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Xesso Strawberry Rear Comfort Glide 4% Lidocaine

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Active ingredient
Lidocaine Hydrochloride 4.625 g/100 mL
Other brand names
Drug classes
Amide Local Anesthetic, Antiarrhythmic
Dosage form
Gel
Route
Rectal
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2022
Label revision date
October 17, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Lidocaine Hydrochloride 4.625 g/100 mL
Other brand names
Drug classes
Amide Local Anesthetic, Antiarrhythmic
Dosage form
Gel
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 2022
Label revision date
October 17, 2025
Manufacturer
Premium Natural Cosmetics Inc
Registration number
M015
NDC root
81777-105
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

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 temporary relief of pain, soreness, or burning in the perianal area (the area around the anus). It is designed to provide comfort during times of discomfort, allowing you to manage symptoms effectively. If you have any questions about its use or how it may help you, consider discussing it with your healthcare provider for more personalized information.

Uses

If you're experiencing discomfort in the perianal area, this medication can provide temporary relief from pain, soreness, or burning sensations. It's designed to help ease these uncomfortable feelings, allowing you to go about your daily activities with less irritation. Always consult with a healthcare professional if you have any questions or concerns about your symptoms.

Dosage and Administration

To use this product effectively, start by cleaning the affected area. It's best to use mild soap and warm water, rinsing thoroughly. After cleansing, gently dry the area by patting or blotting it with toilet tissue or a soft cloth. This preparation helps ensure the product works as intended.

Once the area is clean and dry, you can apply the product externally. You can do this up to six times a day, depending on your needs. Just remember to follow these steps each time for the best results.

What to Avoid

It's important to be aware of certain situations where you should avoid using this product. If you have a known allergy to any of the ingredients, you should not use it, as this could lead to allergic reactions. Additionally, if your symptoms do not improve or if you experience increased redness, irritation, swelling, pain, or any other concerning symptoms, you should stop using the product immediately and consult your doctor.

Remember, this product may be associated with controlled substances, which means it should be used carefully to prevent misuse or dependence (a condition where you rely on a substance). Always prioritize your health and safety by following these guidelines.

Side Effects

You may experience allergic reactions to some ingredients in this product. If you notice that the symptoms you are treating do not improve, or if you develop redness, irritation, swelling, pain, or any other concerning symptoms, it’s important to stop using the product and consult your doctor. Your health and safety are paramount, so please take these signs seriously.

Warnings and Precautions

This product is for external use only, and you should not use it with any mechanical devices. Be aware that some people may have allergic reactions to the ingredients. If you notice that the symptoms you are treating do not improve, or if you experience redness, irritation, swelling, pain, or any other worsening symptoms, stop using the product and consult your doctor. It's also important not to exceed the recommended daily dosage or apply it to cracked or broken skin. If you experience any bleeding, discontinue use and seek medical advice.

In case of an accidental overdose, it’s crucial to get emergency medical help immediately or contact a Poison Control Center. Always prioritize your health and safety when using this product.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, if you suspect an overdose, it is important to be aware of potential signs, which may include unusual drowsiness, confusion, or difficulty breathing.

If you notice any of these symptoms or have concerns about an overdose, seek immediate medical help. It’s always better to err on the side of caution when it comes to your health. Remember, if you are ever in doubt, contacting a healthcare professional is the best course of action.

Pregnancy Use

If you are pregnant or nursing, it’s important to consult with a healthcare professional before using this product. They can provide guidance tailored to your specific situation and help ensure the safety of both you and your baby. Always ask your healthcare provider if you have any questions or concerns about using this product during pregnancy or while breastfeeding. Your health and the health of your child are the top priority.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to consult with your healthcare professional before using any medication, including this product. They can provide guidance tailored to your specific situation and help ensure the safety of both you and your baby. Always prioritize open communication with your healthcare provider regarding any concerns or questions you may have about medications while nursing.

Pediatric Use

It's important to keep this medication out of reach of children to prevent any accidental ingestion. If you suspect that your child has taken too much, seek medical help immediately or contact a Poison Control Center for guidance. Being aware of these precautions can help ensure your child's safety.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that if you or a loved one is an older adult considering this medication, it’s important to consult with a healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

Renal Impairment

If you have kidney problems, 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 include special monitoring or safety considerations tailored for patients with renal impairment (kidney issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your health situation. They can provide guidance based on your individual needs and kidney function.

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 detailed guidelines available regarding how the medication may affect you or how your liver health might influence the medication's effectiveness or safety.

Before starting any new medication, it's essential to discuss your liver condition with your healthcare provider. They can help determine the best approach for your treatment and ensure that you are monitored appropriately. Always keep your doctor informed about your liver health to receive the safest and most effective care.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you.

Always feel free to ask questions and share your complete list of medications and any lab tests you may be undergoing. This way, you can receive the best possible care tailored to your needs.

Storage and Handling

To ensure the best performance of your product, store it at room temperature, ideally between 20 - 25°C (68 - 77°F). It's important to handle the product with care; do not use it if the tamper-evident seal on the outside of the container is broken or missing, as this indicates that the product may not be safe to use.

By following these simple storage and handling guidelines, you can help maintain the product's integrity and ensure your safety.

Additional Information

You should apply this medication rectally to the affected area, up to six times a day. If you are pregnant or nursing, it's important to consult a healthcare professional before using this product. Additionally, be aware that some individuals may experience allergic reactions to the ingredients. If your symptoms do not improve or if you notice any redness, irritation, swelling, pain, or other worsening symptoms, stop using the product and contact your doctor.

FAQ

What is the purpose of this drug?

This drug is for temporary relief of pain, soreness, or burning in the perianal area.

How should I apply this product?

Cleanse the affected area with mild soap and warm water, then gently dry it. Apply the product externally to the affected area up to 6 times daily.

What should I do if I experience allergic reactions?

If you develop allergic reactions or if symptoms like redness, irritation, or swelling increase, discontinue use and consult a doctor.

Are there any warnings I should be aware of?

This product is for external use only, should not be used with a mechanical device, and should not be applied to cracked or broken skin.

What should I do in case of accidental overdose?

Seek medical help or call a Poison Control Center immediately.

Is this product safe to use during pregnancy or nursing?

Consult a health care professional if you are pregnant or nursing before using this product.

How should I store this product?

Store at room temperature between 20 - 25°C (68 - 77°F) and do not use if the tamper evident seal is broken or missing.

What should I do if my symptoms do not improve?

If your symptoms do not subside or if you experience increased redness, irritation, or swelling, discontinue use and consult a doctor.

Packaging Info

Below are the non-prescription pack sizes of Xesso Strawberry Rear Comfort Glide 4% Lidocaine (lidocaine). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Xesso Strawberry Rear Comfort Glide 4% Lidocaine.
Details

Drug Information (PDF)

This file contains official product information for Xesso Strawberry Rear Comfort Glide 4% Lidocaine, 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 pain, soreness, or burning in the perianal area.

Dosage and Administration

When practical, the affected area should be cleansed with mild soap and warm water, followed by thorough rinsing by patting or blotting with an appropriate cleansing pad. The area should then be gently dried by patting or blotting with toilet tissue or a soft cloth prior to the application of this product.

The product is to be applied externally to the affected area up to 6 times daily.

Contraindications

Use of this product is contraindicated in individuals with known allergies to any of its ingredients, as this may lead to allergic reactions.

Additionally, if symptoms being treated do not improve or if there is an increase in redness, irritation, swelling, pain, or other adverse symptoms, the product should be discontinued immediately, and a healthcare professional should be consulted.

Warnings and Precautions

For external use only; this product should not be used in conjunction with any mechanical device. Certain individuals may experience allergic reactions to the ingredients contained in this formulation. If the symptoms being treated do not improve, or if any signs of redness, irritation, swelling, pain, or other adverse reactions develop or worsen, it is imperative to discontinue use immediately and consult a healthcare professional.

Users must adhere strictly to the recommended daily dosage and should not exceed this limit. Application of the product is contraindicated on cracked or broken skin. In the event of any bleeding, the use of this product should be stopped, and medical advice should be sought.

In cases of accidental overdose, it is crucial to seek emergency medical assistance or contact a Poison Control Center without delay.

Side Effects

Certain patients may experience allergic reactions to ingredients in this product. In clinical use, if the symptoms being treated do not subside, or if patients develop redness, irritation, swelling, pain, or any other adverse symptoms that increase in severity, it is recommended to discontinue use and consult a healthcare professional.

It is important for patients to be aware of these potential reactions and to monitor their condition closely while using the product. Prompt medical consultation is advised if any of the aforementioned symptoms occur or worsen.

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 Xesso Strawberry Rear Comfort Glide 4% Lidocaine (lidocaine). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Xesso Strawberry Rear Comfort Glide 4% Lidocaine.
Details

Pediatric Use

Pediatric patients should be advised to keep this medication out of reach of children. In the event of an accidental overdose, it is crucial to seek medical assistance immediately or contact a Poison Control Center for guidance.

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 potential adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

Pregnant patients and those who are nursing should consult a healthcare professional prior to using this product. It is essential for women of childbearing potential to seek guidance from a healthcare provider to assess the potential risks and benefits associated with the use of this product during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a healthcare professional prior to using this product. It is important to seek guidance regarding the use of this medication while nursing. There is no specific data provided on the excretion of this drug in breast milk or its effects on breastfed infants. Therefore, healthcare professionals should evaluate the potential risks and benefits before recommending this product to lactating mothers.

Renal Impairment

Patients with renal impairment may not have specific dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. Therefore, healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the lack of detailed guidance necessitates careful clinical judgment and individualized patient assessment. Regular monitoring of renal function is advisable to ensure patient safety and optimal therapeutic outcomes.

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 overdosage information, it is essential for healthcare professionals to remain vigilant regarding the potential for overdose with this medication. In cases where an overdose is suspected, immediate medical attention should be sought.

Healthcare providers are advised to monitor patients closely for any signs or symptoms that may arise from an overdose. These may include, but are not limited to, increased severity of known side effects, altered mental status, or any unusual physiological responses.

Management of an overdose should be guided by the clinical presentation of the patient. Supportive care is paramount, and symptomatic treatment should be initiated as necessary. Healthcare professionals should also consider contacting a poison control center for additional guidance on the management of overdose cases.

In summary, while specific overdosage information is not available, healthcare professionals should exercise caution, monitor for symptoms, and provide appropriate supportive care in the event of an overdose.

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 compound in these areas.

Postmarketing Experience

Postmarketing experience has revealed reports of allergic reactions to ingredients in this product. These events were reported voluntarily or identified through surveillance programs.

Patient Counseling

Patients should be advised to keep this product out of reach of children. In the event of an accidental overdose, they should seek medical help or contact a Poison Control Center immediately.

It is important to inform patients that some individuals may develop allergic reactions to the ingredients in this product. They should be instructed to discontinue use and consult a doctor if the symptoms being treated do not improve, or if they experience redness, irritation, swelling, pain, or any other concerning symptoms.

Patients who are pregnant or nursing should be encouraged to consult a healthcare professional before using this product. Additionally, they should be reminded to ask a healthcare professional for guidance prior to use, as with any medication.

Storage and Handling

The product is supplied in a container that must be stored at room temperature, specifically within the range of 20 to 25°C (68 to 77°F). It is imperative that the tamper-evident seal on the outside of the container remains intact; the product should not be used if this seal is broken or missing.

Additional Clinical Information

The product is administered rectally and can be applied externally to the affected area up to six times daily. Clinicians should advise patients to consult a healthcare professional if they are pregnant or nursing before using this product. Additionally, patients should be informed that allergic reactions to the ingredients may occur. If symptoms do not improve or if any adverse reactions such as redness, irritation, swelling, or pain develop or worsen, patients should discontinue use and seek medical advice.

Drug Information (PDF)

This file contains official product information for Xesso Strawberry Rear Comfort Glide 4% Lidocaine, 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 Xesso Strawberry Rear Comfort Glide 4% Lidocaine, 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.