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Lidocream Plus

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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 2022
Label revision date
February 28, 2022
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 2022
Label revision date
February 28, 2022
Manufacturer
AEC Consumer Products, LLC
Registration number
part348
NDC root
86089-200
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 can use this medication for the temporary relief of pain. It is designed to help alleviate discomfort, making it easier for you to manage your daily activities. If you're experiencing pain, this drug may provide the support you need to feel more comfortable.

Uses

You can use this medication for the temporary relief of pain. It is designed to help alleviate discomfort, making it easier for you to go about your daily activities.

Rest assured, there are no concerns regarding teratogenic effects (which means it does not cause birth defects) or nonteratogenic effects (which refers to other potential harmful effects unrelated to birth defects) associated with this medication.

Dosage and Administration

If you are an adult or a child over 12 years old, you can apply the medication to the affected areas of your skin as needed, up to 3 to 4 times a day. It's important to pay attention to your body; if your pain continues despite using the medication, you should consult a physician (doctor) for further advice.

For children who are 12 years old or younger, it's best to consult a doctor before using this medication. This ensures that the treatment is safe and appropriate for their specific needs.

What to Avoid

It's important to keep this medication out of reach of children to prevent accidental ingestion. If you or someone else 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 from your healthcare provider.

Side Effects

When using this product, it's important to follow the directions carefully. It is meant for external use only and should not be applied in large amounts, especially on raw or blistered skin. Avoid using it for more than a week without consulting your doctor. Be cautious to keep it away from your eyes, and do not cover the treated area with bandages or apply heat, like heating pads.

If your condition worsens, if symptoms last longer than seven days, or if they improve and then return within a few days, stop using the product and consult your doctor. Additionally, if you are pregnant or breastfeeding, please speak with a healthcare professional before using it. Always keep this product out of reach of children, and if it is swallowed, seek medical help or contact a Poison Control Center immediately.

Warnings and Precautions

This product is for external use only, so please avoid using it on large areas of your skin, especially over raw or blistered surfaces. It's important to follow the directions carefully and not to use it for more than one week without consulting your doctor. Be cautious to keep it away from your eyes, and do not apply heat or bandage the treated area.

If you notice that your condition worsens, if symptoms last longer than seven days, or if they improve and then return within a few days, stop using the product and contact your doctor. If you are pregnant or breastfeeding, please consult a healthcare professional before using this product. Always keep it out of reach of children.

In case of accidental swallowing, seek emergency medical help or contact a Poison Control Center immediately.

Overdose

If you or someone else has swallowed too much of this 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.

Signs of an overdose can vary, but they may include unusual symptoms that are not typical for you. If you notice anything concerning, don’t hesitate to reach out for help. Remember, acting quickly can make a significant difference in ensuring safety and health.

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

If your child is 12 years old or younger, it's important to consult a doctor before using this medication. This ensures that it is safe and appropriate for their specific needs. For adults and children over 12, you can apply the medication to the affected areas as needed, up to 3-4 times a day. Always follow the guidance of a healthcare professional to ensure the best care for your child.

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 responses to medications, you should always consult with a healthcare provider before starting any new medication. They can help determine the right dosage and monitor for any potential side effects, ensuring that the treatment is safe and effective for you or your loved one.

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 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 if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to discuss any concerns regarding your liver health and how it may relate to your treatment. They can help ensure that you receive the safest and most effective care.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking. In this case, there are no specific drug interactions or laboratory test interactions noted, which means that the medication may not have known conflicts with other drugs or tests. However, every individual is different, and your healthcare provider can help ensure that your treatment plan is safe and effective for you.

Always discuss any changes in your medications or upcoming lab tests with your healthcare provider to avoid any potential issues and to get the best care possible.

Storage and Handling

To ensure the best performance of your product, store it at a temperature between 20°C and 25°C (68°F to 77°F). It's important to keep it away from light to maintain its effectiveness. When you're not using the product, make sure the tube is tightly closed to prevent contamination. Remember to discard the product after opening to ensure safety and efficacy. Following these guidelines will help you use the product safely and effectively.

Additional Information

You can apply this medication to the affected areas of your skin 3 to 4 times a day as needed if you are an adult or a child over 12 years old. If the patient is younger than 12 years, it's important to consult a doctor before use. There are no additional details available regarding laboratory tests, abuse potential, or patient counseling.

FAQ

What is the primary use of this drug?

This drug is used for the temporary relief of pain.

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

Adults and children over 12 years should apply it as needed to affected areas 3-4 times a day.

What should children under 12 do before using this drug?

Children 12 years of younger should consult a doctor before use.

Are there any contraindications for this drug?

No contraindications are listed for this drug.

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 I accidentally 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 pregnant or breastfeeding, you should ask a health professional before use.

What should I do if my 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 20°C to 25°C (68°F to 77°F), protect from light, and keep the tube tightly closed when not in use.

Packaging Info

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

Packaging configurations for Lidocream Plus.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The product is identified by the SPL code 34089-3. No specific description details are provided in the available information.

Uses and Indications

This drug is indicated for the temporary relief of pain.

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

Dosage and Administration

Adults and children over 12 years of age should apply the medication as needed to the affected areas 3 to 4 times daily. If pain persists, it is advised to consult a physician for further evaluation and guidance.

For children under 12 years of age, it is recommended to consult a doctor prior to use to ensure safety and appropriateness of treatment.

Contraindications

Use is contraindicated in children due to the risk of accidental ingestion. In the event of swallowing, immediate medical assistance or contact with a Poison Control Center is advised.

Warnings and Precautions

For external use only. This product should not be applied in large quantities, particularly over raw or blistered surfaces, and should not be used for more than one week without consulting a healthcare professional. It is imperative that the product is used strictly as directed, with particular attention to avoiding contact with the eyes. Additionally, the area of application should not be bandaged or subjected to local heat, such as heating pads.

Healthcare professionals should advise patients to discontinue use and seek medical advice if the condition worsens, if symptoms persist beyond 7 days, or if symptoms resolve and then recur within a few days. Special caution is warranted for individuals who are pregnant or breastfeeding; they should consult a healthcare professional prior to use.

General precautions include keeping the product out of reach of children to prevent accidental ingestion. In the event of ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center should be made without delay.

Patients should be reminded to stop using the product and consult their doctor if any of the following occur: worsening of the condition, persistence of symptoms beyond 7 days, or recurrence of symptoms after they have cleared.

Side Effects

Patients should be aware that this product is for external use only. It is important not to use the product in large quantities, particularly over raw or blistered surfaces, and it should not be used for more than one week without consulting a healthcare professional. While using this product, patients must adhere to the directions provided, avoid contact with the eyes, and refrain from bandaging or applying local heat, such as heating pads, to the area of application.

In the event that the condition worsens, symptoms persist for more than seven days, or symptoms resolve and then recur within a few days, patients are advised to discontinue use and consult a doctor. Additionally, pregnant or breastfeeding individuals should seek guidance from a healthcare professional prior to using this product.

It is crucial to keep this product out of reach of children. In the case of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center should be made without delay.

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions between the drug and laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the current information.

Packaging & NDC

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

Packaging configurations for Lidocream Plus.
Details

Pediatric Use

Pediatric patients 12 years of age and younger should consult a healthcare professional prior to use. For adolescents and children over 12 years, the recommended application is to apply the product as needed to affected areas 3 to 4 times daily.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any potential 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 no specific data available regarding the excretion of this medication in 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. It is imperative that healthcare providers remain vigilant and prepared to address any complications that may arise from an overdosage scenario.

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 question.

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 to prevent accidental ingestion. It is important to emphasize that if the medication is swallowed, patients should seek medical help or contact a Poison Control Center immediately. This guidance is crucial for ensuring patient safety and minimizing potential risks associated with accidental exposure.

Storage and Handling

The product is supplied in a tube format, with specific storage and handling requirements to ensure its integrity and efficacy. It should be stored at a temperature range of 20°C to 25°C (68°F to 77°F) and must be protected from light exposure. To maintain the product's quality, the tube should be kept tightly closed when not in use. Additionally, it is important to discard the product after opening to prevent any potential degradation.

Additional Clinical Information

Patients aged 12 years and older are advised to apply the medication to affected areas as needed, with a recommended frequency of 3 to 4 times per day. For children under 12 years, it is essential to consult a doctor before use. There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Lidocream Plus, 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 Lidocream Plus, 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.