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Athletes Foot

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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)
Marketed in the U.S.
Since 2007
Label revision date
April 26, 2024
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
Marketed in the U.S.
Since 2007
Label revision date
April 26, 2024
Manufacturer
Target Corporation
Registration number
ANDA077511
NDC root
11673-080

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Drug Overview

Terbinafine hydrochloride is a prescription-strength antifungal cream designed to treat common skin infections caused by fungi, specifically athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis). This medication works by targeting the fungi responsible for these conditions, helping to cure the infection and relieve uncomfortable symptoms such as itching, burning, cracking, and scaling of the skin.

Available in a convenient 30 g tube, terbinafine hydrochloride is effective in addressing these common fungal infections, providing you with relief and promoting healthier skin. If you're dealing with any of these conditions, this cream may be a suitable option to consider for effective treatment.

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. With this treatment, you can expect to feel more comfortable and get back to your daily activities without the irritation caused by these 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 as your doctor advises. If the infection is on the bottom or sides of your foot, continue applying it twice a day for two weeks. For jock itch and ringworm, apply the cream once a day, either in the morning or at night, for one week, or follow your doctor's instructions. Remember to wash your hands after each use to prevent spreading the infection.

If you are considering this treatment for a child under 12 years old, please consult a doctor first.

What to Avoid

It's important to use this medication safely to avoid potential risks. You should never apply it to your nails or scalp, and it should not be used in or near your mouth or eyes. Additionally, this medication is not intended for treating vaginal yeast infections.

If you accidentally get the medication in your eyes, rinse them thoroughly with water right away. Always follow these guidelines to ensure your safety and the effectiveness of the treatment.

Side Effects

This product is intended for external use only, so be sure to avoid applying it to your nails, scalp, or in and around your mouth and eyes. 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 a doctor. Additionally, 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 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 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 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 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, acting quickly can make a significant difference in the outcome.

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 cream during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions have not been clearly outlined.

Before using this medication, you should consult with your healthcare provider to discuss any potential risks and to ensure that you are making the best choice for your health and the health of your baby. Always prioritize open communication with your doctor regarding any medications you may consider during pregnancy.

Lactation Use

When it comes to breastfeeding, it's important to be aware that there are no specific guidelines or statements regarding nursing mothers or lactation (the process of producing milk). This means that if you are breastfeeding, you may not find detailed information about how certain medications or treatments could affect you or your baby.

If you have concerns about breastfeeding while taking any medication, it's always best to consult with your healthcare provider for personalized advice and to ensure the safety of both you and your infant.

Pediatric Use

If you are considering this medication for your child, it's important to know that it is not recommended for children under 12 years old without consulting a doctor first. Always reach out to your child's healthcare provider to discuss any concerns or questions you may have regarding their treatment. This ensures that your child receives the safest and most effective care tailored to their age and health needs.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that 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 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 if you have hepatic impairment (issues with liver function).

Always consult your healthcare provider for personalized advice and to discuss any concerns regarding your liver health and how it may relate to your treatment. They can help ensure that you receive the safest and most effective care.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking. In this case, there are no specific drug interactions or laboratory test interactions noted, which means that the medication may not have known conflicts with other drugs or tests. However, every individual is different, and your healthcare provider can help ensure that your treatment plan is safe and effective for you.

Always discuss any new medications or changes in your health with your doctor or pharmacist. They can provide personalized advice and help you avoid any potential issues, even if no specific interactions are listed. Your health and safety should always come first.

Storage and Handling

To ensure the safety and effectiveness of your product, it's important to store it properly. Keep it at a controlled room temperature between 20° to 25°C (68° to 77°F). Always check the carton or the crimp on the tube for the lot number and expiration date to ensure you are using a product that is still valid.

When handling the product, be cautious and inspect the seal on the tube. Do not use it if the seal is punctured or not visible, as this indicates that the product may have been tampered with. 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 used for?

Terbinafine hydrochloride is an antifungal cream 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 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, after washing and drying the affected area.

Can children use Terbinafine hydrochloride?

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

Are there any areas where I should not apply this cream?

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

What should I do if I get Terbinafine hydrochloride in my eyes?

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

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

Stop using Terbinafine hydrochloride and ask a doctor if too much irritation occurs or gets worse.

How should I store Terbinafine hydrochloride?

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

What should I do if Terbinafine hydrochloride is swallowed?

If swallowed, get medical help or contact a poison control center right away.

Packaging Info

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

Packaging configurations for Athletes Foot.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

up & up is an antifungal cream formulated with terbinafine hydrochloride at a concentration of 1%. This product is indicated for the treatment of most cases of athlete's foot, jock itch, and ringworm. It provides relief from associated symptoms, including itching, burning, cracking, and scaling. The net weight of the product is 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: The efficacy of this drug may vary based on the severity and duration 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 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 due to the risk of irritation or adverse reactions. Additionally, the product is contraindicated 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 accidental eye contact, the affected area should be rinsed thoroughly with water to mitigate potential irritation.

Healthcare professionals should advise patients to discontinue use and seek medical advice if excessive irritation occurs or if the irritation worsens during treatment.

It is essential 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 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 crucial 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 contacted.

Drug Interactions

There are no specific drug interactions identified in the available data. Additionally, no laboratory test interactions have been reported. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the current information.

Packaging & NDC

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

Packaging configurations for Athletes Foot.
Details

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. The safety and efficacy of this medication in this age group have not been established, and specific dosing recommendations are not provided for children in this category.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

Pregnancy

The available data regarding the use of terbinafine hydrochloride cream during pregnancy is limited. The drug insert does not specify any safety concerns, dosage modifications, or special precautions for pregnant patients. As such, healthcare professionals should weigh the potential benefits against any unknown risks when considering the use of this medication in pregnant individuals. It is advisable to exercise caution and to discuss the potential implications with women of childbearing potential who may be considering treatment. Further studies may be necessary to fully understand the effects of terbinafine hydrochloride cream on fetal outcomes.

Lactation

There are no specific statements regarding the use of this medication in lactating mothers or its effects on breastfed infants. Healthcare professionals should consider the absence of data when advising lactating mothers about the use of this medication.

Renal Impairment

Patients with renal impairment may not have specific dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. Therefore, healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the lack of detailed guidance necessitates careful clinical judgment and individualized patient assessment. Regular monitoring of renal function is advisable to ensure patient safety and therapeutic efficacy.

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, 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 of the patient's condition is essential.

Management procedures should include supportive care and symptomatic treatment as necessary. Continuous monitoring of the patient's vital signs and clinical status is recommended to ensure appropriate interventions are implemented in a timely manner.

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 or 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. Furthermore, when using the 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 tamper-evident tube. It is essential to avoid using the product if the seal on the tube is punctured or not visible.

For optimal storage, the product should be maintained at a controlled room temperature ranging from 20° to 25°C (68° to 77°F). Users are advised to check the carton or the tube crimp for the lot number and expiration date to ensure product integrity and safety.

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 Athletes Foot, 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 Athletes Foot, 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.