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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 2019
Label revision date
October 15, 2020
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 2019
Label revision date
October 15, 2020
Manufacturer
WALGREENS CO.
Registration number
part348
NDC root
0363-4510
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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 provide temporary relief from minor joint and muscle pain. It can be helpful if you're experiencing discomfort due to everyday activities or minor injuries, allowing you to feel more comfortable and maintain your daily routine.

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.

Rest assured, there are no known teratogenic effects (which means it doesn’t cause birth defects) associated with this medication, so it’s considered safe in that regard.

Dosage and Administration

When using this medication, 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 application process clean.

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 concerns regarding abuse, misuse, or dependence associated with this medication. However, always use it responsibly and follow the guidance provided.

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 apply heat or bandage the treated area. 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 make sure to keep it away from your eyes. Avoid bandaging the area or applying heat, like heating pads, while using this product.

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 seek assistance if you suspect an overdose.

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 tailored to your child's needs. Always prioritize safety and seek professional guidance when it comes to treating younger children.

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 or questions with your doctor, especially regarding potential interactions with other medications or existing health conditions.

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 change 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 situation. They can help monitor your kidney health and make any necessary adjustments to your medications.

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, 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 any other medications or supplements you may be using. Your safety and well-being are the top priority, and discussing all aspects of your treatment helps to achieve the best outcomes.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 20°C and 25°C (68°F to 77°F). It’s okay if the temperature occasionally varies between 15°C and 30°C (59°F to 86°F), but try to keep it within the recommended range. Make sure to protect the product from light, as exposure can affect its quality.

For safety, always keep the product out of reach of children and pets. Once you open the product, remember to discard it to maintain safety and effectiveness. Following these guidelines will help you use the product safely and effectively.

Additional Information

You should apply this medication topically by spreading a thin layer on 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 avoid contact with your eyes. Do not cover the area with bandages or apply heat, like heating pads.

If your condition worsens, persists for more than 7 days, or clears up and then comes back 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 this medication out of reach of children and pets, and seek medical help immediately if swallowed.

FAQ

What is the primary use of this drug?

This drug provides temporary relief of 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 warnings I should be aware of?

Yes, this product is for external use only and should not be used on large areas of the body, on cut or irritated skin, or for more than one week without consulting a doctor.

What should I do if I accidentally swallow the drug?

If swallowed, you should 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 20°C to 25°C (68°F to 77°F) and protect it from light. Keep it out of reach of children and pets.

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.

What should I do if my symptoms persist?

If your condition worsens or symptoms persist for more than 7 days, you should stop use and ask a doctor.

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 provided information does not specify the chemical name, physical characteristics, or inactive ingredients of the drug. Therefore, a detailed description cannot be formulated based on the available data. Further information is required to create a comprehensive description.

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.

In the event that the condition worsens, or if symptoms persist for more than seven days or resolve only to recur within a few days, it is essential to discontinue use and consult a physician.

Pregnant or breastfeeding individuals should seek advice from a healthcare professional before using this product.

This product must be kept out of reach of children and pets. In case of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is advised.

Side Effects

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

When using this product, it is essential to adhere strictly to the directions provided. Users should avoid contact with the eyes and refrain from bandaging or applying local heat, such as heating pads, to the area of application.

Patients are advised to discontinue use and consult a doctor if their condition worsens, if symptoms persist for more than seven days, or if symptoms clear up and then recur within a few days.

For individuals who are pregnant or breastfeeding, it is recommended to seek advice from a healthcare professional prior to use. Additionally, this product should 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 made without delay.

Drug Interactions

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

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing infant.

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 medication in human 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 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, immediate medical assistance is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical help or contact a Poison Control Center without delay.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved; therefore, a thorough assessment by a medical professional is recommended to determine the appropriate course of action.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and evaluation are advised to ensure patient safety and effective resolution of any complications arising from the overdosage.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. No specific non-teratogenic effects have been identified. Additionally, there are no detailed findings related to nonclinical toxicology or animal pharmacology and toxicology available.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep the 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 packaging that includes specific NDC numbers. 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 maintain its integrity. Additionally, the product must be kept out of reach of children and pets. Once opened, the product should be discarded to ensure safety and efficacy.

Additional Clinical Information

The product is administered topically, with a recommended application of a thin layer to the affected area every 6 to 8 hours for adults and children aged 12 years and older. The total number of applications should not exceed 3 to 4 within a 24-hour period.

Clinicians should counsel patients to wash their hands with soap and water before and after application. It is important to avoid using the product on large areas of the body, on cut, irritated, or swollen skin, or on puncture wounds, and not to use it for more than one week without consulting a healthcare professional. Patients should adhere strictly to the directions and warnings provided, avoiding contact with the eyes and not applying bandages or local heat to the treated area. They should discontinue use and seek medical advice if the condition worsens, symptoms persist beyond 7 days, or if symptoms resolve and then recur shortly thereafter. Pregnant or breastfeeding individuals should consult a healthcare provider prior to use. Additionally, the product should be kept out of reach of children and pets, and immediate medical assistance should be sought if ingested.

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

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.