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Massage Men Gel Max Size

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This product has been discontinued

Active ingredient
Benzocaine 5 g/100 g
Other brand names
Dosage form
Gel
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2021
Label revision date
July 1, 2021
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Benzocaine 5 g/100 g
Other brand names
Dosage form
Gel
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 2021
Label revision date
July 1, 2021
Manufacturer
Valley of the Sun Cosmetics LLC
Registration number
part348
NDC root
76523-063
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 prevent premature ejaculation, allowing you to temporarily prolong the time until ejaculation occurs. It can be a useful option for those looking to enhance their sexual experience and improve confidence. If you have concerns about premature ejaculation, this medication may be worth discussing with your healthcare provider.

Uses

If you're looking for a way to manage premature ejaculation, this medication can be beneficial. It helps prevent premature ejaculation, allowing for a more satisfying experience. Additionally, it can temporarily prolong the time until ejaculation, giving you greater control during intimate moments.

Dosage and Administration

To use this medication effectively, apply a small amount to the head and shaft of the penis before intercourse, or follow your doctor's specific instructions. It's important to wash the product off after intercourse. Make sure to only apply it to intact, non-inflamed skin to avoid any irritation.

Before you engage in intercourse, allow the gel to dry completely. Remember, this product is not meant for oral use, so keep it away from your mouth. Use it as directed, and do not exceed four applications in a single day to ensure safety and effectiveness.

What to Avoid

It's important to use this product correctly to ensure your safety and well-being. If you find that the product does not provide relief as directed, please stop using it and consult your doctor for further advice. Additionally, if you or your partner experience any rash or irritation, such as burning or itching, discontinue use immediately and seek medical attention if the symptoms continue.

Make sure to avoid contact with your eyes, as this could lead to discomfort or complications. Always prioritize your health and consult a healthcare professional if you have any concerns.

Side Effects

When using this product, it's important to be aware of potential side effects. If you experience premature ejaculation that does not improve with use, it may indicate a condition that requires medical attention, so it's best to stop using the product and consult your doctor. Additionally, if you or your partner notice any rash or irritation, such as burning or itching, discontinue use immediately. If these symptoms continue, please seek medical advice.

Remember, this product is for external use only, and your health and comfort are the top priority.

Warnings and Precautions

This product is for external use only, so please avoid applying it to any internal areas. Be careful not to let it come into contact with your eyes, as this could cause irritation.

If you accidentally swallow the product, seek medical help immediately or contact a poison control center. If you find that the product does not help with premature ejaculation, or if you or your partner experience any rash or irritation, such as burning or itching, stop using it and consult your doctor. It's important to address any underlying conditions that may require medical attention.

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 effects of an overdose for this medication, you should be aware of general signs that may indicate a problem. These can include unusual drowsiness, confusion, or difficulty breathing.

If you notice any of these symptoms or if you believe you have taken too much of the medication, seek medical help right away. Contact your healthcare provider or go to the nearest emergency room. It's always better to be safe and get checked out if you have any concerns about your health.

Pregnancy Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using this medication. They can provide guidance on whether it’s safe for you and your baby. Always prioritize your health and the health of your child by seeking expert advice.

Lactation Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using any medication. This ensures that you understand any potential risks and can make informed decisions about your health and the health of your baby. Always prioritize open communication with your doctor regarding your breastfeeding journey.

Pediatric Use

It's important to keep this medication out of reach of children to ensure their safety. If you need to open the container, be aware that it has a child-resistant closure, which means it is designed to be difficult for children to open. Instructions for how to properly open it are included in the leaflet, so be sure to follow those guidelines carefully. Always prioritize safety when handling medications around children.

Geriatric Use

While there is no specific information about the use of Massage Men Gel Max Size in older adults, it's important to approach any new treatment with caution. Since the drug insert does not mention dosage adjustments or safety concerns for elderly patients, you should consider consulting with a healthcare professional before using this product. This is especially important if you have any underlying health conditions or are taking other medications, as older adults may have different needs and responses to treatments. Always prioritize your health and safety by seeking personalized advice.

Renal Impairment

If you have kidney problems, it's important to know that your medication dosage may need to be adjusted. Regular monitoring of your kidney function tests is essential to ensure your safety and the effectiveness of your treatment. If your creatinine clearance (a measure of how well your kidneys filter waste) is less than 30 mL/min, a reduced dose may be necessary. Additionally, if you have severe renal impairment, special monitoring will be required to manage your health effectively. Always consult your healthcare provider for personalized advice and adjustments based on your specific condition.

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. 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, store it at a temperature between 20-25°C (68-77°F). This temperature range helps maintain the product's quality. When handling the product, be sure to use the child-resistant closure properly; instructions for opening are provided in the accompanying leaflet to help you.

Always keep the product out of reach of children to prevent accidental ingestion. Following these guidelines will help you use the product safely and effectively.

Additional Information

You should use this medication topically, applying it as directed and no more than four times a day. If you are pregnant or breastfeeding, it's important to consult a healthcare professional before using it. Be careful to avoid contact with your eyes.

If you experience premature ejaculation that may be linked to a medical condition, stop using the product and consult your doctor. Additionally, if you or your partner notice any rash or irritation, such as burning or itching, discontinue use and seek medical advice if symptoms persist.

FAQ

What is the purpose of this drug?

This drug helps in the prevention of premature ejaculation and temporarily prolongs the time until ejaculation.

How should I use this product?

Apply a small amount to the head and shaft of the penis before intercourse, and wash it off afterward. Use only on intact, non-inflamed skin and allow the gel to dry prior to intercourse.

How often can I use this product?

Use as directed, not more than four times per day.

What should I do if I experience irritation?

If you or your partner develop a rash or irritation, such as burning or itching, discontinue use and consult a doctor if symptoms persist.

Is this product safe for everyone?

If this product does not provide relief, discontinue use and consult a doctor, as premature ejaculation may require medical supervision.

What precautions should I take while using this product?

Avoid contact with the eyes and keep the product out of reach of children.

Can I use this product if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, ask a health professional before use.

What should I do in case of accidental ingestion?

If swallowed, get medical help or contact a poison control center immediately.

What are the storage conditions for this product?

Store between 20-25°C (68-77°F) and ensure it is kept out of reach of children.

Packaging Info

Below are the non-prescription pack sizes of Massage Men Gel Max Size (benzocaine). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Massage Men Gel Max Size.
Details

Drug Information (PDF)

This file contains official product information for Massage Men Gel Max Size, 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 additional specific description details are provided in the available data.

Uses and Indications

This drug is indicated for the prevention of premature ejaculation in adult males. It assists in temporarily prolonging the time until ejaculation, thereby enhancing control during sexual activity.

Dosage and Administration

The recommended application involves applying a small amount of the product to the head and shaft of the penis prior to intercourse, or as directed by a healthcare professional. It is essential to wash the product off after intercourse. The gel should only be used on intact, non-inflamed skin to ensure safety and efficacy.

Prior to intercourse, the gel must be allowed to dry completely. This preparation step is crucial for optimal performance. The product is not intended for oral use and should be applied as directed, with a maximum frequency of four times per day.

Contraindications

Use of this product is contraindicated in the following situations:

Discontinue use and consult a healthcare professional if the product, when used as directed, does not provide relief. Additionally, if you or your partner experience any rash or irritation, including burning or itching, discontinue use and seek medical advice if symptoms persist. Contact with the eyes should be avoided.

Warnings and Precautions

For external use only. It is imperative to avoid contact with the eyes to prevent irritation or injury.

In the event of accidental ingestion, immediate medical assistance should be sought, or a poison control center should be contacted without delay.

Patients should be advised to discontinue use and consult a healthcare professional if premature ejaculation persists despite proper use of the product, as this may indicate an underlying condition that requires medical evaluation. Additionally, if either the patient or their partner experiences any rash or irritation, including symptoms such as burning or itching, use of the product should be stopped. Should these symptoms continue, it is essential to seek medical advice.

Side Effects

For external use only. Patients should be advised to discontinue use and consult a doctor if premature ejaculation occurs, as it may be indicative of an underlying condition requiring medical supervision. If the product, when used as directed, does not provide relief, it is recommended to stop use and seek medical advice.

Additionally, if patients or their partners experience any rash or irritation, including symptoms such as burning or itching, they should discontinue use immediately. Should these symptoms persist, it is important to consult a healthcare professional for further evaluation and management.

Drug Interactions

There are no specific drug interactions identified for this medication. Additionally, no laboratory test interactions have been reported. 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 Massage Men Gel Max Size (benzocaine). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Massage Men Gel Max Size.
Details

Pediatric Use

Pediatric patients should be advised to keep the medication out of reach of children to prevent accidental ingestion. Additionally, the product features a child-resistant closure. Instructions for proper opening are provided in the accompanying leaflet to ensure safe use by caregivers.

Geriatric Use

There is no specific information regarding the use of Massage Men Gel Max Size in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when considering the use of this product in elderly patients, as the absence of data necessitates careful monitoring and individualized assessment of potential risks and benefits.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully considered, as the effects on fetal outcomes and breastfeeding infants are not fully established. It is essential for women of childbearing potential to discuss their individual circumstances with a healthcare provider to ensure safe use during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding the excretion of this medication in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

Dosage adjustments may be necessary for patients with reduced renal function. Regular monitoring of renal function tests is recommended for patients with known kidney problems. A reduced dose should be considered for patients with a creatinine clearance of less than 30 mL/min. Additionally, special monitoring is required for patients with severe 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 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 further management and intervention strategies.

Documentation of the incident, including the substance involved, the amount taken, and the time of ingestion, is crucial for effective 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 seek immediate medical assistance or contact a poison control center if the product is swallowed. It is important to emphasize the necessity of avoiding contact with the eyes to prevent potential irritation or injury.

Patients should be informed that premature ejaculation may be indicative of an underlying condition that requires medical supervision. If the product, when used as directed, does not provide the desired relief, patients should discontinue use and consult a healthcare professional for further evaluation.

Additionally, healthcare providers should instruct patients to discontinue use if they or their partner experience any rash or irritation, such as burning or itching. If these symptoms persist, it is essential for patients to consult a doctor for appropriate management.

Storage and Handling

The product is supplied in packaging that includes a children-resistant closure, with detailed instructions for opening provided in the accompanying leaflet. It is essential to store the product at a temperature range of 20-25°C (68-77°F) to ensure its stability and efficacy. Proper handling and storage conditions must be adhered to in order to maintain the integrity of the product.

Additional Clinical Information

The product is administered topically and should be used as directed, not exceeding four applications per day. Clinicians should counsel patients to consult a health professional if they are pregnant or breastfeeding before use. Patients are advised to avoid contact with the eyes and to discontinue use if they or their partner experience rash or irritation, such as burning or itching. If symptoms persist, a consultation with a doctor is recommended. Additionally, patients should stop use and seek medical advice if premature ejaculation may be related to an underlying condition requiring supervision.

Drug Information (PDF)

This file contains official product information for Massage Men Gel Max Size, 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 Massage Men Gel Max Size, 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.