Shunga

Description

The product is identified by the SPL code 34089-3. No specific description details are provided in the text.

Uses and Indications

This drug is indicated for the topical application to the head and shaft of the penis prior to intercourse. The recommended dosage is a small amount ranging from 1 to 3 cc, or as directed by a healthcare professional. It is advised to wipe off any excess product before engaging in sexual intercourse.

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

Dosage and Administration

Healthcare professionals are advised to apply a small amount of the medication, ranging from 1 to 3 cc, to the head and shaft of the penis prior to intercourse, or as directed by a physician. It is important to ensure that any excess product is wiped off before engaging in sexual activity to optimize effectiveness and minimize potential side effects.

Contraindications

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

Additionally, the product should not be applied in large quantities or on extensive body surfaces. Contact with the eyes must be avoided; in the event of accidental contact, the eyes should be flushed with water immediately.

Warnings and Precautions

For external use only, this product must be kept out of reach of children. Healthcare professionals should advise patients to avoid contact with the eyes during application. In the event of accidental eye contact, it is imperative to flush the eyes with water immediately. The product should not be applied in large quantities or on extensive body surfaces. Additionally, it is contraindicated in individuals with a known allergy to benzocaine or any other ingredient contained in this formulation.

Patients are instructed to discontinue use and consult a healthcare provider if the product, when used as directed, fails to provide relief. It is important to note that premature ejaculation may necessitate medical supervision. Furthermore, if either the patient or their partner experiences a rash or irritation, such as burning or itching, or if symptoms persist, medical advice should be sought.

In cases where patients experience symptoms such as weakness, confusion, headache, difficulty breathing, or pale, gray, or blue-colored skin up to two hours after use, which may indicate methemoglobinemia, immediate medical attention is required.

Healthcare professionals should remain vigilant regarding these warnings and ensure that patients are adequately informed about the potential risks associated with the use of this product.

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 must be kept out of reach of children. Users should avoid contact with the eyes; in the event of contact, the eyes should be flushed with water immediately. It is advised not to use this product in large quantities or on large body surfaces. Additionally, individuals with a known allergy to benzocaine or any ingredient contained in this product should refrain from use.

Participants should discontinue use and consult a healthcare professional if the product, when used as directed, does not provide relief. Furthermore, if either the user or their partner develops a rash or irritation characterized by burning or itching, or if symptoms persist, medical advice should be sought.

Serious adverse reactions may include symptoms associated with methemoglobinemia, a blood disorder. Patients experiencing weakness, confusion, headache, breathing difficulties, or pale, gray, or blue-colored skin up to two hours after use should seek immediate medical attention.

Drug Interactions

There are currently no specific drug interactions or drug and laboratory test interactions identified for the product. As such, no dosage adjustments or monitoring recommendations are necessary at this time. Healthcare professionals are advised to remain vigilant for any potential interactions that may arise in clinical practice.

Packaging & NDC

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

Pediatric Use

Pediatric patients should use this product for external use only. It is important to keep the product out of reach of children to prevent accidental ingestion or misuse.

Geriatric Use

There is no specific information regarding the use of SHUNGA SENSATION BALM (benzocaine gel) in geriatric patients. The prescribing information does not provide guidance on dosage adjustments, safety concerns, or special precautions for elderly patients. Therefore, healthcare providers should exercise caution when considering the use of this product in individuals aged 65 and older, as the absence of data necessitates careful monitoring and clinical judgment.

Pregnancy

The safety of this product during pregnancy has not been established. This product is contraindicated in pregnancy due to potential risks to the fetus. Pregnant patients or those planning to become pregnant should consult a healthcare provider before use to discuss potential risks and benefits.

Lactation

There is no specific information available regarding the use of this medication in nursing mothers or any lactation considerations. Healthcare professionals should exercise caution and consider the potential risks and benefits when prescribing this medication to lactating mothers. Further research may be necessary to fully understand the implications for breastfed infants.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to 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 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 maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

Additionally, it is recommended to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols and antidotes, if applicable.

Documentation of the incident, including the substance involved, estimated dose, and time of exposure, 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 these contexts.

Postmarketing Experience

Postmarketing experience has identified symptoms associated with methemoglobinemia, a blood disorder. Reports indicate that patients may experience weakness, confusion, headache, and difficulty breathing, as well as pale, gray, or blue-colored skin. These symptoms have been noted to occur within two hours following the use of the product.

Patient Counseling

Healthcare providers should advise patients that this product is intended for external use only and must be kept out of reach of children to prevent accidental ingestion or misuse.

Patients should be informed to avoid contact with the eyes while using this product. In the event of accidental eye contact, they should flush the eyes with water immediately and seek medical attention if irritation persists.

It is important to counsel patients against using this product in large quantities or applying it to large body surfaces, as this may increase the risk of adverse effects.

Additionally, healthcare providers should ensure that patients are aware not to use this product if they have a known allergy to benzocaine or any other ingredient contained in the formulation. Patients should be encouraged to read the label carefully and consult with their healthcare provider if they have any questions or concerns regarding its use.

Storage and Handling

The product is supplied in a container that must be kept tightly closed to maintain its integrity. It should be stored at room temperature, away from direct light exposure to ensure optimal stability. Once opened, the product should be discarded to prevent any potential degradation or contamination.

Additional Clinical Information

Patients should apply a small amount (1 to 3 cc) of the product to the head and shaft of the penis before intercourse, or as directed by a clinician, ensuring to wipe off any excess prior to sexual activity.

Clinicians should counsel patients to discontinue use and seek medical advice if the product does not provide relief as directed, if premature ejaculation occurs, or if either the patient or their partner experiences a rash or irritation, such as burning or itching. Additionally, patients should be advised to consult a doctor if symptoms persist or if they experience weakness, confusion, headache, breathing difficulties, or changes in skin color (pale, gray, or blue) up to 2 hours after use, as these may indicate methemoglobinemia.

Drug Information (PDF)

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

View product document (PDF)