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Theracare Pain Relieving Lidocaine Cream

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Active ingredient
Lidocaine Hydrochloride 4 g/100 g
Other brand names
Drug classes
Amide Local Anesthetic, Antiarrhythmic
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2024
Label revision date
November 27, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Lidocaine Hydrochloride 4 g/100 g
Other brand names
Drug classes
Amide Local Anesthetic, Antiarrhythmic
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2024
Label revision date
November 27, 2024
Manufacturer
Veridian Healthcare
Registration number
M017
NDC root
71101-057
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

TheraCare 4% Lidocaine Cream is a topical medication designed to temporarily relieve minor pain. It works by numbing the area where it is applied, helping to reduce discomfort from various sources such as minor injuries or skin irritations. This cream can be a helpful option for you if you're looking for a way to manage localized pain effectively.

Uses

You can use this medication to temporarily relieve minor pain. It’s designed to help you feel more comfortable when dealing with everyday aches and discomforts. Rest assured, there are no known teratogenic effects (which means it doesn’t cause birth defects) or nonteratogenic effects associated with this medication.

Dosage and Administration

For adults and children 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 exceed three applications within a 24-hour period to ensure safety and effectiveness.

If you are considering this medication for a child who is 12 years old or younger, it’s important to consult a doctor first. 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

When using this product, it's important to be aware of potential side effects. You should only apply it to the skin as directed and avoid contact with your eyes and mucous membranes. If you notice that your condition worsens, or if symptoms last longer than seven days or return after improvement, stop using the product and consult a doctor.

Additionally, do not use this product on large areas of the body, on cuts, irritated skin, or puncture wounds. If you are pregnant or breastfeeding, it's best to consult a healthcare professional before use. Always keep the product out of reach of children, and if swallowed, seek medical help immediately or contact a Poison Control Center at 800-222-1222.

Warnings and Precautions

This product is for external use only, so be sure to avoid contact with your eyes and any mucous membranes. Do not apply it to large areas of your body, or on skin that is cut, irritated, or swollen. It's also important not to use it on puncture wounds. Always follow the directions on the packaging, and do not use the product for more than one week without consulting your doctor.

If your condition worsens or if symptoms last longer than seven 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, please consult a healthcare professional before using this product. Keep it out of reach of children, and if swallowed, seek medical help immediately or contact a Poison Control Center at 800-222-1222.

Overdose

If you or someone else has swallowed too much of a medication, it’s important to seek medical help immediately. You can contact a Poison Control Center at 800-222-1222 for guidance.

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, 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 you are considering using this medication for a child who is 12 years old or younger, it’s important to consult with a doctor first. This ensures that the treatment is safe and appropriate for your child's specific needs. Always prioritize your child's health by seeking professional advice before administering any medication.

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 always a good idea to discuss any medications with a healthcare provider. They can help ensure that the treatment is safe and appropriate, considering any unique health needs or conditions that may be present.

Since there are no dosage adjustments or special precautions mentioned for elderly patients, your healthcare provider will be the best resource for personalized advice. Always keep them informed about any other medications or health issues to ensure safe and effective care.

Renal Impairment

If you have kidney problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or safety considerations for your condition. This means that there are no tailored guidelines for how this medication should be used if you have renal impairment (kidney issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your kidney health. They can help you understand how to manage your treatment effectively.

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 condition and the use of this medication. They can help ensure that you receive the safest and most effective treatment.

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 performance of your product, store it in a cool, dry place at a temperature between 20°C to 25°C (68°F to 77°F). It’s acceptable for the temperature to occasionally range from 15°C to 30°C (59°F to 86°F), but try to keep it within the recommended limits. Make sure to protect the product from light and always keep the container tightly closed when not in use.

Once you open the container, remember to discard it after use to maintain safety and effectiveness. Following these guidelines will help you handle the product safely and ensure it remains in good condition.

Additional Information

You should apply a thin layer of the medication to the affected area every 6 to 8 hours, but do not exceed three applications in a 24-hour period if you are an adult or a child over 12 years old. If the patient is 12 years old or younger, it's important to consult a doctor before use.

FAQ

What is TheraCare 4% Lidocaine Cream used for?

TheraCare 4% Lidocaine Cream is used to temporarily relieve minor pain.

How should I apply TheraCare 4% Lidocaine Cream?

For adults and children over 12 years, apply a thin layer to the affected area every 6 to 8 hours, not exceeding 3 applications in a 24-hour period.

Can children use TheraCare 4% Lidocaine Cream?

Children 12 years or younger should ask a doctor before use.

Are there any contraindications for using TheraCare 4% Lidocaine Cream?

There are no specific contraindications mentioned for this product.

What precautions should I take when using TheraCare 4% Lidocaine Cream?

Do not use on large areas of the body, on cut, irritated, or swollen skin, or on puncture wounds. Avoid contact with eyes and do not apply local heat to the area.

What should I do if my condition worsens while using this cream?

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

Is it safe to use TheraCare 4% Lidocaine Cream during pregnancy or breastfeeding?

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

How should I store TheraCare 4% Lidocaine Cream?

Store the cream at 20°C to 25°C (68°F to 77°F) and protect it from light. Keep the container tightly closed and discard after opening.

What should I do if TheraCare 4% Lidocaine Cream is swallowed?

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

Packaging Info

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

Packaging configurations for Theracare Pain Relieving Lidocaine Cream.
Details

Drug Information (PDF)

This file contains official product information for Theracare Pain Relieving Lidocaine Cream, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

TheraCare 4% Lidocaine Cream is a topical formulation containing 4% lidocaine as the active ingredient. It is designed for local anesthesia and pain relief. The cream is presented in a suitable dosage form for application to the skin. The specific molecular weight and chemical formula of lidocaine are not provided, but it is known for its efficacy in blocking nerve signals in the targeted area. The cream's appearance is consistent with typical topical anesthetic formulations, providing a smooth texture for easy application.

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, a thin layer of the medication should be applied to the affected area every 6 to 8 hours. The total number of applications must not exceed 3 times within a 24-hour period.

For children aged 12 years or younger, it is recommended to consult a physician prior to use.

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; contact with the eyes must be avoided. This product should not be applied to large areas of the body or on cut, irritated, or swollen skin. It is contraindicated for use on puncture wounds.

Users are advised not to exceed one week of continuous use without consulting a healthcare professional. It is imperative to adhere strictly to the directions provided on the carton, including all warnings. Contact with eyes and mucous membranes should be strictly avoided. Additionally, users should refrain from bandaging or applying local heat, such as heating pads, to the area of application.

In the event that the condition worsens, or if symptoms persist beyond seven days or resolve only to recur within a few days, users should discontinue use and seek medical advice. Pregnant or breastfeeding individuals are encouraged to consult a healthcare professional prior to use.

This product must be kept out of reach of children. In the case of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center (800-222-1222) should be contacted without delay.

Side Effects

Patients using this product may experience adverse reactions, particularly if the product is not used as directed. It is important to note that this product is for external use only, and contact with the eyes and mucous membranes should be strictly avoided.

Serious adverse reactions may occur if the product is applied to large areas of the body, on cut, irritated, or swollen skin, or on puncture wounds. Additionally, patients should not use the product for more than one week without consulting a healthcare professional.

Common adverse reactions include worsening of the condition or persistence of symptoms beyond seven days. If symptoms persist or worsen, patients are advised to stop use and consult a doctor.

For pregnant or breastfeeding individuals, it is recommended to seek advice from a healthcare professional prior to use. Furthermore, this product should be kept out of reach of children, and in the event of accidental ingestion, medical assistance should be sought immediately or contact with a Poison Control Center (800-222-1222) should be made.

Patients are encouraged to read and follow all directions and warnings on the carton to minimize the risk of adverse reactions. It is also advised not to bandage or apply local heat, such as heating pads, to the area of use.

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

Packaging configurations for Theracare Pain Relieving Lidocaine Cream.
Details

Pediatric Use

Pediatric patients 12 years of age or younger should consult a healthcare professional prior to use. This precaution is essential to ensure safety and appropriateness of treatment in this age group.

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 therapeutic response, 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 safe use during pregnancy and lactation.

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 drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as there is no available data to guide dosing or monitoring in this population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this medication. Consequently, there are no 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 prescribing 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 without delay. Contacting a Poison Control Center at 800-222-1222 is recommended for further guidance and support.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Healthcare providers should be prepared to assess the patient's condition and implement appropriate management strategies based on the severity of symptoms and the specific substance involved.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. In the event of swallowing, patients should seek medical help or contact a Poison Control Center immediately at 800-222-1222.

Patients should be instructed not to use this 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 inform patients that they should not use the product for more than one week without consulting a doctor.

Healthcare providers should emphasize that patients must stop 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. Patients should be reminded to use the product only as directed and to read and follow all directions and warnings on the carton.

Additionally, patients should be cautioned against allowing the product to come into contact with the eyes and mucous membranes. They should also be advised 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 container that must be kept tightly closed to maintain integrity. 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 prevent degradation. Once opened, the product should be discarded to ensure safety and efficacy.

Additional Clinical Information

The medication is administered topically. For adults and children over 12 years, a thin layer should be applied to the affected area every 6 to 8 hours, with a maximum of three applications within a 24-hour period. For children aged 12 years or younger, it is advised to consult a doctor before use.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

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