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Sunset Novelties Herquake

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Active ingredient
Lidocaine Hydrochloride 3.5 mg/100 mL
Other brand names
Dosage form
Liquid
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2025
Label revision date
February 6, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Lidocaine Hydrochloride 3.5 mg/100 mL
Other brand names
Dosage form
Liquid
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 2025
Label revision date
February 6, 2025
Manufacturer
Private Label Productions LLC
Registration number
M017
NDC root
77632-121
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

This medication is designed to provide temporary relief from pain, soreness, or burning in the perianal area, which is the region around the anus. It can be helpful if you're experiencing discomfort in this sensitive area, allowing you to feel more comfortable during daily activities.

While the specific mechanism of action isn't detailed, its primary purpose is to alleviate discomfort, making it a supportive option for managing perianal pain. If you're dealing with such symptoms, this medication may be worth considering for temporary relief.

Uses

If you're experiencing pain, soreness, or burning in the perianal area, this medication can provide you with temporary relief. It's designed to help ease discomfort in that sensitive region, allowing you to feel more comfortable in your daily activities.

Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) associated with this medication, making it a safer option for those who may be concerned about such risks.

Dosage and Administration

You can use this product to add extra moisture to any part of your body that needs it. Simply apply the product to the affected area and make sure to secure the cap after use.

For best results, you can apply it externally up to six times a day. This allows you to maintain hydration in the areas that need it most throughout your daily routine.

What to Avoid

It's important to keep this medication out of reach of children to ensure their safety. There are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with this medication. Always follow safety guidelines to use it responsibly.

Side Effects

You may experience allergic reactions to some ingredients in this product. If you notice symptoms like redness, irritation, swelling, or pain that do not improve, it's important to stop using the product and consult a doctor. Additionally, if you experience any bleeding, discontinue use and seek medical advice.

In the event of an accidental overdose, please seek medical help immediately or contact a Poison Control Center. Your safety is a priority, so be attentive to any unusual reactions while using this product.

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 important to follow the recommended dosage and not exceed it. If you experience any bleeding while using this product, discontinue use immediately and seek medical advice. Always keep this and all medications out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away. If you are pregnant or nursing, or if you have any questions about using this product, please consult a healthcare professional before use.

Overdose

It's important to keep all medications, including this one, out of reach of children. If you suspect an accidental overdose, you should seek medical help immediately or contact a Poison Control Center.

Signs of an overdose can vary, but if you notice unusual symptoms or feel unwell after taking the medication, don't hesitate to get help. Acting quickly can make a significant difference in ensuring safety and health.

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 questions and discuss any concerns you may have regarding medications during this time. 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 on whether it's safe for you and your baby. Always prioritize open communication with your healthcare provider to ensure the best outcomes for both you and your nursing infant.

Pediatric Use

It's important to keep this medication and all other drugs out of reach of children to prevent accidental ingestion. If you suspect your child has taken too much, seek medical help immediately or contact a Poison Control Center.

If you are pregnant or nursing, it's essential to consult a healthcare professional before using this product. Always prioritize safety and ask questions if you're unsure about its use for your child.

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, it’s important to consult with a healthcare provider before starting the medication. 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 usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment plan.

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 regarding your liver health and how it may relate to your treatment. They can help ensure that you receive the safest and most effective care.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking. In this case, there are no specific drug interactions or laboratory test interactions noted, which means that the medication may not have known conflicts with other drugs or tests. However, every individual is different, and your healthcare provider can help ensure that your treatment plan is safe and effective for you.

Always discuss any changes in your medications or upcoming lab tests with your healthcare provider to avoid any potential issues and to get the best care possible.

Storage and Handling

To ensure the best performance and safety of your product, store it at a temperature between 20-25°C (68-77°F). This temperature range helps maintain the integrity of the device.

When handling the product, be sure to do so with clean hands and in a clean environment to avoid contamination. Always follow any specific disposal instructions provided to ensure safe and responsible disposal of any components.

Additional Information

You should apply the medication externally 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, always ask a healthcare professional if you have any questions or concerns about using this medication.

FAQ

What is the primary use of this product?

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

How should I apply this product?

You should apply it externally to the affected area up to 6 times a day.

Are there any contraindications for this product?

No contraindications are listed for this product.

What should I do if I experience an allergic reaction?

If you develop redness, irritation, swelling, or other symptoms, discontinue use and consult a doctor.

Is this product safe to use during pregnancy or nursing?

As with any drug, consult a health care professional if you are pregnant or nursing before using this product.

What should I do in case of accidental overdose?

Seek medical help or call a Poison Control Center right away.

How should I store this product?

Store it at 20-25°C (68-77°F).

Can I use this product with a mechanical device?

No, this product should not be used with a mechanical device.

What should I do if my symptoms do not improve?

If the symptoms being treated do not subside, consult a doctor.

Is there any specific information for elderly patients?

No specific information regarding geriatric use or safety concerns is provided.

Packaging Info

Below are the non-prescription pack sizes of Sunset Novelties Herquake (numbing lubricant). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Sunset Novelties Herquake.
Details

Drug Information (PDF)

This file contains official product information for Sunset Novelties Herquake, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

Sunset 118 is identified by the National Drug Code (NDC) 77632-121-11. The product is supplied in a volume of 118 mL.

Uses and Indications

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

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

Dosage and Administration

The product is intended for external use only. It should be applied to any area of the body where additional moisture is desired. The application may be performed up to six times per day. After each use, ensure that the cap is securely fastened to maintain product integrity.

Contraindications

Use is contraindicated in individuals who are unable to keep the product out of reach of children. This precaution is necessary to prevent accidental ingestion or misuse by pediatric patients. No other contraindications have been identified.

Warnings and Precautions

This product is intended for external use only and should not be used in conjunction with any mechanical devices.

Allergic reactions to the ingredients in this product may occur in some individuals. If the condition being treated does not improve, or if any adverse reactions such as redness, irritation, swelling, or pain develop or worsen, it is imperative to discontinue use immediately and consult a healthcare professional.

Users must adhere strictly to the recommended daily dosage. Exceeding this dosage may lead to adverse effects. In the event of any bleeding, the use of this product should be discontinued, and medical advice should be sought promptly.

It is essential to keep this and all medications out of the reach of children. In the case of an accidental overdose, immediate medical assistance should be sought, or contact a Poison Control Center without delay.

As with any medication, it is advisable for individuals who are pregnant or nursing to consult a healthcare professional prior to use. Additionally, it is recommended to seek guidance from a healthcare professional before using this product to ensure safety and appropriateness.

Side Effects

Patients may experience allergic reactions to ingredients in this product. Symptoms such as redness, irritation, swelling, or pain may indicate an adverse reaction. If these symptoms develop or worsen, patients are advised to discontinue use and consult a healthcare professional.

In the event of any bleeding, it is recommended that patients discontinue use immediately and seek medical advice.

Additionally, in cases of accidental overdose, patients should seek medical assistance or contact a Poison Control Center without delay.

Drug Interactions

There are no specific drug interactions identified in the available data. Additionally, no laboratory test interactions have been reported. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the current information.

Packaging & NDC

Below are the non-prescription pack sizes of Sunset Novelties Herquake (numbing lubricant). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Sunset Novelties Herquake.
Details

Pediatric Use

Pediatric patients should be closely monitored when using this medication. It is essential to keep this and all drugs out of reach of children to prevent accidental ingestion. In the event of an accidental overdose, immediate medical assistance should be sought, or a Poison Control Center should be contacted without delay.

Healthcare professionals are advised to consult with patients who are pregnant or nursing before recommending this product. It is crucial to ensure that pediatric patients receive appropriate guidance regarding the use of this medication.

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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in 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 their healthcare provider to assess the potential risks and benefits associated with the use of this medication 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, as the effects on breastfed infants and the excretion of the drug in breast milk are not specified. Healthcare professionals can provide personalized recommendations based on the individual circumstances of the lactating mother and her infant.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the text. Therefore, healthcare professionals should exercise caution and consider individual patient factors when prescribing to this population. Regular assessment of renal function may be warranted to ensure safe and effective use of the medication in patients with reduced kidney function.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials for this medication. Consequently, there is no available information regarding dosage adjustments, special monitoring requirements, or precautions 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 warranted based on clinical judgment.

Overdosage

In the event of an accidental overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center. Healthcare professionals should be aware that all medications, including this one, must be stored securely out of reach of children to prevent unintentional ingestion.

Prompt action is crucial in managing an overdose situation. Symptoms may vary depending on the specific drug involved, and healthcare providers should be prepared to assess the patient for any signs of toxicity. The management of an overdose will depend on the clinical presentation and may involve supportive care, symptomatic treatment, and specific interventions as indicated.

It is essential for healthcare professionals to remain vigilant and educate patients and caregivers about the importance of proper medication storage and the steps to take 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 use of the compound in question.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion or misuse. It is important to emphasize the necessity of proper storage to ensure the safety of young children.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a controlled temperature range of 20-25°C (68-77°F) to maintain its integrity and efficacy. Proper storage conditions must be adhered to, ensuring that the product is kept within the specified temperature limits to prevent degradation.

Additional Clinical Information

Patients should apply the product externally to the affected area up to six times as directed. It is important for patients to consult a healthcare professional if they are pregnant or nursing, and to seek advice before using the product. No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Sunset Novelties Herquake, 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 Sunset Novelties Herquake, 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.