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Mandelay

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This product has been discontinued

Active ingredient
Benzocaine 2.13 g/28.35 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 1995
Label revision date
November 9, 2017
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Benzocaine 2.13 g/28.35 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 1995
Label revision date
November 9, 2017
Manufacturer
Majestic Drug Co. , INC.
Registration number
part348
NDC root
10705-077
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

MANDELAY® is a product known as Climax Control Gel. It is designed to help you temporarily prolong the time until ejaculation, which can enhance your sexual experience. This gel works by affecting the sensitivity of the skin, allowing for greater control during intimate moments.

With a net weight of 1.0 oz. (28.35g), MANDELAY® offers a convenient option for those looking to improve their sexual performance and satisfaction.

Uses

If you're looking for a solution to help manage premature ejaculation, this medication can be beneficial. It works by temporarily prolonging the time until ejaculation, allowing for a more satisfying experience during intimate moments. This can help improve your confidence and overall sexual satisfaction.

Dosage and Administration

To use this medication effectively, apply a small amount to the head and shaft of your penis about 2 to 3 minutes before intercourse. If your doctor has given you specific instructions, be sure to follow those as well.

After you are finished with intercourse, it’s important to wash the product off thoroughly. This helps ensure that you maintain proper hygiene and get the best results from the medication.

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 a doctor, as premature ejaculation may indicate an underlying condition that needs medical attention. Additionally, if you or your partner experience any rash or irritation, such as burning or itching, discontinue use and seek medical advice.

To protect your eyes, be sure to avoid any contact with them while using this product. Following these guidelines will help you use the product safely and effectively.

Side Effects

When using this product, it's important 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 and consult a doctor. Additionally, if the product does not provide relief as directed, it may indicate a condition that requires medical attention.

Please remember that this product is for external use only. If swallowed, seek medical help or contact a Poison Control Center immediately.

Warnings and Precautions

This product is intended for external use only, so please avoid contact with your eyes while using it. 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. It's important to note that premature ejaculation may be linked to a condition that requires medical attention.

Keep this product out of reach of children. If it is swallowed, seek medical help immediately or contact a Poison Control Center. Your safety is a priority, so please take these precautions seriously.

Overdose

If you or someone else has swallowed too much of a medication, it’s important to seek medical help immediately. You can do this by contacting a Poison Control Center or going to the nearest emergency room. Acting quickly can make a significant difference in the outcome.

Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms, don’t hesitate to get help right away. Remember, it’s always better to be safe and get checked by a medical professional.

Pregnancy Use

Currently, there is no information available about the use of MANDELAY Male Genital Desensitizer (benzocaine gel) during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions for pregnant individuals have not been addressed in the drug insert.

If you are pregnant or planning to become pregnant, it is essential to consult with your healthcare provider before using this product to ensure your safety and the safety of 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 are no statements indicating that the product is excreted in breast milk or that it poses any risk to your infant. This means you can use the product without concern for its effects on your milk production or your baby's health.

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 and store medications securely to prevent any accidents.

Geriatric Use

While there is no specific information about the use of MANDELAY Male Genital Desensitizer (benzocaine gel) 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 consider consulting with a healthcare professional before using this product. This is especially important if you or your loved one have any underlying health conditions or are taking other medications. Always prioritize safety and ensure that any new treatment is appropriate for your individual health needs.

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 change 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 situation. They can help monitor your kidney health and make any necessary adjustments 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 if you have hepatic impairment (issues with liver function).

Always consult your healthcare provider for personalized advice and to discuss any concerns regarding your liver health and medication use. They can help ensure that you receive the safest and most effective treatment based on your individual needs.

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 best performance of your product, store it at room temperature. It's important to keep the tube tightly closed when not in use to maintain its integrity. Additionally, protect it from excessive heat, as this can affect its effectiveness. Once you open the tube, please remember to discard it after use to ensure safety and prevent contamination. Following these simple guidelines will help you handle the product safely and effectively.

Additional Information

You should apply a small amount of the product to the head and shaft of the penis 2-3 minutes before intercourse, or follow your physician's instructions. After intercourse, make sure to wash the product off. There are no additional details available regarding laboratory tests, abuse potential, or patient counseling.

FAQ

What is MANDELAY®?

MANDELAY® is a climax control gel designed to help temporarily prolong the time until ejaculation.

How do I use MANDELAY®?

Apply a small amount to the head and shaft of the penis 2-3 minutes before intercourse, or use as directed by a physician. Be sure to wash the product off after intercourse.

Are there any contraindications for using MANDELAY®?

No specific contraindications are mentioned for MANDELAY®.

What should I do if I experience irritation while using MANDELAY®?

Stop use and ask a doctor if you or your partner develop a rash or irritation, such as burning or itching.

Is MANDELAY® safe to use during pregnancy?

There is no specific information regarding the use of MANDELAY® during pregnancy.

What should I do if MANDELAY® is swallowed?

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

How should I store MANDELAY®?

Store MANDELAY® at room temperature, keep the tube tightly closed when not in use, and protect it from excessive heat.

Can I use MANDELAY® if I have kidney or liver problems?

No specific information regarding use in patients with kidney or liver problems is provided.

What are the side effects of MANDELAY®?

For external use only, avoid contact with eyes, and stop use if the product does not provide relief or if irritation occurs.

Packaging Info

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

Packaging configurations for Mandelay.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

MANDELAY® is formulated as a Climax Control Gel, designed for topical application. The product has a net weight of 1.0 ounce (28.35 grams).

Uses and Indications

This drug is indicated for the temporary prolongation of the time until ejaculation in adult males. It is intended for use in the management of 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 and 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 2 to 3 minutes prior to intercourse, or as directed by a physician. It is essential that the product is thoroughly washed off after intercourse to ensure proper hygiene and effectiveness.

Contraindications

The product is contraindicated in the following situations:

Patients should discontinue use and consult a healthcare professional if the product, when used as directed, fails to provide relief, as this may indicate an underlying condition requiring medical evaluation. Additionally, if either the patient or their partner experiences a rash or irritation, such as burning or itching, medical advice should be sought. Contact with the eyes should be strictly avoided to prevent potential harm.

Warnings and Precautions

This product is intended for external use only. Healthcare professionals should advise patients to avoid contact with the eyes during application.

In the event that the product does not provide relief when used as directed, it is imperative to stop use and consult a physician. Premature ejaculation may indicate an underlying condition that necessitates medical evaluation and supervision.

Patients should also be instructed to discontinue use and seek medical advice if they or their partner experience any rash or irritation, including symptoms such as burning or itching.

It is essential to keep this product out of the reach of children. In cases of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

Side Effects

Patients using this product should be aware that it is intended for external use only. Care should be taken to avoid contact with the eyes, as this may lead to irritation or other adverse effects.

In clinical practice, if the product does not provide relief when used as directed, patients are advised to stop use and consult a healthcare professional. It is important to note that premature ejaculation may be indicative of an underlying condition that requires medical supervision.

Additionally, patients should discontinue use and seek medical advice if they or their partner experience any rash or irritation, including symptoms such as burning or itching.

In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

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

Packaging configurations for Mandelay.
Details

Pediatric Use

Pediatric patients should be advised to keep this medication out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

Geriatric Use

There is no specific information regarding the use of MANDELAY Male Genital Desensitizer (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 when considering the use of this product in individuals aged 65 and older, as the absence of data necessitates careful monitoring and clinical judgment.

Pregnancy

There is currently no information available regarding the use of MANDELAY Male Genital Desensitizer (benzocaine gel) during pregnancy. As such, the safety of this product in pregnant patients has not been established. There are no known dosage modifications or special precautions recommended for use during pregnancy. Healthcare professionals should consider the lack of data when advising women of childbearing potential and weigh the potential risks versus benefits before prescribing this product.

Lactation

There are no specific warnings or recommendations regarding the use of this product in nursing mothers. Additionally, there are no statements concerning 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 event of an overdosage, immediate medical intervention is crucial. If the substance is ingested, it is imperative to seek medical assistance or contact a Poison Control Center without delay.

Healthcare professionals should be aware that prompt action can significantly influence the outcome of an overdosage situation. Symptoms of overdosage may vary depending on the specific substance involved; therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures should include supportive care and symptomatic treatment as necessary. Continuous evaluation of the patient's condition is recommended to address any complications that may arise.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

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 of swallowing the product, patients should seek medical assistance or contact a Poison Control Center immediately.

Patients should be informed to discontinue use and consult a doctor if the product, when used as directed, fails to provide relief. It is important to note that premature ejaculation may indicate an underlying condition that requires medical supervision.

Additionally, healthcare providers should instruct patients to stop using the product and seek medical advice if they or their partner experience any rash or irritation, including symptoms such as burning or itching.

Patients should also be cautioned to avoid contact with the eyes while using this product to prevent potential irritation or injury.

Storage and Handling

The product is supplied in a tube that must be kept tightly closed when not in use to maintain its integrity. It should be stored at room temperature, away from excessive heat. Once opened, the product should be discarded to ensure safety and efficacy.

Additional Clinical Information

Patients are advised to apply a small amount of the product to the head and shaft of the penis 2-3 minutes before intercourse, or as directed by a physician. It is important to wash the product off after intercourse. No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

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