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Lidocaine hydrochloride

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This product has been discontinued

Active ingredient
Lidocaine Hydrochloride 20 g/1 L
Other brand names
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 2013
Label revision date
April 18, 2013
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Lidocaine Hydrochloride 20 g/1 L
Other brand names
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 2013
Label revision date
April 18, 2013
Manufacturer
Cintas First Aid & Safety
Registration number
part348
NDC root
68421-5100
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

Lidocaine HCl 2% is a burn spray designed to provide temporary pain relief for minor burns, scalds, and sunburn. This water-soluble formulation is intended for first aid treatment, allowing for easy, no-touch application through a convenient pump spray. It is available in a 2 fl. oz. (59.1 mL) bottle under the brand name Xpect First Aid.

Uses

If you’re dealing with minor burns, scalds, or sunburn, this product can help provide temporary pain relief. It’s designed to be used as a first aid treatment, making it a handy option for soothing discomfort from these types of skin injuries.

You can rely on it to ease the pain associated with minor burns, allowing you to feel more comfortable while your skin heals. Remember, it’s specifically for temporary relief, so be sure to follow any additional care instructions for your skin.

Dosage and Administration

If you or your child is 2 years old or 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. However, if your child is under 2 years old, it's important to consult a doctor before using the medication. This will help ensure safety and effectiveness for younger children. Always remember to apply it only to the areas that need treatment.

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. Additionally, be careful not to get the product near your eyes; if it does come into contact with them, rinse your eyes thoroughly with water to prevent discomfort.

Always prioritize your safety by following these guidelines closely. If you have any concerns or questions about using this product, don't hesitate to reach out to a healthcare professional for advice.

Side Effects

This product is intended for external use only. It's important to avoid using it in large amounts, especially on raw or blistered skin, and to 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 your doctor if your condition worsens, if symptoms last longer than seven days, or if the condition improves and then returns within a few days. 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 applying it to large areas of your skin, especially over raw or blistered surfaces. Be careful not to get it near your eyes; if that happens, rinse your eyes thoroughly with water.

You should stop using this product and consult your doctor if your condition worsens, if your symptoms last longer than 7 days, or if your condition improves and then comes back within a few days. Always keep this product out of reach of children. If it is swallowed, 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 drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms, don’t hesitate to get help right away. 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 be cautious with medications. Currently, there is no specific information available about the use of lidocaine hydrochloride spray during pregnancy, which means that safety concerns, dosage adjustments, or special precautions have not been established.

Before using this spray, you should consult your healthcare provider to discuss any potential risks and to ensure that you are making the best choice for your health and the health of your baby. Always prioritize open communication with your doctor regarding any medications you may need during this time.

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 are no known concerns about the product being passed into breast milk or any associated risks for your infant. This means you can continue to breastfeed without worrying about potential effects from this product.

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

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 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 if you have hepatic impairment (issues with liver function).

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver health and medication use. They can help ensure that you receive the safest and most effective treatment based on your individual needs.

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 the medication is generally considered safe to use with other drugs and tests. However, every individual is different, and your healthcare provider can help ensure that your treatment plan is safe and effective for you.

Always discuss any changes in your medications or health status with your healthcare provider to avoid any potential issues and to get the best care possible.

Storage and Handling

To ensure the best performance of your product, store it at room temperature. This means keeping it in a place that is neither too hot nor too cold, typically between 68°F and 77°F (20°C to 25°C).

When handling the product, make sure to do so with clean hands and in a clean environment to maintain its safety and effectiveness. Always follow any specific instructions provided with the product for optimal use. If you have any questions about disposal or other safety measures, refer to the guidelines included with your product.

Additional Information

You can apply this medication topically to the affected area, up to 3-4 times a day for adults and children aged 2 years and older. If the patient is under 2 years old, it's important to consult a doctor before use. There are no additional details available regarding laboratory tests, abuse potential, or patient counseling.

FAQ

What is LIDOCAINE HCl 2% used for?

LIDOCAINE HCl 2% is used for the temporary pain relief associated with minor burns, scalds, and sunburn.

How should I apply LIDOCAINE HCl 2%?

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

Are there any contraindications for using LIDOCAINE HCl 2%?

No specific contraindications are mentioned for LIDOCAINE HCl 2%.

What should I do if I accidentally get LIDOCAINE HCl 2% in my eyes?

If LIDOCAINE HCl 2% gets in your eyes, rinse thoroughly with water.

What should I do if my condition worsens or symptoms persist?

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 LIDOCAINE HCl 2% safe to use during pregnancy?

The insert does not provide specific information regarding the use of LIDOCAINE HCl 2% during pregnancy.

Can nursing mothers use LIDOCAINE HCl 2%?

There are no specific warnings or recommendations regarding the use of LIDOCAINE HCl 2% in nursing mothers.

How should I store LIDOCAINE HCl 2%?

Store LIDOCAINE HCl 2% at room temperature.

What are the warnings associated with LIDOCAINE HCl 2%?

LIDOCAINE HCl 2% is for external use only and should not be used in large quantities, particularly over raw surfaces or blistered areas.

What should I do if LIDOCAINE HCl 2% 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

BURN SPRAY is a topical formulation containing Lidocaine HCl at a concentration of 2%. This product is designed for the first aid treatment of minor burns, scalds, and sunburn. It is presented in a convenient 2 fl. oz. (59.1 mL) pump spray container, facilitating a no-touch application method. The formulation is water-soluble, enhancing its usability in various first aid scenarios. BURN SPRAY is marketed under the brand name Xpect First Aid.

Uses and Indications

This drug is indicated for the temporary relief of pain associated with minor burns. It is intended for use as a first aid treatment for minor burns, scalds, and sunburn.

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. 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 the product is not applied in large quantities, especially over raw surfaces or blistered areas, to prevent potential adverse effects.

Care should be taken to avoid contact with the eyes. In the event of accidental exposure, the affected area should be rinsed thoroughly with water to mitigate irritation.

Healthcare professionals should advise patients to discontinue use and seek medical advice if any of the following occur: the condition worsens, symptoms persist for more than 7 days, or if the condition resolves and then recurs within a few days.

Additionally, it is crucial to keep this product 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

Patients should be aware that the product is for external use only. It is advised not to use the product in large quantities, particularly over raw surfaces or blistered areas, and to avoid contact with the eyes. In the event of accidental contact with the eyes, patients should rinse thoroughly with water.

Patients are instructed to stop use and consult a doctor if the condition worsens, if symptoms persist for more than 7 days, or if the condition clears up and then recurs within a few days.

Additionally, it is important to keep the product out of reach of children. If swallowed, patients should seek medical help or contact a Poison Control Center immediately.

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions between the drug and laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the current information.

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 doctor prior to use. For children aged 2 years and older, the recommended application is to the affected area not more than 3-4 times daily.

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

The safety of lidocaine hydrochloride spray during pregnancy has not been established, as the prescribing information does not provide specific data regarding its use in this population. Consequently, healthcare professionals should exercise caution when considering this medication for pregnant patients. There are no available studies or risk categories to guide the assessment of potential fetal impacts or outcomes associated with lidocaine hydrochloride spray. It is advisable for women of childbearing potential to discuss the risks and benefits of using this medication with their healthcare provider, particularly if they are pregnant or planning to become pregnant.

Lactation

There are no specific warnings or recommendations regarding the use of this product in nursing mothers. Additionally, there are no statements concerning the potential for excretion 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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this 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 important for patients to understand the urgency of the situation and the necessary steps to take if an accidental ingestion occurs.

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 necessary beyond standard storage practices.

Additional Clinical Information

The medication is administered topically, with a recommended frequency of application for adults and children aged 2 years and older being no more than 3-4 times daily to the affected area. For children under 2 years of age, it is advised to consult a doctor prior to use. There is no additional information 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.