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Goodsense

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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
April 20, 2015
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
April 20, 2015
Manufacturer
Geiss, Destin & Dunn, Inc.
Registration number
ANDA077511
NDC root
50804-080
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 skin infections caused by fungi. It is effective in curing most cases of athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis). In addition to treating these conditions, the cream helps relieve symptoms such as itching, burning, cracking, and scaling that often accompany fungal infections.

This cream is available in full prescription strength and contains the same active ingredient found in Lamisil AT, making it a reliable option for those seeking relief from uncomfortable fungal skin conditions.

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 more comfortable and confident as you recover from 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, or follow your doctor's instructions. For jock itch and ringworm, apply the cream once a day, either in the morning or at night, for one week, or as directed by your doctor. 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, be sure to consult a doctor first.

What to Avoid

It's important to use this product safely to avoid any potential issues. You should not apply it to your nails or scalp, and it should never be used in or near your mouth or eyes. Additionally, this product is not intended for treating vaginal yeast infections, so please refrain from using it for that purpose. Following these guidelines will help ensure your safety and the effectiveness of the product.

Side Effects

When using this product, it's important to remember that it is for external use only. Avoid applying it to your nails, scalp, or in areas near your mouth or eyes, as well as for treating vaginal yeast infections. 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 your symptoms worsen. Additionally, keep the product out of reach of children, and if it is 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, 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 condition 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 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, you may be wondering about the use of terbinafine hydrochloride cream. According to the information available, there are no specific warnings or precautions regarding its use during pregnancy. Additionally, the product insert does not indicate any risks to the fetus or state that it is contraindicated for pregnant individuals.

You can use this cream without needing to make any dosage modifications or take special precautions related to your pregnancy. However, it's always a good idea to consult with your healthcare provider before starting any new medication during this time.

Lactation Use

If you are breastfeeding and considering the use of Terbinafine Hydrochloride Cream, you can feel reassured that there are no specific warnings or recommendations against its use for nursing mothers. Currently, there is no information available about whether this cream passes into breast milk or if it poses any risk to your infant.

As always, it's a good idea to consult with your healthcare provider if you have any concerns or questions about using this medication while breastfeeding. They can provide personalized advice based on your situation.

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. For children aged 12 years and older, you can use the medication as directed. Always follow the guidance provided by your healthcare professional to ensure the safety and well-being of your child.

Geriatric Use

While there is no specific information about the use of GoodSense Terbinafine Hydrochloride Cream in older adults, it’s always important to approach any new medication with caution. If you are caring for an older adult, be sure to monitor for any unusual reactions or side effects when using this cream.

Since the drug insert does not mention dosage adjustments or special precautions for elderly patients, it’s advisable to consult with a healthcare professional before starting treatment. They can provide personalized guidance based on individual health needs and any other medications being taken.

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 (liver issues).

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

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 lab tests you undergo, as this helps in managing your health effectively.

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). This helps maintain its quality and performance.

Additionally, you can find important information such as the lot number and expiration date on the carton or the crimp of the tube. Make sure to dispose of the product responsibly once it has expired or if the seal is compromised.

Additional Information

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

FAQ

What is Terbinafine Hydrochloride Cream used for?

Terbinafine Hydrochloride Cream is an antifungal cream that cures most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis). It also relieves itching, burning, cracking, and scaling associated with these conditions.

How should I use Terbinafine Hydrochloride Cream?

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. For jock itch and ringworm, apply once a day for 1 week. Always wash the affected area and dry it completely before application.

Are there any side effects of using Terbinafine Hydrochloride Cream?

For external use only, you should avoid contact with eyes. If irritation occurs or worsens, stop use and consult a doctor. Keep out of reach of children.

Can I use Terbinafine Hydrochloride Cream during pregnancy?

There are no specific warnings or contraindications regarding the use of Terbinafine Hydrochloride Cream during pregnancy mentioned in the provided information.

Is Terbinafine Hydrochloride Cream safe for nursing mothers?

The information provided does not include specific warnings or recommendations for nursing mothers regarding the use of Terbinafine Hydrochloride Cream.

What should I avoid while using Terbinafine Hydrochloride Cream?

Do not use the cream on nails, scalp, in or near the mouth or eyes, or for vaginal yeast infections. If the seal on the tube is broken, do not use it.

What should I do if I accidentally get Terbinafine Hydrochloride Cream in my eyes?

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

What is the storage requirement for Terbinafine Hydrochloride Cream?

Store Terbinafine Hydrochloride Cream at a controlled room temperature of 20°-25°C (68°-77°F).

Packaging Info

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

Packaging configurations for Goodsense.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

GOODSENSE® is a full prescription strength antifungal cream containing 1% Terbinafine Hydrochloride. The product is formulated for topical application and is designed to treat fungal infections. It is comparable to the active ingredient found in Lamisil AT®. Each tube contains a net weight of 0.5 oz (15 g). The National Drug Code (NDC) for this product is 50804-080-01.

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.

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. When applying the medication between the toes, it should be administered 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 medication should also be applied twice daily (morning and night) but for a period of 2 weeks, or as directed by a healthcare professional.

In cases of jock itch and ringworm, the medication should be applied once daily (either morning or night) for 1 week, or as directed by a healthcare professional. It is essential to wash hands thoroughly after each use to prevent the spread of infection.

For children under 12 years of age, it is advised to consult a doctor before use.

Contraindications

The product is contraindicated for use on nails or the scalp. It should not be applied in or near the mouth or the eyes. Additionally, the product is not indicated for the treatment of vaginal yeast infections.

Warnings and Precautions

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 the eyes. Additionally, this product is not indicated for the treatment of vaginal yeast infections.

Care should be taken to avoid contact with the eyes. In the event of accidental eye contact, it is imperative to rinse the eyes thoroughly with water. If irritation occurs or worsens during use, the patient should discontinue use immediately and consult a healthcare professional.

This product must be kept out of reach of children. In the case of ingestion, it is crucial to seek medical assistance or contact a poison control center without delay.

Side Effects

Patients should be aware that 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 the eyes. In the event of eye contact, it is imperative to rinse thoroughly with water.

During the use of this product, if patients experience excessive irritation or if the irritation worsens, they 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 or contact with a poison control center is recommended.

Drug Interactions

There are currently no specific drug interactions identified for the medication. Additionally, no interactions with laboratory tests have been reported. Therefore, no dosage adjustments or monitoring recommendations are necessary at this time. It is advisable to continue standard clinical practices and monitor the patient as per usual protocols.

Packaging & NDC

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

Packaging configurations for Goodsense.
Details

Pediatric Use

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

Geriatric Use

There is no specific information regarding the use of GoodSense Terbinafine Hydrochloride Cream in geriatric patients. The prescribing information does not provide guidance on dosage adjustments, safety concerns, or special precautions for elderly patients. Therefore, healthcare providers should exercise caution and consider individual patient factors when prescribing this medication to geriatric patients, as the absence of specific data necessitates careful monitoring and assessment of treatment outcomes in this population.

Pregnancy

The use of terbinafine hydrochloride cream during pregnancy has not been associated with specific warnings or precautions. The available data does not indicate whether the product is contraindicated in pregnant patients or if there are any known risks to the fetus. Additionally, there are no recommendations for dosage modifications or special precautions for individuals who are pregnant. Healthcare professionals should consider the lack of specific data when advising women of childbearing potential regarding the use of this medication during pregnancy.

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 from the use of Terbinafine Hydrochloride Cream during 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 data limits the ability to make informed decisions regarding its use in this population. Regular monitoring of renal function may be warranted in these patients, although specific recommendations are not provided.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials for this medication. Consequently, there is no available information regarding dosage adjustments, special monitoring requirements, or precautions 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 warranted based on clinical judgment.

Overdosage

In the event of an overdosage, immediate medical intervention is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical assistance or contact a poison control center without delay.

Prompt action is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved; therefore, a thorough assessment by a medical professional is recommended to determine the appropriate course of action and management strategies.

Healthcare providers should ensure that patients are aware of the importance of timely reporting of any suspected overdosage to facilitate effective treatment and minimize risks.

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 identified the following adverse reactions reported voluntarily or through surveillance programs: rash, pruritus, and urticaria. These events have been documented in the context of ongoing safety monitoring.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children. In the event of accidental ingestion, patients should seek medical assistance or contact a poison control center immediately.

Patients should be informed that this product is not intended for use on nails or the scalp, and it should not be applied in or near the mouth or the eyes. Additionally, it is important to clarify that this product is not indicated for the treatment of vaginal yeast infections.

Healthcare providers should instruct patients to discontinue use and consult a doctor if they experience excessive irritation or if the irritation worsens. Furthermore, patients should be cautioned to avoid contact with the eyes while using this product. In case 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.

For optimal storage, the product must be kept at a controlled room temperature ranging from 20° to 25°C (68° to 77°F). It is important to check the carton or the crimp of the tube for the lot number and expiration date to ensure the product's validity 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 Goodsense, 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 Goodsense, 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

Last AI update:

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.