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Intimale Benzocaine Delay Gel

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Active ingredient
Benzocaine 50 mg/1 mL
Other brand names
Drug class
Standardized Chemical Allergen
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 2022
Label revision date
November 6, 2023
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Benzocaine 50 mg/1 mL
Other brand names
Drug class
Standardized Chemical Allergen
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 2022
Label revision date
November 6, 2023
Manufacturer
SKINS SEXUAL HEALTH LIMITED
Registration number
M017
NDC root
81923-369
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 prevent premature ejaculation, allowing for a more satisfying sexual experience. It works by affecting the way your body responds during sexual activity, helping to prolong the time before ejaculation occurs. If you're looking for support in managing this condition, this medication may be a suitable option for you.

Uses

If you're looking for a solution to help with premature ejaculation, this medication can be beneficial. It works by temporarily preventing this condition, allowing for a more satisfying experience. If you have concerns about this issue, consider discussing it with your healthcare provider to see if this option is right for you.

Dosage and Administration

To use this medication effectively, you should apply 3 to 5 pumps to the head and shaft of the penis before engaging in sexual activity, or follow your doctor's specific instructions. After applying the product, gently massage it onto the penis until it is fully absorbed into the skin.

It's important to remember to use only the minimum amount necessary to achieve the desired effect. This helps ensure that you are using the product safely and effectively.

What to Avoid

It's important to be aware of specific instructions regarding the use of this product. If you accidentally swallow it, you should seek medical attention or contact a poison control center right away. This is crucial for your safety.

Currently, there are no listed contraindications, controlled substance classifications, or concerns about abuse, misuse, or dependence associated with this product. However, always use it as directed and consult with a healthcare professional if you have any questions or concerns.

Side Effects

Using this product may lead to some side effects that you should be aware of. If you experience premature ejaculation, it could indicate a condition that needs medical attention. If the product does not help, please stop using it and consult your doctor. Additionally, if you or your partner notice any rashes or irritation, such as burning or itching, discontinue use and seek medical advice.

Remember, this product is for external use only, so be sure to avoid contact with your eyes. If you have any concerns about these side effects, don’t hesitate to reach out to a healthcare professional.

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, or if you or your partner develop any rash or irritation, such as burning or itching, stop using it and consult your doctor.

Be cautious to avoid contact with your eyes. If the product is accidentally swallowed, seek emergency medical help or contact a poison control center right away. Always prioritize your health and safety by following these guidelines.

Overdose

If you or someone else has swallowed this product, it’s important to seek medical attention right away or contact your local poison control center. Acting quickly can help prevent serious health issues.

Signs of an overdose may include unusual symptoms, but specific details on these symptoms are not provided. If you notice anything concerning after ingestion, don’t hesitate to get help. Remember, it’s always better to be safe and get professional advice in these situations.

Pregnancy Use

There is currently no specific information available regarding the use of INTIMALE Benzocaine Delay 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 important to consult with your healthcare provider before using this product to ensure it is safe for you and your baby. Always prioritize open communication with your doctor about any medications or products you are considering 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. Additionally, there are no known concerns about the product being passed into breast milk or any associated risks for your infant. This means you can use the product without worrying about 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 to prevent accidental ingestion. If your child swallows the product, seek medical help or contact a poison control center right away. Taking these precautions can help ensure your child's safety.

Geriatric Use

While there is no specific information about the use of INTIMALE Benzocaine Delay Gel in older adults, it's important to approach any new medication with caution. Since the drug insert does not mention dosage adjustments or safety concerns for elderly patients, you should consult with a healthcare professional before using this product. They can provide personalized advice based on your health status and any other medications you may be taking. Always prioritize your safety and well-being when considering new treatments.

Renal Impairment

If you have kidney problems, it's important to know that there are no specific guidelines, dosage adjustments, or monitoring requirements mentioned for your condition in the provided information. This means that the standard recommendations for medication use may apply to you, but it's always best to consult with your healthcare provider for personalized advice. They can help ensure that any treatment you receive is safe and effective based on your kidney health.

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 ensure that any medication you take is safe and appropriate for your liver health. They can help monitor your condition and make any necessary adjustments to your treatment plan.

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 the medication is generally considered safe to use with other drugs and tests. However, every individual is different, and your healthcare provider can help ensure that your treatment plan is safe and effective for you.

Always discuss any changes in your medications or health status with your healthcare provider to avoid any potential issues and to get the best care possible.

Storage and Handling

To ensure the best performance and safety of your product, store it in a cool, dry place, away from direct sunlight, and keep the temperature below 30°C (86°F). This helps maintain its effectiveness and prevents any potential damage.

When handling the product, always ensure that your hands are clean and dry to avoid contamination. If there are any specific components included with the product, make sure to follow any additional instructions provided for their use or disposal. Proper storage and handling are key to ensuring your product remains safe and effective.

Additional Information

You should apply 3-5 pumps of the product to the head and shaft of the penis before engaging in sexual activity, or follow your doctor's instructions. Make sure to massage the product onto the penis until it is fully absorbed for the best results.

There is no additional information available regarding laboratory tests, abuse potential, or patient counseling.

FAQ

What is the purpose of this drug?

This drug helps to temporarily prevent premature ejaculation.

How should I use this product?

Apply 3-5 pumps to the head and shaft of the penis before sexual activity, or as directed by your doctor. Massage the product onto the penis until fully absorbed.

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 physician.

Is this product safe for external use?

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

What should I do if the product is swallowed?

If the product is swallowed, get medical attention or contact poison control center immediately.

Are there any contraindications for this drug?

No specific contraindications are listed for this drug.

Is there any information regarding use during pregnancy or nursing?

No specific information regarding use during pregnancy or nursing is provided.

How should I store this product?

Store in a cool dry place out of direct sunlight below 30°C (86°F).

What should I do if the product does not provide relief?

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

Is there any information about drug interactions?

No specific drug interactions are mentioned.

Packaging Info

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

Packaging configurations for Intimale Benzocaine Delay Gel.
Details

Drug Information (PDF)

This file contains official product information for Intimale Benzocaine Delay Gel, 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 prevention of premature ejaculation in adult males. It is intended for use in patients who experience this condition, providing a therapeutic option to enhance sexual performance and satisfaction.

Dosage and Administration

The recommended dosage for application is 3 to 5 pumps of the product, which should be applied to the head and shaft of the penis prior to sexual activity, or as directed by a healthcare professional.

The product should be massaged onto the penis until it is fully absorbed. It is important to use only the minimum effective quantity to achieve the desired results.

Contraindications

There are no specific contraindications associated with this product. However, it is imperative to seek immediate medical attention or contact a poison control center if the product is swallowed.

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 physician. Additionally, if either the user or their partner experiences any rash or irritation, including symptoms such as burning or itching, the product should be discontinued immediately, and medical advice should be sought.

This product is intended for external use only. It is crucial to avoid contact with the eyes to prevent irritation or injury.

In the event that the product is ingested, immediate medical attention should be sought, or the poison control center should be contacted without delay.

Healthcare professionals should advise patients to stop using the product and consult their doctor if they do not experience relief as expected or if any adverse skin reactions occur. Regular monitoring and appropriate follow-up are recommended to ensure patient safety and efficacy of treatment.

Side Effects

Patients using this product should be aware of several important warnings and potential adverse reactions. 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 physician.

In addition, if either the patient or their partner experiences a rash or irritation, such as burning or itching, it is recommended to discontinue use and seek medical advice.

This product is intended for external use only, and patients should avoid contact with the eyes to prevent irritation or adverse effects.

Drug Interactions

There are no specific drug interactions or laboratory test interactions identified in the available data. Therefore, no recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

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

Packaging configurations for Intimale Benzocaine Delay Gel.
Details

Pediatric Use

Pediatric patients should be advised to keep this product out of reach of children. In the event that the product is swallowed, it is crucial to seek medical attention or contact a poison control center immediately.

Geriatric Use

There is no specific information regarding the use of INTIMALE Benzocaine Delay Gel in geriatric patients. The prescribing information does not provide details on dosage adjustments, safety concerns, or special precautions that may be necessary for elderly patients. Therefore, healthcare providers should exercise caution and consider individual patient factors when prescribing this medication to geriatric patients, as the absence of specific data necessitates careful clinical judgment. Monitoring for any adverse effects or unusual responses in this population is advisable.

Pregnancy

There is no specific information regarding the use of INTIMALE Benzocaine Delay Gel in pregnant patients. The prescribing information does not provide safety concerns, dosage modifications, or special precautions for use during pregnancy. Healthcare professionals should consider the lack of data when advising women of childbearing potential and weigh the potential risks and benefits before recommending 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 during lactation.

Renal Impairment

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

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 attention is crucial. If the product is ingested, healthcare professionals should advise patients or caregivers to seek medical assistance or contact a poison control center without delay.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. It is recommended that healthcare providers monitor the patient for any symptoms that may arise as a result of the overdosage. The specific symptoms may vary depending on the nature of the product and the amount ingested, thus thorough assessment and management are necessary.

In managing an overdosage situation, healthcare professionals should follow established protocols for the treatment of poisoning, which may include supportive care and symptomatic treatment as indicated. Continuous monitoring of the patient's vital signs and clinical status is advised to ensure appropriate management and to address any complications that may occur.

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.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients that if the product is swallowed, it is imperative to seek medical attention or contact a poison control center immediately. This information is crucial for ensuring patient safety and prompt intervention in case of accidental ingestion.

Storage and Handling

The product is supplied in a configuration that ensures optimal preservation of its integrity. It should be stored in a cool, dry place, away from direct sunlight, and maintained at a temperature below 30°C (86°F) to ensure its efficacy and safety. Proper storage conditions are essential for maintaining the quality of the product throughout its shelf life.

Additional Clinical Information

Patients should apply 3-5 pumps of the product to the head and shaft of the penis prior to sexual activity, or as directed by their healthcare provider. It is important to massage the product onto the penis until it is fully absorbed. 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 Intimale Benzocaine Delay Gel, 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 Intimale Benzocaine Delay Gel, 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.