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Ombre Men Overtime Wipes

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Active ingredient
Benzocaine 7 g/100 mL
Other brand names
Drug class
Standardized Chemical Allergen
Dosage form
Cloth
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
October 7, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Benzocaine 7 g/100 mL
Other brand names
Drug class
Standardized Chemical Allergen
Dosage form
Cloth
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
October 7, 2025
Manufacturer
Sambria Pharmaceuticals, LLC
Registration number
M017
NDC root
54723-007
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 reduce oversensitivity in males before intercourse. By addressing this issue, it aims to enhance comfort and improve the overall experience during intimate moments. If you have concerns about sensitivity, this treatment may be a supportive option for you.

Uses

This medication is designed to help reduce oversensitivity in males before intercourse. By addressing this issue, it can enhance comfort and improve the overall experience.

It's important to note that there are no reported teratogenic effects (which means it does not cause birth defects) associated with this medication. Additionally, there are no nonteratogenic effects mentioned, ensuring that it is safe in this regard.

Dosage and Administration

To use this medication, 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 to ensure proper hygiene.

Remember, this medication is not meant for oral use, so avoid ingesting it. Make sure to use it as directed and do not apply it more than four times a day to stay within safe usage guidelines.

What to Avoid

There are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with this medication. This means that, based on the available information, there are no particular situations or conditions under which you should avoid using it.

However, it's always important to consult with your healthcare provider before starting any new medication to ensure it is appropriate for your individual health needs. They can provide personalized advice and address any questions or concerns you may have.

Side Effects

When using this product, it's important to remember that it is for external use only and should not be applied to broken or irritated skin. Avoid getting it in your eyes. If you find that the product does not relieve your symptoms as expected, or if you or your partner experience any rash or irritation, such as burning or itching, you should stop using it and consult your doctor. Additionally, if your symptoms persist, seeking medical advice is recommended.

Warnings and Precautions

This product is for external use only, so please do not apply it to broken or irritated skin. Be careful to 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 (like burning or itching), stop using it and consult your doctor. Persistent symptoms may indicate a condition that requires medical attention.

If the product is swallowed, seek emergency medical help immediately or contact a Poison Control Center. Always prioritize your health and safety by following these guidelines closely.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, it’s always important to be aware of the signs of an overdose, which can include unusual drowsiness, confusion, or difficulty breathing. If you suspect that you or someone else may have taken too much of a medication, it’s crucial to seek immediate medical help.

In case of an overdose, contact your local emergency services or go to the nearest hospital. Having the medication packaging or information on hand can help medical professionals provide the best care. Always remember that when it comes to medications, it’s better to be safe and get help if you have any concerns.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the safety of benzocaine, a common topical anesthetic, has not been established. In fact, benzocaine is contraindicated during pregnancy due to potential risks to the fetus. This means that using this medication could pose risks, and further studies are needed to fully understand its safety.

Before using benzocaine, you should consult your healthcare provider to discuss any concerns and explore safer alternatives. There are no specific dosage modifications for pregnant individuals, but it's crucial to prioritize your health and the health of your baby by seeking professional advice.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or considerations mentioned regarding nursing mothers or lactation in the information provided. This means that, based on the available data, there are no known risks associated with breastfeeding while using this medication. Always consult with your healthcare provider if you have any concerns or questions about your specific situation.

Pediatric Use

It's important to keep this medication out of reach of children to prevent accidental ingestion. If your child swallows any of 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

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that if you or a loved one is an older adult considering this medication, it’s important to consult with a healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

Renal Impairment

If you have kidney problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations for the medication do not include special monitoring or safety considerations tailored for patients with renal impairment (kidney issues).

Always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your specific health needs. They can provide guidance based on your kidney function and overall 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 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 or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you.

Always feel free to ask questions and share your complete list of medications and any lab tests you may be undergoing. This way, you can receive the best possible care tailored to your needs.

Storage and Handling

To ensure the safety and effectiveness of your product, store it at room temperature. It's important to keep it out of reach of children to prevent any accidental ingestion or misuse. Once you open the product, be sure to discard it after use to maintain safety and hygiene. Following these simple guidelines will help you use the product safely and effectively.

Additional Information

You should apply a small amount of the product to the head and shaft of the penis before intercourse, or follow your doctor's instructions. Be sure to wash the product off after intercourse. It is important to note that this product is not suitable for oral use and should not be used more than four times a day.

FAQ

What is the primary use of this drug?

This drug is used for reducing oversensitivity in the male in advance of intercourse.

How should I apply this drug?

Apply a small amount to the head and shaft of the penis before intercourse, or use as directed by your doctor.

What should I do after using this drug?

You should wash the product off after intercourse.

Is this drug safe to use during pregnancy?

Benzocaine is contraindicated in pregnancy due to potential risks to the fetus, and its safety has not been established.

What precautions should I take while using this drug?

This drug is for external use only. Do not use it on broken or irritated skin, and avoid contact with eyes.

What should I do if I experience irritation or rash?

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

What should I do if I swallow this drug?

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

How often can I use this drug?

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

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

Stop using the product and consult your doctor, as premature ejaculation may require medical supervision.

How should I store this drug?

Store at room temperature and keep out of reach of children. Discard after opening.

Packaging Info

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

Packaging configurations for Ombre Men Overtime Wipes.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for reducing oversensitivity in males in advance of intercourse.

There are no teratogenic or nonteratogenic effects associated with this drug.

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, or as directed by a physician. It is essential to wash the product off after intercourse to ensure proper hygiene.

The product is not intended for oral use and should be utilized as directed. Patients should not exceed a maximum of four applications per day.

Contraindications

There are no contraindications associated with the use of this product. It is deemed safe for use in the absence of specific conditions or situations that would warrant avoidance.

Warnings and Precautions

The product is intended for external use only and should not be applied to broken or irritated skin. Healthcare professionals should advise patients to avoid contact with the eyes during application.

Patients are instructed to discontinue use and consult a healthcare provider if the product does not provide relief when used as directed. It is important to note that premature ejaculation may be indicative of an underlying condition that requires medical supervision. Additionally, if either the patient or their partner experiences any rash or irritation, such as burning or itching, they should stop using the product and seek medical advice. Persistent symptoms should also prompt a consultation with a healthcare professional.

In the event of accidental ingestion, immediate medical assistance should be sought, or the local Poison Control Center should be contacted without delay.

Monitoring for adverse reactions and the effectiveness of the treatment is essential, and healthcare providers should remain vigilant for any signs of complications that may necessitate further evaluation or intervention.

Side Effects

Patients using this product should be aware that it is intended for external use only and should not be applied to broken or irritated skin. Care should be taken to avoid contact with the eyes during application.

In clinical practice, if the product does not provide relief when used as directed, patients are advised to consult a healthcare professional, as premature ejaculation may be indicative of an underlying condition that requires medical supervision. Additionally, if either the patient or their partner experiences any rash or irritation, such as burning or itching, it is recommended to discontinue use and seek medical advice.

Should symptoms persist despite following the usage instructions, patients should also consult their doctor for further evaluation and guidance.

Drug Interactions

There are currently no documented drug interactions associated with the use of this medication. Additionally, there are no known interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

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

Packaging configurations for Ombre Men Overtime Wipes.
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

The safety of benzocaine during pregnancy has not been established, and its use is contraindicated due to potential risks to the fetus. Pregnant patients or those planning to become pregnant should consult a healthcare provider before using benzocaine. While no specific dosage modifications are provided for pregnant individuals, there may be associated risks with the use of benzocaine during pregnancy, and further studies are needed to determine its safety profile. Healthcare professionals should exercise caution and consider the potential fetal impacts when advising patients regarding the use of benzocaine during pregnancy.

Lactation

There are no specific warnings or considerations regarding nursing mothers or lactation mentioned in the provided text. Therefore, healthcare professionals may consider the use of this medication in lactating mothers without specific contraindications. Further monitoring of breastfed infants may be warranted, although no specific effects on nursing infants have been documented.

Renal Impairment

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in 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 absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant regarding the potential for overdose with this medication. In cases where an overdose is suspected, immediate medical attention should be sought.

Healthcare providers are advised to monitor patients closely for any signs or symptoms that may indicate an overdose. These may include, but are not limited to, increased severity of known side effects, unusual behavioral changes, or any other atypical clinical manifestations.

Management of an overdose should be guided by the clinical presentation of the patient. Supportive care is paramount, and symptomatic treatment should be initiated as necessary. It is recommended that healthcare professionals consult local poison control centers or relevant toxicology resources for specific guidance on the management of overdose cases.

In summary, while specific overdosage information is not available, healthcare professionals should exercise caution, monitor for symptoms, and provide appropriate supportive care in the event of an overdose.

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 understanding of the compound's potential effects in these areas.

Postmarketing Experience

No postmarketing experience details are available in the insert.

Patient Counseling

Healthcare providers should advise patients that in the event of accidental ingestion, it is crucial to seek medical assistance immediately or contact a Poison Control Center. This prompt action is essential to ensure the safety and well-being of the patient.

Storage and Handling

The product is supplied in a configuration that ensures optimal usability. It should be stored at room temperature, away from direct sunlight and moisture. To maintain safety, it is essential to keep the product out of reach of children. Once opened, the product must be discarded to ensure proper handling and safety.

Additional Clinical Information

Patients should apply a small amount of the product to the head and shaft of the penis before intercourse, or as directed by a clinician. It is important to wash the product off after intercourse and to note that it is not suitable for oral use. The product should be used as directed and not more than four times per day.

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 Ombre Men Overtime Wipes, 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 Ombre Men Overtime Wipes, 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.