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Gembooxt Topical Numbing Cream

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Active ingredient
Lidocaine Hcl 0.05 g/1 g
Other brand names
Drug classes
Amide Local Anesthetic, Antiarrhythmic
Dosage form
Cream
Route
Rectal
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2026
Label revision date
January 30, 2026
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Lidocaine Hcl 0.05 g/1 g
Other brand names
Drug classes
Amide Local Anesthetic, Antiarrhythmic
Dosage form
Cream
Route
Rectal
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 2026
Label revision date
January 30, 2026
Manufacturer
Guangdong Quadrant Ecological Technology Co. , Ltd.
Registration number
M017
NDC root
76986-023
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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 local and anorectal itching and discomfort associated with anorectal disorders. It can also help alleviate pain, burning, and soreness in the affected area, making it a supportive option for those experiencing these uncomfortable symptoms.

Uses

If you're experiencing discomfort in the anal area, this medication can help provide temporary relief from local itching and discomfort associated with anorectal disorders. It’s also effective for alleviating pain, burning, and soreness in that region.

Using this treatment can help you feel more comfortable and manage the symptoms that can be quite bothersome. Always remember to follow the recommended guidelines for use to ensure the best results.

Dosage and Administration

Before using this medication, it's important to prepare the area properly. For adults and children aged 12 years and older, start by cleaning the affected area with mild soap and warm water, then rinse it thoroughly. After cleaning, gently dry the area by patting or blotting it with toilet tissue or a soft cloth.

You can apply the medication up to six times a day, depending on your needs. If you are considering this medication for a child under 12 years old, be sure to consult a doctor first for guidance.

What to Avoid

You should avoid using this product on broken or irritated skin, as it can cause further irritation or complications. Additionally, do not insert it into the rectum using your fingers or any mechanical device or applicator, as this poses risks of misuse and potential harm. Always follow these guidelines to ensure your safety and the effectiveness of the product.

Side Effects

For your safety, this product is intended for external use only. You should stop using it and consult a doctor if you notice any signs of an allergic reaction, such as redness, irritation, swelling, or pain that begins or worsens. Additionally, if you do not see any improvement within 7 days, it's important to seek medical advice. If you are pregnant or breastfeeding, please consult your doctor before using this product.

Warnings and Precautions

This product is for external use only, so please avoid applying it to broken or irritated skin. Keep it out of reach of children, and if it is swallowed, seek medical help or contact a Poison Control Center immediately.

You should stop using the product and consult your doctor if you notice any signs of an allergic reaction, such as redness, irritation, swelling, or pain that begins or worsens. Additionally, if you do not see any improvement within 7 days, or if you are pregnant or breastfeeding, it’s important to talk to your doctor before continuing use.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, it's important to be aware of the general signs of an overdose, which can include symptoms like extreme drowsiness, confusion, or difficulty breathing. If you suspect an overdose, it’s crucial to seek immediate medical help.

In case of an emergency, call your local emergency services or go to the nearest hospital. Always keep medications out of reach of children and follow the prescribed dosage to prevent any potential risks. If you have any concerns or questions about your medication, don’t hesitate to reach out to your healthcare provider for guidance.

Pregnancy Use

If you are pregnant or breastfeeding, it’s important to consult your doctor before using this medication. Your healthcare provider can help you understand any potential risks and ensure that you make the safest choice for you and your baby. Always prioritize open communication with your doctor regarding any medications you may be considering during this time.

Lactation Use

If you are pregnant or breastfeeding, it’s important to consult your doctor before using any medication. This ensures that you understand any potential risks and can make informed decisions about your health and the health of your baby. Always prioritize open communication with your healthcare provider regarding your breastfeeding journey.

Pediatric Use

When using this medication for children, it's important to follow specific guidelines. For children aged 12 years and older, you can apply the medication up to six times a day. However, if your child is under 12 years old, you should consult a doctor before use. 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 advice when necessary.

Geriatric Use

If you are caring for an older adult or are an older adult yourself, it's important to know how to use this medication safely. For adults and children aged 12 and older, you can apply the medication up to six times a day. However, if the person is under 12 years old, it's best to consult a doctor before use to ensure safety and proper dosage.

Always keep in mind that older adults may have different health needs, so it's wise to monitor for any unusual reactions or side effects when using this medication. If you have any concerns, don't hesitate to reach out to a healthcare professional for guidance.

Renal Impairment

If you have kidney issues, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations for the medication do not change based on renal impairment. However, it’s always best to discuss your individual situation with your healthcare provider, as they can offer personalized advice and monitor your health closely.

Make sure to keep your doctor informed about your kidney health, as they may need to adjust your treatment plan based on your overall condition and any other medications you may be taking.

Hepatic Impairment

If you have liver problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or precautions related to your condition. This means that there are no tailored recommendations for how the medication may affect you differently due to your liver health.

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific situation. They can help determine the best approach based on your liver function and overall health.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. Currently, there are no specific drug interactions or laboratory test interactions noted for this medication. However, every individual’s health situation is unique, and your provider can help ensure that your treatment plan is safe and effective for you. Always feel free to ask questions and share all the medications and supplements you are using to avoid any potential issues.

Storage and Handling

To ensure the safety and effectiveness of your product, store it at room temperature. It's important to keep it out of reach of children to prevent any accidental ingestion or misuse. Once you open the product, be sure to discard it after use to maintain safety and hygiene. Following these simple guidelines will help you use the product safely and effectively.

Additional Information

You will apply this medication rectally, up to six times a day. It's important to monitor for any allergic reactions, such as redness, irritation, swelling, or pain. If you notice these symptoms or if your condition does not improve within seven days, stop using the product and consult your doctor.

If you are pregnant or breastfeeding, be sure to ask your doctor before using this medication. Keep it out of reach of children, and if it is swallowed, seek medical help or contact a Poison Control Center immediately.

FAQ

What is the drug indicated for?

The drug is indicated for the temporary relief of local and anorectal itching and discomfort associated with anorectal disorders, as well as pain, burning, and soreness.

Who can use this drug?

This drug is for adults and children 12 years and older. For children under 12 years, you should ask a doctor.

How should I apply the drug?

You should clean the area with mild soap and warm water, gently dry it, and then apply the drug up to 6 times daily.

Are there any contraindications for this drug?

Yes, do not use the drug on broken or irritated skin.

What should I do if I experience an allergic reaction?

Stop use and ask a doctor if you observe symptoms such as redness, irritation, swelling, or pain that begin or worsen.

What precautions should I take if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, ask a doctor before use.

What should I do if I swallow the drug?

Keep the drug out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

How should I store the drug?

Store the drug at room temperature and discard it after opening.

Can I insert the drug into the rectum with fingers or devices?

No, do not insert the drug into the rectum with fingers or any mechanical device or applicator.

Packaging Info

Below are the non-prescription pack sizes of Gembooxt Topical Numbing Cream (lidocaine hcl). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Gembooxt Topical Numbing Cream.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the temporary relief of local and anorectal itching and discomfort associated with anorectal disorders. It is also indicated for the temporary relief of pain, burning, and soreness in the anorectal area.

Limitations of Use: This product is intended for short-term use only and should not be used as a substitute for professional medical advice or treatment of underlying conditions.

Dosage and Administration

For adults and children aged 12 years and older, it is recommended that the application site be cleaned with mild soap and warm water, followed by thorough rinsing. The area should then be gently dried by patting or blotting with toilet tissue or a soft cloth prior to application. The product may be applied up to six times daily.

For children under 12 years of age, consultation with a healthcare professional is advised before use.

Contraindications

Use is contraindicated in patients with broken or irritated skin due to the potential for exacerbation of the condition. Additionally, insertion into the rectum using fingers, mechanical devices, or applicators is contraindicated to prevent misuse and associated risks.

Warnings and Precautions

For external use only. It is imperative to keep this product out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact a Poison Control Center without delay.

This product should not be applied to broken or irritated skin. Healthcare professionals are advised to instruct patients to discontinue use and consult a physician if any of the following occur: an allergic reaction, characterized by symptoms such as redness, irritation, swelling, or pain, is observed or worsens; there is no improvement in the condition after 7 days of use; or if the patient is pregnant or breastfeeding, a healthcare provider should be consulted prior to use.

Side Effects

For external use only. Patients should discontinue use and consult a healthcare professional if any allergic reactions occur, characterized by symptoms such as redness, irritation, swelling, or pain, or if these symptoms worsen. Additionally, if there is no improvement within 7 days of use, patients are advised to stop using the product and seek medical advice. Pregnant or breastfeeding individuals should also consult a doctor prior to use.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Gembooxt Topical Numbing Cream (lidocaine hcl). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Gembooxt Topical Numbing Cream.
Details

Pediatric Use

Pediatric patients aged 12 years and older may apply the medication up to 6 times daily. For children under 12 years of age, it is advised to consult a doctor before use.

Geriatric Use

Elderly patients may apply the medication up to six times daily, similar to adults and children aged 12 years and older. However, for children under 12 years, it is advised to consult a physician before use.

Healthcare providers should consider the potential for altered pharmacokinetics in geriatric patients, which may necessitate careful monitoring of treatment effects and safety. It is essential to evaluate the individual needs and health status of elderly patients to ensure appropriate dosing and to mitigate any risks associated with increased frequency of application.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to assess the potential risks and benefits associated with the use of this drug during pregnancy and lactation. The safety of this medication in pregnant women has not been established, and caution is advised to ensure the well-being of both the mother and the fetus.

Lactation

Lactating mothers are advised to consult a healthcare professional prior to using this medication. There is limited information available regarding the excretion of this drug in human breast milk and its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

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 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

There is currently no specific information available regarding overdosage for this medication. Healthcare professionals are advised to monitor patients closely for any unusual symptoms or adverse effects that may arise. In the event of suspected overdosage, it is recommended to initiate supportive care and symptomatic treatment as necessary.

Healthcare providers should consider contacting a poison control center or a medical toxicologist for guidance on management strategies tailored to the individual patient's needs. Continuous assessment and monitoring of vital signs and clinical status are essential in managing any potential complications associated with overdosage.

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

No postmarketing experience details are provided in the insert for GEMBOOXT TOPICAL NUMBING CREAM (lidocaine hcl cream).

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 not to use the product on broken or irritated skin. They should be informed to discontinue use and consult a doctor if they experience any signs of an allergic reaction or if symptoms such as redness, irritation, swelling, or pain develop or worsen. Additionally, if there is no improvement within 7 days of use, patients should seek medical advice. Pregnant or breastfeeding patients are encouraged to consult a healthcare professional before using the product.

When using this product, patients should be reminded to apply only the recommended amount unless otherwise directed by a healthcare provider. It is important to inform patients that they should not insert the product into the rectum using fingers, mechanical devices, or applicators.

Storage and Handling

The product is supplied in a configuration that ensures optimal usability. It should be stored at room temperature, away from direct sunlight and moisture. To maintain safety, it is essential to keep the product out of reach of children. Once opened, the product must be discarded to ensure proper safety and efficacy.

Additional Clinical Information

The product is administered rectally and may be applied up to six times daily. Clinicians should counsel patients to discontinue use and consult a doctor if any allergic reactions occur, including symptoms such as redness, irritation, swelling, or pain. Patients should also seek medical advice if there is no improvement within seven days. Pregnant or breastfeeding individuals are advised to consult a healthcare professional before use. Additionally, the product should be kept out of reach of children, and immediate medical assistance should be sought if ingested.

No further information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Gembooxt Topical 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 Gembooxt Topical 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.