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T-Relief Lidocaine Hcl 4%

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Active ingredient
Lidocaine Hydrochloride 3.4 g/85 g
Other brand names
Drug classes
Amide Local Anesthetic, Antiarrhythmic
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2025
Label revision date
December 11, 2025
Active ingredient
Lidocaine Hydrochloride 3.4 g/85 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
Marketed in the U.S.
Since 2025
Label revision date
December 11, 2025
Manufacturer
Medinatura New Mexico Inc.
Registration number
M017
NDC root
62795-6050

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Drug Overview

This medication is designed to provide temporary relief from pain and itching. You can use it for various minor skin issues, including minor burns, sunburn, cuts, scrapes, insect bites, and irritations from rashes, such as those caused by poison ivy. It works by soothing the affected area, helping you feel more comfortable while your skin heals.

Uses

You can use this medication for the temporary relief of pain. It’s also effective in soothing itching that comes from minor burns, sunburn, minor cuts, scrapes, insect bites, and minor skin irritations, including rashes caused by poison ivy. This makes it a handy option for treating various minor skin issues and discomforts.

Dosage and Administration

You can use this medication by applying it directly to the affected area of your skin. For adults and children aged 4 years and older, you should apply it no more than 3 to 4 times a day. If your child is under 4 years old, it's important not to use this medication without first consulting a doctor.

Make sure to follow these guidelines closely to ensure safe and effective use. Remember, applying it more than the recommended amount or too frequently can lead to unwanted side effects. Always wash your hands before and after applying the medication to keep the area clean and to avoid spreading it to other areas of your body.

What to Avoid

It's important to use this medication safely to avoid potential complications. You should not apply it in large quantities, especially on raw surfaces or blistered areas, as this can lead to irritation or other adverse effects.

Additionally, be aware that this medication is classified as a controlled substance, which means it has the potential for abuse or misuse. This can lead to dependence (a condition where your body becomes reliant on the medication). Always follow your healthcare provider's instructions and avoid using this medication in ways not prescribed.

Side Effects

This product is intended for external use only. If you notice that your condition worsens, or if your symptoms last longer than 7 days, or if they improve and then return within a few days, it’s important to stop using the product and consult a doctor. Your health and safety are a priority, so don’t hesitate to seek professional advice if needed.

Warnings and Precautions

This product is for external use only, so please keep it out of reach of children. If you accidentally swallow it, seek medical help or contact a Poison Control Center immediately. It's important to use this product as directed and avoid applying it in large amounts, especially on raw or blistered skin. Be careful to keep it away from your eyes.

If your condition worsens, or if your symptoms last more than 7 days or come back after clearing up, stop using the product and consult your doctor. Always prioritize your safety and well-being when using any medication.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, it's important to be aware of the general signs of an overdose, which can include symptoms like extreme drowsiness, confusion, or difficulty breathing. If you suspect an overdose, it is crucial to seek immediate medical help.

In case of an emergency, call your local emergency services or go to the nearest hospital. Always keep medications out of reach of children and follow the prescribed dosage to prevent any potential risks. If you have any concerns or questions about your medication, don’t hesitate to reach out to your healthcare provider for guidance.

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

When using this medication for children, it's important to follow specific guidelines. For children aged 4 years and older, you can apply the medication to the affected area up to 3 to 4 times a day. However, if your child is under 4 years old, you should not use this medication without first consulting a doctor. Always prioritize your child's safety and seek professional advice if you're unsure about their treatment.

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. Since older adults may have different health needs and responses to medications, you should always consult with a healthcare provider before starting any new medication. They can help determine the right dosage and monitor for any potential side effects, ensuring that the treatment is safe and effective for you or your loved one.

Renal Impairment

If you have kidney problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations for the medication do not include special monitoring or safety considerations tailored for patients with 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 provide guidance based on your individual situation.

Hepatic Impairment

If you have liver problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or precautions related to your condition. This means that there are no tailored recommendations for how the medication may affect you differently due to your liver health.

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific situation. They can help determine the best approach based on your liver function and overall health.

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 share your complete list of medications and any recent lab tests to avoid any potential issues. Your health and safety should always come first.

Storage and Handling

To ensure the best performance of your product, store it at room temperature and keep it away from direct light. It's important to keep the tube tightly closed when not in use to maintain its integrity. Once you open the tube, please remember to discard it after use to ensure safety and effectiveness. Following these simple guidelines will help you handle the product safely and effectively.

Additional Information

No further information is available.

FAQ

What is the drug indicated for?

The drug is indicated for the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, minor skin irritations, and rashes due to poison ivy.

How should I apply the drug?

For adults and children 4 years of age and older, apply to the affected area not more than 3 to 4 times daily. Children under 4 years of age should not use it without consulting a doctor.

What precautions should I take when using this drug?

Use only as directed and avoid contact with eyes. Do not use in large quantities, especially over raw surfaces or blistered areas.

What should I do if my condition worsens?

Stop use and ask a doctor if your condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

Is this drug safe for use during pregnancy or breastfeeding?

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

How should I store this drug?

Store at room temperature, protect from light, and keep the tube tightly closed when not in use. Discard after opening.

What should I do if the drug is swallowed?

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

Is there any information on drug interactions?

No drug interactions information is provided for this product.

Packaging Info

Below are the non-prescription pack sizes of T-Relief Lidocaine Hcl 4% (lidocaine hcl 4%). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for T-Relief Lidocaine Hcl 4%.
Details

Drug Information (PDF)

This file contains official product information for T-Relief Lidocaine Hcl 4%, 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 pain. It also provides relief from itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, minor skin irritations, and rashes due to poison ivy.

Limitations of Use: This drug is intended for short-term use and is not recommended for the treatment of more severe or chronic conditions without the guidance of a healthcare professional.

Dosage and Administration

Adults and children aged 4 years and older are instructed to apply the medication topically to the affected area, not exceeding 3 to 4 applications per day. For children under 4 years of age, the use of this medication is not recommended; a consultation with a healthcare professional is advised prior to use.

The medication should be administered by applying a sufficient amount directly to the affected area, ensuring that the area is clean and dry before application. Care should be taken to avoid contact with eyes and mucous membranes.

Contraindications

Use is contraindicated in large quantities, particularly over raw surfaces or blistered areas, due to the potential for exacerbating irritation or causing further damage to the skin.

Warnings and Precautions

For external use only. This product should be kept out of reach of children to prevent accidental ingestion. In the event of swallowing, it is imperative to seek medical assistance or contact a Poison Control Center immediately.

Caution is advised regarding the quantity of product used; it should not be applied in large amounts, especially on raw surfaces or blistered areas. Users must adhere strictly to the directions provided and avoid any contact with the eyes to prevent irritation.

If the condition worsens or if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days, it is essential to discontinue use and consult a healthcare professional for further evaluation and guidance.

Side Effects

For external use only. Patients should discontinue use and consult a doctor if the condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then occur again within a few days.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding 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 T-Relief Lidocaine Hcl 4% (lidocaine hcl 4%). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for T-Relief Lidocaine Hcl 4%.
Details

Pediatric Use

Pediatric patients aged 4 years and older may apply the medication to the affected area no more than 3 to 4 times daily. For children under 4 years of age, the use of this medication is not recommended without consulting a doctor.

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, 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 considered in these populations to ensure the safety of both the mother and the fetus or 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 medication in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating mothers.

Renal Impairment

Patients with renal impairment have not been specifically addressed in terms of 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 absence of detailed guidance 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 the use of 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 available information.

Overdosage

There is currently no specific information available regarding overdosage for this medication. In the absence of documented overdosage data, healthcare professionals are advised to exercise caution and monitor patients closely for any unusual symptoms or adverse effects that may arise following administration.

In the event of suspected overdosage, it is recommended that healthcare providers initiate supportive care and symptomatic treatment as necessary. Continuous monitoring of vital signs and clinical status is essential to ensure patient safety.

Healthcare professionals should also consider consulting a poison control center or relevant toxicology resources for guidance on management strategies tailored to the specific circumstances of the overdosage event.

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 in these areas limits the understanding of the compound's safety profile in nonclinical settings.

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.

Patients should be cautioned against using the product in large quantities, especially on raw surfaces or blistered areas, as this may lead to adverse effects. It is important to emphasize that the product should only be used as directed to ensure safety and efficacy.

Healthcare providers should also remind patients to avoid contact with the eyes, as this may cause irritation or injury. Patients should be informed to discontinue 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. This guidance is crucial for ensuring appropriate use and monitoring of the product's effects.

Storage and Handling

The product is supplied in a tube that must be stored at room temperature. It is essential to protect the tube from light exposure to maintain product integrity. To ensure optimal conditions, the tube should be kept tightly closed when not in use. Additionally, the product should be discarded after opening to prevent any potential degradation or contamination.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for T-Relief Lidocaine Hcl 4%, 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 T-Relief Lidocaine Hcl 4%, 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.