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Prolong Plus

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This product has been discontinued

Active ingredient
Benzocaine 4.2 g/56 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 2017
Label revision date
December 19, 2017
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Benzocaine 4.2 g/56 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 2017
Label revision date
December 19, 2017
Manufacturer
WSM Investment LL. Topco Sales
Registration number
part348
NDC root
69797-104
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 temporarily slow the onset of ejaculation. It can be beneficial for individuals seeking to manage premature ejaculation, allowing for a more satisfying sexual experience. While the specific details of how it works are not provided, its primary purpose is to assist in this common concern.

Uses

If you're looking for a way to manage premature ejaculation, this medication can help. It works by temporarily slowing the onset of ejaculation, giving you more control during intimate moments. This can enhance your overall experience and improve your confidence. Always consult with your healthcare provider to see if this treatment is right for you.

Dosage and Administration

To use this medication effectively, apply a small amount to the head and shaft of your penis before intercourse, or follow your doctor's specific instructions. Make sure to rub the product into the skin until it is fully absorbed.

It's important to remove any excess product to prevent unwanted numbing during intercourse. After you are finished, wash the product off to ensure cleanliness and comfort. Following these steps will help you use the medication safely and effectively.

What to Avoid

It's important to be aware of certain guidelines when using this product. While there are no specific contraindications or concerns regarding abuse, misuse, or dependence, you should stop using the product and consult a doctor if it does not provide relief as directed. Your health and safety are paramount, so always seek professional advice if you have any questions or concerns about your treatment.

Side Effects

Using this product may lead to some side effects that you should be aware of. If you experience any rash or irritation, such as burning or itching, you should stop using it immediately and consult a doctor. It's important to note that premature ejaculation could be a sign of a medical condition that requires professional attention. If the product does not help as expected, please discontinue use and seek medical advice.

Remember, this product is for external use only, and you should avoid contact with your eyes. Your safety and comfort are important, so don't hesitate to reach out to a healthcare provider if you have any concerns.

Warnings and Precautions

It's important to use this product only as directed and for external use only. If you experience premature ejaculation, it may be a sign of a condition that needs medical attention. If the product does not help, stop using it and consult your doctor.

Be cautious to avoid contact with your eyes, as this can cause irritation. If you or your partner notice any rash, burning, or itching, discontinue use immediately. In case of accidental swallowing, seek medical help or contact a Poison Control Center right away. Your safety and well-being are paramount, so don't hesitate to reach out for help if needed.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While there is no specific information available about the signs of overdose for this medication, general symptoms can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these signs, or if you are concerned about a possible overdose, seek medical help right away.

In case of an overdose, contacting your local emergency services or going to the nearest hospital is crucial. Always keep the medication packaging with you, as it can help healthcare professionals understand what you've taken. Remember, it's better to be safe and get checked out if you have any doubts.

Pregnancy Use

When considering the use of PROLONG PLUS - benzocaine cream during pregnancy, it's important to note that there is no specific information available regarding its safety, dosage adjustments, or any special precautions for pregnant individuals. This means that the effects of this cream on pregnancy have not been clearly studied or established.

If you are pregnant or planning to become pregnant, it is advisable to consult with your healthcare provider before using this product. They can help you weigh the potential risks and benefits based on your individual circumstances. Always prioritize your health and the health of your baby when making decisions about medication use during pregnancy.

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. Currently, there is no information available about whether this product is excreted in breast milk or any potential risks it may pose to your infant.

As always, if you have any concerns or questions about using this product while breastfeeding, it's a good idea to consult with your healthcare provider for personalized advice.

Pediatric Use

It's important to keep this medication out of reach of children. If a child accidentally swallows it, you should seek medical help immediately or contact a Poison Control Center. Taking quick action can help ensure their safety. Always be vigilant about where you store medications to prevent any accidental ingestion.

Geriatric Use

While there is no specific information about the use of PROLONG PLUS (benzocaine cream) in older adults, it’s important to approach its use with caution. Since the drug insert does not mention any dosage adjustments or safety concerns for elderly patients, you should consult with a healthcare professional before using this product. They can provide guidance tailored to your individual health needs and any potential interactions with other medications you may be taking. Always prioritize safety and ensure that any treatment is appropriate for your situation.

Renal Impairment

If you have kidney problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations for the medication do not include special monitoring or safety considerations tailored for patients with renal impairment (kidney issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your kidney health. They can provide guidance based on your individual situation.

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 should be used 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 determine the best course of action based on your individual situation.

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 and share any concerns you may have regarding your medications or tests.

Storage and Handling

To ensure the safety and effectiveness of your product, store it at room temperature, ideally between 20°-25°C (68°-77°F). This temperature range helps maintain the product's integrity. Before using it, always check that the seal under the cap is intact; do not use the product if the seal is broken or missing, as this could compromise its safety.

By following these simple storage and handling guidelines, you can help ensure that the product remains safe and effective for your use.

Additional Information

No further information is available.

FAQ

What is the purpose of this drug?

This drug helps in temporarily slowing the onset of ejaculation.

How should I use this product?

Apply a small amount to the head and shaft of the penis before intercourse, rub it into the skin until absorbed, and remove any excess to avoid unwanted numbing.

What should I do after intercourse?

You should wash the product off after intercourse.

Are there any contraindications for this drug?

No specific contraindications are listed for this drug.

What should I do if I don't experience relief?

If this product, used as directed, does not provide relief, discontinue use and consult a doctor.

Is this product safe for external use?

Yes, this product is for external use only, but avoid contact with eyes.

What should I do if I experience irritation?

Discontinue use if you or your partner develops a rash or irritation, such as burning or itching.

What if the product is swallowed?

If swallowed, seek medical help or call a Poison Control Center right away.

Is there any information regarding use during pregnancy?

No specific information regarding safety concerns or precautions during pregnancy is provided.

Can nursing mothers use this product?

There are no specific warnings or recommendations regarding the use of this product in nursing mothers.

How should I store this product?

Store at room temperature between 20°-25°C (68°-77°F) and do not use if the seal under the cap is broken or missing.

Packaging Info

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

Packaging configurations for Prolong Plus.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The product is identified by the SPL code 34089-3. No specific description details are provided in the text.

Uses and Indications

This drug is indicated for the temporary slowing of the onset of ejaculation in adult males. It is intended for use in patients experiencing premature ejaculation.

Limitations of Use: This drug is not intended for use in females or in pediatric populations. It should be used as part of a comprehensive treatment plan that may include counseling or behavioral techniques.

Dosage and Administration

Healthcare professionals should instruct patients to apply a small amount of the product to the head and shaft of the penis prior to intercourse, or as directed by a physician. The product should be gently rubbed into the skin of the penis until fully absorbed. It is important to remove any excess product to prevent unwanted numbing effects before engaging in intercourse. Following intercourse, patients should wash the product off thoroughly.

Contraindications

There are no contraindications associated with the use of this product. However, if the product does not provide relief when used as directed, it is advised to discontinue use and consult a healthcare professional.

Warnings and Precautions

Premature ejaculation may indicate an underlying condition that necessitates medical supervision. If the product does not provide relief when used as directed, it is imperative to discontinue use and consult a healthcare professional for further evaluation and management.

This product is intended for external use only. Healthcare professionals should advise patients to avoid contact with the eyes to prevent irritation or injury.

In the event that either the patient or their partner experiences a rash or irritation, such as burning or itching, it is essential to discontinue use immediately.

In cases of accidental ingestion, prompt medical assistance should be sought, or the Poison Control Center should be contacted without delay.

Overall, if the product fails to deliver the expected results when used as directed, it is crucial to cease use and seek medical advice.

Side Effects

Patients using this product may experience adverse reactions that necessitate careful monitoring and management. Notably, premature ejaculation may indicate an underlying condition that requires medical supervision. If the product does not provide relief when used as directed, patients are advised to discontinue use and consult a healthcare professional.

This product is intended for external use only, and it is crucial to avoid contact with the eyes. In the event that either the patient or their partner develops a rash or experiences irritation, such as burning or itching, it is recommended to discontinue use immediately.

These precautions are essential to ensure the safety and well-being of patients and their partners during treatment.

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 Prolong Plus (benzocaine). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Prolong Plus.
Details

Pediatric Use

Pediatric patients should be advised to keep this medication out of reach of children. In the event of accidental ingestion, it is crucial to seek medical assistance or contact a Poison Control Center immediately.

Geriatric Use

Elderly patients may not have specific dosage adjustments, safety concerns, or special precautions outlined in the drug insert for PROLONG PLUS (benzocaine cream). As such, healthcare providers should exercise caution when prescribing this medication to geriatric patients, given the lack of targeted clinical findings or recommendations for this population.

It is advisable for healthcare providers to monitor elderly patients closely for any potential adverse effects or unusual responses to treatment, considering the general physiological changes associated with aging that may affect drug metabolism and response.

Pregnancy

There is no specific information regarding the use of PROLONG PLUS - benzocaine cream during pregnancy. The drug insert does not provide safety concerns, dosage modifications, or special precautions for pregnant patients. Therefore, healthcare professionals should exercise caution when considering the use of this product in pregnant women, as the potential risks and effects on fetal outcomes are not well characterized. It is advisable to weigh the benefits against any unknown 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 provided about the potential for excretion in breast milk or any associated risks to breastfed infants.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

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 absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include monitoring vital signs, providing symptomatic treatment, and ensuring the patient's safety.

If available, consultation with a poison control center or a medical toxicologist is recommended to guide the management of the overdose effectively.

Documentation of the incident, including the substance involved, the amount taken, and the time of ingestion, is crucial for appropriate treatment and follow-up care.

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 insert text.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. In the event that the product is swallowed, patients should be instructed to seek medical help or contact a Poison Control Center immediately.

Additionally, healthcare providers should inform patients that if the product, when used as directed, does not provide relief, they should discontinue use and consult a doctor for further evaluation and guidance.

Storage and Handling

The product is supplied in a configuration that includes an NDC number for identification. It should be stored at room temperature, specifically within the range of 20° to 25°C (68° to 77°F).

It is imperative to ensure that the seal under the cap remains intact; the product should not be used if this seal is broken or missing. Proper handling and storage conditions are essential to maintain the integrity and efficacy of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Prolong Plus, 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 Prolong Plus, 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.