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Silka

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Active ingredient
Terbinafine Hydrochloride 1 g/100 g
Other brand names
Drug class
Allylamine Antifungal
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2007
Label revision date
July 2, 2025
Active ingredient
Terbinafine Hydrochloride 1 g/100 g
Other brand names
Drug class
Allylamine Antifungal
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2007
Label revision date
July 2, 2025
Manufacturer
Genomma Lab USA, Inc.
Registration number
ANDA077511
NDC root
50066-080

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 common skin infections caused by fungi, specifically athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis). This cream works by effectively curing these infections and relieving associated symptoms such as itching, burning, cracking, and scaling of the skin.

This medication is available in full prescription strength and comes in a 1-ounce (30 g) tube, making it easy to apply to the affected areas. If you're dealing with any of these fungal skin conditions, Terbinafine Hydrochloride Cream can help restore your skin's health and comfort.

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 other nonteratogenic effects reported.

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 follow your doctor's instructions. If the infection is on the bottom or sides of your foot, apply it twice a day for two weeks, or as directed by your doctor. For jock itch and ringworm, you should apply the cream once a day, either in the morning or at night, for one week, or as your doctor advises. 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 product safely and effectively. You should avoid applying it to your nails or scalp, as well as in or near your mouth or eyes. Additionally, do not use this product for vaginal yeast infections. Following these guidelines will help ensure your safety and the best possible results.

Side Effects

When using this product, it's important to apply it only to the skin and avoid areas such as the nails, scalp, mouth, eyes, and vaginal area. If the product accidentally gets into your eyes, rinse them thoroughly with water. You should stop using the product and consult a doctor if you experience excessive irritation or if the irritation worsens.

Keep this product out of reach of children. If swallowed, seek medical help or contact a Poison Control Center immediately.

Warnings and Precautions

This product is intended for external use only, so please avoid applying it to your nails or scalp, and do not use it in or near your mouth or eyes. It is also not suitable for treating vaginal yeast infections. If you accidentally get the product in 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. Additionally, 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 get checked by a medical professional.

Pregnancy Use

The safety of this product during pregnancy has not been established, which means that it may not be safe for you or your developing baby. In fact, the use of terbinafine is specifically contraindicated (not recommended) during pregnancy due to potential risks to the fetus.

If you are pregnant or planning to become pregnant, it is crucial to consult your healthcare provider before using this product. They can help you understand the risks and explore safer alternatives if necessary. Your health and the health of your baby are the top priority.

Lactation Use

If you are breastfeeding and considering the use of Silka Antifungal (terbinafine hydrochloride), 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 medication 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 before starting any new medication while breastfeeding, to ensure it’s safe for you and your baby.

Pediatric Use

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

Geriatric Use

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

Always keep in mind that older adults may have different responses to medications, so monitoring for any unusual side effects is essential. If you have any questions or concerns, don’t hesitate to reach out to your doctor or pharmacist for guidance.

Renal Impairment

If you have kidney problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to be adjusted based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your specific condition. They can provide guidance based on your individual health needs.

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 or tests you may be taking. In this case, there are no known drug interactions or laboratory test interactions associated with the medication. However, your healthcare provider can help ensure that your overall treatment plan is safe and effective, taking into account all the medications and tests you may be using. Always feel free to ask questions and share your complete health history to get the best care possible.

Storage and Handling

To ensure the best performance and safety of your product, store it at a controlled room temperature between 20° to 25°C (68° to 77°F). It's important to check the packaging before use: do not use the product if the seal on the tube is punctured or not visible, as this indicates that the product may have been tampered with. Additionally, you should look for the lot number and expiration date on the carton or tube crimp to confirm that the product is still within its safe usage period.

By following these simple storage and handling guidelines, you can help maintain the integrity and effectiveness of the product.

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 1% is an antifungal cream used to cure most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis).

How does Terbinafine Hydrochloride Cream work?

It relieves symptoms such as itching, burning, cracking, and scaling associated with these fungal infections.

What are the instructions for applying the 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.

Are there any contraindications for using 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 get the cream in my eyes?

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

Is this cream safe to use during pregnancy?

The safety of Terbinafine Hydrochloride Cream during pregnancy has not been established, and it is contraindicated due to potential risks to the fetus.

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

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

How should I store Terbinafine Hydrochloride Cream?

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

Can children use this cream?

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

Packaging Info

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

Packaging configurations for Silka.
Details

Drug Information (PDF)

This file contains official product information for Silka, 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 indicated for the treatment of athlete's foot. This product is marketed under the brand name SILKA® and is available in a full prescription strength. The cream is packaged in a net weight of 1 oz (30 g).

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 aged 12 years and older should follow these instructions for proper use. To open the tube, the tip of the cap should be used to break the seal. Prior to application, the affected skin must be washed with soap and water and thoroughly dried.

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 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 be applied twice daily (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 daily (morning or night) for 1 week, or as directed by a healthcare professional. It is important to wash hands after each use to prevent the spread of infection.

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

Contraindications

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

When using this product, care must be taken to avoid contact with the eyes. In the event of eye contact, it is imperative to rinse thoroughly with water to mitigate potential irritation.

Users should discontinue use and consult a healthcare professional 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 advised without delay.

Side Effects

Patients using this product should be aware that it is intended for external use only. It is contraindicated for application on nails or the scalp, and it should not be used in or near the mouth or eyes, nor for the treatment of vaginal yeast infections.

During use, patients must take care to avoid contact with the eyes. In the event of eye contact, it is advised to rinse thoroughly with water. If excessive irritation occurs or worsens, patients should discontinue use and consult a healthcare professional.

Additionally, this product should be kept out of reach of children. In the case of accidental ingestion, it is crucial to seek medical assistance or contact a Poison Control Center immediately.

Drug Interactions

No drug interactions or drug and laboratory test interactions have been identified in the available data. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

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

Packaging configurations for Silka.
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 age range.

Geriatric Use

There is no specific information regarding the use of Silka Antifungal (terbinafine hydrochloride cream) in geriatric patients. The prescribing information does not provide guidance on dosage adjustments, safety concerns, or special precautions that may be necessary for elderly patients.

Healthcare providers should exercise caution when prescribing this medication to geriatric patients, considering the lack of data on its use in this population. Monitoring for efficacy and potential adverse effects is advisable, as elderly patients may have different pharmacokinetic and pharmacodynamic responses compared to younger individuals.

Pregnancy

The safety of this product during pregnancy has not been established. Terbinafine is contraindicated in pregnancy due to potential risks to the fetus. Pregnant women should consult a healthcare provider before using this product to discuss potential risks and benefits.

Lactation

There are no specific warnings or recommendations regarding the use of Silka Antifungal (terbinafine hydrochloride) in lactating mothers. Additionally, there is no information available concerning the potential for excretion of this product in breast milk or any associated risks to breastfed infants.

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 this medication to individuals with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment and monitoring of these patients.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to 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 assistance is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical help or contact a Poison Control Center without delay.

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

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

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the use of the compound in these contexts.

Postmarketing Experience

No postmarketing experience details are available in the provided text.

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 eyes. Additionally, it is important to communicate 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, with specific attention to tamper evidence. It is essential to inspect the seal on the tube; the product should not be used if the seal is punctured or not visible.

Storage conditions require the product to be maintained at a controlled room temperature of 20° to 25°C (68° to 77°F). For traceability, the lot number and expiration date can be found on the carton or the crimp of the tube.

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 Silka, 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 Silka, 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.