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Thera Plus Max Strength Lidocaine Pain Relief Liquid

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Active ingredient
Lidocaine Hydrochloride 40 mg/1 mL
Other brand names
Drug classes
Amide Local Anesthetic, Antiarrhythmic
Dosage form
Liquid
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 30, 2023
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Lidocaine Hydrochloride 40 mg/1 mL
Other brand names
Drug classes
Amide Local Anesthetic, Antiarrhythmic
Dosage form
Liquid
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 30, 2023
Manufacturer
Fourstar Group USA, Inc.
Registration number
M017
NDC root
80684-098
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 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.

Dosage and Administration

If you are an adult or a child 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 3 applications within a 24-hour period.

For children who are 12 years old or younger, it’s important to consult a doctor before using this medication. This ensures that the treatment is safe and appropriate for their age and condition. Always follow these guidelines to help manage your symptoms effectively.

What to Avoid

It's important to use this product safely to avoid potential issues. You should not use it on large areas of your body, on cut, irritated, or swollen skin, or on puncture wounds. Additionally, if 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 mucous membranes. Avoid bandaging the area or applying local heat, such as heating pads, and do not use it alongside other topical pain relievers. Following these guidelines will help ensure your safety and the effectiveness of the treatment.

Side Effects

If you experience any worsening of your condition, redness, or irritation while using this product, it's important to stop using it and consult a doctor. Additionally, if your symptoms last more than 7 days or improve only to return shortly after, seek medical advice.

Please remember that this product is for external use only and is flammable, so keep it away from fire or flames.

Warnings and Precautions

This product is for external use only, so please avoid using it on large areas of your body or on any cut, irritated, or swollen skin. It should not be applied to puncture wounds, and you should not use it for more than one week without consulting your doctor. Remember, this product is flammable, so keep it away from fire or flames.

If you accidentally swallow this product, seek medical help or contact a Poison Control Center immediately. You should also stop using the product and call your doctor if your condition worsens, if you notice any redness or irritation, or if your symptoms last more than seven days or return shortly after clearing up.

Overdose

If you or someone else has swallowed a medication and you suspect an overdose, it’s important to act quickly. You should seek medical help immediately or contact a Poison Control Center. They can provide guidance on what to do next.

Signs of an overdose can vary, but they may include unusual symptoms that are not typical for the medication. If you notice any concerning changes in behavior or health, don’t hesitate to reach out for help. Remember, it’s always better to be safe and get professional advice in these situations.

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

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, it’s important to consult with a healthcare provider before starting the medication. 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 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 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 (liver issues).

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 be cautious when using this medication. You should not use it at the same time as other topical analgesics (pain-relieving creams or gels applied to the skin). Mixing these products can increase the risk of side effects or reduce their effectiveness.

Always discuss any medications you are taking with your healthcare provider. They can help ensure that your treatment is safe and effective, taking into account all the products you may be using.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 20° - 25°C (68° - 77°F). It's important to keep it away from direct sunlight, as exposure can affect its quality.

When handling the product, always do so with clean hands and in a sterile field (a clean area free from germs) to maintain safety and effectiveness. 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.

FAQ

What is the primary use of this drug?

This drug is used to temporarily relieve minor pain.

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

Apply a thin layer to the affected area every 6 to 8 hours, not to exceed 3 applications in a 24-hour period.

What should children 12 years or younger do before using this drug?

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

What precautions should I take when using this drug?

Do not allow contact with the eyes and mucous membranes, do not bandage or apply local heat to the area of use, and do not use at the same time as other topical analgesics.

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

Stop use and ask a doctor if your condition worsens, if redness is present, if irritation develops, or if symptoms persist for more than 7 days.

Is this drug safe to use during pregnancy or breastfeeding?

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

What are the storage conditions for this drug?

Store at 20° - 25°C (68° - 77°F) in a cool, dry place away from direct sunlight.

What should I do if I accidentally swallow this drug?

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

Are there any teratogenic effects associated with this drug?

No teratogenic effects are mentioned for this drug.

Can I use this drug on large areas of my body?

No, do not use on large areas of the body or on cut, irritated, or swollen skin.

Packaging Info

Below are the non-prescription pack sizes of Thera Plus Max Strength Lidocaine Pain Relief Liquid (lidocaine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Thera Plus Max Strength Lidocaine Pain Relief Liquid.
Details

Drug Information (PDF)

This file contains official product information for Thera Plus Max Strength Lidocaine Pain Relief Liquid, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

No specific description details are available for SPL code 34089-3 in the provided text.

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 of this product is contraindicated in the following situations:

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

During use, contact with the eyes and mucous membranes must be avoided to prevent irritation or injury. Additionally, the area of application should not be bandaged, subjected to local heat (such as heating pads), or used concurrently with other topical analgesics, as these practices may enhance absorption and increase the risk of adverse reactions.

Warnings and Precautions

For external use only. This product is flammable; therefore, it must be kept away from fire or flame to prevent any risk of ignition.

General precautions should be observed when using this product. It is contraindicated for application on large areas of the body, as well as on cut, irritated, or swollen skin. Additionally, the product should not be applied to puncture wounds. Prolonged use beyond one week is not recommended without prior consultation with a healthcare professional.

In the event of accidental ingestion, immediate medical assistance should be sought, or the local Poison Control Center should be contacted without delay.

Patients should discontinue use and consult a physician if any of the following occur: worsening of the condition, presence of redness, development of irritation, or if symptoms persist for more than seven days or resolve only to recur within a few days.

Side Effects

Patients should discontinue use and consult a healthcare professional if any of the following occur: worsening of the condition, presence of redness, development of irritation, or if symptoms persist for more than 7 days or resolve and then recur within a few days.

This product is intended for external use only. It is important to note that the formulation is flammable; therefore, patients should keep it away from fire or flame to avoid potential hazards.

Drug Interactions

Concurrent use of this medication with other topical analgesics is contraindicated. The combination may increase the risk of adverse effects without providing additional therapeutic benefit. It is advised to avoid using multiple topical analgesics simultaneously to ensure patient safety and efficacy of treatment. Monitoring for any signs of irritation or adverse reactions is recommended if there is a need to switch to or from another topical analgesic.

Packaging & NDC

Below are the non-prescription pack sizes of Thera Plus Max Strength Lidocaine Pain Relief Liquid (lidocaine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Thera Plus Max Strength Lidocaine Pain Relief Liquid.
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.

Geriatric Use

There is no specific information 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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in 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 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 not been specifically addressed in the drug insert text 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 the lack of data necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients, although specific recommendations are not provided.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this drug. 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.

Overdosage

In the event of an overdosage, immediate medical intervention is crucial. If the substance is ingested, it is imperative to seek medical assistance or contact a Poison Control Center without delay.

Healthcare professionals should be aware that prompt action can significantly influence the outcome of an overdosage situation. Symptoms of overdosage may vary depending on the specific substance involved; therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous evaluation and appropriate interventions should be implemented based on the clinical presentation and severity of symptoms.

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 these contexts.

Postmarketing Experience

No postmarketing experience details are available in the insert.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center 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, and 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 doctor. They should be advised to stop using the product and consult a healthcare professional if their condition worsens, if redness is present, if irritation develops, or if symptoms persist for more than 7 days or clear up and then recur within a few days.

When using this product, patients must be reminded to follow the directions and warnings provided in the carton carefully. They should be cautioned against allowing the product to come into contact with the eyes and mucous membranes. Additionally, patients should not bandage the area of use, apply local heat (such as heating pads), or use a medicated patch in conjunction with this product. It is also essential to inform patients not to use this product simultaneously with other topical analgesics.

Storage and Handling

The product is supplied in packaging that ensures its integrity and stability. It should be stored at a temperature range of 20° to 25°C (68° to 77°F). It is essential to keep the product in a cool, dry place, away from direct sunlight to maintain its efficacy and safety. Proper storage conditions are crucial for preserving the quality of the product throughout its shelf life.

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 additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Thera Plus Max Strength Lidocaine Pain Relief Liquid, 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 Thera Plus Max Strength Lidocaine Pain Relief Liquid, 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.

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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.