Symptom checker
Select audience type

Switch between content for healthcare professionals (PRO) and general audience (GEN).

ADD CONDITION

items per page

Unburn

Last content change checked dailysee data sync status

Active ingredient
Lidocaine Hydrochloride 2.5 g/100 mL
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 2013
Label revision date
December 1, 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
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 2013
Label revision date
December 1, 2017
Manufacturer
Water-Jel Technologies
Registration number
part348
NDC root
59898-500
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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

Unburn is a topical medication designed to provide temporary relief from pain associated with various skin conditions. You can use it for sunburn, minor burns, minor skin irritations, and insect bites. This product aims to soothe discomfort and help you feel more comfortable while your skin heals.

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.

This means that if you experience pain from these conditions, this product may help alleviate that discomfort and make you feel more comfortable. Always remember to follow the instructions for use to ensure safety and effectiveness.

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 for the best outcomes.

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 recommended guidelines to ensure your safety and well-being. If you have any questions or concerns, consult your healthcare provider for personalized advice.

Side Effects

This product is intended for external use only, so please avoid using 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 7 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 of your skin, especially over raw or blistered surfaces. While using this product, 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 returns 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 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 for guidance.

Signs of an overdose can vary, but they may include unusual symptoms that are not typical for the medication. Always err on the side of caution and get help if you are unsure. Remember, timely action can make a significant difference in ensuring safety and health.

Pregnancy Use

The safety of lidocaine hydrochloride gel during pregnancy has not been established, so it is important to approach its use with caution. This product is generally not recommended for pregnant women unless it is clearly necessary. There may be potential risks to the fetus, so you should consult your healthcare provider for personalized advice before using it.

If you are pregnant and considering this gel, your healthcare provider may suggest dosage adjustments to ensure safety. Always weigh the potential benefits against the risks to your baby, and only use the product if the benefits clearly justify any potential risks.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of this product while nursing. Additionally, there is no information available about whether this product is excreted in 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 to do this no more than 3 to 4 times a 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 keep in mind that older adults may have different responses to medications, so discussing any concerns with a doctor is essential for ensuring safety and effectiveness.

Renal Impairment

There are no specific guidelines, dosage adjustments, or monitoring requirements mentioned for patients with kidney problems in the provided information. If you have renal impairment (kidney issues), it's important to consult your healthcare provider for personalized advice and to ensure your treatment is safe and effective. Always keep your doctor informed about your kidney health, as they can provide the best recommendations tailored to your needs.

Hepatic Impairment

If you have liver problems, it's important to know that there are no specific guidelines, dosage adjustments, or special monitoring requirements mentioned for your condition in the provided information. This means that the standard recommendations apply, but you should always consult your healthcare provider for personalized advice. They can help ensure that any medications you take are safe and appropriate for your liver health.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking. In this case, there are no specific drug interactions or laboratory test interactions noted, which means that this medication is generally considered safe to use alongside other treatments and tests. However, every individual is different, and your healthcare provider can help ensure that your overall treatment plan is safe and effective for you. Always feel free to ask questions or express any concerns you may have regarding your medications or tests.

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, as this can damage the product.

When handling the product, make sure to maintain a clean environment to prevent contamination. Always follow any specific instructions provided for safe use and disposal to ensure your safety and the effectiveness of the product.

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 patient is under 2 years old, consult a doctor before use.

It's important 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 returns within a few days. Always keep the medication out of reach of children, and if 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 Unburn used for?

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

How should I use Unburn?

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

Are there any contraindications for using Unburn?

There are no specific contraindications mentioned, but do not use in large quantities, particularly over raw surfaces or blistered areas.

What should I do if my condition worsens while using Unburn?

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 Unburn safe to use during pregnancy?

The safety of Unburn during pregnancy has not been established. Consult a healthcare provider for advice, as there may be potential risks to the fetus.

What precautions should I take when using Unburn?

Avoid contact with eyes and keep the product out of the reach of children. If swallowed, seek medical help or contact a Poison Control Center immediately.

What are the storage conditions for Unburn?

Store Unburn 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 provided information does not specify the chemical name, physical characteristics, or inactive ingredients of the drug. Therefore, a detailed description cannot be formulated based on the available data. Further information is required to create a comprehensive description.

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 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, to prevent potential adverse effects.

When using this product, it is imperative to avoid contact with the eyes. In the event of eye contact, immediate rinsing with water is recommended.

Healthcare professionals should advise patients to discontinue use and seek medical attention if the condition worsens, if symptoms persist for more than 7 days, or if the condition resolves and then recurs within a few days. These actions are crucial to ensure appropriate management of the patient's condition.

It is essential to keep this product out of the reach of children. In cases of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay to ensure the safety of the child.

Side Effects

Patients should be aware that this product is for external use only. It is important to avoid using the product in large quantities, particularly over raw surfaces or blistered areas, as this may lead to adverse effects.

While using this product, patients should take care to avoid contact with the eyes. If any adverse reactions occur, such as worsening of the condition, persistence of symptoms 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. In the event that the product is swallowed, it is crucial to seek medical help or contact a Poison Control Center immediately.

Drug Interactions

No specific drug interactions have been identified for this medication. Additionally, there are no reported interactions with laboratory tests. 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

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.

Pregnancy

The safety of lidocaine hydrochloride gel 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 healthcare providers to be consulted for advice regarding its use.

Dosage adjustments may be necessary for pregnant individuals, and healthcare providers should be consulted to determine the appropriate dosage. Pregnant women should use this product only if the potential benefit justifies the potential risk to the fetus.

Lactation

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

Renal Impairment

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there is no information available 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.

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, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and evaluation are recommended to ensure patient safety and effective resolution of any complications arising from the overdosage.

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 question. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

Postmarketing Experience

Serious adverse reactions to this product may be reported voluntarily by healthcare professionals and consumers to 1-800-275-3433. Reports received through this channel contribute to ongoing pharmacovigilance efforts and help ensure the continued safety and efficacy of the product.

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 use the product in large quantities, especially on raw surfaces or blistered areas, to prevent potential complications.

Patients should be informed 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 quality and effectiveness throughout its shelf life.

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, consultation with a doctor is advised prior to use.

Patients should be counseled to discontinue use and seek medical advice if the condition worsens, persists beyond 7 days, or resolves only to recur within a few days. It is important to keep the product out of reach of children, and in the event of ingestion, immediate medical assistance or contact with a Poison Control Center is necessary. 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.