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Bliss Republic Lidocaine Numbing Cream

Last content change checked dailysee data sync status

This product has been discontinued

Active ingredient
Lidocaine Hydrochloride 5 mg/100 mL
Other brand names
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
February 16, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Lidocaine Hydrochloride 5 mg/100 mL
Other brand names
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
February 16, 2024
Manufacturer
Sargass Group Limited Liability Company
Registration number
M017
NDC root
84028-111
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

This medication is designed to provide temporary relief from discomfort in the anal and rectal area, including symptoms such as itching, pain, soreness, or burning that may be associated with various anorectal disorders or inflammation. It comes in a cream form, making it easy to apply directly to the affected area for soothing relief.

If you're experiencing any of these symptoms, this cream may help alleviate your discomfort and improve your quality of life. Always consult with a healthcare professional for guidance on the best treatment options for your specific needs.

Uses

If you're experiencing discomfort in the anal or rectal area, this medication can help provide temporary relief. It is designed to ease symptoms such as itching, pain, soreness, or burning that may occur due to various anorectal disorders or inflammation.

Using this treatment can help you feel more comfortable and manage the discomfort associated with these conditions effectively. Always consult with a healthcare professional if you have any questions or concerns about your symptoms.

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 or ineffective treatment.

Currently, there are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with this cream. Always follow the instructions provided to ensure your safety and the best possible 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 worsening of other symptoms. In such cases, seek immediate medical attention.

Warnings and Precautions

This product is intended for external use only, so please avoid applying it to any internal areas. If you are allergic to lidocaine, do not use this product, as it may cause a serious reaction. Additionally, if you are pregnant or breastfeeding, it’s important to refrain from using this product.

If you accidentally use too much, 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 help or contact the Poison Control Center. Signs of an overdose can vary, but they may include unusual symptoms that are more severe than what you typically experience with the medication.

Always take overdosing seriously. If you notice any concerning symptoms or if you are unsure, don’t hesitate to reach out for professional assistance 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. Doing so can pose risks to your health and the health of your baby. Always consult with your healthcare provider for guidance on safe medication use during pregnancy and while nursing. Your health and the well-being of your child are the top priority, so make sure to discuss any concerns or questions you may have.

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 medication.

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. As you age, your body may process medications differently, and factors like kidney function (renal impairment) and changes in cognition can affect how well a drug works or how it may impact you.

If you are an older adult or a caregiver, it’s wise to discuss any concerns with your healthcare provider. They can help determine the best approach for your individual health needs, ensuring that any medication you take is safe and effective for you. Always keep your doctor informed about all medications you are taking, as this can help prevent potential interactions or side effects.

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 (issues with liver function).

Always consult your healthcare provider for personalized advice and to discuss any concerns regarding your liver health and medication use. They can help ensure that your treatment is safe and effective based on your individual health 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 way, you can work together to ensure your treatment is safe and effective.

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. Additionally, please check the packaging before use; do not use the product if the packaging is damaged or missing, as this could compromise its safety and integrity. Following these simple guidelines will help you use the product safely and effectively.

Additional Information

No further information is available.

FAQ

What is the purpose of this cream?

This cream provides temporary relief from local and anorectal discomfort, itching, pain, soreness, or burning associated with anorectal disorders or inflammation.

How should I apply this cream?

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

Can children use this cream?

Children under 12 years should consult a doctor before using this cream.

Are there any allergies I should be aware of?

Avoid using this product if you have a known allergy to lidocaine.

Is this cream safe to use during pregnancy or breastfeeding?

Do not use this cream while pregnant or breastfeeding.

What should I do in case of an overdose?

In case of accidental overdose, seek immediate medical assistance or contact the Poison Control Center.

What should I do if my symptoms do not improve?

Discontinue use and consult a doctor if your symptoms show no signs of improvement, or if you experience redness, irritation, swelling, or worsening pain.

How should I store this cream?

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

Can I insert this cream into the rectum?

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

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

This product is presented in a 30 mL dosage form, identified by the National Drug Code (NDC) 84028-111-11. The formulation is a cream, characterized by its specific labeling.

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.

Limitations of Use: This product is intended for symptomatic relief and does not address the underlying causes of anorectal conditions. It is recommended for use in adults and children as directed.

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 insertion into the rectum using fingers, applicators, or any medical devices. This restriction is in place to prevent potential complications associated with improper administration. No other contraindications have been specified in the provided data.

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 symptoms.

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.

Packaging configurations for Bliss Republic Lidocaine Numbing Cream.
Details

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before 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

There is no specific information 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 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 procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs.

It is recommended that healthcare providers remain vigilant and prepared to implement appropriate interventions based on the clinical presentation of the patient following an 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 postmarketing experience details are available in the insert text.

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

No further data are available.

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

Last AI update:

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.