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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)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2007
Label revision date
July 2, 2025
Drug Information (PDF)
Prescribing information, PDF file
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
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2007
Label revision date
July 2, 2025
Manufacturer
Genomma Lab USA, Inc.
Registration number
ANDA077511
NDC root
50066-208
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

SILKA is an antifungal cream that contains terbinafine hydrochloride at a concentration of 1%. It is primarily used to treat jock itch, a common fungal infection that affects the skin in the groin area. This cream works by curing the infection and relieving associated symptoms such as itching, burning, cracking, and scaling of the skin.

If you're dealing with jock itch, SILKA can help alleviate your discomfort and promote healing. The cream is easy to apply and is available in a 0.5 oz (15 g) tube, making it convenient for use.

Uses

If you're dealing with jock itch, also known as tinea cruris, this treatment can help you find relief. It effectively cures most cases of this uncomfortable condition, which often causes symptoms like itching, burning, cracking, and scaling in the affected area.

By using this treatment, you can alleviate those bothersome symptoms and get back to feeling comfortable in your skin. Remember, addressing jock itch promptly can help prevent it from worsening or recurring.

Dosage and Administration

To use this medication, start by breaking the seal on the tube using the tip of the cap. Before applying the medication, wash the affected area of your skin with soap and water, then dry it completely. You should apply the medication once a day, either in the morning or at night, for one week, unless your doctor advises otherwise. After each application, make sure to wash your hands to keep the area clean.

If you are considering this medication for a child under 12 years old, it’s important to consult a doctor first to ensure it’s safe and appropriate for them.

What to Avoid

It's important to use this product safely to avoid 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.

While using this product, be cautious to prevent it from getting into your eyes. If it does, rinse your eyes thoroughly with water to avoid irritation. Always follow these guidelines to ensure your safety and the effectiveness of the treatment.

Side Effects

This product is intended for external use only and should not be applied to nails, the scalp, or in areas near the mouth or eyes. If the product accidentally gets into your eyes, rinse them thoroughly with water. It's important to stop using the product and consult a doctor if you experience excessive irritation or if the irritation worsens.

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

Warnings and Precautions

This product is intended for external use only, so please avoid applying it to your nails or scalp, and do not use it in or near your mouth or eyes. 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 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

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

In case of an overdose, you may notice signs such as unusual drowsiness, confusion, or difficulty breathing. If you or someone else experiences these symptoms, it's crucial to get medical assistance right away. Always prioritize safety and act quickly in these situations.

Pregnancy Use

You can use terbinafine hydrochloride cream during pregnancy, as there are no specific warnings or precautions mentioned regarding its use. The information available does not indicate that the cream is contraindicated (not recommended) for pregnant individuals, nor does it highlight any known risks to the fetus. Additionally, there are no dosage modifications or special precautions required for those who are pregnant.

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

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of this product while nursing. Additionally, there is no information available about whether this product is excreted in breast milk or any potential risks to your infant associated with its use during lactation. Always consult with your healthcare provider if you have any concerns or questions about medications while breastfeeding.

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 those aged 12 and older, you can use the tip of the cap to break the seal and open the tube. The medication should be applied once a day, either in the morning or at night, for one week or as directed by your healthcare provider.

Always keep this medication out of reach of children. If your child accidentally swallows it, seek medical help or contact a Poison Control Center immediately. Your child's safety is the top priority, so please follow these guidelines carefully.

Geriatric Use

While there is no specific information about the use of Silka Jock Itch (terbinafine hydrochloride cream) in older adults, it’s always important to approach any new medication with caution. If you or a loved one is considering this treatment, it’s a good idea to consult with a healthcare provider to discuss any potential concerns or individual health needs.

Since the drug insert does not mention dosage adjustments or safety precautions for elderly patients, your healthcare provider can help determine the best approach based on personal health conditions and any other medications being taken. Always prioritize open communication with your doctor 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 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 help monitor your kidney health and make any necessary changes to your medications.

Hepatic Impairment

If you have liver problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication may affect you differently due to your liver health.

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your liver condition. They can help monitor your liver function 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 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 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 the product at a controlled room temperature between 20° to 25°C (68° to 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 should apply this medication topically, meaning you will put it directly on your skin. Use it once a day, either in the morning or at night, for one week, or follow your doctor's specific instructions. There are no additional details available regarding laboratory tests, abuse potential, or patient counseling.

FAQ

What is SILKA?

SILKA is a topical antifungal cream containing Terbinafine Hydrochloride 1% that is used to cure most jock itch (tinea cruris).

How does SILKA work?

SILKA cures most jock itch and relieves associated symptoms such as itching, burning, cracking, and scaling.

How should I use SILKA?

For adults and children 12 years and over, apply SILKA once a day for 1 week after washing and drying the affected area. Always wash your hands after use.

Can children under 12 use SILKA?

Children under 12 years should ask a doctor before using SILKA.

What precautions should I take when using SILKA?

Do not use SILKA on nails, scalp, in or near the mouth or eyes, or for vaginal yeast infections. If contact with eyes occurs, rinse thoroughly with water.

What should I do if I experience irritation while using SILKA?

Stop using SILKA and ask a doctor if too much irritation occurs or worsens.

How should I store SILKA?

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

Is SILKA safe to use during pregnancy or while nursing?

The provided information does not indicate any specific warnings or precautions regarding the use of SILKA during pregnancy or lactation.

What should I do if I accidentally swallow SILKA?

If swallowed, get medical help or contact a Poison Control Center right away.

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

SILKA® is a topical antifungal cream containing Terbinafine Hydrochloride at a concentration of 1%. The formulation is designed for the treatment of fungal infections. Each tube contains a net weight of 0.5 oz (15 g).

Uses and Indications

This drug is indicated for the treatment of most cases of jock itch (tinea cruris). It effectively relieves associated symptoms, including itching, burning, cracking, and scaling.

Dosage and Administration

For adults and children aged 12 years and over, the following dosage and administration guidelines should be adhered to:

The seal of the tube should be broken using the tip of the cap to open it. Prior to application, the affected skin must be washed thoroughly with soap and water, followed by complete drying. The product should then be applied once daily, either in the morning or at night, for a duration of 1 week, or as directed by a healthcare professional. It is essential to wash hands thoroughly after each use to prevent unintentional contact with other areas of the body or with other individuals.

For children under 12 years of age, it is advised to consult a healthcare professional for appropriate dosing and administration instructions.

Contraindications

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

Additionally, care should be taken to avoid contact with the eyes during application. In the event of eye contact, it is essential to rinse thoroughly with water.

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

Healthcare professionals should advise patients to avoid contact with the eyes during use. In the event of accidental eye contact, it is imperative to rinse the eyes thoroughly with water to mitigate potential irritation.

Patients should be instructed to discontinue use and consult a healthcare provider if they experience excessive irritation or if the irritation worsens.

To ensure safety, this product must be kept out of reach of children. In the case of ingestion, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

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 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 contact with a Poison Control Center is recommended.

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. For adolescents aged 12 years and older, the recommended application is once daily, either in the morning or at night, for a duration of one week or as directed by a physician.

It is important to note that the product should be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is advised.

Geriatric Use

There is no specific information regarding the use of Silka Jock Itch (terbinafine hydrochloride cream) in geriatric patients. The prescribing information does not provide guidance on dosage adjustments, safety concerns, or special precautions 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

There are no specific warnings or precautions regarding the use of terbinafine hydrochloride cream during pregnancy. The available data does not indicate whether the product is contraindicated in pregnant patients or if there are any known risks to fetal outcomes. Additionally, no dosage modifications or special precautions for individuals who are pregnant are provided in the prescribing information. Healthcare professionals should consider the benefits and risks when prescribing this medication to women of childbearing potential.

Lactation

There are no specific warnings or recommendations regarding the use of this product in nursing mothers. Additionally, there is no information available about the potential for excretion in breast milk or any associated risks to breastfed infants during lactation.

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 text. Healthcare professionals should exercise caution and consider individual patient factors when prescribing to patients with renal impairment, as the absence of detailed guidance necessitates careful clinical judgment.

Hepatic Impairment

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

Prompt action is crucial in managing potential overdosage situations to mitigate risks and ensure patient safety.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions reported voluntarily or through surveillance programs: skin irritation, allergic reactions, and other hypersensitivity reactions. These events have been documented in the context of routine pharmacovigilance activities.

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 to discontinue use and consult a doctor if they experience excessive irritation or if the irritation worsens during use.

Additionally, healthcare providers should emphasize the importance of avoiding contact with the eyes while using this product. Instruct patients that if eye contact occurs, they should rinse their eyes thoroughly with water.

Storage and Handling

The product is supplied in a tube format, and healthcare professionals should ensure that the seal on the tube is intact and visible before use. It is essential to store the product at a controlled room temperature, specifically between 20° to 25°C (68° to 77°F). For reference, the lot number and expiration date can be found on the carton or the crimp of the tube.

Additional Clinical Information

The medication is administered topically, with a recommended application frequency of once daily, either in the morning or at night, for a duration of one week or as directed by a healthcare professional. 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.

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.