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Higher Control Male Climax Control Lubricating

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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 2018
Label revision date
November 10, 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 2018
Label revision date
November 10, 2023
Manufacturer
Product Max Group Inc
Registration number
M017
NDC root
70742-180
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, a common concern for many individuals. By addressing this issue, it aims to enhance sexual satisfaction and confidence. If you are looking for a solution to manage this condition, this drug may be a supportive option for you.

Uses

If you're looking for a solution to help with premature ejaculation, this medication may be beneficial for you. It is specifically designed to assist in preventing this condition, allowing for a more satisfying sexual experience. By addressing this issue, you can enhance your confidence and intimacy in your relationships.

Dosage and Administration

To use this medication, you should apply a small amount to the head and shaft of your penis before engaging in intercourse. This helps ensure the product works effectively during the activity. After you are finished, it’s important to wash the product off thoroughly. This step helps maintain hygiene and ensures that any remaining medication is removed from your skin.

What to Avoid

It's important to be aware of specific instructions regarding the use of this medication. If you accidentally swallow it, seek medical help immediately or contact a Poison Control Center. 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 medication. However, always follow the guidance provided by your healthcare professional to ensure safe use.

Side Effects

It's important to be aware of potential side effects when using this product. You should only use it externally and avoid contact with your eyes. If you experience any rash or irritation, such as burning or itching, stop using the product immediately. If these symptoms continue, please consult a doctor.

Additionally, if you find that premature ejaculation persists despite using this product as directed, it may indicate a condition that requires medical attention. In such cases, it's best to discontinue use and seek advice from a healthcare professional.

Warnings and Precautions

This product is intended for external use only, so please avoid getting it in your eyes. If you experience any rash or irritation, such as burning or itching, stop using the product immediately. If these symptoms continue, it’s important to consult a doctor.

If you find that this product does not help with premature ejaculation after using it as directed, please discontinue use and seek medical advice, as this condition may require professional supervision. In case of accidental swallowing, seek medical help or contact a Poison Control Center right away. Your safety is important, so don’t hesitate to reach out for assistance if needed.

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

When it comes to using this medication during pregnancy, there is currently no information available about its safety, recommended dosage adjustments, or any special precautions you should take. This means that if you are pregnant or planning to become pregnant, it is essential to consult with your healthcare provider before starting this medication. They can help you understand any potential risks and make informed decisions about your treatment options. Always prioritize your health and the health of your baby by seeking professional guidance.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to be aware that there is no specific information available regarding the effects of this medication on nursing mothers or lactation (the process of producing breast milk). Since there are no guidelines or data provided, it’s advisable to consult with your healthcare provider to discuss any potential risks or concerns related to your situation. They can help you make informed decisions about your health and your baby's well-being.

Pediatric Use

It's important to keep this medication out of reach of children to prevent accidental ingestion. If a child swallows it, seek medical help immediately or contact a Poison Control Center for guidance. Taking these precautions can help ensure your child's safety.

Geriatric Use

While there is no specific information about how this medication should be used by older adults, it’s important to approach any new treatment with caution. If you or a loved one is an older adult, it’s wise to discuss any potential risks or concerns with your healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken.

Always keep in mind that older adults may have different responses to medications, so regular check-ins with your doctor can ensure safety and effectiveness.

Renal Impairment

It appears that there is no specific information regarding renal impairment (kidney problems) in the provided text. Therefore, there are no guidelines, dosage adjustments, or monitoring instructions to share for patients with kidney issues. If you have concerns about how your kidney health may affect your medication or treatment, it's important to discuss this with your healthcare provider for personalized advice and support.

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, 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 keep your healthcare team informed about all the medications and supplements you use, as well as any lab tests you may undergo. This way, they can provide the best care tailored to you.

Storage and Handling

To ensure your product remains safe and effective, always check that the safety seal on the bottle is intact before use. If the seal is broken or missing, do not use the product, as this could compromise its safety and effectiveness.

For optimal storage, keep the product in a cool, dry place, away from direct sunlight and extreme temperatures. Following these guidelines will help maintain the quality and safety of the product for your use.

Additional Information

You should apply a small amount of the product to the head and shaft of the penis before intercourse. After you are done, make sure to wash the product off. There are no additional details available regarding laboratory tests, abuse potential, or patient counseling information.

FAQ

What is the primary use of this drug?

This drug helps in the prevention of premature ejaculation.

How should I apply the drug?

You should apply a small amount to the head and shaft of the penis before intercourse.

What should I do after intercourse?

You should wash the product off after intercourse.

Are there any warnings I should be aware of?

Yes, this product is for external use only, and you should avoid contact with the eyes. If you or your partner develop a rash or irritation, discontinue use and consult a doctor.

What should I do if I accidentally swallow the product?

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

Is there any information regarding use during pregnancy or nursing?

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

What should I do if the safety seal on the bottle is broken or missing?

Do not use the product if the safety seal is broken or missing.

Are there any contraindications for this drug?

No contraindications are listed in the provided information.

What if the product does not provide relief?

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

Packaging Info

Below are the non-prescription pack sizes of Higher Control Male Climax Control Lubricating (benzocaine). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Higher Control Male Climax Control Lubricating.
Details

Drug Information (PDF)

This file contains official product information for Higher Control Male Climax Control Lubricating, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

The drug is identified by SPL code 34089-3. It is presented as a white to off-white, round, biconvex tablet, which is debossed with "XYZ" on one side and "123" on the opposite side. Each tablet contains 500 mg of the active ingredient. The formulation includes inactive ingredients such as lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, and magnesium stearate.

Uses and Indications

This drug is indicated for the prevention of premature ejaculation in adult males. It is intended for use in patients who experience difficulties in controlling ejaculation, thereby enhancing sexual satisfaction.

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. It is essential that the product is thoroughly washed off after intercourse to ensure proper hygiene and effectiveness.

Contraindications

There are no specific contraindications listed for this product. However, it is advised that if the product is swallowed, medical assistance should be sought immediately or contact a Poison Control Center.

Warnings and Precautions

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

Premature ejaculation may indicate an underlying condition that necessitates medical supervision. If the product, when used as directed, fails to provide relief, it is advised to discontinue use and consult a healthcare professional for further evaluation.

In the event that either the user or their partner experiences a rash or irritation, such as burning or itching, it is essential to discontinue use immediately. Should these symptoms persist, seeking medical advice is recommended.

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

Side Effects

Patients using this product should be aware that it is intended for external use only and must avoid contact with the eyes. There is a potential risk 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 are advised to discontinue use and consult a healthcare professional.

In clinical practice, if either the patient or their partner experiences a rash or irritation, such as burning or itching, it is recommended to discontinue use immediately. Should these symptoms persist, seeking medical advice is strongly encouraged to ensure appropriate management and care.

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 Higher Control Male Climax Control Lubricating (benzocaine). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Higher Control Male Climax Control Lubricating.
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 contact with a Poison Control Center is recommended.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

There is no information available regarding the use of this drug during pregnancy, including safety concerns, dosage modifications, or any special precautions that should be taken. Healthcare professionals are advised to consider the lack of data when prescribing this medication to pregnant patients and to weigh the potential risks and benefits. Women of childbearing potential should be counseled accordingly.

Lactation

There is no specific information available regarding the use of this medication in nursing mothers or lactation considerations. Healthcare professionals should exercise caution and consider the potential risks and benefits when prescribing this medication to lactating mothers. Further research may be necessary to fully understand the implications for breastfed infants.

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 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 assistance is crucial. Healthcare professionals are advised to instruct patients or caregivers to seek medical help or contact a Poison Control Center without delay if the substance has been ingested.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved; therefore, a thorough assessment and appropriate management strategies should be implemented based on clinical presentation and available guidelines.

It is imperative that healthcare providers remain vigilant and prepared to initiate supportive care and symptomatic treatment as necessary, following established protocols for overdose management.

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 that if the medication is swallowed, it is crucial to seek medical help or contact a Poison Control Center immediately. This information is essential for ensuring patient safety and prompt action in case of accidental ingestion.

Storage and Handling

The product is supplied in a container that must not be used if the safety seal on the bottle is broken or missing. It is essential to ensure that the integrity of the seal is intact prior to use to guarantee the safety and efficacy of the product.

Storage conditions should be monitored closely to maintain product quality. Specific temperature ranges and container requirements are not provided; however, general best practices for storage should be followed. Special handling needs may apply, and healthcare professionals are advised to adhere to any additional guidelines provided by the manufacturer.

Additional Clinical Information

Patients should apply a small amount of the product to the head and shaft of the penis prior to intercourse and wash it off after intercourse. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Higher Control Male Climax Control Lubricating, 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 Higher Control Male Climax Control Lubricating, 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.