Symptom checker
Select audience type

Switch between content for healthcare professionals (PRO) and general audience (GEN).

ADD CONDITION

items per page

Intimale Maximum Strength Delay

Last content change checked dailysee data sync status

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)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2021
Label revision date
November 11, 2023
Drug Information (PDF)
Prescribing information, PDF file
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
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2021
Label revision date
November 11, 2023
Manufacturer
SKINS SEXUAL HEALTH LIMITED
Registration number
M017
NDC root
81923-197
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 addressing the underlying factors that contribute to this condition, helping you gain better control during intimate moments. If you're looking for support in managing this issue, this medication may be a helpful 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 your sexual health, consider discussing this option with your healthcare provider to see if it's right for you.

Dosage and Administration

Before you engage in sexual activity, it's important to prepare properly. Start by shaking the product gently and then apply 3 or more sprays to the head and shaft of the penis. The amount you use can depend on how much numbness (anaesthesia) you want to achieve. After applying, massage the area for about twenty seconds or until the product is fully absorbed. You should apply this 3-5 minutes before intercourse to allow it to take effect.

Once applied, you will begin to feel the effects within 3-5 minutes. If you find that the desired effect isn't achieved after the product has absorbed, you can gradually increase the number of sprays, but remember to always use the minimum amount needed. It's crucial not to exceed 10 sprays in total. After using the product, make sure to wash your hands thoroughly to avoid any unintended contact.

What to Avoid

You should avoid using this product if you have broken or inflamed skin, if your partner is pregnant, or if you plan to apply it to large areas of your body or use it orally. These precautions are important to ensure your safety and the safety of others. Always follow these guidelines to prevent any potential risks associated with improper use.

Side Effects

Using this product may lead to some side effects. You should be aware that if you or your partner experience any rash or irritation, such as burning or itching, it's important to stop using the product and consult a physician. Additionally, if you find that the product does not help with premature ejaculation, which may indicate a condition needing medical attention, you should also discontinue use and seek advice from a healthcare professional.

It's crucial to use this product only as directed and for external use only. Avoid applying it to broken or inflamed skin, on large areas of the body, or if your partner is pregnant. Remember to keep it away from your eyes to prevent irritation.

Warnings and Precautions

If you are considering using this product for premature ejaculation, it's important to know that this condition may require medical supervision. If you do not experience relief while using the product as directed, please stop using it and consult your doctor.

This product is for external use only, so be sure to avoid contact with your eyes. If you or your partner notice any rash or irritation, such as burning or itching, discontinue use immediately and reach out to your physician for advice.

In the event that the product is swallowed, seek medical attention right away or contact your local poison control center for assistance. Your safety is a priority, so please take these precautions seriously.

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 know 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.

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 swallows any of 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

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

It appears that there is no specific information regarding renal impairment (kidney problems) in the provided text. This means there are no dosage adjustments, special monitoring, or safety considerations outlined 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, who can offer personalized guidance based on your individual situation.

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 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 new medications or tests with your healthcare provider to avoid potential issues and to get personalized advice tailored to your health needs.

Storage and Handling

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

Before using the product, check that the seal under the cap is intact. If the seal is broken or missing, do not use the product, as this may compromise its safety and effectiveness. Always handle the product with care to ensure it remains in good condition.

Additional Information

You should apply this product topically, using 3 to 5 sprays on the head and shaft of the penis about 3 minutes before intercourse. Make sure to shake the bottle gently before use and massage the product into the skin for around twenty seconds until it is absorbed. After applying, wash your hands thoroughly.

It's important to note that if you experience premature ejaculation, it may be a sign of a condition that needs medical attention. If the product does not help when used as directed, stop using it and consult a physician. Remember, this product is for external use only—avoid contact with your eyes, and if you or your partner experience any irritation, such as burning or itching, discontinue use and seek medical advice. Keep the product out of reach of children, and if ingested, contact a medical professional or poison control immediately. Do not use it on broken skin, if your partner is pregnant, on large areas of the body, or orally.

FAQ

What is the purpose of this drug?

This drug helps to temporarily prevent premature ejaculation.

How should I apply the drug?

Apply 3-5 minutes prior to intercourse, shaking gently before use. Use 3 or more sprays on the head and shaft of the penis and massage for about twenty seconds until absorbed.

What should I do if I don't feel the desired effect?

If you do not experience the desired effect after the product has absorbed, gradually increase the dosage until you achieve the desired effect.

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 I experience irritation?

If you or your partner develop a rash or irritation, such as burning or itching, discontinue use and consult a physician.

How should I store this drug?

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

What should I do if the product is swallowed?

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

Is this drug safe for nursing mothers?

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

Can I use this drug if my partner is pregnant?

No, you should not use this drug if your partner is pregnant.

Packaging Info

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

Packaging configurations for Intimale Maximum Strength Delay.
Details

Drug Information (PDF)

This file contains official product information for Intimale Maximum Strength Delay, 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 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 product should be applied 3 to 5 minutes prior to intercourse. Prior to application, the container must be shaken gently. Depending on the desired level of anaesthesia, 3 or more sprays should be applied to the head and shaft of the penis. The product should be massaged into the penis for approximately twenty seconds or until it is completely absorbed.

After application, hands must be washed thoroughly to prevent unintended exposure. The onset of action is typically felt within 3 to 5 minutes. If the desired effect is not achieved after the product has fully absorbed, the dosage may be gradually increased, ensuring that the minimum effective quantity is always used. It is important to note that the maximum dosage should not exceed 10 sprays.

Contraindications

Use is contraindicated in the following situations:

Application on broken or inflamed skin is prohibited due to the risk of exacerbating the condition. The product should not be used if the partner is pregnant, as potential risks to fetal development are not established. Additionally, application on large areas of the body is contraindicated to prevent systemic absorption and potential adverse effects. Oral use is also prohibited to avoid unintended ingestion and associated complications.

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 for further evaluation and management.

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

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 and seek medical advice.

In cases where the product is ingested, prompt medical attention should be sought, or the poison control center should be contacted without delay to ensure appropriate care.

Side Effects

Patients using this product may experience adverse reactions that necessitate careful consideration. Serious adverse reactions include the potential for premature ejaculation, which may indicate an underlying condition requiring 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 localized skin 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.

This product is intended for external use only and should not be applied to broken or inflamed skin. Additionally, it should not be used on large areas of the body, orally, or if the partner is pregnant. Patients should avoid contact with the eyes to prevent further complications.

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions between the drug and 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 Intimale Maximum Strength Delay (lidocaine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Intimale Maximum Strength Delay.
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 available 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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, 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 characterized, 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 to consider alternative treatment options when necessary.

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

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 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

There is currently no available information regarding teratogenic effects. Additionally, no data has been provided concerning non-teratogenic effects. The nonclinical toxicology section does not contain any relevant information at this time. Furthermore, there is no information available related to animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are available 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 includes an NDC number for identification. It is essential to store the product in a cool, dry place, ensuring that the temperature remains below 30°C (86°F) and that it is kept out of direct sunlight.

Healthcare professionals should also be aware that the product must not be used if the seal under the cap is broken or missing, as this may compromise the integrity of the product. Proper handling and storage conditions are crucial to maintain the product's efficacy and safety.

Additional Clinical Information

The product is administered topically, with application recommended 3-5 minutes prior to intercourse. Clinicians should instruct patients to shake the product gently before use and to apply 3 or more sprays to the head and shaft of the penis, massaging for approximately twenty seconds or until absorption occurs. It is essential for patients to wash their hands thoroughly after application.

Patients should be counseled 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. The product is for external use only, and contact with the eyes should be avoided. In the event of a rash or irritation, such as burning or itching, use should be discontinued, and medical advice sought. Additionally, the product should be kept out of reach of children, and immediate medical attention should be sought if swallowed. It should not be applied to broken or inflamed skin, used if a partner is pregnant, applied to large areas of the body, or used orally.

Drug Information (PDF)

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