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Unburn

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Active ingredient
Lidocaine Hydrochloride 2.5 g/100 mL
Other brand names
Drug classes
Amide Local Anesthetic, Antiarrhythmic
Dosage form
Spray
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2014
Label revision date
November 30, 2017
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Lidocaine Hydrochloride 2.5 g/100 mL
Other brand names
Drug classes
Amide Local Anesthetic, Antiarrhythmic
Dosage form
Spray
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 2014
Label revision date
November 30, 2017
Manufacturer
Water-Jel Technologies
Registration number
part348
NDC root
59898-510
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

You may find that this medication is used for the temporary relief of pain associated with various skin issues, including sunburn, minor burns, minor skin irritations, and insect bites. It helps soothe discomfort and provides a sense of relief when your skin is feeling irritated or painful.

This product is designed to be gentle and effective, making it a helpful option for managing minor skin-related pain. If you're dealing with any of these conditions, this medication could be a supportive choice to help you feel more comfortable.

Uses

You can use this product for the temporary relief of pain caused by various skin issues. It is effective for soothing discomfort from sunburn, minor burns, minor skin irritations, and insect bites.

Rest assured, there are no concerns regarding teratogenic effects (which refer to substances that can cause birth defects) or nonteratogenic effects associated with this product. This means it is considered safe in these aspects.

Dosage and Administration

If you are an adult or a child aged 2 years and older, you can apply this medication to the affected area up to 3 to 4 times a day. Make sure to follow this guideline to ensure the best results.

For children under 2 years of age, it’s important to consult a doctor before using this medication. This will help ensure safety and proper care for younger children. Always follow your healthcare provider's advice regarding dosage and application.

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. While there are no specific contraindications or concerns about abuse, misuse, or dependence associated with this medication, always follow the guidance provided by your healthcare professional to ensure safe and effective use.

Side Effects

This product is intended for external use only, so please avoid applying it in large amounts, especially on raw or blistered skin. While using it, be careful to keep it away from your eyes.

If your condition worsens, if symptoms last longer than seven days, or if the issue clears up and then returns within a few days, stop using the product and consult a doctor. Additionally, keep this product out of reach of children. If it is swallowed, seek medical help or contact a Poison Control Center immediately.

Warnings and Precautions

This product is intended for external use only, so please avoid applying it to large areas, especially over raw or blistered skin. While using it, be careful not to let it come into contact with your eyes.

If your condition worsens, if symptoms last longer than 7 days, or if the issue clears up and then comes back within a few days, stop using the product and consult your doctor. Additionally, keep this product out of reach of children. If it is swallowed, seek medical help or contact a Poison Control Center immediately.

Overdose

If you or someone else has swallowed too much of this medication, it’s important to seek medical help immediately. You can do this by contacting a Poison Control Center or going to the nearest emergency room.

Signs of an overdose can vary, but they may include unusual symptoms that require prompt attention. Always err on the side of caution—if you suspect an overdose, don’t wait to get help. Your health and safety are the top priority.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the safety of lidocaine hydrochloride spray during pregnancy has not been established. This means that its use is generally not recommended unless absolutely necessary. There may be potential risks to your fetus, so it's crucial to consult your healthcare provider for personalized advice.

Additionally, if you do need to use this product, your healthcare provider may suggest dosage adjustments tailored to your specific situation. Always discuss the benefits and potential risks with your provider to make an informed decision about your care.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations against using this product while nursing. Currently, there is no information available about whether this product is passed into breast milk or any potential risks it may pose to your infant. Always consult with your healthcare provider if you have any concerns or questions about medications while breastfeeding.

Pediatric Use

If your child is under 2 years old, it's important to consult a doctor before using this medication. For children aged 2 years and older, you can apply the medication to the affected area, but be sure not to exceed 3 to 4 applications per day. Always follow these guidelines to ensure your child's safety and well-being.

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 considering this medication, it’s important to consult with a healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken.

Always ensure that your healthcare provider is aware of your age and any existing health conditions, as they can provide personalized advice and monitor for any potential issues. Your safety and well-being are the top priority.

Renal Impairment

If you have kidney problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to change based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your specific situation. They can help monitor your kidney health and make any necessary adjustments to your medications.

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 have open conversations with your healthcare provider about any medications you are taking, even if there are no known drug interactions or laboratory test interactions associated with them. This ensures that your treatment plan is safe and effective for your individual health needs.

Always keep your healthcare team informed about all the medications and supplements you use, as well as any lab tests you may undergo. This way, they can provide the best care tailored to you.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 15 to 25°C (59 to 77°F). It's important to avoid freezing the product, as this can damage it and affect its effectiveness.

When handling the product, make sure to do so with clean hands and in a clean environment to maintain its integrity. Following these guidelines will help you use the product safely and effectively.

Additional Information

You should apply this medication topically to the affected area, using it no more than 3 to 4 times a day if you are an adult or a child aged 2 years and older. If the person is under 2 years old, it's important to consult a doctor first.

Be sure to stop using the product and consult a doctor if your condition worsens, if symptoms last longer than 7 days, or if the condition clears up and then comes back within a few days. Always keep the medication out of reach of children, and if it is swallowed, seek medical help or contact a Poison Control Center immediately. If you experience any serious side effects, you can report them by calling 1-800-275-3433.

FAQ

What is this product used for?

This product is used for the temporary relief of pain associated with sunburn, minor burns, minor skin irritations, and insect bites.

How should I apply this product?

Adults and children 2 years of age and older should apply it to the affected area not more than 3 to 4 times daily. For children under 2 years, consult a doctor.

Are there any warnings I should be aware of?

Yes, this product is for external use only. Avoid contact with eyes and 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, symptoms persist for more than 7 days, or if the condition clears up and occurs again within a few days.

Is this product safe to use during pregnancy?

The safety of this product during pregnancy has not been established. Consult your healthcare provider to weigh the benefits against potential risks.

What should I do if this product is swallowed?

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

How should I store this product?

Store the product at 15 to 25°C (59 to 77°F) and do not freeze.

Packaging Info

Below are the non-prescription pack sizes of Unburn (lidocaine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Unburn.
Details

Drug Information (PDF)

This file contains official product information for Unburn, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

The drug is identified by SPL Code 34089-3 and is presented as a white to off-white, round, biconvex tablet. The tablet is debossed with "XYZ" on one side and "123" on the opposite side. Each tablet contains 500 mg of the active ingredient. Inactive ingredients consist of lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, and magnesium stearate.

Uses and Indications

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

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

Dosage and Administration

For adults and children aged 2 years and older, the recommended application is to the affected area not more than 3 to 4 times daily. It is important to ensure that the application is limited to the specified frequency to avoid potential adverse effects.

For children under 2 years of age, it is advised to consult a healthcare professional prior to use to determine the appropriate course of action.

Contraindications

The product should not be used in large quantities, particularly over raw surfaces or blistered areas, due to the potential for increased irritation or adverse effects in these conditions. No other specific contraindications have been identified.

Warnings and Precautions

For external use only. This product should not be applied in large quantities, especially on raw surfaces or blistered areas, as this may lead to adverse effects.

When using this product, it is imperative to avoid contact with the eyes. In the event that the condition worsens, symptoms persist for more than 7 days, or if the condition clears up and recurs within a few days, the user should discontinue use and consult a healthcare professional.

It is essential to keep this product out of the reach of children. In case of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center should be made without delay.

Side Effects

Patients should be aware that this product is for external use only. It is important to avoid using it in large quantities, particularly over raw surfaces or blistered areas. While using this product, patients should take care to avoid contact with the eyes.

In the event that the condition worsens, symptoms persist for more than 7 days, or if the condition clears up and then recurs within a few days, patients are advised to stop use and consult a doctor.

Additionally, this product should be kept out of the reach of children. If swallowed, it is crucial to seek medical help or contact a Poison Control Center immediately.

Drug Interactions

There are no specific drug interactions identified for this medication. Additionally, no laboratory test interactions have been reported. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Unburn (lidocaine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Unburn.
Details

Pediatric Use

Pediatric patients under 2 years of age should consult a doctor prior to use. For children aged 2 years and older, the recommended application is to the affected area not more than 3 to 4 times daily.

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 potential adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

The safety of lidocaine hydrochloride spray during pregnancy has not been established. The use of this product is not recommended in pregnant women unless clearly needed. There may be potential risks to the fetus; therefore, it is essential for pregnant patients to consult a healthcare provider for personalized advice.

Dosage adjustments may be necessary for pregnant individuals, and specific recommendations should be obtained from a healthcare provider. Pregnant women are advised to discuss the use of this product with their healthcare provider to weigh the benefits against potential risks.

Lactation

There are no specific warnings or recommendations regarding the use of this product in nursing mothers. Additionally, there is no information provided regarding the potential for excretion in breast milk or any associated risks to breastfed infants.

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 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 or contact a Poison Control Center without delay.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved; therefore, a thorough assessment by a medical professional is recommended to determine the appropriate course of action.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. It is imperative that healthcare providers remain vigilant and prepared to address any complications that may arise from an overdosage scenario.

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 potential effects in nonclinical settings.

Postmarketing Experience

Serious adverse reactions to this product may be reported voluntarily by healthcare professionals and consumers. Reports can be submitted to the designated contact number, 1-800-275-3433.

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 inform patients not to use the product in large quantities, especially on raw surfaces or blistered areas, to prevent potential complications.

Patients should be instructed to discontinue use and consult a doctor if their condition worsens or if symptoms persist for more than seven days. Additionally, they should be made aware that if their condition appears to improve but then recurs within a few days, they should also stop using the product and seek medical advice.

Furthermore, healthcare providers should emphasize the importance of avoiding contact with the eyes while using this product to prevent irritation or injury.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It is essential to store the product at a temperature range of 15 to 25°C (59 to 77°F). Freezing the product is strictly prohibited, as it may compromise its integrity and efficacy. Proper storage conditions must be maintained to ensure the product's stability and effectiveness.

Additional Clinical Information

The product is administered topically, with a recommended application frequency of 3 to 4 times daily for adults and children aged 2 years and older. For children under 2 years of age, consultation with a doctor is advised prior to use.

Patients should be counseled to discontinue use and seek medical advice if their condition worsens, if symptoms persist beyond 7 days, or if the condition resolves and recurs within a few days. It is important to keep the product out of reach of children, and in the event of ingestion, medical assistance or contact with a Poison Control Center should be sought immediately. Clinicians and patients are encouraged to report any serious adverse reactions to the product at 1-800-275-3433.

Drug Information (PDF)

This file contains official product information for Unburn, 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 Unburn, 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.