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Lidocaine hydrochloride

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This product has been discontinued

Active ingredient
Lidocaine Hydrochloride 18 g/1 L
Other brand names
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 2022
Label revision date
November 11, 2013
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Lidocaine Hydrochloride 18 g/1 L
Other brand names
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 2022
Label revision date
November 11, 2013
Manufacturer
Provision Medical
Registration number
part348
NDC root
69103-5100
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

Provision First Aid Burn Spray is designed to provide temporary pain relief for minor burns. This spray helps soothe discomfort associated with burns, making it easier for you to manage the pain while your skin heals. With a convenient 2 fl. oz. (59.1 ml) size, it’s a handy addition to your first aid supplies for quick relief when you need it.

Uses

You can use this medication for temporary relief from pain caused by minor burns. It helps soothe discomfort and makes it easier for you to manage your symptoms while your skin heals.

Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) associated with this medication, so it is considered safe in that regard.

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 cleaned area. You can do this up to 3 to 4 times a day, ensuring that you allow the spray to dry before covering the area with clothing or a bandage.

If you have a child under 2 years of age, it’s important to consult a physician (doctor) before using the burn spray. They can provide guidance on the best treatment options for younger children. Always follow these instructions carefully to promote healing and avoid complications.

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 accidentally gets into your eyes, rinse them thoroughly with water to prevent discomfort.

While there are no specific contraindications or concerns about abuse, misuse, or dependence associated with this product, following these guidelines will help ensure your safety and well-being. Always prioritize using the product as directed.

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 for external use only, so please avoid using it on large areas of your skin, especially over raw or blistered spots. Be careful not to apply it near your eyes; if it does come into contact with 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. Additionally, keep this product out of reach of children. If a child accidentally swallows it, seek medical help or contact the 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 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 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 information available about the use of Lidocaine Hydrochloride during pregnancy is limited. The drug insert does not provide specific guidance on safety, dosage adjustments, or any special precautions for pregnant individuals.

Given this lack of information, it's essential to discuss any concerns or questions with your healthcare provider. They can help you understand the potential risks and benefits based on your individual situation. Always prioritize open communication with your medical team when it comes to medications during pregnancy.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of lidocaine hydrochloride while nursing. The information available does not indicate any concerns about lidocaine being passed into breast milk or any associated risks for your infant.

As always, if you have any questions or concerns about medications while breastfeeding, it's a good idea to consult with your healthcare provider for personalized advice.

Pediatric Use

When using burn spray for children, you can apply it to the affected area for those aged 2 years and older. Make sure to spray an even layer over the cleaned area, but do this no more than 3 to 4 times a day. If your child is under 2 years old, it's important to consult a physician (doctor) before using the spray to ensure it's safe for them. Always prioritize your child's safety and well-being when treating burns.

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 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 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 any necessary precautions or adjustments based on your kidney health.

Hepatic Impairment

If you have liver problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or precautions related to your condition. This means that there are no tailored recommendations for how your liver health might affect the use of this medication.

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for you, especially if you have concerns about your liver function. Your doctor can help determine the best approach based on your individual health needs.

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 all the medications and supplements you are using. This helps to avoid any potential issues and ensures that you receive the best possible treatment tailored to your needs.

Storage and Handling

To ensure the best quality and safety of your product, store it at room temperature, away from direct light. It's important to keep the container tightly closed when not in use to prevent contamination. Once you open the container, please remember to discard it after use to maintain safety and effectiveness. 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 an even layer over the cleaned affected area. This can be done for adults and children aged 2 years and older, up to 3-4 times a day. If you are considering using this spray for a child under 2 years old, it's important to consult a physician first for guidance.

FAQ

What is Provision First Aid Burn Spray used for?

Provision First Aid Burn Spray is used for temporary pain relief for minor burns.

Who can use Provision First Aid Burn Spray?

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

How should I apply Provision First Aid Burn Spray?

Spray an even layer over the cleaned affected area not more than 3-4 times daily.

Are there any contraindications for using this spray?

No contraindications are listed for Provision First Aid Burn Spray.

What should I avoid when using this spray?

Do not use in large quantities, particularly over raw or blistered areas, and avoid contact with eyes.

What should I do if the condition worsens or persists?

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

How should I store Provision First Aid Burn Spray?

Store at room temperature, protect from light, and keep the container tightly closed.

Is there any information regarding use during pregnancy or lactation?

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

What should I do if the spray is swallowed?

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

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

The Provision First Aid Line™ First Aid Burn Spray is 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 recommended that a physician be consulted prior to use to determine the appropriate course of action.

Contraindications

Use is contraindicated in the following situations:

Application in large quantities, especially over raw or blistered areas, is not recommended due to the potential for increased 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 potential harm.

Warnings and Precautions

For external use only. It is imperative that this product is not applied in large quantities, especially over raw or blistered areas, as this may lead to adverse effects. Care should also be taken to avoid contact with the eyes; in the event of accidental exposure, the affected area should be rinsed thoroughly with water.

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.

Additionally, this product must be kept out of reach of children. In the case 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 this 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.

This product should be kept out of reach of children. In case of ingestion, immediate medical assistance should be sought, or the Poison Control Center should be contacted right away.

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 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

There is no specific information 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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

There are no specific statements regarding the use of Lidocaine Hydrochloride during pregnancy, including safety concerns, dosage modifications, or special precautions. As such, the potential risks to pregnant patients and fetal outcomes remain undefined. Healthcare professionals should consider the lack of data when prescribing this medication to women of childbearing potential and weigh the benefits against any potential risks. It is advisable to exercise caution and to discuss the implications of treatment with pregnant patients or those planning to become pregnant.

Lactation

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

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 the use of this medication. Consequently, there are no established 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 available information.

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 the 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 should include supportive care and symptomatic treatment as necessary. Continuous evaluation of the patient's condition is recommended to address any complications that may arise.

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.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. In the event that the medication is swallowed, patients should be instructed to seek medical help immediately or contact the Poison Control Center for assistance. It is essential for patients to understand the importance of these precautions to ensure their safety and the safety of others.

Storage and Handling

The product is supplied in a container that must be kept tightly closed to maintain its integrity. It should be stored at room temperature, away from direct light exposure to protect its quality. Once opened, the product should be discarded to ensure 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.