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Skins Delay Maximum Strength Lidocaine

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Active ingredient
Lidocaine Hydrochloride 10 mg/1 mL
Other brand names
Drug classes
Amide Local Anesthetic, Antiarrhythmic
Dosage form
Solution
Route
Topical
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2021
Label revision date
November 11, 2023
Active ingredient
Lidocaine Hydrochloride 10 mg/1 mL
Other brand names
Drug classes
Amide Local Anesthetic, Antiarrhythmic
Dosage form
Solution
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2021
Label revision date
November 11, 2023
Manufacturer
SKINS SEXUAL HEALTH LIMITED
Registration number
M017
NDC root
81923-199

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, which can be a concern for many individuals. By using this drug, you may find it easier to manage your sexual performance and enhance your overall experience. If you have questions about how it works or whether it’s right for you, consider discussing it with a healthcare professional for personalized advice.

Uses

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

Dosage and Administration

To use this medication effectively, start by applying 3 or more sprays to the head and shaft of the penis, depending on how much numbness (anaesthesia) you want to achieve. After spraying, gently massage the area for about twenty seconds to help the product absorb properly. It’s important to wash your hands thoroughly after application to avoid any unwanted contact with other areas.

You should begin to feel the effects of the product within 3 to 5 minutes. While you can use up to 10 sprays, it’s best to wait and see how you feel before applying more, as you want to use the minimum amount necessary for effectiveness. Remember, do not exceed 10 sprays in total to ensure safe use.

What to Avoid

It's important to use this medication safely. You should not apply it to broken or inflamed skin, on large areas of your body, or take it orally. Additionally, avoid using it if your partner is pregnant, as this could pose risks.

While there are no specific contraindications or concerns about abuse, misuse, or dependence associated with this medication, following these guidelines will help ensure your safety and the effectiveness of the treatment. Always consult with your healthcare provider 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 a rash or irritation, such as burning or itching, it's important to stop using the product and consult a physician. Additionally, if the product is swallowed, seek medical attention or contact a poison control center right away.

This product is for external use only, so avoid contact with your eyes and do not apply it to broken or inflamed skin. If you or your partner are pregnant, or if you plan to use it on large areas of the body, it's best to avoid using this product altogether. If you find that it does not provide relief from premature ejaculation, please discontinue use and consult a physician.

Warnings and Precautions

It's important to use this product only as directed and for external use only. Avoid getting it in your eyes, as this can cause irritation. If you or your partner experience any rash, burning, or itching, stop using the product and consult your doctor.

If you find that the product does not help with premature ejaculation, it may indicate a condition that requires medical attention, so please discontinue use and speak with your physician. In case the product is swallowed, seek medical help or contact a poison control center right away.

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 ensure safety and proper care.

Signs of an overdose may not always be obvious, so it's crucial to be vigilant. If you notice unusual symptoms or feel unwell after taking the product, don’t hesitate to reach out for help. Remember, your health and safety are the top priority.

Pregnancy Use

If you are pregnant or planning to become pregnant, it is important to be aware that you should not use this medication if your partner is pregnant. This precaution is in place to ensure the safety of both you and your partner during this sensitive time. Always consult with your healthcare provider for personalized advice and to discuss any potential risks associated with medications while pregnant. Your health and the health of your baby are the top priority.

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 is no information available about whether this product is excreted in breast milk or any potential risks it may pose to your infant.

As always, if you have any concerns or questions about using this product while breastfeeding, it's a good idea to consult with your healthcare provider for personalized advice.

Pediatric Use

It's important to keep this medication out of reach of children to prevent accidental ingestion. If your child accidentally swallows the product, seek medical attention or contact your local poison control center right away. Taking these precautions can help ensure your child's safety.

Geriatric Use

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. If you or a loved one is an older adult, it’s always wise to discuss any medications with a healthcare provider, especially considering potential changes in health or how the body processes drugs as we age.

Since there are no dosage adjustments or special precautions mentioned for elderly patients, your healthcare provider can help determine the best approach based on individual health needs. Always keep them informed about any other medications being taken or health conditions present, as this can help ensure safe and effective treatment.

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 treatment, it's important to discuss this with your healthcare provider for personalized advice and recommendations.

Hepatic Impairment

If you have liver 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 apply, but you should always consult your healthcare provider for personalized advice. They can help determine the best approach for your treatment and monitor your liver function as needed.

Make sure to keep your doctor informed about your liver health, as they may need to conduct regular tests to ensure your safety while using any medication. Your well-being is a priority, so don't hesitate to ask questions or express any concerns you may have.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking, even if there are no specific drug interactions or laboratory test interactions noted for your treatment. This ensures that your healthcare team can monitor your health effectively and make informed decisions about your care.

Always feel free to ask questions and share any concerns you may have regarding your medications or tests. Your safety and well-being are the top priorities, and your healthcare provider is there to help you navigate your treatment plan.

Storage and Handling

To ensure the safety and effectiveness of your product, store it in a cool, dry place away from direct sunlight. It's important to keep the temperature below 30°C (86°F) to maintain its integrity. Before using the product, always check that the seal under the cap is intact; do not use it if the seal is broken or missing, as this could compromise its safety.

By following these simple storage and handling guidelines, you can help ensure that the product remains safe and effective for your use.

Additional Information

This product is applied topically, meaning it is used on the skin. It's important to remember that premature ejaculation can sometimes be linked to a medical condition, so if you don't find relief after using this product as directed, you should stop using it and consult a doctor.

For safety, use this product only on the skin and avoid contact with your eyes. If you or your partner experience any rash or irritation, such as burning or itching, stop using it and seek medical advice. Keep it out of reach of children, and if swallowed, seek medical help or contact a poison control center right away. Do not apply it to broken or inflamed skin, on large areas of the body, or if your partner is pregnant.

FAQ

What is the purpose of this drug?

This drug helps to temporarily prevent premature ejaculation.

How should I apply the drug?

Apply 3 or more sprays to the head and shaft of the penis, massaging it in for around twenty seconds until optimal absorption is reached.

How long does it take for the drug to work?

You will feel the product start to work after 3-5 minutes.

What should I do if I don't feel relief?

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

Are there any contraindications for using this drug?

Do not use this drug on broken or inflamed skin, if your partner is pregnant, on large areas of the body, or orally.

What should I do if the product is swallowed?

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

How should I store this drug?

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

Is this drug safe for nursing mothers?

There are no specific warnings or recommendations regarding the use of this product in nursing mothers.

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 drug for external use only?

Yes, this drug is for external use only and should avoid contact with eyes.

Packaging Info

Below are the non-prescription pack sizes of Skins Delay Maximum Strength Lidocaine (lidocaine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Skins Delay Maximum Strength Lidocaine.
Details

Drug Information (PDF)

This file contains official product information for Skins Delay Maximum Strength Lidocaine, 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 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 difficulties in controlling ejaculation during sexual activity.

Dosage and Administration

The recommended dosage involves applying 3 or more sprays to the head and shaft of the penis, with the exact number depending on the desired level of anaesthesia. After application, the area should be gently massaged for approximately twenty seconds or until optimal absorption is achieved.

Healthcare professionals should advise patients to wash their hands thoroughly after use to prevent unintentional contact with other areas. The onset of action is typically felt within 3 to 5 minutes. While a maximum of 10 sprays may be applied, it is advisable to wait until the full effects are experienced before considering additional applications. It is essential to use the minimum effective quantity and not to exceed the maximum limit of 10 sprays.

Contraindications

Use is contraindicated in the following situations:

  • Application on broken or inflamed skin due to the potential for exacerbating the condition.

  • Use in pregnant partners, as safety has not been established in this population.

  • Application over large areas of the body, which may increase the risk of systemic absorption and adverse effects.

  • Oral administration, as this route is not indicated for the product.

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.

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

In the event that either the patient or their partner experiences a rash or irritation, such as burning or itching, it is essential to discontinue use and seek medical advice promptly.

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

Side Effects

Patients using this product may experience a range of adverse reactions. Serious adverse reactions include the potential for premature ejaculation, which 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.

Common adverse reactions may include local irritation, such as burning or itching. In the event that either the patient or their partner develops a rash or experiences irritation, it is recommended to discontinue use and seek medical advice.

The product is intended for external use only, and patients should avoid contact with the eyes. If the product is accidentally swallowed, immediate medical attention or contact with a poison control center is necessary. Additionally, the product should not be applied to broken or inflamed skin, on large areas of the body, or used orally. It is also contraindicated for use if the partner is pregnant.

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions with laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the current information.

Packaging & NDC

Below are the non-prescription pack sizes of Skins Delay Maximum Strength Lidocaine (lidocaine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Skins Delay Maximum Strength Lidocaine.
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

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

Pregnant patients should not use this medication if their partner is pregnant. The potential risks associated with exposure during pregnancy have not been fully established, and caution is advised to prevent any adverse fetal outcomes. Healthcare professionals are encouraged to discuss the implications of this medication with women of childbearing potential and their partners to ensure informed decision-making regarding its use.

Lactation

There are no specific warnings or recommendations regarding the use of this product in nursing mothers. Additionally, there is no information available about the potential for excretion in breast milk or any associated risks to 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

There is no information available regarding the use of this medication in patients with hepatic impairment. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions specified for individuals with compromised liver function. Healthcare professionals should exercise caution and consider the overall clinical context when prescribing this medication to patients with liver problems, as the absence of specific guidance necessitates careful evaluation of potential risks and benefits.

Overdosage

In the event of an overdosage, immediate medical attention is essential. 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 critical to mitigate potential adverse effects associated with overdosage. It is recommended that healthcare providers monitor the patient closely for any symptoms that may arise as a result of the overdosage.

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

Postmarketing Experience

No postmarketing experience details are provided in the insert.

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 integrity and safety. It must be stored in a cool, dry place, away from direct sunlight, to maintain its efficacy. The recommended storage temperature is below 30°C (86°F).

Healthcare professionals should ensure that the product is not used if the seal under the cap is broken or missing, as this may compromise the product's safety and effectiveness.

Additional Clinical Information

The product is administered topically and is intended for external use only. Clinicians should counsel patients that premature ejaculation may indicate an underlying condition that requires medical supervision. If the product does not provide relief when used as directed, patients should discontinue use and consult a physician.

Patients are advised to avoid contact with eyes and to discontinue use if they or their partner experience any rash or irritation, such as burning or itching, seeking medical advice if this occurs. The product should be kept out of reach of children, and immediate medical attention should be sought if the product is swallowed. It is contraindicated for use on broken or inflamed skin, on large areas of the body, orally, or if the partner is pregnant.

Drug Information (PDF)

This file contains official product information for Skins Delay Maximum Strength Lidocaine, 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 Skins Delay Maximum Strength Lidocaine, 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.

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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.