doctor before using this medication. For those aged 12 and older, you can use it as directed.

When treating athlete's foot, apply the medication twice a day—once in the morning and once at night. For infections between the toes, continue this for one week; for the bottom or sides of the foot, use it for two weeks. For jock itch and ringworm, apply it once a day for one week. Always keep this product out of reach of children, and if it is swallowed, seek medical help or contact a poison control center immediately.

Geriatric Use

When it comes to using Terbinafine Hydrochloride Cream, there is no specific information available about how it should be used by older adults. This means that there are no special dosage adjustments, safety concerns, or precautions outlined for elderly patients.

If you are caring for an older adult who may need this treatment, it’s always a good idea to consult with a healthcare professional. They can provide personalized advice and ensure that the cream is used safely and effectively.

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 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 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 it 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

The medication is applied topically, meaning you will use it on the skin. If you experience excessive irritation or if the irritation worsens, you should stop using the product and consult your doctor.

It's important to keep this medication out of reach of children. If a child accidentally swallows it, seek medical help or contact a poison control center immediately.

FAQ

What is Terbinafine Hydrochloride Cream used for?

Terbinafine Hydrochloride Cream is an antifungal cream that cures most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis).

How does Terbinafine Hydrochloride Cream work?

It relieves itching, burning, cracking, and scaling associated with these fungal conditions.

What are the instructions for using Terbinafine Hydrochloride Cream for athlete's foot?

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

Can children use Terbinafine Hydrochloride Cream?

Children under 12 years should ask a doctor before use.

Are there any warnings associated with Terbinafine Hydrochloride Cream?

Yes, it is for external use only and should not be used on nails, scalp, in or near the mouth or eyes, or for vaginal yeast infections.

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

Stop use and ask a doctor if too much irritation occurs or gets worse.

How should I store Terbinafine Hydrochloride Cream?

Store at controlled room temperature between 20°-25°C (68°-77°F) and do not use if the seal on the tube is broken.

Is there any information about using Terbinafine Hydrochloride Cream during pregnancy or while nursing?

There are no specific warnings or recommendations regarding its use during pregnancy or lactation.

What should I do if the cream is swallowed?

Keep out of reach of children and if swallowed, get medical help or contact a poison control center right away.

Packaging Info

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

Packaging configurations for Terbinafine Hydrochloride.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Premier Value Athlete's Foot Cream contains Terbinafine Hydrochloride at a concentration of 1%. This formulation is designed as an antifungal cream specifically indicated for the treatment of most cases of athlete's foot. The product is packaged in a net weight of 1 oz (30 g). It has undergone independent testing to ensure its efficacy and quality. A satisfaction guarantee is also provided with the product.

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 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 administered 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 also be applied twice a day (morning and night) but for a duration of 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 in the following situations:

  • Application on nails or scalp is not recommended.

  • Use in or near the mouth or eyes is contraindicated due to potential irritation or adverse effects.

  • The product should not be used 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.

Healthcare professionals should advise patients to discontinue use and consult a physician if excessive irritation occurs or if the 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 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, immediate medical assistance should be sought, or a poison control center should be contacted without delay.

Drug Interactions

There are no reported drug interactions associated with the use of this medication. Additionally, no interactions with laboratory tests have been identified. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug interactions.

Packaging & NDC

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

Packaging configurations for Terbinafine Hydrochloride.
Details

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. For patients aged 12 years and older, the product may be used as directed.

In the treatment of athlete's foot, the following application guidelines are recommended: for lesions located between the toes, the product should be applied twice daily (morning and night) for 1 week, or as directed by a healthcare provider. For lesions on the bottom or sides of the foot, it should be applied twice daily for 2 weeks, or as directed.

For the treatment of jock itch and ringworm, the product should be applied once daily (morning or night) for 1 week, or as directed by a healthcare provider.

It is important to keep this product out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought or a poison control center contacted.

Geriatric Use

There is no specific information regarding the use of Terbinafine Hydrochloride Cream in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as the absence of data necessitates careful consideration of individual patient factors and potential risks. Monitoring for any adverse effects is advisable, given the lack of established guidelines for this population.

Pregnancy

There is no specific information available regarding the use of Terbinafine Hydrochloride during pregnancy, including safety concerns, dosage modifications, or special precautions. Given the lack of data, healthcare professionals should weigh the potential benefits against any unknown risks when considering the use of this medication in pregnant patients. It is advisable to discuss treatment options with women of childbearing potential and to consider alternative therapies when appropriate.

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

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established 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, it is imperative to keep the product out of reach of children. Should ingestion occur, immediate medical assistance is required. Healthcare professionals should advise caregivers to contact a poison control center without delay.

Prompt intervention is crucial to mitigate potential adverse effects associated with overdosage. The specific symptoms of overdosage may vary depending on the substance involved; therefore, a thorough assessment and appropriate management strategies should be implemented based on clinical presentation and available guidelines.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

No postmarketing experience details are available in the provided data.

Patient Counseling

Healthcare providers should advise patients to keep the 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 the product should not be used on nails or the scalp, and they should avoid application in or near the mouth and eyes. Additionally, patients should be cautioned against using the product for vaginal yeast infections.

Healthcare providers should encourage patients to discontinue use and consult a doctor if they experience excessive irritation or if the irritation worsens. When using the product, patients must be reminded to avoid contact with the eyes, and 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 product is administered topically. Clinicians should advise patients to discontinue use and consult a doctor if excessive irritation occurs or worsens. It is also important to keep the product out of reach of children; if ingested, patients should seek medical assistance or contact a poison control center immediately.

Drug Information (PDF)

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

View product document (PDF)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Terbinafine Hydrochloride, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

Learn more in our Editorial Policy

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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.