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Lidocaine hydrochloride

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Active ingredient
Lidocaine Hydrochloride 20 mg/1 g
Other brand names
Drug classes
Amide Local Anesthetic, Antiarrhythmic
Dosage form
Gel
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2026
Label revision date
March 24, 2026
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Lidocaine Hydrochloride 20 mg/1 g
Other brand names
Drug classes
Amide Local Anesthetic, Antiarrhythmic
Dosage form
Gel
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 2026
Label revision date
March 24, 2026
Manufacturer
Oncora Pharma, LLC
Registration number
M017
NDC root
85477-307
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

Topicaine is an ultra external gel that contains 2% lidocaine, a medication commonly used to numb the skin. This gel is designed to provide temporary relief from pain and itching caused by various minor skin issues, including burns, sunburn, cuts, scrapes, insect bites, and other minor irritations.

When applied to the affected area, Topicaine works by blocking nerve signals in your skin, helping to alleviate discomfort and promote a sense of relief. It's a convenient option for managing minor skin pain and irritation, allowing you to feel more comfortable in your daily activities.

Uses

You can use this medication for the temporary relief of pain and itching caused by various skin issues. It is effective for minor burns, sunburn, minor cuts, scrapes, insect bites, and minor skin irritations. This means that if you experience discomfort from any of these conditions, this product can help soothe your skin and alleviate your symptoms.

Rest assured, there are no known teratogenic effects (which means it does not cause birth defects) associated with this medication, making it a safer option for those concerned about such risks.

Dosage and Administration

If you are an adult or a child aged 2 years and older, you can apply the medication directly to the affected area of your skin. You should do this up to 3 to 4 times each day for the best results.

However, if your child is under 2 years old, it’s important not to use this medication without first consulting a doctor. Always follow your healthcare provider's advice to ensure safe and effective use.

What to Avoid

It's important to use this medication responsibly. You should avoid using it in large quantities, especially on raw surfaces or blistered areas, as this can lead to complications. There are no specific contraindications or concerns regarding abuse, misuse, or dependence associated with this medication, but always follow the recommended guidelines for safe use. If you have any questions or concerns, consult your healthcare provider for personalized advice.

Side Effects

When using this product, it's important to remember that it is for external use only. Avoid getting it in your eyes, and refrain from applying it in large amounts, especially on raw or blistered skin.

If your condition worsens, or if your symptoms last longer than 7 days or return after clearing up, you should stop using the product and consult a doctor.

Warnings and Precautions

This product is intended for external use only, so please avoid applying it to your eyes. It's important not to use large amounts, especially on raw or blistered skin, as this can lead to irritation or other issues.

If your condition worsens, or if symptoms last longer than 7 days or return shortly after improvement, stop using the product and consult your doctor. Additionally, if you accidentally swallow any of the product, seek medical assistance immediately or contact a Poison Control Center for help.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, it’s always important to be aware of the potential risks associated with taking more than the recommended dose. If you suspect an overdose, look for signs such as unusual drowsiness, confusion, or difficulty breathing.

In the event of an overdose, it’s crucial to seek immediate medical help. You can call your local emergency number or go to the nearest hospital. Always keep the medication packaging on hand to provide healthcare professionals with important information. Remember, it’s better to be safe and get checked if you have any concerns about your health.

Pregnancy Use

Currently, there is no information available about the use of Topicaine Ultra during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions for pregnant individuals have not been addressed in the drug insert. If you are pregnant or planning to become pregnant, it is essential to consult your healthcare provider before using this medication to ensure it is safe for you and your baby.

Lactation Use

If you are breastfeeding, it's important to consult your doctor before using this product. There is a possibility that the ingredients may pass into your breast milk, which means your nursing infant could be exposed to it. Due to this potential risk, you should exercise caution when considering this product while breastfeeding. Always prioritize your health and your baby's safety by discussing any concerns with your healthcare provider.

Pediatric Use

If your child is 2 years old or older, you can apply the medication externally to the affected area up to 3 to 4 times a day. However, if your child is under 2 years old, it’s important not to use this medication without first consulting a doctor. Always prioritize your child's safety and seek professional advice when needed.

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 for personalized advice. 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 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 your treatment plan is safe and effective for your specific health needs.

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 differently due to your liver health.

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver function and how it relates to your treatment. They can help ensure that your medication is safe and effective for you.

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 tests you might be undergoing. This way, you can avoid any potential issues and receive the best care possible.

Storage and Handling

To ensure the best performance and safety of your product, store it at a controlled room temperature between 20° to 25°C (68° to 77°F). This temperature range helps maintain the integrity of the device.

When handling the product, make sure to do so in a clean environment to avoid contamination. Always follow any specific instructions provided for use and disposal to ensure safety and effectiveness.

Additional Information

For adults and children aged 2 years and older, you can apply the medication externally to the affected area up to 3 to 4 times a day. However, if your child is under 2 years old, you should not use this medication without consulting a doctor first. There are no additional details available regarding laboratory tests, abuse potential, or patient counseling.

FAQ

What is Topicaine?

Topicaine is an ultra external gel containing 2% lidocaine, used for temporary relief of pain and itching.

What conditions can Topicaine help relieve?

Topicaine is indicated for temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, and minor skin irritations.

How should I use Topicaine?

Adults and children 2 years and older should apply Topicaine externally to the affected area up to 3–4 times daily. Do not use in large quantities, especially over raw surfaces or blistered areas.

Is Topicaine safe for children under 2 years?

No, Topicaine should not be used in children under 2 years. Consult a doctor for advice.

Are there any warnings when using Topicaine?

Yes, Topicaine is for external use only. Avoid contact with the eyes and do not use in large quantities over raw surfaces or blistered areas.

What should I do if my condition worsens or does not improve?

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

Can I use Topicaine while pregnant?

There is no specific information regarding the use of Topicaine during pregnancy. Consult your doctor for advice.

Is it safe to use Topicaine while breastfeeding?

Nursing mothers should consult a doctor before using Topicaine, as there is a potential for excretion in breast milk.

How should Topicaine be stored?

Store Topicaine at USP controlled room temperature between 20° to 25°C (68° to 77°F).

Packaging Info

Below are the non-prescription pack sizes of Topicaine Ultra. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Topicaine Ultra.
Details

Drug Information (PDF)

This file contains official product information for Topicaine Ultra, 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 specified drug.

Uses and Indications

This drug is indicated for the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, and minor skin irritations.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Adults and children aged 2 years and older are instructed to apply the medication externally to the affected area up to 3 to 4 times daily. For children under 2 years of age, the use of this medication is not recommended; healthcare professionals should be consulted for appropriate alternatives or guidance.

Contraindications

Use is contraindicated in patients who may apply the product in large quantities, especially over raw surfaces or blistered areas, due to the potential for adverse effects. No other contraindications have been identified.

Warnings and Precautions

For external use only. Healthcare professionals should advise patients to avoid contact with the eyes when using this product. It is important to instruct patients not to apply the product in large quantities, especially over raw surfaces or blistered areas, to prevent potential adverse effects.

Patients should be informed to discontinue use and seek medical advice if their condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. In the event of accidental ingestion, immediate medical assistance should be sought, or the patient should contact a Poison Control Center without delay.

Side Effects

Patients should be aware that this product is intended for external use only. It is crucial to avoid contact with the eyes during application. Additionally, the use of large quantities, especially over raw surfaces or blistered areas, is not recommended.

In the event that the condition worsens, or if symptoms persist for more than 7 days, patients are advised to discontinue use and consult a healthcare professional. If symptoms clear up and then recur within a few days, it is also recommended to seek medical advice.

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 Topicaine Ultra. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Topicaine Ultra.
Details

Pediatric Use

Pediatric patients aged 2 years and older may apply the medication externally to the affected area up to 3–4 times daily. For children under 2 years of age, the use of this medication is not recommended, and consultation with a healthcare professional is advised.

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

There is currently no information available regarding the use of Topicaine Ultra during pregnancy, including safety concerns, dosage modifications, or any special precautions that should be taken. Healthcare professionals should consider this lack of data when prescribing Topicaine Ultra to pregnant patients and weigh the potential risks and benefits. Women of childbearing potential should be counseled accordingly, and alternative treatments may be considered in the absence of established safety profiles for this medication during pregnancy.

Lactation

Nursing mothers should consult a doctor before using this product. There is a potential for excretion in breast milk, and caution is advised when using this product while breastfeeding due to the risk of infant exposure.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials for this medication. Consequently, there is no available information regarding dosage adjustments, special monitoring requirements, or precautions 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 warranted based on clinical judgment.

Overdosage

There is currently no specific information available regarding overdosage for this medication. Healthcare professionals are advised to monitor patients closely for any signs of adverse effects or symptoms that may arise from excessive dosing.

In the event of suspected overdosage, it is recommended that healthcare providers initiate supportive care and symptomatic treatment as necessary. Patients should be evaluated for potential complications, and appropriate interventions should be implemented based on clinical judgment.

For further guidance, healthcare professionals should refer to established protocols and consult relevant toxicology resources.

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

Postmarketing experience has identified the following adverse reactions reported voluntarily or through surveillance programs: allergic reactions, which include anaphylaxis, as well as skin reactions, such as rash and pruritus.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. In the event that the product is swallowed, patients should seek medical help or contact a Poison Control Center immediately.

Patients should be instructed to 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.

While using this product, it is important for patients to avoid contact with the eyes. Additionally, they should be cautioned against using large quantities, especially on raw surfaces or blistered areas, to minimize the risk of adverse effects.

Storage and Handling

The product is supplied in accordance with the National Drug Code (NDC) specifications. It should be stored at a controlled room temperature of 20° to 25°C (68° to 77°F) to maintain its efficacy and stability. Proper storage conditions are essential to ensure the integrity of the product throughout its shelf life.

Additional Clinical Information

Patients aged 2 years and older are advised to apply the medication externally to the affected area up to 3–4 times daily. For children under 2 years, the use of this medication is not recommended, and consultation with a doctor is necessary. No further information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Topicaine Ultra, 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 Topicaine Ultra, 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

Last AI update:

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.