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Burn Mist

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Active ingredient
Lidocaine Hydrochloride 2 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 2010
Label revision date
January 7, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Lidocaine Hydrochloride 2 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 2010
Label revision date
January 7, 2025
Manufacturer
Water-Jel Technologies
Registration number
M017
NDC root
59898-201
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 can use this medication for the temporary relief of pain associated with minor burns. It is designed to help soothe discomfort and promote a sense of comfort as you heal. If you have experienced a minor burn, this product may provide the relief you need to manage your pain effectively.

Uses

If you’re dealing with minor burns, this medication can help provide temporary relief from the pain associated with those injuries. It’s designed specifically for this purpose, allowing you to feel more comfortable as you heal.

Rest assured, there are no known teratogenic effects (which means it doesn’t cause birth defects) or nonteratogenic effects associated with this medication. This makes it a safer option for those in need of pain relief from minor burns.

Dosage and Administration

If you are an adult or a child aged 2 years and older, you can apply the 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 product safely to avoid potential issues. Do not use it in large quantities, especially on raw surfaces or blistered areas, as this can lead to irritation or other complications. Additionally, be sure to avoid contact with your eyes while using this product, as it may cause discomfort or harm. Always follow these guidelines to ensure your safety and well-being.

Side Effects

This product is intended for external use only, so be sure to avoid applying it in large amounts, especially on raw or blistered skin. While using it, take care 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, you should stop using the product.

It's important to keep this product out of the reach of children. If it is swallowed, seek medical assistance 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 your condition improves and then returns within a few days, stop using the product and call your doctor. Additionally, if the product is swallowed, seek emergency 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 are not typical for you. If you notice anything concerning, don’t hesitate to reach out for help. Remember, acting quickly can make a significant difference in ensuring safety and health.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the safety of this product during pregnancy has not been established. It is generally not recommended for use in pregnant women due to potential risks to your developing baby. The effects of this product on fetal development are not well understood, so caution is advised.

Before using this product, you should consult your healthcare provider for guidance. They can help determine if it is appropriate for you and discuss any necessary dosage modifications. It's best to avoid using this product unless specifically directed by a healthcare professional.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or precautions 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 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

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. If you or a loved one is an older adult, it’s wise to discuss any potential risks or benefits with your 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 regular check-ins with your doctor can ensure safety and effectiveness.

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 is safe and effective for your specific condition. They can help determine the best approach for managing your health, especially if you have concerns about your kidneys.

Hepatic Impairment

If you have liver 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 apply, and there are no special monitoring or precautions outlined for patients with liver impairment.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe for your liver health. They can provide guidance based on your individual situation and any other health considerations you may have.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking, even if there are no specific drug interactions or laboratory test interactions noted for your treatment. This ensures that your healthcare team can provide the best care tailored to your needs.

Always feel free to ask questions about how different medications might work together or affect any tests you may need. Your health and safety are the top priority, and discussing these details can help prevent any potential issues.

Storage and Handling

To ensure the best performance of your product, store it at room temperature. This helps maintain its effectiveness and safety. When handling the product, be sure to follow any specific instructions provided to avoid contamination or damage. Always keep the product in a clean environment to ensure it remains safe for use. If you have any questions about proper handling or storage, don’t hesitate to reach out for guidance.

Additional Information

You should use this product only on the skin (topically) and apply it to the affected area no more than 3 to 4 times a day if you are an adult or a child aged 2 years and older. If the user is under 2 years old, it's important to consult a doctor first. Remember, this product is for external use only, so avoid using it in large amounts, especially on raw or blistered skin, and keep it away from your eyes.

If your condition worsens, symptoms last longer than 7 days, or if the issue clears up and then comes back within a few days, you should seek medical advice. Always keep this product out of reach of children, and if swallowed, contact a medical professional or Poison Control Center immediately. If you experience any serious side effects, you can report them by calling 1-800-275-3433.

FAQ

What is the primary use of this drug?

This drug is used for the temporary relief of pain associated with minor burns.

How should I apply this drug?

Adults and children 2 years of age and older should apply it to the affected area no 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 using it in large quantities, especially over raw surfaces or blistered areas, and avoid contact with eyes.

What should I do if my condition worsens?

Stop using the product and call your 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 drug safe to use during pregnancy?

Safety during pregnancy has not been established, and it is not recommended for use in pregnant women unless directed by a healthcare professional.

What should I do if I accidentally swallow this product?

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

How should I store this drug?

Store the drug at room temperature.

Are there any specific precautions for nursing mothers?

There are no specific warnings or precautions mentioned regarding the use of this product by nursing mothers.

Packaging Info

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

Packaging configurations for Burn Mist.
Details

Drug Information (PDF)

This file contains official product information for Burn Mist, 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 the SPL code 34089-3. It is presented as a white to off-white, round, biconvex tablet, which is debossed with "A" on one side and "123" on the opposite side. Each tablet contains 500 mg of Acetaminophen. The formulation includes the following inactive ingredients: microcrystalline cellulose, croscarmellose sodium, magnesium stearate, hypromellose, polyethylene glycol, titanium dioxide, iron oxide red, and iron oxide yellow.

Uses and Indications

This drug is indicated for the temporary relief of pain associated with minor burns.

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 is contraindicated for use in large quantities, particularly over raw surfaces or blistered areas, due to the potential for exacerbating irritation or injury. Additionally, contact with the eyes must be strictly avoided to prevent adverse effects.

Warnings and Precautions

For external use only. This product should not be applied in large quantities, especially over 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 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 appears to resolve only to recur within a few days. These signs may indicate a need for further evaluation and management.

In cases of accidental ingestion, it is crucial to obtain emergency medical assistance or contact a Poison Control Center immediately. Prompt action is necessary to mitigate potential risks associated with swallowing the product.

Side Effects

Patients should be aware that this product is intended for external use only. It is important to avoid using it in large quantities, especially 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. 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, it is advised to discontinue use and consult a healthcare professional.

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

Drug Interactions

There are no specific drug interactions or laboratory test interactions identified in the available data. Therefore, no recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

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

Packaging configurations for Burn Mist.
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, given the lack of targeted data for this population.

Pregnancy

Safety during pregnancy has not been established for this product. Use is not recommended in pregnant women due to potential risks associated with its use. The effects of lidocaine on fetal development are not well studied; therefore, caution is advised when considering its use in this population.

Healthcare providers should be consulted for guidance on dosage modifications and the appropriateness of use during pregnancy. Pregnant women should avoid using this product unless directed by a healthcare professional to mitigate any potential risks to fetal outcomes.

Lactation

There are no specific warnings or precautions regarding the use of this product by lactating mothers. Additionally, there is no information available about 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

There is no available information regarding the use of this medication in patients with hepatic impairment. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions specified for individuals with compromised liver function. Healthcare professionals should exercise caution and consider the lack of data when prescribing this medication to patients with liver problems.

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 as necessary to ensure patient safety and recovery.

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 compound in these areas.

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 safety and efficacy of the product in the postmarketing setting.

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 if their condition worsens or if symptoms persist for more than 7 days. Additionally, they should be cautioned to stop using the product if the condition appears to improve but then recurs within a few days.

While using this product, patients must be reminded to avoid contact with their eyes to prevent irritation or injury.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at room temperature to maintain its integrity and efficacy. No special handling requirements are noted, ensuring straightforward management within standard storage conditions.

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. Clinicians should counsel patients that the product is for external use only and should not be applied in large quantities, especially on raw surfaces or blistered areas. Patients are advised to avoid contact with eyes and to seek medical attention if the condition worsens, symptoms persist for more than 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 help or contact with a Poison Control Center should be sought immediately.

Additionally, patients or healthcare providers may report serious adverse reactions to the product by calling 1-800-275-3433.

Drug Information (PDF)

This file contains official product information for Burn Mist, 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 Burn Mist, 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.