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Theracare 4% Lidocaine Cream

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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
December 27, 2025
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
December 27, 2025
Manufacturer
Veridian Healthcare
Registration number
M017
NDC root
71101-933
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

This medication is designed to temporarily relieve minor pain. It can be helpful for various everyday discomforts, providing you with some relief when you need it most. While the specific details about how it works are not provided, its primary purpose is to ease pain effectively.

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

To use this medication effectively, you should apply a thin layer directly to the affected area of your skin. If you are an adult or a child over 12 years old, you can do this every 6 to 8 hours. However, make sure not to apply it more than three times in a 24-hour period to avoid any potential issues.

If you have a child who is 12 years old or younger, it’s important to consult a doctor before using this medication. Following these guidelines will help ensure that you use the product safely and effectively.

What to Avoid

It's important to use this product safely to avoid potential complications. You should not use it on large areas of your body, on cut, irritated, or swollen skin, or on puncture wounds. Additionally, if you find that you need to use it for more than one week, please consult your doctor first.

While using this product, make sure to keep it away from your eyes, and avoid bandaging the area or applying local heat, such as heating pads. Following these guidelines will help ensure your safety and the effectiveness of the treatment.

Side Effects

When using this product, it's important to apply it only to small areas of unbroken skin and avoid contact with your eyes. You should not use it on large areas, on cuts, or on swollen skin, and it should not be used for more than a week without consulting a doctor. If your condition worsens or if symptoms last longer than seven days, or if they improve and then return shortly after, stop using the product and seek medical advice.

If you are pregnant or breastfeeding, please consult a healthcare professional before use. In case of accidental ingestion, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

Warnings and Precautions

This product is for external use only, so please avoid getting it in your eyes. Do not apply it to large areas of your body, on cut, irritated, or swollen skin, or on puncture wounds. It's important to use this product only as directed and to read all instructions carefully. Avoid using it for more than one week without consulting your doctor, and do not apply bandages or use local heat, like heating pads, on the treated area.

If your condition worsens, or if your symptoms last longer than 7 days or come back after clearing up, stop using the product and contact your doctor. Always keep this product out of reach of children. If swallowed, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

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 1-800-222-1222 for guidance.

Signs of an overdose may include unusual symptoms, so it's crucial to be aware of how you or the person affected is feeling. If you notice any concerning changes, don’t hesitate to get help right away. Your safety is the top priority, so act quickly 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 using this medication for your child who is 12 years old or younger, it’s important to consult with a doctor first. For children over 12 and adults, you can apply a thin layer of the medication to the affected area every 6 to 8 hours, but be sure not to exceed three applications in a 24-hour period.

Always keep the medication out of reach of children. If your child accidentally swallows it, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

Geriatric Use

While there is no specific information about the use of TheraCare 4% Lidocaine Cream 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 cream. They can help determine if it’s appropriate for you or your loved one, considering any unique health needs or conditions that may be present. Always prioritize safety and seek guidance tailored to older adults' specific situations.

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 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 monitor your kidney function 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 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 or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you.

Always feel free to ask questions and share your complete list of medications and any lab tests you may be undergoing. This way, you can receive the best possible 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 not in use, make sure to keep the tube 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 pregnant or breastfeeding, it's important to consult a healthcare professional before using this product. Additionally, keep it out of reach of children. If the medication is swallowed, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

FAQ

What is the primary use of this drug?

This drug temporarily relieves minor pain.

How should I apply this drug?

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.

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 warnings I should be aware of?

This product is for external use only and you should avoid contact with the eyes.

What should I avoid while using this product?

Do not use on large areas of the body, on cut or irritated skin, or for more than one week without consulting a doctor.

What should I do if I swallow this product?

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

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 protect from light.

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

No description information is available for the drug.

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 3 applications within a 24-hour period.

For children aged 12 years or younger, it is advised to consult a physician for appropriate dosing instructions.

The medication is intended for topical application. Care should be taken to ensure that a thin layer is applied to the affected area as specified.

Contraindications

Use of this product is contraindicated in the following situations:

Application on large areas of the body, or on cut, irritated, or swollen skin is not recommended due to the potential for increased absorption and adverse effects. It should not be applied to puncture wounds, as this may lead to complications or infection. Prolonged use beyond one week without consulting a healthcare professional is contraindicated to prevent potential systemic effects.

Additionally, during use, contact with the eyes must be avoided to prevent irritation or injury. Bandaging the area of application or applying local heat, such as heating pads, is also contraindicated, as these practices may enhance absorption and increase the risk of adverse reactions.

Warnings and Precautions

For external use only, this product must be applied with caution to prevent adverse effects. It is imperative to avoid contact with the eyes, as this may lead to irritation or injury.

This product should not be used on large areas of the body, nor should it be applied to cut, irritated, or swollen skin. Additionally, it is contraindicated for use on puncture wounds. Prolonged use beyond one week is not recommended without prior consultation with a healthcare professional.

When utilizing this product, it is essential to adhere strictly to the provided directions. Users must read and follow all instructions and warnings indicated on the carton. Contact with the eyes must be avoided, and 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, it is crucial to discontinue use and seek medical advice.

To ensure safety, this product should be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center (1-800-222-1222) should be contacted without delay.

Side Effects

Patients using this product should be aware that it is intended for external use only and must avoid contact with the eyes. 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 the use of this product, patients should refrain from allowing contact with the eyes and should not bandage or apply 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.

Additionally, it is important for patients who are pregnant or breastfeeding to seek advice from a healthcare professional before using this product. In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center (1-800-222-1222) should be contacted.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

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 patients 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.

It is essential to keep this medication out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact a Poison Control Center at 1-800-222-1222.

Geriatric Use

Elderly patients may not have specific information regarding the use of TheraCare 4% Lidocaine Cream, as the drug insert does not provide details on dosage adjustments, safety concerns, or special precautions for this population. Healthcare providers should exercise caution when prescribing this medication to geriatric patients, considering the potential for altered pharmacokinetics and increased sensitivity to topical anesthetics in older adults. Monitoring for efficacy and adverse effects is recommended to ensure safe and effective use in this demographic.

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 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 regarding 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.

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. It is recommended to contact a Poison Control Center at 1-800-222-1222 for expert guidance on managing the situation.

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

If pregnant or breast-feeding, it is advised to consult a health professional before use. No non-teratogenic effects have been specified in the available data. Additionally, there are no details provided regarding nonclinical toxicology or animal pharmacology and toxicology.

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 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 1-800-222-1222.

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 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 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 tube 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. When not in use, the tube should be kept tightly closed to prevent contamination. Additionally, the product should be discarded after opening 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, not exceeding three applications within a 24-hour period. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. Additionally, it is important to keep the product out of reach of children; if ingested, patients should seek medical assistance or contact a Poison Control Center immediately at 1-800-222-1222.

No further information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

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.