Pleasure Balm

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for use as a prolonging gel specifically designed for men, functioning as a male genital desensitizer.

Consultation with a healthcare professional is advised prior to use if the partner is pregnant due to potential teratogenic effects. No nonteratogenic effects have been mentioned.

Dosage and Administration

Adults aged 18 years and older should apply a small amount of the product to the head and shaft of the penis 5 to 10 minutes prior to intercourse, or as directed by a healthcare practitioner. It is recommended to use the smallest amount necessary to achieve the desired effect. Any excess gel should be wiped off before engaging in intercourse. Following intercourse, the product should be washed off thoroughly. This product is intended for external use only.

The route of administration is through external application to the head and shaft of the penis. The method of application involves applying the gel 5 to 10 minutes before intercourse, with the frequency of use being as needed prior to intercourse or as specifically directed by a healthcare practitioner.

Contraindications

Use of this product is contraindicated in individuals with a known allergy to Benzocaine or any other ingredient contained in the formulation.

In cases of accidental ingestion, immediate medical assistance should be sought or contact with a poison control center is advised.

Premature ejaculation may indicate an underlying condition that necessitates medical supervision; therefore, use is not recommended without prior consultation.

Healthcare professionals should advise patients to consult a doctor if their partner is pregnant before using this product.

Contact with the eyes should be avoided; in the event of exposure, the eyes must be rinsed thoroughly with water.

Warnings and Precautions

Use of this product is contraindicated in individuals with a known allergy to Benzocaine or any other component of the formulation. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a poison control center is advised.

Premature ejaculation may indicate an underlying condition that necessitates medical evaluation. Healthcare professionals should be consulted prior to use if the partner is pregnant, to ensure safety for both parties.

Care should be taken to avoid contact with the eyes. Should contact occur, it is imperative to rinse the eyes thoroughly with water to mitigate potential irritation.

Adverse reactions, including hypersensitivity or allergic responses, have been reported. In such instances, the product should be discontinued immediately.

Discontinuation and consultation with a healthcare provider are recommended under the following circumstances:

• If the product does not provide relief when used as directed.

• If either the user or their partner experiences a rash or irritation, such as burning or itching.

• If the condition worsens or if symptoms persist beyond 7 days, or if symptoms resolve and then recur within a few days.

• If any of the following symptoms occur: weakness, confusion, headache, difficulty breathing, or the appearance of pale, gray, or blue-colored skin. These symptoms may indicate methemoglobinemia, a rare disorder that can manifest up to 2 hours after use.

Monitoring for these adverse effects is essential to ensure patient safety and effective management of any potential complications.

Side Effects

Patients should be aware that hypersensitivity or allergic reactions may occur with the use of this product. In the event of such reactions, it is imperative to discontinue use immediately.

Additionally, the product is contraindicated in individuals who have a known allergy to Benzocaine or any other ingredient contained in the formulation. It is essential for patients to inform their healthcare provider of any known allergies prior to using this product to avoid potential adverse reactions.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Pleasure Balm (benzocaine). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients should be advised to keep this medication out of reach of children. It is essential to ensure that children do not have access to the medication to prevent accidental ingestion or misuse.

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 or those planning to become pregnant should consult a healthcare professional prior to use. There is limited data regarding the safety of this medication during pregnancy, and potential risks to fetal outcomes have not been fully established. It is essential for women of childbearing potential to discuss their individual circumstances with their healthcare provider to ensure appropriate management and to weigh the benefits against any potential risks.

Lactation

Lactating mothers should consult a doctor prior to use of this product. There is a potential for excretion in breast milk, and the safety of this product during lactation has not been established. Caution is advised when using this product while breastfeeding.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication 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 these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to 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 prescribing information.

Overdosage

In the event of an overdosage, it is imperative that immediate medical assistance is sought. Healthcare professionals should advise patients or caregivers to contact a poison control center without delay if the substance has been ingested.

Symptoms of overdosage may vary depending on the specific substance involved; therefore, a thorough assessment by a medical professional is essential. Prompt recognition of symptoms can facilitate timely intervention and management.

Management of overdosage typically involves supportive care and symptomatic treatment. Healthcare providers should monitor the patient closely and provide appropriate interventions based on the clinical presentation. It is crucial to follow established protocols for the specific substance involved to ensure optimal patient outcomes.

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 compound in these areas.

Postmarketing Experience

Postmarketing experience has identified hypersensitivity and allergic reactions as known adverse events associated with the use of the product. In instances of such reactions, it is recommended that the use of the product be discontinued. These events have been reported voluntarily and through surveillance programs.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. Patients should be instructed to discontinue use and consult a doctor if the product, when used as directed, does not provide relief. Additionally, they should seek medical advice if they or their partner develop a rash or irritation, such as burning or itching, or if their condition worsens. Patients should be informed that if symptoms persist for more than 7 days or clear up and then recur within a few days, they should also consult a healthcare professional.

It is important to communicate that the appearance of symptoms such as weakness, confusion, headache, difficulty breathing, or pale, gray, or blue-colored skin may indicate methemoglobinemia, a rare disorder that can develop within 2 hours of use. Patients should be cautioned against using the product if they are allergic to Benzocaine or any other ingredient contained in it.

In the event of accidental ingestion, patients should seek medical assistance or contact a poison control center immediately. Healthcare providers should also discuss that premature ejaculation may be indicative of an underlying condition that requires medical supervision. Patients should be advised to consult a doctor prior to use if their partner is pregnant.

Furthermore, it is essential to instruct patients to avoid contact with the eyes and to rinse thoroughly with water if contact occurs. Patients should be made aware of known adverse reactions, including hypersensitivity or allergy, and should discontinue use if such reactions occur.

Storage and Handling

The product is supplied in a configuration that ensures optimal usability. It is essential to store the product at room temperature to maintain its integrity and effectiveness. Additionally, it should be kept out of reach of children to prevent accidental ingestion. Once opened, the product must be discarded to ensure safety and efficacy.

Additional Clinical Information

The product is administered topically, with a recommended application of a small amount to the head and shaft of the penis 5-10 minutes prior to intercourse, or as directed by a healthcare practitioner. It is advised to use the smallest amount necessary to achieve the desired effect, and any excess gel should be wiped off before intercourse. The product should be washed off after intercourse.

Clinicians should counsel patients to keep the product out of reach of children and to discontinue use and consult a doctor if relief is not achieved as directed. Patients should also be advised to consult a doctor prior to use if their partner is pregnant and to avoid contact with eyes, rinsing thoroughly with water if contact occurs.

Drug Information (PDF)

This file contains official product information for Pleasure Balm, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)