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Massage Men Gel Max Time

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This product has been discontinued

Active ingredient
Benzocaine 7 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 2, 2021
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Benzocaine 7 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 2, 2021
Manufacturer
Valley of the Sun Cosmetics LLC
Registration number
part348
NDC root
76523-068
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 supportive 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 you to have more control during intimate moments. Additionally, it can temporarily prolong the time until ejaculation, enhancing your overall experience. This can lead to improved confidence and satisfaction in your sexual health.

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 be aware of certain precautions when using this product. If you experience premature ejaculation, it may be a sign of an underlying condition that needs medical attention. If the product does not help as directed, stop using it and consult your doctor. Additionally, if you or your partner notice any rash or irritation, such as burning or itching, discontinue use immediately and seek medical advice if the symptoms continue.

Make sure to avoid contact with your eyes, as this can lead to discomfort. Always prioritize your health and safety by following these guidelines.

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 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 unsure, 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 concerns about an overdose.

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, and you can find instructions for opening it in the accompanying leaflet. Always supervise your child around medications to prevent accidental ingestion.

Geriatric Use

When considering the use of Massage Men Gel Max Time (benzocaine gel) for older adults, it's important to note that the drug insert does not provide specific information about how this product may affect elderly patients. This means there are no special dosage adjustments, safety concerns, or precautions outlined for older individuals.

As always, if you or a caregiver are considering using this gel, it's wise to consult with a healthcare professional. They can provide personalized advice based on your health needs and any other medications you may be taking.

Renal Impairment

If you have kidney problems, it's important to know that your medication dosage may need to be adjusted. This is because renal impairment can affect how your body processes certain drugs. Your healthcare provider will likely monitor your renal function tests regularly to ensure your kidneys are working properly.

If you have decreased creatinine clearance (a measure of kidney function), your doctor may recommend a reduced dose of your medication to avoid potential side effects. Always communicate openly with your healthcare team about your kidney health to ensure safe and effective treatment.

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 discuss any concerns you may have regarding your liver function and how it relates to your treatment. They can help ensure that your medication is safe and effective for you.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking, even if there are no known drug interactions or laboratory test interactions associated with them. This ensures that your treatment plan is safe and effective for your individual health needs.

Always feel free to ask questions and share your complete list of medications and any lab tests you may undergo. Your healthcare provider can help you understand how these factors may affect your health and treatment.

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 integrity.

When handling the product, be sure to use the child-resistant closure properly. Instructions for opening are provided in the accompanying leaflet, so please refer to that for guidance. Following these storage and handling tips will help you use the product safely and effectively.

Additional Information

You should apply this medication topically, following the directions provided, and not use it more than four times a day. If you are pregnant or breastfeeding, it's important to consult a healthcare professional before using this product. Be careful to avoid contact with your eyes.

If you or your partner experience any rash or irritation, such as burning or itching, stop using the product immediately. If these symptoms continue, seek advice from a doctor. Additionally, if you notice that premature ejaculation might be linked to a medical condition, consult your doctor for further evaluation.

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 drug?

Apply a small amount to the head and shaft of the penis before intercourse, allowing the gel to dry. Wash the product off after intercourse.

How often can I use this drug?

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

Are there any precautions I should take?

Use only on intact, non-inflamed skin, and avoid contact with eyes.

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 drug safe to use during pregnancy or breastfeeding?

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

What should I do if I don't see improvement?

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

What should I do in case of accidental ingestion?

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

How should I store this drug?

Store between 20-25°C (68-77°F) and keep out of reach of children.

Packaging Info

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

Packaging configurations for Massage Men Gel Max Time.
Details

Drug Information (PDF)

This file contains official product information for Massage Men Gel Max Time, 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 sexual performance and satisfaction.

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:

Premature ejaculation may indicate an underlying condition that requires medical supervision. If the product does not provide relief when used as directed, discontinue use and consult a healthcare professional.

Discontinue use if you or your partner experience rash or irritation, including burning or itching. If symptoms persist, seek medical advice.

Avoid contact with eyes.

Warnings and Precautions

For external use only. It is imperative that this product is not applied to any internal areas or ingested.

General precautions should be observed to avoid contact with the eyes. In the event of accidental contact, rinse thoroughly with water and seek medical attention if irritation persists.

In cases of ingestion, immediate medical assistance is required. Contact a poison control center or seek emergency medical help without delay.

If premature ejaculation occurs, it may indicate an underlying condition that necessitates medical evaluation. Should this product, when used as directed, fail to provide the desired relief, it is advised to discontinue use and consult a healthcare professional.

Additionally, if either the user or their partner experiences any rash or irritation, including symptoms such as burning or itching, the use of this product should be stopped immediately. Persistent symptoms should be evaluated by a healthcare provider.

Side Effects

For external use only. Patients should be advised to discontinue use and consult a doctor if they experience premature ejaculation that may be due to 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 develop a 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 doctor for further evaluation and management.

Drug Interactions

No specific drug interactions have been identified for the product. 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 Massage Men Gel Max Time (benzocaine). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Massage Men Gel Max Time.
Details

Pediatric Use

Pediatric patients should be monitored closely, and the product must be kept out of reach of children to prevent accidental ingestion. Specific instructions for opening the product are provided in the accompanying leaflet, as children may exhibit resistance to closure mechanisms.

Geriatric Use

There is no specific information regarding the use of Massage Men Gel Max Time (benzocaine gel) in geriatric patients. The prescribing information does not provide guidance on dosage adjustments, safety concerns, or special precautions for elderly patients. Therefore, healthcare providers should exercise caution and consider individual patient factors when prescribing this medication to geriatric patients. Monitoring for efficacy and potential adverse effects is advisable, given the lack of targeted data for this population.

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 in these populations to ensure the safety of both the mother and the fetus or infant.

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

Renal impairment may necessitate dosage adjustments for patients with reduced kidney function. It is important to monitor renal function tests in these patients to ensure safety and efficacy. Additionally, a reduced dose should be considered for patients with decreased creatinine clearance to mitigate the risk of adverse effects.

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, the following management procedures should be considered:

  1. Assessment: Conduct a thorough assessment of the patient's clinical status, including vital signs and level of consciousness.

  2. Supportive Care: Provide supportive care as needed, which may include airway management, oxygen supplementation, and intravenous fluids.

  3. Consultation: Engage with a poison control center or a medical toxicologist for guidance on specific interventions and antidotes, if applicable.

  4. Documentation: Document all findings, interventions, and the patient's response to treatment meticulously.

Healthcare professionals should remain vigilant and prepared to implement appropriate measures in the event of an overdose, even in the absence of specific overdosage information.

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 compound in these areas.

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 inform patients that premature ejaculation may be indicative of an underlying condition that requires medical supervision. If the product, when used as directed, does not provide relief, patients should discontinue use and consult a doctor.

Patients should also be made aware that if they or their partner experience any rash or irritation, such as burning or itching, they should discontinue use of the product. Should these symptoms persist, it is essential to consult a healthcare professional. Additionally, healthcare providers should emphasize the importance of avoiding contact with the eyes to prevent potential irritation or injury.

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, it is recommended to consult a doctor. Additionally, patients should stop use and seek medical advice if premature ejaculation may be related to a condition requiring medical supervision.

Drug Information (PDF)

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