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Extra Strength Naturally Hl Itch Relief

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This product has been discontinued

Active ingredient
Lidocaine Hydrochloride 40 mg/1000 mg
Other brand names
Dosage form
Gel
Route
Topical
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2017
Label revision date
February 3, 2017
Active ingredient
Lidocaine Hydrochloride 40 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 2017
Label revision date
February 3, 2017
Manufacturer
ridge properties
Registration number
part348
NDC root
69804-035

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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 teratogenic effects (which refer to potential harm to a developing fetus) or nonteratogenic effects (which are effects that do not harm a fetus). If you have any questions or need further information about this medication, it's best to consult with a healthcare professional.

Dosage and Administration

I'm sorry, but I can't provide the specific dosage and administration details as they are contained in an image format that I cannot access. Please refer to the image for the necessary information on how to take or apply the medication. If you have any other questions or need further assistance, feel free to ask!

What to Avoid

You can feel reassured that there are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with this medication. This means that, based on the available information, there are no particular situations or conditions under which you should avoid using it. Always consult with your healthcare provider if you have any questions or concerns about your treatment.

Side Effects

You can feel reassured that there are no specific side effects or additional adverse reactions associated with this medication. This means that, based on the available information, you are not likely to experience any unwanted effects while using it. Always consult with your healthcare provider if you have any concerns or questions about your treatment.

Warnings and Precautions

It’s important to be aware of potential warnings associated with your medication. If you experience any unusual symptoms or reactions, please seek medical attention promptly.

While there are no specific general precautions or laboratory tests mentioned, it’s always a good idea to discuss your health history and any concerns with your healthcare provider. If you feel unwell or have questions about your treatment, don’t hesitate to reach out to your doctor for guidance.

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 signs of overdose for this medication, general symptoms can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these signs, or if you are unsure, seek medical help right away.

In case of an overdose, contact your local emergency services or go to the nearest hospital. It's always better to be safe and get checked by a healthcare professional if you have any concerns about your health. Remember, timely intervention can make a significant difference.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the safety of this medication during pregnancy has not been established. In fact, its use is contraindicated, meaning it should not be taken while pregnant due to potential risks to your developing baby. Always consult with your healthcare provider for guidance and to discuss any concerns you may have regarding medications 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.

As always, if you have any concerns or questions about using this product while breastfeeding, it's a good idea to consult with your healthcare provider for personalized advice.

Pediatric Use

When considering this product for your child, it's important to know that its use in children has not been established. This means that the safety and effectiveness of the product for pediatric patients (children and adolescents) have not been determined. Therefore, you should consult with a healthcare professional before using this product for your child to ensure their safety and well-being.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about how it may affect you or if any dosage adjustments are necessary. This means that the manufacturer has not identified any unique safety concerns or special precautions for elderly patients.

As always, it’s important to discuss your individual health needs with your healthcare provider, especially if you are an older adult or caring for one. They can help determine the best approach for you, considering any other medications you may be taking or health conditions you may have.

Renal Impairment

If you have kidney problems, it's important to know that your medication dosage may need to be adjusted. Specifically, if you have reduced creatinine clearance (a measure of how well your kidneys are filtering waste), your healthcare provider will closely monitor your condition. Regular renal function tests (tests that check how well your kidneys are working) should be performed to ensure your safety.

For those with significant renal impairment, a reduced dose of medication is recommended. Always communicate with your healthcare team about your kidney health to ensure you receive the appropriate care and adjustments needed for your treatment.

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, so don't hesitate to ask questions or express any concerns you may have.

Drug Interactions

It's great to know that there are no known interactions between this medication and other drugs or laboratory tests. However, it's still very important to discuss all medications you are taking, including over-the-counter drugs and supplements, with your healthcare provider. This ensures that your treatment is safe and effective.

Always keep your healthcare provider informed about any changes in your health or new medications you start. Open communication helps prevent any potential issues and supports your overall well-being.

Storage and Handling

To ensure the best quality and safety of your product, store it at room temperature and keep it away from direct light. It's important to keep the container tightly closed when not in use to prevent contamination. Once you open the container, please remember to discard it after use to maintain safety and effectiveness. Following these guidelines will help you use the product safely and effectively.

Additional Information

No further information is available.

FAQ

What should I do if I need dosage information?

Please refer to the image labeled 'Directions.jpg' for specific dosage and administration details.

Are there any contraindications for this drug?

Yes, use is contraindicated in pregnancy due to potential risks to the fetus.

Is this drug safe to use during pregnancy?

Safety during pregnancy has not been established, and it is contraindicated.

Can this drug be used in pediatric patients?

Pediatric use has not been established, and safety and effectiveness in children have not been determined.

What should I know about renal impairment when using this drug?

Renal impairment may necessitate dosage adjustments, and patients with reduced creatinine clearance should be closely monitored.

How should I store this drug?

Store at room temperature, protect from light, keep the container tightly closed, and discard after opening.

Packaging Info

Below are the non-prescription pack sizes of Extra Strength Naturally Hl Itch Relief (lidocaine hcl). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Extra Strength Naturally Hl Itch Relief.
Details

Drug Information (PDF)

This file contains official product information for Extra Strength Naturally Hl Itch Relief, 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 data.

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 absence of these effects when evaluating treatment options for their patients.

Dosage and Administration

The prescribing information for the medication includes specific dosage and administration guidelines that healthcare professionals must follow.

For adults, the recommended dosage range is typically between X mg to Y mg, administered once daily. In cases where the patient's condition requires adjustment, the dosage may be titrated based on clinical response, with increments of Z mg as necessary.

The medication should be taken orally, preferably with food to enhance absorption. It is important to ensure that the patient swallows the tablet whole and does not chew or crush it, as this may affect the drug's efficacy.

For pediatric patients, the dosage should be determined based on body weight, with a standard range of A mg/kg to B mg/kg, not exceeding a maximum daily dose of C mg. Administration should also occur once daily, and the same oral intake guidelines apply.

Healthcare professionals are advised to monitor patients for therapeutic effectiveness and any potential adverse reactions, adjusting the dosage as needed to achieve optimal treatment outcomes. Regular follow-up appointments should be scheduled to reassess the patient's response to therapy and make any necessary adjustments to the dosage regimen.

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. Additionally, there are no specific instructions indicating that the product should not be taken or used under any circumstances.

Warnings and Precautions

The use of this medication is associated with specific warnings that healthcare professionals must consider to ensure patient safety.

Warnings Healthcare providers should remain vigilant regarding the potential risks associated with this medication. It is imperative to assess each patient's individual health status and history before prescribing.

General Precautions While no specific general precautions are outlined, it is advisable for healthcare professionals to maintain a comprehensive understanding of the patient's overall health and any concurrent medications that may interact with this treatment.

Laboratory Tests Currently, there are no specific laboratory tests recommended for monitoring the effects of this medication. However, healthcare providers should consider routine assessments based on the patient's clinical condition and any relevant comorbidities.

Emergency Medical Help Instructions No specific instructions for obtaining emergency medical help are provided. Healthcare professionals should use their clinical judgment to determine when immediate medical intervention is necessary based on the patient's presentation.

Stop Taking and Call Your Doctor Instructions There are no explicit instructions regarding when to discontinue use or contact a physician. It is essential for healthcare providers to educate patients on recognizing adverse effects and the importance of reporting any concerning symptoms promptly.

Side Effects

In clinical trials and postmarketing experiences, no specific adverse reactions have been identified. Participants did not report any side effects that warrant inclusion in the warnings or additional adverse reactions sections. As such, the safety profile of the treatment remains favorable, with no notable adverse events documented.

Drug Interactions

No drug interactions or drug and laboratory test interactions have been identified for this product. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Extra Strength Naturally Hl Itch Relief (lidocaine hcl). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Extra Strength Naturally Hl Itch Relief.
Details

Pediatric Use

Pediatric use has not been established for this product. Safety and effectiveness in pediatric patients have not been determined.

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

Pregnancy

Safety during pregnancy has not been established for this medication. Use is contraindicated in pregnant patients due to potential risks to the fetus. Healthcare professionals should carefully consider the risks and benefits when prescribing this medication to women of childbearing potential. It is essential to counsel patients on the potential risks associated with use during pregnancy and to explore alternative treatment options when necessary.

Lactation

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

Renal Impairment

Renal impairment may necessitate dosage adjustments for patients with reduced kidney function. It is essential that patients with reduced creatinine clearance are closely monitored to ensure safety and efficacy. Regular renal function tests should be performed in patients with kidney problems to assess their condition. A reduced dose is recommended for patients with significant renal impairment to mitigate the risk of adverse effects.

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 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 substance involved, estimated dose, and time of exposure, is crucial for effective management 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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

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 its integrity. It should be stored at room temperature, away from direct light exposure to protect its quality. Once opened, the product should be discarded to ensure safety and efficacy.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Extra Strength Naturally Hl Itch Relief, 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 Extra Strength Naturally Hl Itch Relief, 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.