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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 2025
Label revision date
February 3, 2025
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 2025
Label revision date
February 3, 2025
Manufacturer
Veridian Healthcare
Registration number
M017
NDC root
71101-056
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) associated with this medication, making it a safer option for those who may be concerned about such risks.

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 more than 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 and warnings. You should only apply it to the skin and avoid contact with your eyes and mucous membranes. Do not use it on large areas, on cuts, or on irritated skin, and avoid using it for more than a week without consulting a doctor. If your condition worsens, if symptoms last longer than seven days, or if they improve and then return, stop using the product and seek medical advice.

If you are pregnant or breastfeeding, it's best to consult a healthcare professional before using this product. Additionally, if the product is 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 persist for more than seven days, or if they clear up 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. 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 act quickly. You should seek medical help immediately or contact a Poison Control Center at 800-222-1222.

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

If you are considering 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 professional guidance when it comes to the health of your little ones.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that if you or a loved one is an older adult considering this medication, it’s important to consult with a healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

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 health situation. They can help you understand how to manage your treatment effectively while considering your kidney health.

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 should be used if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your liver health. They can help determine the best course of action based on your individual situation.

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 is generally considered safe to use with other drugs and 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 new medications or tests with your healthcare provider to avoid potential issues and to get the best care tailored to your needs.

Storage and Handling

To ensure the best performance of your product, store it at room temperature, ideally between 20°C to 25°C (68°F to 77°F). It's important to keep the product protected from light to maintain its effectiveness. When you're not using the container, make sure to keep it 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 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. There are no additional details available regarding laboratory tests, abuse potential, or postmarketing experiences related to this medication.

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, but do not use on large areas of the body, cut, irritated, or swollen skin, or puncture wounds.

What should I do if I experience side effects?

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

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

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

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

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

How should I store TheraCare 4% Lidocaine Cream?

Store at room temperature, 20°C to 25°C (68°F to 77°F), protect from light, and keep the container tightly closed when not in use.

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. Lidocaine is a local anesthetic that provides temporary relief from pain and discomfort. The cream is designed for external use and is presented in a cream dosage form. It is characterized by its smooth texture and is typically packaged in a suitable container 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 12 years of age or younger, it is recommended to consult a physician prior to use.

Contraindications

The product is contraindicated for use on large areas of the body or on cut, irritated, or swollen skin due to the potential for adverse effects. Additionally, it should not be applied to puncture wounds. Prolonged use beyond one week without consulting a healthcare professional is also contraindicated to ensure safety and efficacy.

Warnings and Precautions

For external use only; contact with 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 use without consulting a healthcare professional.

When utilizing this product, it is imperative to adhere strictly to the provided directions. All instructions and warnings on the carton should be read and followed meticulously. Care should be taken to prevent contact with the eyes and mucous membranes. 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 beyond seven days, or if symptoms resolve and then recur within a few days, users must discontinue use and seek medical advice. Pregnant or breastfeeding individuals should consult a healthcare professional prior to use.

This product should 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 (800-222-1222) is recommended.

Side Effects

Patients using this product should be aware of several important safety warnings and potential adverse reactions. This product is intended for external use only, and contact with the eyes and mucous membranes should be strictly avoided. It is contraindicated for use on large areas of the body, on cut, irritated, or swollen skin, and on puncture wounds. Additionally, patients should not use the product for more than one week without consulting a healthcare professional.

While using this product, it is crucial to adhere to the directions provided on the carton. Patients should refrain from bandaging the area of application or applying local heat, such as heating pads, to the treated area.

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. In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center (800-222-1222) should be contacted 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 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 before use. It is important to assess the appropriateness of treatment and dosage for this age group, as specific recommendations may vary based on individual health needs and conditions.

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 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. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. Healthcare providers should consider individual circumstances and the specific health needs of the patient when making recommendations.

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 no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to 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 overdose, 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 guidance on managing the situation effectively.

Symptoms of overdose may vary depending on the specific substance involved. It is essential for healthcare providers to assess the patient’s condition thoroughly and monitor for any adverse effects that may arise.

Management of an overdose should be conducted in a clinical setting, where healthcare professionals can implement appropriate interventions based on the severity of the symptoms and the substance involved. Continuous monitoring and supportive care may be necessary to ensure patient safety and recovery.

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. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 800-222-1222 if the product is swallowed. It is important to instruct patients not to apply the product to large areas of the body or on cut, irritated, or swollen skin, as well as to avoid using it on puncture wounds.

Patients should be informed that the product should not be used for more than one week without consulting a healthcare professional. They should be encouraged to stop use 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.

When using the product, patients must be reminded to follow the directions and warnings provided on the carton carefully. They should be cautioned against allowing the product to come into contact with the eyes and mucous membranes. Additionally, patients should 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 stored at room temperature, specifically between 20°C to 25°C (68°F to 77°F). It is essential to protect the product from light exposure to maintain its integrity. The container should remain tightly closed when not in use to prevent contamination and degradation. Additionally, any unused product should be discarded after opening 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 3 applications within a 24-hour period. For children aged 12 years or younger, it is advised to consult a doctor before use.

No further 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.