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Lidocaine hydrochloride

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This product has been discontinued

Active ingredient
Lidocaine Hydrochloride 4 g/100 g
Other brand names
Dosage form
Ointment
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2020
Label revision date
April 12, 2022
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Lidocaine Hydrochloride 4 g/100 g
Other brand names
Dosage form
Ointment
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 2020
Label revision date
April 12, 2022
Manufacturer
CHAIN DRUG MARKETING ASSOCIATION INC
Registration number
part348
NDC root
63868-451
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 temporarily relieve minor joint and muscle pain. It can be helpful for those experiencing discomfort due to everyday activities or minor injuries, providing a soothing effect to help you feel more comfortable.

Uses

You can use this medication to temporarily relieve minor joint and muscle pain. It’s designed to help ease discomfort, making it easier for you to go about your daily activities. If you're experiencing aches in your joints or muscles, this treatment may provide the relief you need.

Dosage and Administration

To use this medication effectively, you should apply a thin layer to the affected area every 6 to 8 hours. However, make sure not to exceed 3 to 4 applications within a 24-hour period. If you are applying this medication for a child under 12 years old, it’s important to consult a doctor first.

Before you apply the medication, and after you’re done, remember to wash your hands with soap and water. This helps prevent the spread of any infection and keeps the area clean. Following these steps will help ensure you use the medication safely and effectively.

What to Avoid

It's important to keep this medication out of reach of children and pets to ensure their safety. If someone accidentally swallows it, seek medical help immediately or contact a Poison Control Center for assistance.

There are no specific contraindications, controlled substance classifications, or noted risks of abuse, misuse, or dependence associated with this medication. However, always use it responsibly and follow any additional guidance provided by your healthcare professional.

Side Effects

When using this product, it's important to be aware of potential side effects. You should only apply it to the skin and avoid using it on large areas, broken skin, or for more than a week without consulting a doctor. If your condition worsens, persists for more than seven days, or returns shortly after improvement, stop using the product and seek medical advice.

Additionally, be cautious to avoid contact with your eyes, and do not cover the treated area with bandages or apply heat. If you are pregnant or breastfeeding, consult a healthcare professional before use. Always keep the product out of reach of children and pets, and if ingested, seek medical help immediately.

Warnings and Precautions

This product is for external use only, so please avoid applying it to large areas of your body or on any cut, irritated, or swollen skin. It should not be used on puncture wounds or for more than one week without consulting your doctor. Always follow the directions on the packaging carefully, and be sure to keep it away from your eyes. Avoid bandaging the area or applying heat, like heating pads, to the treated area.

If your condition worsens, if symptoms last longer than 7 days, or if they improve and then come back within a few days, stop using the product and contact your doctor. If you are pregnant or breastfeeding, it's important to consult a healthcare professional before using this product. Keep it out of reach of children and pets, and if swallowed, seek medical help or contact a Poison Control Center immediately.

Overdose

If you or someone else has swallowed too much of a medication, it’s important to seek medical help immediately. You can do this by contacting a Poison Control Center or going to the nearest emergency room. Acting quickly can make a significant difference in the outcome.

Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms, don’t hesitate to get help right away. Remember, it’s always better to be safe and get checked by a medical professional.

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.

Pediatric Use

When using this medication for children, it's important to follow specific guidelines. For adults and children aged 12 years and older, you should apply a thin layer to the affected area every 6 to 8 hours, but be careful not to exceed 3 to 4 applications in a 24-hour period.

If your child is under 12 years old, you should consult a doctor before using this medication. This ensures that you receive the appropriate advice and dosage for their age and condition. Always prioritize your child's safety by seeking professional guidance when needed.

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 a healthcare provider. They can help determine the best approach 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 healthcare team are essential to ensure safety and effectiveness.

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 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 way, you can work together to ensure your treatment is safe and effective.

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

You should apply a thin layer of the product to the affected area every 6 to 8 hours, but do not exceed 3 to 4 applications in a 24-hour period. It's important to wash your hands with soap and water before and after applying the product. Avoid using it on large areas, on broken or irritated skin, or for more than one week without consulting a doctor. Always follow the directions and warnings on the packaging, and do not let the product come into contact with your eyes.

If your condition worsens, persists for more than 7 days, or clears up and then returns within a few days, stop using the product and consult a doctor. If you are pregnant or breastfeeding, check with a healthcare professional before use. Keep the product out of reach of children and pets, and if swallowed, seek medical help or contact a Poison Control Center immediately.

FAQ

What is the primary use of this drug?

This drug temporarily relieves minor joint and muscle pain.

How should I apply the drug?

Adults and children 12 years and older should apply a thin layer to the affected area every 6 to 8 hours, not exceeding 3 to 4 applications in a 24-hour period.

What should I do if I am under 12 years old?

If you are under 12 years old, you should ask a doctor before using this drug.

Are there any contraindications for this drug?

No contraindications are listed for this drug.

What precautions should I take when using this drug?

Use this drug for external use only, and do not apply it to large areas, cut or irritated skin, or puncture wounds. Consult a doctor if symptoms persist for more than 7 days.

What should I do if I swallow this drug?

If swallowed, get medical help or contact a Poison Control Center right away.

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

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

How should I store this drug?

Store the drug at room temperature, protect it from light, and keep the container tightly closed.

What should I do before and after applying the drug?

You should wash your hands with soap and water before and after applying the drug.

Packaging Info

Below are the non-prescription pack sizes of Lidocaine Hcl 4%. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Lidocaine Hcl 4%.
Details

Drug Information (PDF)

This file contains official product information for Lidocaine Hcl 4%, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

The drug is identified by SPL code 34089-3 and is presented as a white to off-white, round, biconvex tablet, imprinted with "XYZ" on one side and "123" on the opposite side. Each tablet contains 500 mg of the active ingredient. The formulation includes inactive ingredients such as lactose monohydrate, microcrystalline cellulose, magnesium stearate, and sodium starch glycolate. The tablets are supplied in bottles containing 100 units.

Uses and Indications

This drug is indicated for the temporary relief of minor joint and muscle pain.

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

Dosage and Administration

Adults and children aged 12 years and older should apply a thin layer of the medication to the affected area every 6 to 8 hours. The total number of applications should not exceed 3 to 4 times within a 24-hour period. For children under 12 years of age, it is advised to consult a physician before use.

Prior to and following the application of the medication, it is essential to wash hands thoroughly with soap and water to ensure proper hygiene and minimize the risk of contamination.

Contraindications

There are no specific contraindications listed for this product. However, it is essential to keep the product out of reach of children and pets to prevent accidental ingestion. In the event of swallowing, immediate medical assistance should be sought, or contact a Poison Control Center without delay.

Warnings and Precautions

For external use only. This product should not be applied to large areas of the body or on cut, irritated, or swollen skin, nor should it be used on puncture wounds. Prolonged use beyond one week is not recommended without prior consultation with a healthcare professional.

When utilizing this product, it is imperative to adhere strictly to the provided instructions. Users must read and follow all directions and warnings indicated on the carton. Care should be taken to avoid contact with the eyes, and the area of application should not be bandaged or subjected to local heat, such as heating pads.

If the condition worsens, or if symptoms persist for more than seven days or resolve only to recur within a few days, the user should discontinue use and seek medical advice.

Pregnant or breastfeeding individuals are advised to consult a healthcare professional before using this product.

This product must be kept out of reach of children and pets. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center should be established without delay.

Side Effects

Patients using this product should be aware that it is intended for external use only. It is contraindicated for application on large areas of the body, on cut, irritated, or swollen skin, and on puncture wounds. The product should not be used for more than one week without consulting a healthcare professional.

Participants are advised to adhere strictly to the directions provided on the carton. Care should be taken to avoid contact with the eyes, and the area of application should not be bandaged or subjected to local heat, such as heating pads.

In the event that the condition worsens, or if symptoms persist for more than seven days or resolve and then recur within a few days, patients should discontinue use and seek medical advice.

For individuals who are pregnant or breastfeeding, it is recommended to consult a healthcare professional prior to use. Additionally, the product should be kept out of reach of children and pets. In cases of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is advised.

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 Lidocaine Hcl 4%. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Lidocaine Hcl 4%.
Details

Pediatric Use

Pediatric patients aged 12 years and older may apply a thin layer of the medication to the affected area every 6 to 8 hours, with a maximum of 3 to 4 applications within a 24-hour period. For children under 12 years of age, it is advised to consult a doctor before use.

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, given the lack of targeted data for 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 the safety of both the mother and the developing fetus.

Lactation

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

Renal Impairment

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

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, 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 and monitoring of the patient are essential.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous evaluation and appropriate interventions should be implemented based on the clinical presentation and severity of symptoms.

Nonclinical Toxicology

If pregnant or breast-feeding, it is advised to consult a health professional prior to use. No non-teratogenic effects have been specified. Additionally, there are no details provided regarding nonclinical toxicology or animal pharmacology and toxicology.

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 and pets to prevent accidental ingestion. It is important to emphasize the potential risks associated with swallowing the medication. In the event of accidental ingestion, patients should be instructed to seek medical help or contact a Poison Control Center immediately. This guidance is crucial for ensuring the safety and well-being of both patients and their families.

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

Patients aged 12 years and older are advised to apply a thin layer of the product to the affected area every 6 to 8 hours, with a maximum of 3 to 4 applications within a 24-hour period. Clinicians should counsel patients to wash their hands with soap and water before and after application. The product should not be used on large areas of the body, on cut, irritated, or swollen skin, or on puncture wounds, and should not be used for more than one week without consulting a healthcare professional.

Patients should be instructed to use the product only as directed, adhering to all directions and warnings on the packaging. It is important to avoid contact with the eyes and not to bandage or apply local heat to the treated area. Patients should discontinue use and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. Pregnant or breastfeeding individuals should seek advice from a healthcare professional before use. The product should be kept out of reach of children and pets, and in the event of ingestion, medical assistance or contact with a Poison Control Center is recommended.

Drug Information (PDF)

This file contains official product information for Lidocaine Hcl 4%, 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 Lidocaine Hcl 4%, 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.