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Lidocaine hydrochloride

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This product has been discontinued

Active ingredient
Lidocaine Hydrochloride 200 mL/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 2012
Label revision date
July 31, 2012
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Lidocaine Hydrochloride 200 mL/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 2012
Label revision date
July 31, 2012
Manufacturer
Afassco Inc.
Registration number
part348
NDC root
51532-6101
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

This product is a burn spray designed to provide temporary relief from pain caused by minor burns. It acts as an external analgesic, meaning it helps to alleviate pain quickly and washes off easily, making it convenient for use on affected areas.

Packaged in a 2 fl. oz. (59 mL) bottle, this burn spray is manufactured for Afassco, ensuring a reliable option for managing minor burn discomfort.

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.

You can rest assured that this medication does not have teratogenic effects, meaning it won’t cause harm to a developing fetus if used during pregnancy. Additionally, there are no nonteratogenic effects noted, which means it’s considered safe in that regard as well.

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 area. You can do this up to 3 to 4 times a day, ensuring that you apply it evenly each time for the best results.

If you are caring for a child under 2 years of age, it’s important to consult a physician (a medical doctor) before using the spray to ensure it’s safe and appropriate for their needs. Always follow these guidelines to help promote healing and comfort.

What to Avoid

It's important to use this medication safely. You should not use it in large amounts, especially on raw or blistered skin, as this can lead to irritation. Additionally, avoid applying it near your eyes; if it accidentally gets into your eyes, rinse them thoroughly with water.

If your condition worsens or does not improve after 7 days, or if it clears up and then comes back, please stop using the product and consult your doctor. Your health and safety are the top priority, so always follow these guidelines to ensure proper use.

Side Effects

For this product, it is important to note that it is intended for external use only. If your condition worsens or does not improve after 7 days, or if it clears up and then returns, you should stop using the product and consult your doctor.

Currently, there are no specific adverse reactions or side effects listed for this product. However, always be mindful of how your body responds and seek medical advice if you have any concerns.

Warnings and Precautions

This product is intended for external use only. If you accidentally swallow it, seek medical help or contact a Poison Control Center immediately. It's important to avoid using large amounts, especially on raw or blistered skin, as this can lead to complications.

Be cautious not to apply the product 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 returns, stop using the product and consult your doctor for further advice.

Overdose

If you or someone else has swallowed a medication in excess, 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. Acting quickly can make a significant difference in the outcome.

Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms, don’t hesitate to get help right away. Remember, it’s always better to be safe and get checked by a medical professional.

Pregnancy Use

Currently, there is no available information about the use of Lidocaine Hydrochloride during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions for pregnant individuals have not been established. If you are pregnant or planning to become pregnant, it is essential to discuss any medications with your healthcare provider to ensure the best care for you and your baby. Always prioritize open communication with your doctor regarding any treatments you may be considering.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to consult your physician before using this product. There is a possibility that it may be excreted in breast milk, which means it could potentially affect your baby. However, the specific effects on nursing infants are not known. Taking these precautions can help ensure the safety and well-being of both you and your child.

Pediatric Use

If your child is under 2 years old, it's important to consult a physician (doctor) before using this burn spray. For children aged 2 years and older, you can apply the spray by spraying an even layer over the cleaned affected area. This can be done up to 3 to 4 times a day, but be sure to follow the recommended guidelines for safe use. Always keep an eye on how your child responds to the treatment and reach out to a healthcare professional if you have any concerns.

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 there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment plan.

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 great to know that there are no reported drug interactions or interactions with laboratory tests for this medication. However, it's still very important to discuss all medications you are taking, including over-the-counter drugs and supplements, with your healthcare provider. This ensures that your treatment is safe and effective, and helps avoid any potential issues.

Always keep your healthcare provider informed about any changes in your health or medications, as they can provide personalized advice tailored to your specific situation. Your safety and well-being are the top priority!

Storage and Handling

To ensure the best quality and safety of your product, store it at room temperature and keep it 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

No further information is available.

FAQ

What is the primary use of this burn spray?

This burn spray provides temporary pain relief for minor burns.

How should I use the burn spray?

For adults and children 2 years and older, spray an even layer over the cleaned affected area up to 3-4 times daily. For children under 2, consult a physician.

Are there any warnings I should be aware of?

This product is for external use only. Do not use in large quantities, especially over raw or blistered areas, and avoid contact with eyes.

What should I do if the condition worsens?

Stop use and ask a doctor if the condition worsens or persists for more than 7 days, or if it clears up and then returns.

Is this burn spray safe to use during pregnancy?

There is no specific information regarding the use of this product during pregnancy, so consult a physician.

Can nursing mothers use this burn spray?

Nursing mothers should consult a physician before using this product, as there is a potential for excretion in breast milk.

What should I do if I accidentally swallow the burn spray?

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

How should I store the burn spray?

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

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

Burn Spray is an external analgesic formulated to provide rapid pain relief. This product is designed for easy application and can be washed off effortlessly. It is available in a 2 fluid ounce (59 mL) container. Burn Spray is manufactured for Afassco, located in Minden, NV 89423.

Uses and Indications

This drug is indicated for the temporary relief of pain associated with minor burns. There are no teratogenic effects associated with its use, nor are there any nonteratogenic effects mentioned.

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

Use of this product is contraindicated in the following situations:

Application in large quantities, particularly over raw or blistered areas, is not recommended due to the potential for increased irritation and adverse effects.

The product should not be applied near the eyes; in the event of contact, it is essential to rinse thoroughly with water to mitigate the risk of irritation.

If the condition worsens or persists for more than 7 days, or if it clears up and then returns, discontinuation of use is advised, and a healthcare professional should be consulted.

Warnings and Precautions

For external use only. Ingestion of the product necessitates immediate medical attention or contact with a Poison Control Center.

Caution is advised against the application of large quantities, especially on raw or blistered areas, as this may exacerbate irritation or lead to adverse effects. The product should not be applied near the eyes; in the event of contact, it is imperative to rinse the area thoroughly with water to mitigate potential harm.

Healthcare professionals should instruct patients to discontinue use and seek medical advice if the condition worsens, persists for more than 7 days, or if symptoms resolve and then recur. Regular monitoring of the patient's condition is recommended to ensure safety and efficacy during treatment.

Side Effects

For external use only. Patients are advised to stop 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. No specific adverse reactions or side effects have been reported in clinical trials or postmarketing experiences.

Drug Interactions

There are no documented drug interactions associated with the use of this medication. Additionally, there are no reported interactions between this medication and laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug interactions.

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 under 2 years of age should consult a physician prior to use. For children aged 2 years and older, the recommended dosage involves spraying an even layer of burn spray over the cleaned affected area, not to exceed 3-4 applications 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 adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

There is currently no information available regarding the use of Lidocaine Hydrochloride during pregnancy, including safety concerns, dosage modifications, or any special precautions that should be taken. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients and weigh the potential risks and benefits. Women of childbearing potential should be counseled on the absence of established safety data in pregnancy.

Lactation

Lactating mothers should consult a physician before using this product. There is a potential for excretion in breast milk, and the effects on a nursing infant are not known.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

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 assistance is crucial. If the substance is ingested, healthcare professionals should be contacted without delay, or the individual should reach out to a Poison Control Center for guidance.

Symptoms of overdosage may vary depending on the specific substance involved; therefore, it is essential to monitor the patient closely for any adverse effects. Prompt recognition of symptoms can facilitate timely intervention and improve outcomes.

Management of overdosage typically involves supportive care and symptomatic treatment. Healthcare providers should assess the patient's condition and implement appropriate measures based on the severity of symptoms and the specific circumstances of 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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are provided in the insert.

Patient Counseling

Healthcare providers should advise patients that in the event of accidental ingestion, it is crucial to seek medical assistance immediately or contact a Poison Control Center. This prompt action is essential to ensure the safety and well-being of the patient.

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

No further data are available.

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.