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Shunga

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This product has been discontinued

Active ingredient
Benzocaine 1.125 g/15 g
Other brand names
Dosage form
Aerosol, Spray
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2010
Label revision date
November 9, 2022
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Benzocaine 1.125 g/15 g
Other brand names
Dosage form
Aerosol, Spray
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 2010
Label revision date
November 9, 2022
Manufacturer
Eau Zone Oils & Fragrances LTD
Registration number
part348
NDC root
63240-5100
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

This medication is designed to help you manage premature ejaculation by temporarily prolonging the time until ejaculation. It works by reducing sensitivity in the penis, which can enhance your experience during intercourse. If you find that oversensitivity is affecting your sexual performance, this drug may be a helpful option for you.

Uses

If you're looking for a way to enhance your sexual experience, this medication can help by temporarily prolonging the time until ejaculation. It works by reducing the sensitivity of the penis, which can be beneficial if you find that you are overly sensitive before intercourse.

By using this medication, you may find it easier to enjoy intimacy without the worry of premature ejaculation, allowing for a more satisfying experience for both you and your partner.

Dosage and Administration

To use this medication effectively, you should spray 3 to 8 doses onto the head and shaft of your penis about 5 to 10 minutes before engaging in intercourse. It's important to note that the exact number of sprays you need may differ from person to person, so start with the minimum amount that works for you.

After intercourse, make sure to wash off the medication thoroughly. This will help ensure that you are using the product safely and effectively. Always remember to follow these guidelines for the best results.

What to Avoid

It's important to use this medication safely. You should never inhale it, as this can lead to serious complications. Additionally, be mindful of the dosage; do not exceed 24 sprays within a 24-hour period to avoid potential risks.

While there are no specific contraindications or concerns about abuse, misuse, or dependence associated with this medication, following these guidelines will help ensure your safety and the effectiveness of your treatment. Always consult with your healthcare provider if you have any questions or concerns.

Side Effects

You should be aware that this product is for external use only and should not come into contact with your eyes. If it does, rinse your eyes with water immediately. It's important not to exceed 24 sprays in a 24-hour period, and you should avoid inhaling the product or using it in large amounts on large areas of your body. If you have an allergy to benzocaine or any of the ingredients, do not use this product.

If you experience any adverse reactions, such as a rash, burning, or itching, or if the product does not provide relief as expected, stop using it and consult your doctor. Additionally, if symptoms persist, seek medical advice.

Warnings and Precautions

This product is for external use only, so please avoid contact with your eyes. If it does get into your eyes, rinse them with water immediately. You should not use more than 24 sprays in a 24-hour period, and it's important not to inhale the product or apply it in large amounts on large areas of your body. If you are allergic to benzocaine or any other ingredient in this product, do not use it.

Keep this product out of reach of children. If you find that the product does not relieve your symptoms as directed, or if you or your partner experience any rash or irritation, such as burning or itching, stop using it and consult your doctor. Additionally, if symptoms persist, seek medical advice.

Overdose

Using this medication safely is important to avoid any potential overdose. You should never exceed 24 sprays in a 24-hour period, as using more than this can lead to serious health issues. Additionally, avoid applying it in large quantities or on large areas of your body, as this increases the risk of overdose.

If you suspect an overdose, look for signs such as unusual drowsiness, confusion, or difficulty breathing (respiratory depression). If you notice any of these symptoms, seek immediate medical help. Always prioritize your safety and consult a healthcare professional if you have any concerns about your usage.

Pregnancy Use

The safety of this product during pregnancy has not been established, and it is contraindicated, meaning it should not be used if you are pregnant. There may be potential risks to your fetus associated with its use, so it is crucial to consult your healthcare provider before considering this product. Currently, there are no specific dosage modifications provided for pregnant individuals, but your healthcare provider can guide you on the best course of action for your health and the health of your baby.

Lactation Use

If you are breastfeeding, it's important to be cautious when considering the use of this product, as it may be excreted in breast milk (meaning it can pass into your milk and potentially affect your baby). Currently, there is limited information on how benzocaine, a key ingredient in this product, may impact nursing infants.

To ensure the safety of both you and your baby, it is highly recommended that you consult with your healthcare provider before using this product while breastfeeding. They can help you weigh the benefits and risks based on your specific situation.

Pediatric Use

It's important to keep this medication out of reach of children. This precaution helps prevent accidental ingestion, which can be dangerous. Always store it in a safe place where children cannot access it, ensuring their safety at all times. If you have any concerns or questions about the medication, don't hesitate to reach out to your healthcare provider for guidance.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that if you or a loved one is an older adult, it’s important to consult with a healthcare provider before starting the medication. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

Renal Impairment

There are no specific guidelines, dosage adjustments, or monitoring requirements mentioned for patients with kidney problems in the provided information. If you have renal impairment (kidney issues), it's important to consult your healthcare provider for personalized advice and to ensure your treatment is safe and effective. Always keep your doctor informed about your kidney health, as they can provide the best recommendations tailored to your 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 (liver issues).

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

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking, even if there are no specific drug interactions or laboratory test interactions noted for your treatment. This ensures that your healthcare team can provide the best care tailored to your needs.

Always feel free to ask questions and share all the medications and supplements you are using. This helps your provider monitor your health effectively and make informed decisions about your treatment.

Storage and Handling

To ensure the best results, store the product in a cool, dry place, keeping it below 25ºC (77ºF). This helps maintain its effectiveness. Each spray application delivers 7.0 mg of Benzocaine, and you can expect approximately 170 doses from each container.

Before using, check the base of the container for the LOT (lot number) and Expiry Date to confirm its safety and effectiveness. Always handle the product with care to maintain its integrity and ensure your safety.

Additional Information

No further information is available.

FAQ

What is the purpose of this drug?

This drug helps in temporarily prolonging the time until ejaculation by diminishing tactile sensations to the penis and is used for reducing oversensitivity in advance of intercourse.

How should I apply the spray?

Spray 3 to 8 doses on the head and shaft of the penis, between 5 to 10 minutes prior to intercourse. Use the minimum effective quantity.

Are there any contraindications for this product?

This product is contraindicated in pregnancy and should not be used if you are allergic to benzocaine or any ingredient contained in this product.

What precautions should I take while using this product?

This product is for external use only. Avoid contact with eyes, do not inhale, and do not exceed a maximum of 24 sprays in 24 hours.

What should I do if I experience irritation?

Stop use and ask your doctor if this product does not provide relief, or if you or your partner develops a rash or irritation, such as burning or itching.

Is this product safe to use during pregnancy?

The safety of this product during pregnancy has not been established, and there may be potential risks to the fetus.

Can nursing mothers use this product?

Nursing mothers should exercise caution when using this product due to the potential for excretion in breast milk and should consult a healthcare provider.

How should I store this product?

Store below 25ºC (77ºF).

Packaging Info

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

Packaging configurations for Shunga.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The drug is identified by the SPL code 34089-3 and is presented as a white to off-white powder. Its chemical name is insert chemical name here. The formulation includes inactive ingredients, which are insert inactive ingredients here.

Uses and Indications

This drug is indicated for the temporary prolongation of the time until ejaculation by diminishing tactile sensations to the penis. It is specifically used for reducing oversensitivity in advance of intercourse.

Dosage and Administration

Healthcare professionals are advised to administer the product as follows:

The recommended dosage is to spray between 3 to 8 doses onto the head and shaft of the penis. This application should occur approximately 5 to 10 minutes prior to sexual intercourse. It is important to note that the effective number of sprays and the required application delay may vary among individuals; therefore, practitioners should encourage patients to determine their minimum effective quantity for optimal results.

Following intercourse, it is essential to wash off the product to ensure proper hygiene and minimize any potential side effects.

Contraindications

Use of this product is contraindicated in patients who are unable to avoid inhalation, as inhalation may lead to adverse effects. Additionally, exceeding the maximum recommended dosage of 24 sprays within a 24-hour period is contraindicated due to the potential for increased risk of side effects.

Warnings and Precautions

The product is intended for external use only. Healthcare professionals should advise patients to avoid contact with the eyes; in the event of accidental contact, it is imperative to flush the eyes with water immediately.

Patients must not exceed the maximum dosage of 24 sprays within a 24-hour period. Inhalation of the product is contraindicated, and it should not be applied in large quantities or on extensive body surfaces. Additionally, individuals with a known allergy to benzocaine or any other ingredient in this formulation should refrain from using the product.

General precautions include ensuring that the product is kept out of reach of children to prevent accidental ingestion or misuse.

Patients should be instructed to discontinue use and consult a healthcare provider if the product does not provide relief when used as directed. Medical supervision may be necessary for cases of premature ejaculation. Furthermore, if either the patient or their partner experiences a rash or irritation, such as burning or itching, or if symptoms persist, they should seek medical advice promptly.

Side Effects

Patients using this product should be aware of several important warnings and potential adverse reactions. This product is intended for external use only and should not be applied to the eyes; in the event of contact with the eyes, it is advised to flush with water immediately. Users should not exceed a maximum of 24 sprays within a 24-hour period and should avoid inhalation. Additionally, the product should not be used in large quantities or on large body surfaces. It is contraindicated in individuals with a known allergy to benzocaine or any other ingredient contained in this formulation.

In clinical use, patients are advised to discontinue use and consult a healthcare professional if the product, when used as directed, fails to provide relief. Furthermore, if either the patient or their partner experiences a rash or irritation, such as burning or itching, medical advice should be sought. Persistent symptoms should also prompt a consultation with a healthcare provider.

Drug Interactions

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

Packaging & NDC

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

Packaging configurations for Shunga.
Details

Pediatric Use

Pediatric patients should be advised to keep this medication out of reach of children. It is essential to ensure that the medication is stored safely to prevent accidental ingestion or misuse.

Geriatric Use

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

Pregnancy

The safety of this product during pregnancy has not been established, and it is contraindicated in pregnant patients. There may be potential risks to the fetus associated with the use of this product during pregnancy. Due to these concerns, pregnant women are advised to consult a healthcare provider before using this product. No specific dosage modifications for pregnant individuals are provided.

Lactation

Nursing mothers should exercise caution when using this product due to the potential for excretion in breast milk. There is a lack of data on the effects of benzocaine on nursing infants. It is recommended that lactating mothers consult a healthcare provider before using this product while breastfeeding.

Renal Impairment

There is no information available regarding renal impairment, including dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of specific guidance when treating patients with renal impairment.

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 overdosage, it is critical to adhere to the recommended dosage guidelines to mitigate potential adverse effects. The maximum allowable dosage is 24 sprays within a 24-hour period. Exceeding this limit may lead to an increased risk of toxicity and associated complications.

Healthcare professionals should be vigilant regarding the application of the product. It is advised not to use the product in large quantities or on extensive body surfaces, as this may heighten the likelihood of systemic absorption and subsequent overdosage.

In cases where overdosage is suspected, immediate assessment of the patient is essential. Monitoring for symptoms related to excessive exposure is recommended, although specific symptoms have not been detailed in the provided information. Appropriate management should be initiated based on the clinical presentation and severity of symptoms.

Healthcare providers are encouraged to consult relevant clinical guidelines and toxicology resources for further management strategies in the event of an overdosage scenario.

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 question. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

Postmarketing Experience

Postmarketing experience has revealed reports of adverse reactions associated with the use of benzocaine products. These reactions include, but are not limited to, skin irritation, allergic reactions, and hypersensitivity reactions. These events have been reported voluntarily or identified through surveillance programs.

Patient Counseling

Healthcare providers should advise patients that the product is intended for external use only and must be kept out of reach of children to prevent accidental ingestion or misuse.

Patients should be informed to avoid contact with the eyes while using the product. In the event of accidental eye contact, they should immediately flush the eyes with water to minimize irritation or injury.

It is important to counsel patients against inhaling the product, as this may lead to respiratory discomfort or other adverse effects.

Additionally, healthcare providers should emphasize the importance of adhering to the recommended dosage, instructing patients not to exceed a maximum of 24 sprays within a 24-hour period to avoid potential overdose or increased side effects.

Storage and Handling

The product is supplied in a container that provides approximately 170 spray doses, with each spray application containing 7.0 mg of Benzocaine. The National Drug Code (NDC) numbers are available for reference.

Storage conditions require that the product be maintained at temperatures below 25ºC (77ºF). It is essential to check the base of the container for the Lot number and Expiry Date to ensure product integrity and compliance with usage guidelines.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Shunga, 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 Shunga, 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.