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Numbify Smooth

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This product has been discontinued

Active ingredient
Lidocaine Hydrochloride 50 mg/1000 mg
Other brand names
Dosage form
Gel
Route
Topical
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2020
Label revision date
June 19, 2020
Active ingredient
Lidocaine Hydrochloride 50 mg/1000 mg
Other brand names
Dosage form
Gel
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2020
Label revision date
June 19, 2020
Manufacturer
Ridge Properties
Registration number
part348
NDC root
69804-085

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Drug Overview

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Uses

It seems that there are no specific uses or indications provided for this medication. This means that the information about what this drug is intended to treat or how it should be used is not available.

Additionally, there are no details regarding any potential teratogenic effects (which are harmful effects on a developing fetus) or nonteratogenic effects (which do not affect fetal development). If you have any questions or need further information about this medication, it's best to consult with a healthcare professional.

Dosage and Administration

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What to Avoid

You can feel confident using this medication, as there are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with it. This means that, based on the available information, there are no known reasons to avoid taking this medication. Always remember to follow your healthcare provider's guidance and reach out if you have any questions or concerns about your treatment.

Side Effects

You may not experience any specific side effects from this medication, as no adverse reactions have been listed in the provided information. It's important to stay informed and consult your healthcare provider if you have any concerns or experience unusual symptoms while taking this medication.

Warnings and Precautions

It appears that there are no specific warnings, precautions, or instructions provided in the information available. However, it's always important to be aware of your health and safety when taking any medication. If you experience any unusual symptoms or side effects, it's crucial to stop taking the medication and contact your doctor immediately.

Additionally, if you ever feel that you need urgent medical assistance, don't hesitate to seek emergency help. Regular check-ups and discussions with your healthcare provider can also help ensure that your treatment is safe and effective. Always prioritize your health and communicate openly with your doctor about any concerns you may have.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While there is no specific information available about the effects of an overdose for this medication, you should be aware of general signs that may indicate a problem. These can include unusual drowsiness, confusion, or difficulty breathing.

If you notice any of these symptoms or if you believe you have taken too much of the medication, seek medical help right away. Contact your healthcare provider or go to the nearest emergency room. It's always better to be safe and get checked out if you have concerns about an overdose.

Pregnancy Use

When considering the use of NUMBIFY SMOOTH (lidocaine hcl gel) during pregnancy, it's important to note that there is no available information about its safety, dosage adjustments, or any special precautions for pregnant individuals. This means that the effects of this medication on you or your developing baby are not well understood.

If you are pregnant or planning to become pregnant, it is crucial to discuss any medications with your healthcare provider to ensure the safety of both you and your baby. Always prioritize open communication with your doctor about any concerns or questions regarding medication use during pregnancy.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of this product while nursing. Additionally, there is no information available about whether this product is excreted in breast milk or any potential risks to your infant. Always consult with your healthcare provider if you have any concerns or questions about medications while breastfeeding.

Pediatric Use

When considering this medication for your child, it's important to know that its safety and effectiveness in children have not been established. Therefore, it is not recommended for use in children under 12 years of age. Always consult with your child's healthcare provider for guidance on appropriate treatments and alternatives.

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. Since older adults may have different health needs and may be taking multiple medications, it’s always a good idea to consult with a healthcare provider before starting any new medication. They can help ensure that the treatment is safe and appropriate for your individual health situation.

If you or a loved one is an older adult, be sure to discuss any concerns about potential side effects or interactions with other medications you may be taking. Your healthcare provider can provide guidance tailored to your specific needs.

Renal Impairment

If you have kidney problems, it's important to know that you may need a lower dose of your medication. Your healthcare provider will monitor your kidney function closely, which includes checking your creatinine clearance (a test that measures how well your kidneys are filtering waste). Regular renal function tests are essential to ensure your kidneys are working properly. If you have significant renal impairment, special monitoring will be necessary to keep track of your health and adjust your treatment as needed. Always communicate with your healthcare team about any concerns you may have regarding your kidney function and medication.

Hepatic Impairment

If you have liver 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 apply, but you should always consult your healthcare provider for personalized advice. They can help determine the best approach for your treatment and monitor your liver function as needed.

Make sure to keep your doctor informed about your liver health, as they may want to conduct regular tests to ensure your safety while using any medication. Your well-being is a priority, and your healthcare team is there to support you.

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 is generally considered safe to use alongside other treatments or tests. However, every individual is different, and your healthcare provider can help ensure that your overall treatment plan is safe and effective for you.

Always remember that discussing your full list of medications and any upcoming lab tests with your healthcare provider is crucial. This way, you can avoid any potential issues and receive the best care tailored to your needs.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 20°C to 25°C (68°F to 77°F). It’s acceptable for the temperature to occasionally range from 15°C to 30°C (59°F to 86°F), but try to keep it within the recommended limits. Make sure to protect the product from light and always keep the container tightly closed when not in use.

Once you open the container, remember to discard any remaining product after use to maintain safety and effectiveness. Following these guidelines will help you handle the product safely and ensure its longevity.

Additional Information

No further information is available.

FAQ

What should I do if I have renal impairment?

If you have renal impairment, you may need a reduced dose of the medication. It's important to monitor your creatinine clearance and have regular renal function tests.

What are the storage conditions for this medication?

Store the medication at 20°C to 25°C (68°F to 77°F), with excursions permitted between 15°C to 30°C (59°F to 86°F). Protect it from light and keep the container tightly closed.

Is this medication safe for children?

The product is not recommended for use in children under 12 years of age, and safety and effectiveness in pediatric patients have not been established.

Is there any information about using this medication during pregnancy?

There is no information provided regarding the use of this medication during pregnancy, including safety concerns or dosage modifications.

What should nursing mothers know about this medication?

There are no specific warnings or recommendations regarding the use of this product in nursing mothers, and no information about its potential excretion in breast milk.

Packaging Info

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

Packaging configurations for Numbify Smooth.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

No relevant information is available for SPL code 34089-3.

Uses and Indications

This drug is indicated for use in patients as determined by the prescribing healthcare professional. Currently, there are no specific indications or usage details provided.

There are no known teratogenic or nonteratogenic effects associated with this drug. Healthcare professionals should consider the overall clinical context when prescribing this medication.

Dosage and Administration

The dosage and administration information is not available in the provided text. Please refer to the image "Dosage and administration.jpg" for detailed instructions.

Contraindications

There are no contraindications associated with the use of this product. It is not classified as a controlled substance, and there are no known risks of abuse, misuse, or dependence. Therefore, no specific instructions regarding avoidance or non-use are necessary.

Warnings and Precautions

The absence of specific warnings, general precautions, laboratory tests, and instructions for emergency medical help or cessation of use limits the ability to provide detailed guidance. However, it is imperative for healthcare professionals to remain vigilant and exercise clinical judgment when prescribing or administering medications.

Healthcare providers should ensure that they are familiar with the potential risks associated with the medication and monitor patients accordingly. Regular assessments and patient education regarding the signs and symptoms that warrant immediate medical attention are essential components of safe medication management.

In the absence of specific laboratory tests or monitoring parameters, practitioners are encouraged to consider standard clinical practices relevant to the therapeutic area and individual patient needs. It is advisable to maintain open lines of communication with patients regarding any adverse effects or concerns that may arise during treatment.

In cases where patients experience unexpected reactions or complications, healthcare professionals should be prepared to provide appropriate interventions and referrals as necessary.

Side Effects

There are no specific adverse reactions or side effects associated with the use of this product as indicated in the provided information. Clinical trials and postmarketing experiences have not reported any additional adverse reactions or important notes. Therefore, healthcare professionals should be aware that the absence of documented adverse reactions does not preclude the possibility of individual patient experiences. Monitoring for any unexpected effects is advisable during treatment.

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 Numbify Smooth (lidocaine hcl). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Numbify Smooth.
Details

Pediatric Use

Safety and effectiveness in pediatric patients have not been established. The product is not recommended for use in children under 12 years of age.

Geriatric Use

There is no specific information available 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

There is no information available regarding the use of NUMBIFY SMOOTH (lidocaine hcl gel) during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients and weigh the potential risks and benefits. Women of childbearing potential should be advised to discuss their pregnancy status and any plans for pregnancy with their healthcare provider before using this product.

Lactation

There are no specific warnings or recommendations regarding the use of this product in nursing mothers. Additionally, there is no information available concerning the potential for excretion in breast milk or any associated risks to breastfed infants.

Renal Impairment

Patients with renal impairment may necessitate a reduced dose of the medication. It is essential for healthcare professionals to monitor creatinine clearance in these patients to ensure appropriate dosing. Regular renal function tests should be performed in patients with kidney problems to assess their condition. Additionally, special monitoring is required for patients with significant renal impairment to mitigate potential risks associated with the medication.

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 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 information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

Additionally, it is recommended to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols and antidotes, if applicable.

Documentation of the incident, including the amount and timing of the substance taken, is crucial for effective treatment and follow-up care.

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 fully evaluate the nonclinical toxicology profile.

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 individuals.

Storage and Handling

The product is supplied in a container that must be kept tightly closed to maintain integrity. It should be stored at a temperature range of 20°C to 25°C (68°F to 77°F), with permissible excursions between 15°C to 30°C (59°F to 86°F). It is essential to protect the product from light to prevent degradation. Additionally, the product should be discarded after opening to ensure safety and efficacy.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Numbify Smooth, 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 Numbify Smooth, 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.

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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.