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Lidocaine Pain Relieving Creme

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This product has been discontinued

Active ingredient
Lidocaine Hydrochloride 4 g/100 g
Other brand names
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 2020
Label revision date
September 30, 2020
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Lidocaine Hydrochloride 4 g/100 g
Other brand names
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 2020
Label revision date
September 30, 2020
Manufacturer
Velocity Pharma LLC
Registration number
part348
NDC root
76168-206
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

You may be looking for a medication that temporarily relieves minor pain. This type of drug is commonly used to help manage discomfort from various conditions, such as headaches, muscle aches, or minor injuries. While the specific name of the drug isn't provided, its primary purpose is to offer quick relief from pain, making it a helpful option when you need to feel more comfortable.

Uses

You can use this medication to temporarily relieve minor pain. It’s designed to help ease discomfort, making it a useful option when you need quick relief. 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

If you are an adult or a child over 12 years old, you should apply a thin layer of the medication to the affected area every 6 to 8 hours. However, make sure not to apply it more than three times in a 24-hour period. After you apply the medication, remember to wash your hands with soap and water to avoid spreading it to other areas.

For children who are 12 years old or younger, it’s important to consult a doctor before using this medication. They can provide guidance on the appropriate use and dosage for younger patients.

What to Avoid

It's important to use this medication safely to avoid potential issues. You should not apply it to large areas of your body or on skin that is cut, irritated, or swollen. Additionally, avoid using it on puncture wounds. If you find that you need to use this medication for more than one week, please consult your doctor for guidance. Following these instructions will help ensure your safety and the effectiveness of the treatment.

Side Effects

You 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's important to use it as directed and avoid contact with your eyes. Additionally, do not bandage the area or apply local heat, such as heating pads.

If your condition worsens, or if symptoms last more than seven days or return after clearing up, you should stop using the product and consult a doctor. If you are pregnant or breastfeeding, it's best to check with a healthcare professional before using it. Always keep this product out of reach of children and pets, and if swallowed, seek medical help or contact a Poison Control Center 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, and you should not use it 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. Additionally, do not cover the treated area with bandages or apply heat, such as heating pads.

If your condition worsens, or if your symptoms last longer than seven days or return after improvement, stop using the product and contact your doctor. It's also important to keep this product out of reach of children. 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 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

Before using this medication for children aged 12 years and younger, it's important to consult with a doctor. For those over 12 years old, you can apply a thin layer to the affected area every 6 to 8 hours, but be sure not to exceed three applications in a 24-hour period.

Always keep this medication out of reach of children and pets. If it is accidentally swallowed, seek medical help or contact a Poison Control Center immediately.

Geriatric Use

While there is no specific information about the use of Lidocaine Pain Relieving Creme in older adults, it’s important to approach its use with caution. Since the drug insert does not mention any dosage adjustments or safety concerns for elderly patients, you should consult with a healthcare professional before using this product. They can provide personalized advice based on your health status and any other medications you may be taking. Always prioritize safety and ensure that any treatment is appropriate for your individual needs.

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 is safe and effective for your specific health needs. They can help determine the best approach for managing your condition while considering your kidney health.

Hepatic Impairment

If you have liver problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or precautions related to your condition. This means that there are no tailored recommendations for how the medication may affect you differently due to your liver health.

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific situation. They can help determine the best approach based on your liver function and overall health.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be 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 feel free to ask questions and share any concerns you may have regarding your medications or health tests.

Storage and Handling

To ensure the best use of your product, store it at room temperature, ideally between 20°C to 25°C (68°F to 77°F). Always remember to close the cap tightly after each use to maintain its integrity. It's important to keep the product out of reach of children and pets for safety. Additionally, please discard the product after opening to prevent any potential contamination or loss of effectiveness. Following these guidelines will help you use the product safely and effectively.

Additional Information

You should use this medication only on the skin (topically) and follow the specific instructions for application. For adults and children over 12 years, apply a thin layer to the affected area every 6 to 8 hours, but do not exceed three applications in a 24-hour period. Always wash your hands with soap and water after applying the product. If you are treating a child under 12 years, consult a doctor first.

Remember, this product is for external use only. Avoid using it on large areas of the body, on broken or irritated skin, or on puncture wounds. Do not use it for more than a week without consulting a doctor. Make sure to read and follow all directions and warnings on the packaging. Keep it away from your eyes, and do not apply heat or bandage the area. If your condition worsens or does not improve after 7 days, or if symptoms return shortly after clearing up, 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 temporarily relieves minor pain.

How should adults and children over 12 years use this drug?

Apply a thin layer to the affected area every 6 to 8 hours, not exceeding 3 applications in a 24-hour period. Remember to wash your hands after applying.

What should I do if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, ask a health professional before use.

Are there any contraindications for using this drug?

No specific contraindications are mentioned, but do not use on large areas of the body, cut, irritated, or swollen skin.

What should I do if I accidentally swallow this drug?

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

What precautions should I take when using this drug?

Use only as directed, avoid contact with eyes, and do not bandage or apply local heat to the area of use.

What should I do if my condition worsens or symptoms persist?

Stop use and ask a doctor if your condition worsens or if symptoms persist for more than 7 days.

How should I store this drug?

Store at room temperature, between 20°C to 25°C (68°F to 77°F), and keep out of reach of children and pets.

Packaging Info

Below are the non-prescription pack sizes of Lidocaine Pain Relieving Creme (lidocaine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Lidocaine Pain Relieving Creme.
Details

Drug Information (PDF)

This file contains official product information for Lidocaine Pain Relieving Creme, 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. The tablet is debossed with "A" on one side and "1" on the opposite side. Each tablet contains 1 mg of the active ingredient. Inactive ingredients consist of lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, and color additives.

Uses and Indications

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

There are no teratogenic effects associated with this drug. Additionally, no nonteratogenic effects have been reported.

Dosage and Administration

For adults and children over 12 years of age, the recommended dosage is to apply a thin layer of the medication to the affected area every 6 to 8 hours. It is important not to exceed three applications within a 24-hour period. After each application, the hands should be washed thoroughly with soap and water to prevent unintentional contact with other areas of the body or surfaces.

For children aged 12 years and younger, it is advised to consult a physician for appropriate dosing and administration guidance.

Contraindications

Use is contraindicated on large areas of the body or on cut, irritated, or swollen skin due to the potential for adverse effects. Application on puncture wounds is also contraindicated to prevent complications. Prolonged use beyond one week without consulting a healthcare professional is not recommended, as it may lead to unforeseen risks.

Warnings and Precautions

For external use only. This product is contraindicated for application on large areas of the body, as well as on cut, irritated, or swollen skin. It should not 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 directions. Users must read and follow all instructions and warnings indicated on the packaging. Care should be taken to avoid contact with the eyes. Additionally, 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 if symptoms resolve and then recur within a few days, the user should discontinue use and seek medical advice.

This product must be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center should be made 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.

During use, it is essential to adhere strictly to the directions provided. Patients 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 pregnant or breastfeeding individuals, it is recommended to seek advice from a healthcare professional prior to use. Additionally, the 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.

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 Lidocaine Pain Relieving Creme (lidocaine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Lidocaine Pain Relieving Creme.
Details

Pediatric Use

Pediatric patients 12 years and younger should consult a healthcare professional before use. For adolescents and adults over 12 years, the recommended application is a thin layer to the affected area every 6 to 8 hours, with a maximum of 3 applications within a 24-hour period.

It is essential to keep the product out of reach of children and pets. In the event of accidental ingestion, immediate medical assistance or contact with a Poison Control Center is advised.

Geriatric Use

Elderly patients may not have specific dosage adjustments, safety concerns, or special precautions outlined in the drug insert for Lidocaine Pain Relieving Creme. As there is no available information regarding the use of this medication in geriatric populations, healthcare providers should exercise caution when prescribing to elderly patients.

It is advisable to monitor these patients closely for any potential adverse effects, given the lack of targeted data. Individual patient factors, including comorbidities and concurrent medications, should be considered when determining the appropriateness of Lidocaine Pain Relieving Creme for elderly patients.

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 considered in these populations to ensure maternal and fetal safety.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data on 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

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

Prompt action is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

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

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 these contexts.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions reported voluntarily or through surveillance programs: allergic reactions, which include rash, itching, and hives; as well as systemic reactions, which encompass dizziness, drowsiness, and confusion.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children and pets to prevent accidental ingestion or misuse. Instruct patients that if the product is swallowed, they should seek medical help or contact a Poison Control Center immediately.

Patients should be informed not to use the product on large areas of the body or on cut, irritated, or swollen skin, and it should not be applied to puncture wounds. It is important to counsel patients against using the product for more than one week without consulting a doctor.

Healthcare providers should emphasize that patients must stop using the product and consult a doctor if their condition worsens or if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days.

Patients should be reminded to use the product only as directed and to read and follow all directions and warnings on the carton. Additionally, they should be cautioned to avoid contact with the eyes and not to bandage or apply local heat, such as heating pads, to the area of use.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at room temperature, maintaining a range of 20°C to 25°C (68°F to 77°F).

To ensure the integrity of the product, the cap must be closed tightly between uses. Additionally, it is crucial to keep the product out of reach of children and pets to prevent accidental ingestion. 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 over 12 years, not exceeding three applications within a 24-hour period. After application, patients should wash their hands with soap and water. For children aged 12 years and younger, consultation with a doctor is advised prior to use.

Clinicians should counsel patients that the product is for external use only and should not be applied to large areas of the body, cut, irritated, or swollen skin, or puncture wounds. Patients are advised not to use the product for more than one week without consulting a doctor. It is important to follow all directions and warnings on the packaging, avoid contact with the eyes, and refrain from bandaging or applying local heat to the treated area. Patients should discontinue use and seek medical advice if their condition worsens, symptoms persist beyond 7 days, or if symptoms recur shortly after resolution. Pregnant or breastfeeding individuals should consult a health professional before use, and the product should be kept out of reach of children and pets. In case of ingestion, immediate medical assistance or contact with a Poison Control Center is necessary.

Drug Information (PDF)

This file contains official product information for Lidocaine Pain Relieving Creme, 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 Pain Relieving Creme, 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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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.