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Lidostat

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Active ingredient
Lidocaine Hydrochloride 40 mg/1 g
Other brand names
Drug classes
Amide Local Anesthetic, Antiarrhythmic
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2013
Label revision date
November 5, 2023
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Lidocaine Hydrochloride 40 mg/1 g
Other brand names
Drug classes
Amide Local Anesthetic, Antiarrhythmic
Dosage form
Cream
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 2013
Label revision date
November 5, 2023
Manufacturer
Clinical Therapeutic Solutions
Registration number
M017
NDC root
44577-704
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

LidoStat CREAM is a medical strength pain cream that contains lidocaine HCl (a local anesthetic) at a concentration of 4% in a 20% urea vehicle. This cream is designed to provide temporary relief from pain and itching associated with minor skin irritations. Its penetrating formula helps to soothe discomfort effectively.

This product is dispensed only by physicians, ensuring that you receive the appropriate care and guidance for its use. If you're experiencing minor skin irritations, LidoStat CREAM may be a helpful option for alleviating your symptoms.

Uses

You can use this medication for the temporary relief of pain and itching caused by minor skin irritations. It’s designed to help soothe discomfort and make your skin feel better.

Rest assured, there are no concerns regarding teratogenic effects (which means it doesn’t cause birth defects) or nonteratogenic effects associated with this medication. This makes it a safe option for managing minor skin issues.

Dosage and Administration

When using this medication, you should apply it directly to the affected area on your skin. This is suitable for both adults and children who are two years old or older. Make sure to limit your applications to no more than three to four times a day to avoid any potential issues.

If you have a child who is under two years of age, it’s important to consult with a doctor before using this medication. They can provide guidance on the best course of action for your child's specific needs.

What to Avoid

It's important to use this medication safely. You should not use it on children under 2 years of age unless a physician has specifically directed you to do so. Additionally, avoid contact with your eyes, as this can cause irritation. Be cautious not to apply it in large amounts, especially on raw surfaces or blistered areas, to prevent potential complications. Always follow these guidelines to ensure your safety and well-being.

Side Effects

When using this product, it's important to apply it only as directed and avoid contact with your eyes. You should not use it on children under 2 years of age unless a doctor advises you to do so. Be cautious not to apply it in large amounts, especially on raw or blistered skin.

If you notice that your symptoms last more than seven days, or if they improve and then come back within a few days, stop using the product and consult a doctor. Additionally, if you experience increased redness, irritation, swelling, or pain, seek medical advice. Always keep this product out of reach of children, and if it is swallowed, contact a physician immediately.

Warnings and Precautions

This product is intended for external use only, so please avoid applying it to your eyes and do not use it on children under 2 years of age unless a doctor has specifically instructed you to do so. It's important to follow the directions carefully and avoid using large amounts, especially on raw or blistered skin.

If you notice that your symptoms last longer than seven days, or if they seem to improve and then come back within a few days, stop using the product and consult your doctor. Additionally, if you experience increased redness, irritation, swelling, pain, or any other concerning symptoms, seek medical advice. Always keep this product out of reach of children, and if it is swallowed, contact a physician immediately.

Overdose

If you or someone else has swallowed too much of this medication, it’s important to consult a physician right away. Signs of an overdose can vary, but they may include unusual symptoms that are not typical when taking the medication as prescribed.

In any case of suspected overdose, seeking immediate medical help is crucial. Don’t wait for symptoms to appear; reach out to a healthcare professional to ensure safety and receive the appropriate care.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the safety of lidocaine, a medication often used for pain relief, has not been established. There are potential risks to your fetus, which is why lidocaine is generally not recommended during pregnancy unless absolutely necessary. If your healthcare provider determines that the benefits outweigh the risks, they may suggest using it under careful supervision.

Additionally, if you do need to use lidocaine while pregnant, your doctor may need to adjust the dosage. Always consult with your healthcare provider before using this medication to ensure the safest approach for you and your baby.

Lactation Use

If you are breastfeeding and considering the use of LidoStat cream, you can feel reassured that there are no specific warnings or recommendations against its use for nursing mothers. Currently, there is no information available about whether the cream is passed into breast milk or if it poses any risk to your infant while you are lactating (producing milk).

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

Pediatric Use

It's important to be cautious when using this medication for children. You should not use it on children under 2 years of age unless a doctor specifically advises you to do so. For children who are 2 years old or older, you can apply the medication externally to the affected area as directed.

If your child is under 2 years old, it's best to consult with a doctor before using this product. Always prioritize your child's safety and follow medical advice closely.

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. If you or a loved one is an older adult, it’s wise to discuss any potential risks or benefits with your healthcare provider. They can help determine the best course of action based on individual health needs and any other medications being taken.

Always keep in mind that older adults may have different responses to medications, so regular check-ins with your doctor can ensure safety and effectiveness.

Renal Impairment

If you have kidney problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to be adjusted based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your specific condition. They can provide guidance based on your individual health needs.

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 differently due to your liver health.

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver function and how it relates to your treatment. They can help ensure that your medication is safe and effective for you.

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 can monitor your health effectively and make informed decisions about your care.

Always feel free to ask questions and share all the medications and supplements you are using. This helps to avoid any potential issues and ensures that you receive the best possible treatment tailored to your needs.

Storage and Handling

To ensure the best performance of your product, store it at room temperature, specifically between 68-77ºF (20º-25ºC). This temperature range helps maintain the integrity and effectiveness of the device.

When handling the product, make sure to do so in a clean environment to avoid contamination. Always follow any specific instructions provided for use to ensure safety and effectiveness. If you have any questions about disposal or further handling, please refer to the guidelines provided with your product.

Additional Information

You should apply this medication topically (on the skin) to the affected area. For adults and children aged two years and older, use it no more than three to four times a day. If the patient is under two years old, it's important to consult a doctor before use.

FAQ

What is LidoStat CREAM used for?

LidoStat CREAM is used for the temporary relief of pain and itching caused by minor skin irritations.

Who can use LidoStat CREAM?

LidoStat CREAM can be used by adults and children two years or older. For children under 2 years of age, you should ask a doctor.

How should I apply LidoStat CREAM?

Apply LidoStat CREAM externally to the affected area, and do not use more than three to four times per day.

Are there any contraindications for using LidoStat CREAM?

You should not use LidoStat CREAM on children under 2 years of age unless directed by a physician.

What should I do if symptoms persist?

If symptoms persist for more than seven days or if they clear up and occur again within a few days, stop use and ask a doctor.

Can I use LidoStat CREAM during pregnancy?

The safety of lidocaine during pregnancy has not been established, and it should only be used if clearly needed and the benefits outweigh the risks.

Is there any information about using LidoStat CREAM while nursing?

There are no specific warnings or recommendations regarding the use of LidoStat cream in nursing mothers.

What precautions should I take when using LidoStat CREAM?

Avoid contact with eyes, use only as directed, and do not use in large quantities, particularly over raw surfaces or blistered areas.

How should I store LidoStat CREAM?

Store LidoStat CREAM at room temperature, between 68-77ºF (20º-25ºC).

What should I do if LidoStat CREAM is swallowed?

Keep LidoStat CREAM out of reach of children, and if swallowed, consult a physician.

Packaging Info

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

Packaging configurations for Lidostat.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

LidoStat CREAM is a topical formulation containing 4% Lidocaine HCl in a 20% urea vehicle, designed for medical strength pain relief. This penetrating formula is specifically dispensed by physicians to ensure appropriate use. The product is packaged in a net weight of 2.0 oz (56 g).

Uses and Indications

This drug is indicated for the temporary relief of pain and itching associated with minor skin irritations.

There are no teratogenic or nonteratogenic effects reported for this drug.

Dosage and Administration

For adults and children aged two years and older, the medication should be applied externally to the affected area. The application frequency should not exceed three to four times per day.

For children under two years of age, it is advised to consult a physician before use.

Contraindications

Use is contraindicated in the following situations:

  • The product should not be used in children under 2 years of age unless directed by a physician, due to potential safety concerns.

  • Contact with the eyes must be avoided to prevent irritation or injury.

  • The product should not be applied in large quantities, especially over raw surfaces or blistered areas, as this may exacerbate irritation or lead to adverse effects.

Warnings and Precautions

This product is intended for external use only. It is contraindicated for use in children under 2 years of age unless specifically directed by a physician. Healthcare professionals should advise patients to avoid contact with the eyes during application. The product should be used strictly as directed, and caution is advised against applying it in large quantities, particularly on raw surfaces or blistered areas.

Patients should be instructed to discontinue use and consult a physician if any of the following occur: symptoms persist for more than seven days, or if symptoms resolve and then recur within a few days. Additionally, if there is an increase in redness, irritation, swelling, pain, or any other concerning symptoms, medical advice should be sought.

It is imperative to keep this product out of reach of children. In the event of accidental ingestion, immediate consultation with a physician is recommended.

Side Effects

Patients using this product should be aware that it is intended for external use only. It is contraindicated for use in children under 2 years of age unless directed by a physician. During application, patients should avoid contact with the eyes and use the product only as directed. Caution is advised to prevent the use of large quantities, particularly over raw surfaces or blistered areas.

In the event that symptoms persist for more than seven days, or if symptoms clear up and then recur within a few days, patients are advised to stop use and consult a doctor. Additionally, if there is an increase in redness, irritation, swelling, pain, or other symptoms, medical advice should be sought promptly.

Patients should also ensure that the product is kept out of reach of children. In the case of accidental ingestion, it is important to consult a physician immediately.

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

Packaging configurations for Lidostat.
Details

Pediatric Use

Pediatric patients under 2 years of age should not use this medication unless directed by a physician. For children aged 2 years and older, the medication is to be applied externally to the affected area. It is important for caregivers to consult a doctor before administering this treatment to infants.

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

The safety of lidocaine during pregnancy has not been established, and its use is contraindicated due to potential risks to the fetus. There may be associated risks when lidocaine is administered to pregnant women; therefore, it should only be used if clearly needed, and the benefits must outweigh the risks.

Dosage adjustments may be necessary for pregnant patients, and it is advised that they consult a physician prior to use. Pregnant women should use lidocaine only under the guidance of a healthcare provider to ensure appropriate monitoring and management of any potential risks.

Lactation

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

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

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 event of an overdosage, it is imperative that healthcare professionals take immediate action. If the product is ingested, the first step is to consult a physician for further evaluation and management.

Potential symptoms of overdosage may vary depending on the specific substance involved. Therefore, a thorough assessment of the patient's condition is essential to determine the appropriate course of action.

Management procedures should be guided by the severity of the symptoms and the specific circumstances of the overdosage. Healthcare providers are advised to monitor the patient closely and provide supportive care as needed. In cases where the overdosage is significant, further medical intervention may be required, including but not limited to activated charcoal administration or other decontamination methods, as deemed appropriate by the physician.

It is crucial for healthcare professionals to remain vigilant and act promptly in the event of an overdosage to ensure patient safety and optimal outcomes.

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 understanding of the compound's potential effects in these areas.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Patients should be advised to consult a physician immediately if the product is swallowed. It is important to inform patients that this product should not be used on children under 2 years of age unless specifically directed by a physician.

Patients should be instructed to stop using the product and seek medical advice if symptoms persist for more than seven days, or if symptoms clear up and then recur within a few days. Additionally, they should be cautioned to discontinue use and consult a doctor if they experience increased redness, irritation, swelling, pain, or any other concerning symptoms.

While using this product, patients must be reminded to avoid contact with the eyes and to use the product only as directed. They should also be advised against using large quantities, especially on raw surfaces or blistered areas, to prevent potential adverse effects.

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 room temperature, maintaining a range of 68 to 77ºF (20 to 25ºC). Proper storage conditions are crucial to ensure the integrity and efficacy of the product.

Additional Clinical Information

The medication is administered topically, with a recommended application frequency of three to four times per day for adults and children aged two years and older. For children under two years of age, it is advised to consult a doctor before use. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Lidostat, 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 Lidostat, 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

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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.