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Bliss Republic Lidocaine Numbing Cream

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Active ingredient
Lidocaine Hydrochloride 4 mg/100 mL
Other brand names
Drug classes
Amide Local Anesthetic, Antiarrhythmic
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2024
Label revision date
May 13, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Lidocaine Hydrochloride 4 mg/100 mL
Other brand names
Drug classes
Amide Local Anesthetic, Antiarrhythmic
Dosage form
Cream
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 2024
Label revision date
May 13, 2025
Manufacturer
Sargass Group Limited Liability Company
Registration number
M017
NDC root
84028-121
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (3 NDCs)
Packaging & NDC Codes (3)

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

You may find this medication helpful for the temporary relief of discomfort in the anal and rectal area. It is designed to alleviate symptoms such as itching, pain, soreness, or burning that can occur due to various anorectal disorders or inflammation.

This medication works locally to provide soothing relief, making it easier for you to manage these uncomfortable symptoms. If you're experiencing any of these issues, this product may be a suitable option to consider for temporary relief.

Uses

If you're experiencing discomfort in the anal or rectal area, this medication can provide temporary relief from symptoms such as itching, pain, soreness, or burning. These symptoms may be associated with various anorectal disorders or inflammation.

You can use this treatment to help ease your discomfort and improve your quality of life during these challenging times. It's important to follow the guidance provided by your healthcare professional for the best results.

Dosage and Administration

Before you use this product, make sure to gently dry the area where you will apply it. You can do this by patting or blotting the skin with toilet tissue or a clean, soft cloth.

For adults, you can apply the product up to six times a day, depending on your needs. If you are considering using it for a child under 12 years old, it’s important to consult a doctor first to ensure it’s safe and appropriate for them.

What to Avoid

It's important to use this cream safely and effectively. You should never insert the cream into the rectum using your fingers, applicators, or any medical devices, as this can lead to complications.

Currently, there are no specific contraindications, controlled substance classifications, or noted risks of abuse, misuse, or dependence associated with this cream. Always follow the instructions provided to ensure your safety and the best results.

Side Effects

If you have a known allergy to lidocaine, it's important to avoid using this product. Additionally, you should not use it while pregnant or breastfeeding. In the event of an accidental overdose, seek immediate medical help or contact the Poison Control Center.

You should stop using the product and consult a doctor if your symptoms do not improve, or if you experience any redness, irritation, swelling, pain, or if other symptoms worsen. In such cases, seek immediate medical attention.

Warnings and Precautions

This product is intended for external use only. If you have a known allergy to lidocaine, it’s important to avoid using this product. Additionally, if you are pregnant or breastfeeding, you should not use it.

If you accidentally use too much of this product, seek immediate medical help or contact the Poison Control Center. You should also stop using the product and consult your doctor if your symptoms do not improve, or if you experience any redness, irritation, swelling, pain, or if any other symptoms worsen. In such cases, getting emergency help is crucial.

Overdose

If you suspect an accidental overdose, it’s crucial to seek immediate medical assistance or contact the Poison Control Center. Signs of an overdose can vary, but they may include unusual symptoms that are not typical for you.

Always err on the side of caution—if you notice anything concerning, don’t hesitate to get help right away. Your health and safety are the top priority.

Pregnancy Use

It is important to avoid using this medication if you are pregnant or breastfeeding. The potential risks to your baby during pregnancy and while nursing are significant, and it is best to prioritize their health and safety. If you are planning to become pregnant or are currently pregnant, please consult your healthcare provider for guidance on safe treatment options.

Lactation Use

It is important to avoid using this medication while you are pregnant or breastfeeding. This precaution is in place to ensure the safety of both you and your baby. If you have any questions or concerns about medications during this time, it's best to consult with your healthcare provider for guidance tailored to your situation.

Pediatric Use

If you have a child under 12 years old, it's important to consult a doctor before using this medication. This ensures that the treatment is safe and appropriate for their age and health needs. Always prioritize your child's well-being by seeking professional guidance when it comes to their health.

Geriatric Use

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. If you or a loved one is an older adult, it’s always wise to discuss any medications with a healthcare provider, especially since older individuals may have different health needs and responses to treatments.

Since there are no dosage adjustments or safety concerns specifically noted for elderly patients, your healthcare provider can help determine the best approach based on individual health conditions and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective care.

Renal Impairment

If you have kidney problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to change based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your specific situation. They can help monitor your kidney health and make any necessary adjustments to your medications.

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 if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver health and medication use. They can help ensure that you receive the safest and most effective treatment based on your individual needs.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking, even if there are no specific drug interactions or laboratory test interactions noted for your treatment. This ensures that your healthcare team can monitor your health effectively and make informed decisions about your care.

Always feel free to ask questions and share all the medications and supplements you are using. This helps to avoid any potential issues and ensures that you receive the best possible treatment tailored to your needs.

Storage and Handling

To ensure the best performance and safety of your product, store it at room temperature, away from direct sunlight. This helps maintain its effectiveness and integrity.

Before using the product, check the packaging carefully. If it is damaged or missing, do not use it, as this could compromise safety. Following these simple guidelines will help you use the product safely and effectively.

Additional Information

You should apply this topical product up to six times a day. However, it's important to avoid using it if you have a known allergy to lidocaine, and you should not use it while pregnant or breastfeeding. Always follow the recommended dosage unless your doctor advises otherwise.

Be cautious, as some people may have allergic reactions to certain ingredients. Do not insert the cream into the rectum with fingers, applicators, or any medical devices. Keep it out of reach of children and avoid contact with your eyes. If the cream is accidentally ingested, seek medical help right away. If your symptoms do not improve or if you experience redness, irritation, swelling, pain, or any worsening symptoms, stop using the product and consult your doctor.

FAQ

What is this drug used for?

This drug is used for temporary relief of local and anorectal discomfort, itching, pain, soreness, or burning associated with anorectal disorders or inflammation.

How should I apply this product?

Before applying, gently dry the area with toilet tissue or a clean, soft cloth. You can apply it up to 6 times daily.

Are there any warnings I should be aware of?

Avoid using this product if you have a known allergy to lidocaine, and do not use it while pregnant or breastfeeding.

What should I do if I experience adverse reactions?

Discontinue use and consult a doctor if symptoms do not improve or if you experience redness, irritation, swelling, or pain.

Can children use this product?

Children under 12 years should consult a doctor before use.

What should I avoid while using this cream?

Do not insert this cream into the rectum using fingers, applicators, or any medical devices.

How should I store this product?

Store at room temperature, away from direct sunlight, and do not use if the packaging is damaged or missing.

Packaging Info

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.

Packaging configurations for Bliss Republic Lidocaine Numbing Cream.
Details

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)

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 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

Use of this product is contraindicated in patients who intend to insert the cream into the rectum using fingers, applicators, or any medical devices. This method of application may lead to adverse effects and is not recommended. No other contraindications have been specified.

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 management of their condition.

Side Effects

Patients should be aware of the potential adverse reactions associated with this product. Serious adverse reactions may occur, particularly in individuals with a known allergy to lidocaine; such patients should avoid using this product entirely. Additionally, the use of this product is contraindicated during pregnancy and breastfeeding.

In the event of an accidental overdose, it is crucial for patients to seek immediate medical assistance or contact the Poison Control Center.

Patients are advised to 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

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions with 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 Bliss Republic Lidocaine Numbing Cream (lidocaine numbing cream). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Bliss Republic Lidocaine Numbing Cream.
Details

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 therapeutic response, 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 profile in this population. Healthcare professionals are advised to consider alternative treatments for pregnant patients and to counsel women of childbearing potential regarding the importance of effective contraception during treatment.

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 procedures may include supportive care and symptomatic treatment, tailored to the individual’s clinical presentation.

It is recommended that healthcare providers remain vigilant and prepared to implement appropriate interventions based on the severity of symptoms and the specific circumstances surrounding the overdose.

Nonclinical Toxicology

The use of this product is contraindicated during pregnancy and breastfeeding due to potential teratogenic effects. Additionally, some individuals may exhibit heightened sensitivity, leading to allergic reactions to specific ingredients contained within the product.

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

Postmarketing Experience

No specific postmarketing experience details are available in the extracted data. As such, there are no reported adverse events or case reports to summarize at this time.

Patient Counseling

Patients should be advised to keep the 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. It is crucial to keep the product out of reach of children and to avoid contact with the eyes. In the event of accidental ingestion, immediate medical attention should be sought. 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)

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 Bliss Republic Lidocaine Numbing Cream, 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

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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.