Symptom checker
Select audience type

Switch between content for healthcare professionals (PRO) and general audience (GEN).

ADD CONDITION

items per page

Shopko

Last content change checked dailysee data sync status

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 1, 2014
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 1, 2014
Manufacturer
Shopko Stores Operating Co. , LLC
Registration number
ANDA077511
NDC root
37012-080
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 eliminating the fungus, this cream helps relieve uncomfortable symptoms such as itching, burning, cracking, and scaling associated with these conditions.

If you're dealing with any of these fungal infections, Terbinafine Hydrochloride Cream can provide relief and help restore your skin's health.

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 the patient is a child under 12 years old, consult a doctor before use.

What to Avoid

It's important to use this product safely to avoid potential issues. You should not use it on your nails or scalp, in or near your mouth or eyes, or for treating vaginal yeast infections. If you experience excessive irritation or if it worsens while using the product, stop using it immediately and consult your doctor.

While using this product, be careful to keep it away from your eyes. If it accidentally gets into your eyes, rinse them thoroughly with water. Following these guidelines will help ensure your safety and the effectiveness of the product.

Side Effects

This product is intended for external use only and should not be applied to nails, the scalp, or in and around the 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 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 the 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 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 symptoms that are not typical for the medication. If you notice any concerning changes in behavior or health, don’t hesitate to get help. Remember, it’s always better to be safe and get checked out if you suspect an overdose.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that there are no specific statements about the use of terbinafine hydrochloride cream during pregnancy. The information available does not highlight any safety concerns, contraindications (situations where the product should not be used), or special precautions related to its use while pregnant.

As always, it's best to consult with your healthcare provider before using any medication during pregnancy to ensure it is safe for you and your baby.

Lactation Use

If you are breastfeeding, you can use terbinafine hydrochloride cream without specific warnings or recommendations against it. The information available does not indicate any particular concerns or precautions for nursing mothers regarding this medication.

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

Pediatric Use

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

When treating athlete's foot, apply the medication twice a day, in the morning and at night, for one week, or follow your doctor's instructions. For jock itch and ringworm, apply it once a day, either in the morning or at night, for one week, or as advised by a doctor. Always keep this medication out of reach of children, and if it is swallowed, seek medical help or contact a poison control center immediately.

Geriatric Use

While there is no specific information about the use of Shopko Athlete's Foot Cream (terbinafine hydrochloride) in older adults, it's important to approach any new medication with caution. If you or a loved one is considering this treatment, it's wise to consult with a healthcare provider to discuss any potential safety concerns or special precautions that may be relevant.

Since the drug insert does not mention dosage adjustments for elderly patients, your healthcare provider can help determine the appropriate use based on individual health needs. Always ensure that any treatment aligns with your overall health plan, especially if there are existing medical conditions or medications involved.

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 kidney function might affect the use of this medication.

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

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 ensure that any medication you take is safe and appropriate for your liver health. They can help monitor your condition and make any necessary adjustments to your treatment plan.

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 this medication is generally considered safe to use alongside other treatments and tests. However, every individual is different, and your healthcare provider can help ensure that your overall treatment plan is safe and effective for you. Always feel free to ask questions or express any concerns you may have regarding your medications or tests.

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

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, 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, apply the cream 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.

What are the application instructions for jock itch and ringworm?

For jock itch and ringworm, apply the cream once a day for 1 week, or as directed by a doctor.

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

Do not use Terbinafine Hydrochloride Cream 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 the cream?

If you experience too much irritation or if it gets worse, stop using the cream and ask a doctor.

Is this cream safe for children?

For children under 12 years, you should ask a doctor before use. Adults and children 12 years and older can use it as directed.

What should I do if the cream gets into my eyes?

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

How should I store Terbinafine Hydrochloride Cream?

Store the cream at a controlled room temperature of 20°-25°C (68°-77°F) and keep it out of reach of children.

What should I do if the seal on the tube is broken?

Do not use the cream if the seal on the tube is broken or not visible.

Packaging Info

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

Packaging configurations for Shopko.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Terbinafine Hydrochloride Cream 1% is an antifungal formulation designed for topical application. It is indicated for the treatment of most cases of athlete's foot. The product is presented in a cream dosage form, with a net weight of ½ ounce (15 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 is primarily established for the aforementioned conditions. There are no indications or data provided regarding its use in other dermatological or systemic fungal infections.

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 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.

In the case of jock itch and ringworm, the medication should be applied once a day (either 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 scalp, in or near the mouth or eyes, and for the treatment of vaginal yeast infections.

In the event of excessive irritation or worsening symptoms, discontinue use and consult a healthcare professional. Care should be taken to avoid contact with the eyes; if contact occurs, rinse thoroughly with water.

Warnings and Precautions

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

Care should be taken to avoid contact with the eyes. In the event of eye contact, it is imperative to rinse thoroughly with water.

Users should discontinue use and consult a healthcare professional if excessive irritation occurs or if 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 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, it is imperative to seek medical assistance or contact a poison control center immediately.

Drug Interactions

No specific drug interactions have been identified for this medication. Additionally, there are no reported interactions with laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

Packaging & NDC

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

Packaging configurations for Shopko.
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.

For the treatment of athlete's foot, the recommended application is twice daily (morning and night) for one week, or as directed by a healthcare provider. In the case of jock itch and ringworm, the product should be applied once daily (morning or night) for one 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 or contact with a poison control center is advised.

Geriatric Use

Elderly patients may not have specific dosage adjustments, safety concerns, or special precautions outlined in the drug insert for Shopko Athlete's Foot Cream (terbinafine hydrochloride). As there is no available information 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 data. Clinical judgment should guide the decision-making process, taking into account the individual health status and comorbidities of geriatric patients.

Pregnancy

There are no specific statements regarding the use of terbinafine hydrochloride cream during pregnancy. The prescribing information does not mention any safety concerns, contraindications, or special precautions related to the use of this product in pregnant patients. As such, healthcare professionals should consider the lack of data when advising women of childbearing potential and weigh the potential benefits against any unknown risks to fetal outcomes.

Lactation

There are no specific warnings or recommendations regarding the use of terbinafine hydrochloride cream in lactating mothers. Additionally, there are no specific considerations or precautions related to lactation mentioned in the provided text. Therefore, healthcare professionals may consider the use of this medication in nursing mothers without specific concerns related to breastfeeding.

Renal Impairment

There is no specific information regarding renal impairment, dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function provided in the insert. Healthcare professionals should exercise caution when prescribing to patients with renal impairment, as the lack of data necessitates careful consideration of individual patient circumstances.

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 available information.

Overdosage

In the event of an overdosage, immediate medical intervention is crucial. If the substance is ingested, it is imperative to seek medical assistance or contact a poison control center without delay.

Healthcare professionals should be aware that prompt action can significantly influence the outcome of an overdosage situation. Symptoms may vary depending on the specific substance involved, and monitoring for any adverse effects is essential.

Management of overdosage should include supportive care and symptomatic treatment as necessary. Continuous assessment of the patient's condition is recommended to address any complications that may arise.

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 compound in these areas.

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; 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 product's efficacy 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 Shopko, 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 Shopko, 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.