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Lidocaine hydrochloride

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Active ingredient
Lidocaine Hydrochloride 20 mg/1 mL
Other brand names
Drug classes
Amide Local Anesthetic, Antiarrhythmic
Dosage form
Liquid
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2024
Label revision date
September 1, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Lidocaine Hydrochloride 20 mg/1 mL
Other brand names
Drug classes
Amide Local Anesthetic, Antiarrhythmic
Dosage form
Liquid
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 2024
Label revision date
September 1, 2024
Manufacturer
Wildman Business Group
Registration number
M017
NDC root
84269-3500
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

Burn Spray is a first aid product designed to provide temporary pain relief for minor burns. It comes in a 2 fl. oz. (59.1 ml) bottle, making it convenient for home use or to take with you when needed. This spray works by soothing the affected area, helping to alleviate discomfort associated with minor burns.

Uses

If you’re dealing with minor burns, this medication can provide temporary relief from the pain. It’s designed to help soothe discomfort, allowing you to feel more comfortable as you heal.

Rest assured, this medication does not have any known teratogenic effects, meaning it does not cause harm to a developing fetus. This makes it a safer option for those who are pregnant or may become pregnant.

Dosage and Administration

When using burn spray for treating burns, you should first clean the affected area thoroughly. For adults and children aged 2 years and older, spray an even layer of the burn spray over the burn site. You can do this up to 3 to 4 times a day, ensuring that you apply it evenly each time.

If you have a child under 2 years of age, it's important to consult a physician (doctor) before using the spray. This ensures that the treatment is safe and appropriate for their age. Always follow these guidelines to help promote healing and comfort.

What to Avoid

It's important to use this product safely to avoid any potential issues. You should not apply it in large amounts, especially on raw or blistered skin, as this could lead to irritation or other complications. Additionally, be careful not to use it near your eyes; if it does come into contact with your eyes, rinse them thoroughly with water to prevent discomfort.

While there are no specific contraindications or concerns about abuse, misuse, or dependence mentioned, following these guidelines will help ensure your experience is safe and effective. Always prioritize your health and well-being when using any product.

Side Effects

This product is intended for external use only. Avoid using it in large amounts, especially on raw or blistered skin, and keep it away from your eyes. If the product accidentally gets into your eyes, rinse them thoroughly with water.

You should stop using the product and consult a doctor if your condition worsens, persists for more than 7 days, or if it clears up and then returns. Additionally, keep this product out of reach of children. If swallowed, seek medical help or contact the 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 if you have raw or blistered areas. Be careful not to use it near your eyes; if it accidentally gets in your eyes, rinse them thoroughly with water.

If your condition worsens, does not improve after 7 days, or clears up and then comes back, stop using the product and consult your doctor. It's also important to keep this product out of reach of children. If a child swallows it, seek medical help or contact the Poison Control Center immediately.

Overdose

If you or someone else has swallowed too much of a medication, it’s important to seek medical help immediately. You can do this by contacting your local 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 the medication. If you notice any concerning changes in behavior or health, don’t hesitate to get help. Remember, acting quickly can make a significant difference in the outcome.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that there is no specific information available about the use of Lidocaine Hydrochloride during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions related to its use in pregnant individuals have not been clearly established.

Before using this medication, you should discuss it with your healthcare provider to understand any potential risks and to ensure the best care for you and your baby. Always prioritize open communication with your doctor regarding any medications you may need during pregnancy.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or considerations mentioned regarding nursing mothers or lactation in the information provided. This means that, based on the available data, there are no known risks associated with breastfeeding while using this medication. However, it's always a good idea to consult with your healthcare provider if you have any concerns or questions about your specific situation.

Pediatric Use

When using burn spray for children aged 2 years and older, you can apply an even layer over the cleaned affected area up to 3-4 times a day. However, if your child is under 2 years old, it's important to consult a physician (doctor) before using the spray. This ensures that you get the best advice for your child's specific needs. Always prioritize safety and follow the recommended guidelines for use.

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 healthcare providers may not have tailored guidelines for elderly patients.

If you or a loved one is an older adult considering this medication, it’s important to discuss any potential risks and benefits with your healthcare provider. They can help determine the best approach based on individual health needs and circumstances.

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 you understand how your kidney health may affect your medication and what steps to take for your safety.

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 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 monitor your health effectively and make informed decisions about your care.

Always feel free to ask questions and share any concerns you may have regarding your medications or tests. Your safety and well-being are the top priority, and your healthcare provider is there to help you navigate your treatment plan.

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 not to freeze the product, as this can affect its effectiveness. Once you open the product, be sure to discard any unused portion to maintain safety and quality. Following these simple guidelines will help you use the product safely and effectively.

Additional Information

You should apply the burn spray topically, which means you will spray it directly onto the affected area of clean skin. For adults and children aged 2 years and older, use it no more than 3 to 4 times a day. If the patient is under 2 years old, it's important to consult a physician before use.

FAQ

What is Burn Spray used for?

Burn Spray is used for temporary pain relief of minor burns.

Who can use Burn Spray?

Burn Spray is for adults and children 2 years of age and older. For children under 2 years, consult a physician.

How should I apply Burn Spray?

Spray an even layer of Burn Spray over the cleaned affected area no more than 3-4 times daily.

Are there any contraindications for using Burn Spray?

No specific contraindications are mentioned for Burn Spray.

What should I do if I accidentally get Burn Spray in my eyes?

If Burn Spray gets in your eyes, rinse thoroughly with water.

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

Stop use and ask a doctor if your condition worsens or persists for more than 7 days.

How should I store Burn Spray?

Store Burn Spray at room temperature, protect it from light, and do not freeze.

Is there any information about using Burn Spray during pregnancy or while nursing?

No specific information regarding use during pregnancy or nursing is provided.

What precautions should I take when using Burn Spray?

Do not use Burn Spray in large quantities, particularly over raw or blistered areas, and keep it out of reach of children.

Packaging Info

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

Packaging configurations for Lidocaine Hydrochloride.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Provision is a First Aid Burn Spray formulated for the temporary relief of pain associated with minor burns. This product is available in a dosage form of 2 fluid ounces (59.1 ml). The reorder number for this item is 3500.

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, an even layer of burn spray should be applied to the cleaned affected area. This application may be performed up to 3 to 4 times daily, ensuring that the area is adequately covered without excessive application.

In the case of children under 2 years of age, it is imperative to consult a physician prior to use to determine the appropriate course of action.

Contraindications

The product should not be applied in large quantities, particularly over raw or blistered areas, due to the potential for irritation or adverse effects. Additionally, application near the eyes is contraindicated; in the event of contact, the area should be rinsed thoroughly with water to mitigate any risk of irritation.

Warnings and Precautions

For external use only. It is imperative that the product is not applied in large quantities, especially on raw or blistered areas, to prevent potential adverse effects.

Care should be taken to avoid contact with the eyes. In the event of accidental exposure, it is essential to rinse the eyes thoroughly with water to mitigate any irritation.

Healthcare professionals should advise patients to discontinue use and seek medical advice if the condition worsens, persists for more than 7 days, or if symptoms resolve and then return.

To ensure safety, the product must be kept out of reach of children. In cases of ingestion, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

Side Effects

For external use only. Patients are advised not to use the product in large quantities, particularly over raw or blistered areas, and to avoid contact with the eyes. In the event of accidental contact with the eyes, it is recommended to rinse thoroughly with water.

Patients should discontinue use and consult a doctor if the condition worsens or persists for more than 7 days, or if the condition clears up and then returns.

It is important to keep this product out of reach of children. In case of ingestion, medical help should be sought immediately, or the Poison Control Center should be contacted without delay.

Drug Interactions

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

Packaging & NDC

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

Packaging configurations for Lidocaine Hydrochloride.
Details

Pediatric Use

Pediatric patients aged 2 years and older may use the burn spray by applying an even layer over the cleaned affected area up to 3-4 times daily. For infants and children under 2 years of age, it is recommended to consult a physician prior to use.

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 no specific information regarding the use of Lidocaine Hydrochloride during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients. The potential risks and benefits should be carefully evaluated, and alternative treatments may be considered in the absence of established safety profiles for this drug in pregnant individuals. Women of childbearing potential should be counseled on the importance of informing their healthcare provider if they are pregnant or plan to become pregnant while using this medication.

Lactation

There are no specific warnings or considerations regarding nursing mothers or lactation mentioned in the provided text. Therefore, healthcare professionals may consider the use of this medication in lactating mothers without specific concerns related to breastfeeding. However, as with any medication, it is advisable to monitor breastfed infants for any potential adverse effects.

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

In the event of an overdosage, immediate medical intervention is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical assistance or contact the Poison Control Center without delay.

Prompt action 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 and management strategies.

Healthcare providers should be prepared to implement supportive care and symptomatic treatment as necessary, based on the clinical presentation of the patient. Continuous monitoring and evaluation may be required to ensure patient safety and effective management 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 these contexts.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

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

Additionally, patients should be instructed to stop using the medication and consult a doctor if their condition worsens, persists for more than 7 days, or if the condition clears up and then returns. This guidance is essential for ensuring patient safety and effective management of their health condition.

Storage and Handling

The product is supplied in packaging that includes specific NDC numbers. It should be stored at room temperature, ensuring that it is protected from light exposure. Freezing the product is not permitted, as it may compromise its integrity. Additionally, once opened, the product must be discarded to maintain safety and efficacy.

Additional Clinical Information

The product is administered topically, with a recommended application of an even layer of burn spray over the cleaned affected area for adults and children aged 2 years and older, not exceeding 3-4 times daily. For children under 2 years of age, clinicians are advised to consult a physician prior to use.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Lidocaine Hydrochloride, 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 Lidocaine Hydrochloride, 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.