Pleasure Balm

Description

Kama Sutra Pleasure Balm is a prolonging gel specifically formulated for men. This male genital desensitizer is designed to enhance the experience of intimacy by temporarily reducing sensitivity. The product is presented in a gel form and is packaged in a 1.7 fl oz (50 ml) container.

Uses and Indications

This drug is indicated for use as a prolonging gel specifically designed for men. It functions as a male genital desensitizer to assist in enhancing sexual performance.

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 topically 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 thoroughly washed off.

The administration is performed via topical application, specifically to the head and shaft of the penis, and should be done as needed before intercourse or according to the instructions provided by a healthcare professional.

Contraindications

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

This product is intended for external use only. Contact with the eyes should be avoided; in the event of contact, the eyes must be rinsed thoroughly with water.

Warnings and Precautions

For external use only. This product should not be used by individuals who are allergic to Benzocaine or any other ingredient contained within. It is safe to use only with latex condoms. Healthcare professionals should be aware that premature ejaculation may indicate an underlying condition that requires medical supervision. Prior to use, consultation with a doctor is advised if the partner is pregnant.

Care should be taken to avoid contact with the eyes; in the event of contact, the affected area should be rinsed thoroughly with water. Known adverse reactions include hypersensitivity or allergy, which necessitates discontinuation of use.

Discontinuation of use and consultation with a healthcare provider is recommended if the product, when used as directed, fails to provide relief. Additionally, if either the user or their partner experiences a rash or irritation, such as burning or itching, or if the condition worsens or symptoms persist for more than 7 days or recur shortly after resolution, medical advice should be sought.

Particular attention should be given to the appearance of symptoms such as weakness, confusion, headache, difficulty breathing, or pale, gray, or blue-colored skin, as these may indicate methemoglobinemia, a serious condition requiring immediate medical attention.

In the event of accidental ingestion, it is imperative to seek medical assistance or contact a Poison Control Center without delay.

Side Effects

Patients using this product should be aware of several important warnings and potential adverse reactions. This product is intended for external use only and should not be used by individuals who are allergic to Benzocaine or any other ingredient contained in the formulation. It is crucial to consult a healthcare professional prior to use if the partner is pregnant, as well as to seek medical advice if premature ejaculation is suspected to be due to an underlying condition requiring supervision.

In clinical practice, hypersensitivity or allergic reactions have been reported among users. In such instances, it is advised to discontinue use immediately. Additionally, care should be taken to avoid contact with the eyes; if contact occurs, the affected area should be rinsed thoroughly with water.

This product is safe to use only with latex condoms, and users should adhere to this guideline to ensure safety and efficacy.

Drug Interactions

The use of this product is contraindicated in individuals with a known allergy to Benzocaine or any other component of the formulation.

In cases where a partner is pregnant, it is advised to consult a healthcare professional before using this product. This precaution is essential to ensure safety and mitigate any potential risks associated with use during pregnancy.

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 kept out of reach of children. In the event of accidental ingestion, immediate medical assistance or contact with a Poison Control Center is advised.

Additionally, it is recommended that healthcare professionals consult a doctor prior to use if the patient's partner is pregnant.

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.

Pregnancy

Pregnant patients should consult a healthcare professional prior to using this medication, especially if their partner is pregnant. The potential risks and benefits must be carefully weighed, as the effects on fetal outcomes are not fully established. It is essential for healthcare providers to consider individual circumstances and provide appropriate guidance to ensure the safety of both the patient and the developing fetus.

Lactation

There are no specific warnings or recommendations regarding the use of this product in nursing mothers. Additionally, there are no statements concerning the potential for excretion in breast milk or any associated risks to breastfed infants.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment.

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 absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include monitoring vital signs, providing symptomatic treatment, and ensuring the patient's safety.

If available, consultation with a poison control center or a medical toxicologist is recommended to guide further management and treatment options.

Documentation of the incident, including the amount and timing of the substance taken, is crucial for effective management and follow-up care.

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 question. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

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, contributing to the overall understanding of the product's safety profile.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children. In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately.

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. It is important to inform patients that they should consult a healthcare professional if their condition worsens or if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. Patients should also be made aware of serious symptoms that may indicate methemoglobinemia, including weakness, confusion, headache, difficulty breathing, and/or pale, gray, or blue-colored skin.

This product is for external use only, and patients should be cautioned against using it if they are allergic to Benzocaine or any other ingredient in the formulation. It is safe to use only with latex condoms, and patients should be informed that premature ejaculation may be indicative of a condition that requires medical supervision. Healthcare providers should recommend that patients consult a doctor prior to use if their partner is pregnant.

Patients should be advised to avoid contact with the eyes; if contact occurs, they should rinse thoroughly with water. Lastly, healthcare providers should inform patients of the potential for hypersensitivity or allergic reactions, advising them to 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

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

Clinicians should counsel patients to keep the product out of reach of children and to seek medical assistance or contact a Poison Control Center immediately if swallowed. Patients should discontinue use and consult a doctor if the product does not provide relief, if a rash or irritation develops, if the condition worsens, or if symptoms persist for more than 7 days. They should also be aware of serious symptoms such as weakness, confusion, headache, difficulty breathing, or changes in skin color, which may indicate methemoglobinemia. Consultation with a doctor is advised if the partner is pregnant, and patients should 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)