Bliss Republic Lidocaine Numbing Cream

Description

The product is identified by SPL code 34089-3. It is presented as a white to off-white, round, biconvex tablet, imprinted 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 relief of local and anorectal discomfort, including itching, pain, soreness, or burning associated with anorectal disorders or inflammation.

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

Dosage and Administration

Before applying this product, healthcare professionals should instruct patients to gently dry the application area by patting or blotting it with toilet tissue or a clean, soft cloth.

For adults, the product may be applied up to 6 times daily, ensuring that the application is evenly distributed over the affected area.

For children under 12 years of age, it is recommended to consult a doctor prior to use to determine the appropriate course of action.

Contraindications

The use of this cream is contraindicated for rectal administration. Specifically, it should not be inserted into the rectum using fingers, applicators, or any medical devices. This restriction is in place to ensure safe and effective use of the product.

Warnings and Precautions

This product is intended for external use only. Healthcare professionals should advise patients to avoid using this product if they have a known allergy to lidocaine, as this may lead to serious adverse reactions.

It is contraindicated for use during pregnancy or breastfeeding. Patients should be informed of the potential risks associated with the use of this product in these populations.

In the event of an accidental overdose, it is imperative to seek immediate medical assistance or contact the Poison Control Center. Prompt action is essential to mitigate potential complications.

Patients should be instructed to discontinue use and consult a healthcare provider if the treated symptoms do not show signs of improvement. Additionally, if any redness, irritation, swelling, pain, or other symptoms manifest or worsen, immediate medical attention should be sought. Monitoring for these adverse effects is crucial to ensure patient safety and effective treatment outcomes.

Side Effects

Patients should be aware of the potential adverse reactions associated with this product. It is crucial to avoid using this product if there is a known allergy to lidocaine. Additionally, the use of this product is contraindicated during pregnancy and breastfeeding.

In the event of an accidental overdose, patients are advised to seek immediate medical assistance or contact the Poison Control Center.

Patients should discontinue use and consult a healthcare professional if the treated symptoms do not show signs of improvement. Furthermore, if any redness, irritation, swelling, pain, or other symptoms manifest or worsen, immediate medical attention should be sought.

Drug Interactions

There are no specific drug interactions or laboratory test interactions identified in the available data. Therefore, no dosage adjustments or monitoring recommendations are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Bliss Republic Lidocaine Numbing Cream (lidocaine numbing cream). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional prior to use. It is important to assess the appropriateness of treatment and dosage for this age group, as specific recommendations may vary based on individual health needs and conditions.

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 efficacy, given the lack of targeted data for this population.

Pregnancy

Pregnant patients and those who are breastfeeding should not use this medication. The potential risks associated with the use of this drug during pregnancy have not been established, and there is insufficient data to determine its safety for fetal outcomes. Healthcare professionals are advised to consider alternative treatments for women who are pregnant or nursing.

Lactation

Lactating mothers are advised against the use of this medication while breastfeeding. There is no available data on the excretion of this drug in human breast milk or its effects on breastfed infants. Therefore, the potential risks to nursing infants must be considered, and alternative treatments should be explored for lactating mothers.

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 event of an accidental overdose, it is imperative to seek immediate medical assistance or contact the Poison Control Center. Prompt intervention is crucial to mitigate potential adverse effects associated with overdosage.

Healthcare professionals should be aware that symptoms of overdose may vary depending on the specific substance involved. Therefore, a thorough assessment of the patient's condition is essential.

Management of an overdose typically involves supportive care and symptomatic treatment. Continuous monitoring of the patient's vital signs and clinical status is recommended. In cases where specific antidotes are available, their administration should be considered based on the clinical scenario and the substance involved.

It is essential for healthcare providers to remain vigilant and prepared to implement appropriate interventions to ensure patient safety and optimal outcomes in cases of overdose.

Nonclinical Toxicology

The use of this product is contraindicated during pregnancy and breastfeeding due to potential teratogenic effects. Individuals with heightened sensitivity may experience allergic reactions to certain ingredients contained within the formulation, although these effects are not classified as teratogenic.

No relevant information is available regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Patients should be advised to keep this product out of reach of children and to avoid contact with the eyes. In the event of accidental ingestion, it is crucial to seek medical attention immediately.

Healthcare providers should instruct patients to discontinue use and consult a doctor if the treated symptoms do not show signs of improvement. Additionally, patients should be informed to seek immediate medical attention if they experience any redness, irritation, swelling, pain, or if other symptoms manifest or worsen.

When using this product, patients must adhere to the recommended daily dosage unless otherwise directed by a healthcare professional. It is important to note that some individuals may have heightened sensitivity and could experience allergic reactions to specific ingredients in the product. Patients should also be cautioned against inserting the cream into the rectum using fingers, applicators, or any medical devices.

Storage and Handling

The product is supplied in packaging that must be stored at room temperature. It is essential to protect the product from direct sunlight to maintain its integrity. Healthcare professionals should refrain from using the product if the packaging is damaged or missing, as this may compromise safety and efficacy.

Additional Clinical Information

Patients should be advised that the product is for topical administration, with a recommended application frequency of up to six times daily. Clinicians should counsel patients to avoid use if they have a known allergy to lidocaine and to refrain from using the product during pregnancy or breastfeeding. It is important for patients to adhere to the prescribed dosage unless otherwise directed by a healthcare professional.

Patients with heightened sensitivity may experience allergic reactions to certain ingredients. The product should not be inserted into the rectum using fingers, applicators, or any medical devices. Additionally, it should be kept out of reach of children and away from the eyes. In the event of accidental ingestion, immediate medical attention is necessary. Patients should discontinue use and consult a doctor if symptoms do not improve or if any adverse reactions, such as redness, irritation, swelling, or pain, occur or worsen.

Drug Information (PDF)

This file contains official product information for Bliss Republic Lidocaine Numbing Cream, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)