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Waxup Numbing

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Active ingredient
Lidocaine Hydrochloride 50 mg/1 mL
Other brand names
Drug classes
Amide Local Anesthetic, Antiarrhythmic
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 2022
Label revision date
November 6, 2023
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Lidocaine Hydrochloride 50 mg/1 mL
Other brand names
Drug classes
Amide Local Anesthetic, Antiarrhythmic
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 2022
Label revision date
November 6, 2023
Manufacturer
CONSTRUSOLUTION, LLC
Registration number
M015
NDC root
83163-386
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 help relieve local itching and discomfort in the perianal area. It provides temporary relief from pain, irritation, or burning sensations, making it useful for those experiencing these uncomfortable symptoms. If you're dealing with such issues, this medication may offer you some much-needed comfort.

Uses

If you're experiencing discomfort in the perianal area, this medication can help relieve local itching and discomfort. It’s designed to provide temporary relief from pain, irritation, or burning sensations you might be feeling. This can make daily activities more comfortable and improve your overall well-being.

Dosage and Administration

To use this product effectively, start by cleaning the affected area with mild soap and warm water. After rinsing, gently pat or blot the area dry using toilet tissue or a soft cloth. Once the area is dry, you can apply the product externally. You should do this up to six times a day or after each bowel movement, depending on your needs.

If you are considering this product for a child under 12 years old, it’s important to consult a doctor first to ensure it’s safe and appropriate for their use.

What to Avoid

It's important to use this product safely and effectively. You should never exceed the recommended daily dosage unless your doctor specifically instructs you to do so. Additionally, avoid inserting this product into the rectum using your fingers or any mechanical device or applicator, as this can lead to complications.

By following these guidelines, you can help ensure that you use the product correctly and minimize any potential risks. If you have any questions or concerns, don't hesitate to reach out to your healthcare provider for guidance.

Side Effects

When using this product, it's important to be aware of potential side effects. You should stop using it and consult a doctor if the symptoms you are treating do not improve, or if you experience any redness, irritation, swelling, pain, or other worsening symptoms.

Additionally, some individuals may have allergic reactions to the ingredients in this product. If you notice any signs of an allergic reaction, such as rash or difficulty breathing, seek medical attention immediately. Remember, this product is for external use only.

Warnings and Precautions

This product is intended for external use only, so please avoid using it internally or exceeding the recommended daily dosage unless your doctor advises otherwise. If you notice that your condition worsens or does not improve within 7 days, or if you experience any bleeding, it’s important to consult a doctor promptly.

You should stop using this product and contact your doctor if the symptoms you are treating do not improve, or if you develop increased redness, irritation, swelling, pain, or any other concerning symptoms. Be aware that some individuals may have allergic reactions to the ingredients, so monitor your body’s response. If the product is accidentally swallowed, seek medical help or contact a Poison Control Center immediately. If you are pregnant or breastfeeding, please consult a healthcare professional before using this product.

Overdose

If you or someone else has swallowed too much of a medication, it’s important to act quickly. You should seek medical help immediately or contact a Poison Control Center. They can provide guidance on what to do next.

Signs of an overdose can vary, but it’s crucial to be aware of any unusual symptoms that may arise. If you notice anything concerning, don’t hesitate to reach out for help. Remember, acting fast can make a significant difference in ensuring safety and health.

Pregnancy Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using this medication. They can provide guidance on whether it’s safe for you and your baby. Always prioritize your health and the health of your child by seeking expert advice.

Lactation Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional 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 doctor regarding your breastfeeding journey and any medications you may consider.

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 professional guidance when it comes to your child's health.

Geriatric Use

When it comes to using this medication for older adults, there are no specific guidelines or dosage adjustments mentioned in the information provided. This means that the standard dosage applies, and there are no additional safety concerns or precautions specifically for elderly patients.

However, it's always important to consult with a healthcare provider about any medications, especially if you or a loved one is an older adult. They can help ensure that the treatment is safe and appropriate based on individual health needs.

Renal Impairment

If you have kidney problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or safety considerations for your condition. This means that there are no tailored guidelines for how this medication may affect you if you have 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 help monitor your kidney function and make any necessary adjustments to 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 should be used if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your liver health. They can help determine the best course of action based on your individual situation.

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 has a complete understanding of your health and can provide the best care possible.

Always feel free to ask questions about how different medications might affect each other or any tests you may need. Your safety and well-being are the top priority, and discussing your medications helps to avoid any potential issues.

Storage and Handling

To ensure the best performance of your product, it's important to store it properly. Keep the product in its container and protect it from excessive heat and direct sunlight. This will help maintain its effectiveness and safety.

When handling the product, always do so with care to avoid any damage. Following these simple storage and handling guidelines will help you use the product safely and effectively.

Additional Information

You should apply this medication topically (on the skin) to the affected area, up to six times a day or after each bowel movement. If you are pregnant or breastfeeding, it's important to consult with a healthcare professional before using this product to ensure it's safe for you.

FAQ

What is the primary use of this drug?

This drug helps relieve local itching and discomfort in the perianal area, providing temporary relief from pain, irritation, or burning.

How should adults use this product?

Adults should cleanse the affected area with mild soap and warm water, gently dry it, and apply the product externally up to 6 times daily or after each bowel movement.

What should children under 12 do before using this product?

Children under 12 years of age should consult a doctor before use.

Are there any contraindications for this drug?

No specific contraindications are mentioned for this drug.

What should I do if I experience worsening symptoms?

If your condition worsens or does not improve within 7 days, or if you experience redness, irritation, swelling, or pain, consult a doctor.

Can I use this product if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, you should ask a health professional before using this product.

What precautions should I take when using this product?

Do not exceed the recommended daily dosage unless directed by a doctor, and do not put this product into the rectum using fingers or any mechanical device.

What should I do if I swallow this product?

If swallowed, seek medical help or contact a Poison Control Center immediately.

Is this product safe for external use?

Yes, this product is for external use only.

Packaging Info

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

Packaging configurations for Waxup Numbing.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The product is identified by the SPL code 34089-3. No additional specific description details are provided in the available text.

Uses and Indications

This drug is indicated for the temporary relief of local itching and discomfort in the perianal area. It is also effective in alleviating pain, irritation, or burning associated with these conditions.

Dosage and Administration

For adults, it is recommended to cleanse the affected area with mild soap and warm water when practical. After cleansing, the area should be rinsed by patting or blotting with an appropriate cleansing pad. The area must then be gently dried by patting or blotting with toilet tissue or a soft cloth prior to the application of the product. The product should be applied externally to the affected area up to six times daily or after each bowel movement.

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

Contraindications

Use of this product is contraindicated in the following situations:

Exceeding the recommended daily dosage is contraindicated unless directed by a healthcare professional, as it may lead to adverse effects. Additionally, the product should not be administered rectally using fingers, mechanical devices, or applicators, due to the risk of injury or improper use.

Warnings and Precautions

For external use only. It is imperative that the recommended daily dosage is not exceeded unless specifically directed by a healthcare professional. The product should not be administered rectally using fingers, mechanical devices, or applicators.

When utilizing this product, healthcare professionals should advise patients to seek medical consultation if the condition worsens or fails to improve within 7 days. Immediate medical attention is warranted in the event of bleeding.

Patients should discontinue use and consult a healthcare provider if the symptoms being treated do not subside, or if any redness, irritation, swelling, pain, or other adverse symptoms develop or intensify. It is important to note that some individuals may experience allergic reactions to the ingredients contained in this product.

In cases of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center without delay. Additionally, it is recommended that pregnant or breastfeeding individuals consult a healthcare professional prior to use to ensure safety.

Side Effects

Patients using this product should be aware that it is intended for external use only. In clinical practice, it is important to monitor for any adverse reactions that may arise during treatment.

Participants are advised to stop use and consult a healthcare professional if the symptom being treated does not subside, or if any of the following symptoms develop or worsen: redness, irritation, swelling, pain, or other related symptoms.

Additionally, there is an allergy alert associated with this product, as certain individuals may develop allergic reactions to its ingredients. It is crucial for patients to be vigilant and report any signs of an allergic response to their healthcare provider.

Drug Interactions

There are no specific drug interactions or laboratory test interactions identified in the available data. Therefore, no recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

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

Packaging configurations for Waxup Numbing.
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

There is no specific geriatric use information provided in the prescribing information for this medication. Consequently, there are no recommended age considerations, dosage adjustments, safety concerns, or special precautions for elderly patients. Healthcare providers should exercise clinical judgment when prescribing this medication to geriatric patients, considering the individual health status and potential comorbidities that may affect treatment outcomes. Regular monitoring and assessment of therapeutic response and tolerability are advised in this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is no specific data available regarding the excretion of this medication in breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to 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 prescribing information.

Overdosage

In the event of an overdosage, immediate medical intervention is crucial. If the substance is ingested, it is imperative to seek medical assistance or contact a Poison Control Center without delay.

Healthcare professionals should be aware that prompt action can significantly influence the outcome of an overdosage situation. Symptoms of overdosage may vary depending on the specific substance involved; therefore, a thorough assessment of the patient's condition is essential.

Management procedures should include monitoring vital signs and providing supportive care as needed. It is advisable to have the patient’s medical history and any available information regarding the ingested substance on hand to facilitate appropriate treatment.

In summary, swift action and appropriate medical guidance are vital in managing cases of overdosage effectively.

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 these contexts.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. In the event that the product is swallowed, patients should seek medical help or contact a Poison Control Center immediately.

Patients should be instructed not to exceed the recommended daily dosage unless directed by a healthcare professional. It is important to inform patients that the product should not be inserted into the rectum using fingers, mechanical devices, or applicators.

Healthcare providers should counsel patients to discontinue use and consult a doctor if the symptoms being treated do not subside, or if they experience any redness, irritation, swelling, pain, or other symptoms that develop or worsen. Patients should be made aware that certain individuals may develop allergic reactions to the ingredients in this product, and they should be informed of the allergy alert.

Additionally, patients should be advised that if their condition worsens or does not improve within 7 days of use, they should consult a doctor. In cases of bleeding, it is crucial for patients to seek prompt medical attention.

Storage and Handling

The product is supplied in a container designed to safeguard its integrity. It is essential to protect the product from excessive heat and direct sunlight to maintain its efficacy and safety. Proper storage conditions should be observed to ensure optimal performance.

Additional Clinical Information

Patients should apply the medication topically to the affected area, with a frequency of up to six times daily or after each bowel movement. Clinicians are advised to counsel patients to consult a health professional if they are pregnant or breastfeeding 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 Waxup Numbing, 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 Waxup Numbing, 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.