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Theracare 4% 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 2021
Label revision date
May 21, 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 2021
Label revision date
May 21, 2024
Manufacturer
Veridian Healthcare
Registration number
M017
NDC root
71101-930
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

When using this medication, if you are an adult or a child over 12 years old, you should apply a thin layer to the affected area every 6 to 8 hours. However, make sure not to exceed more than 3 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. Always follow these instructions carefully to achieve the best results.

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 apply it only as directed and avoid contact with your eyes and mucous membranes. You should not use it on large areas of your body, on cut or irritated skin, or for more than one week without consulting a doctor. If your condition worsens, 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 seek medical advice.

If you are pregnant or breastfeeding, please consult a healthcare professional before use. Keep this product out of reach of children, and if swallowed, seek medical help or contact a Poison Control Center immediately 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, on cut, irritated, or swollen skin, or on puncture wounds. It's important to follow the directions carefully and not to 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. Additionally, 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 or contact a Poison Control Center (800-222-1222) immediately.

Overdose

If you or someone else has swallowed too much of this 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 may include unusual symptoms, so be alert for any changes in behavior or health. If you notice anything concerning, don’t hesitate to get help right away. Your safety is the top priority, so acting quickly can make a difference.

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 with a doctor before using this medication. For children over 12 and adults, 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 follow these guidelines to ensure safe and effective use.

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, especially since older adults may have different health needs and may be taking other medications.

Since there are no dosage adjustments or special precautions mentioned for elderly patients, your healthcare provider can help determine the best approach for you, considering your overall health and any other medications you may be taking. 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 may affect you or how your kidney function might influence its use.

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 monitor your condition and make any necessary adjustments to your treatment plan.

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 (issues with liver function).

Before starting any new medication, including this one, you should discuss your liver health with your healthcare provider. They can help determine the best approach for your treatment and ensure your safety.

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 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 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. 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 contraindications listed for TheraCare 4% Lidocaine Cream.

What precautions should I take when using this cream?

Do not use on large areas of the body, on cut or irritated skin, or for more than one week without consulting a doctor. Avoid contact with eyes and do not apply local heat.

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 TheraCare 4% Lidocaine Cream safe to use 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 4% Lidocaine Cream (lidocaine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Theracare 4% Lidocaine Cream.
Details

Drug Information (PDF)

This file contains official product information for Theracare 4% 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 tube for convenient 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 advised to consult a physician before 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 to adhere strictly to the recommended usage guidelines. The product should not be used for more than one week without prior consultation with a healthcare professional. It is imperative to read and follow all directions and warnings provided on the packaging.

Contact with the eyes and mucous membranes must 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 for more than seven days or resolve only to recur within a few days, users should discontinue use and seek medical advice.

Pregnant or breastfeeding individuals are advised to consult a healthcare professional before using this product.

This product should 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 should be aware of several important warnings and precautions. This product is intended for external use only, and contact with the eyes and mucous membranes should be strictly avoided. It should not be applied to large areas of the body, on cut, irritated, or swollen skin, or on puncture wounds. Additionally, the product should not be used 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. Furthermore, 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 advised.

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions with 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 4% Lidocaine Cream (lidocaine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Theracare 4% Lidocaine Cream.
Details

Pediatric Use

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

Geriatric Use

There is no specific information available regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

Pregnancy

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

Lactation

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

Overdosage

In the event of an overdose, immediate medical assistance is crucial. If the substance is ingested, healthcare professionals are advised to seek medical help or contact a Poison Control Center at 800-222-1222 without delay.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. It is important for healthcare providers to assess the patient's condition and initiate appropriate management procedures based on the severity of the overdose and the specific substance involved.

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 this product out of reach of children to prevent accidental ingestion. Instruct patients that if the product is swallowed, they should seek medical help or contact a Poison Control Center immediately at 800-222-1222.

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, 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 to avoid 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 4% 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 4% 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.