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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 2011
Label revision date
February 7, 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 2011
Label revision date
February 7, 2024
Manufacturer
Safetec of America, Inc.
Registration number
M017
NDC root
61010-5100
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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

Safetec First Aid Burn Spray is designed to provide temporary pain relief for minor burns. This spray can help soothe discomfort and support your healing process after experiencing a burn. It comes in a convenient 3 fl. oz. (88.7 ml) size, making it easy to keep on hand for quick access when you need it.

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, there are no concerns regarding teratogenic effects (which means it doesn’t cause birth defects) or nonteratogenic effects (which refers to other potential harmful effects that don’t involve birth defects) associated with this medication. This makes it a safe option for managing your pain from minor burns.

Dosage and Administration

When using burn spray for treating burns, you should apply an even layer over the cleaned affected area. For adults and children aged 2 years and older, you can do this up to 3 to 4 times a day. It's important to ensure the area is clean before applying the spray to help with healing.

If you have a child under 2 years of age, it's best to consult a physician (doctor) before using the spray. They can provide guidance on the safest and most effective treatment options for younger children.

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 can lead to irritation. 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

It's important to use this product only on the skin and avoid applying it in large amounts, especially on raw or blistered areas. Be careful not to get it near your eyes; if that happens, rinse your eyes thoroughly with water.

If your condition worsens, lasts more than 7 days, or clears up and then comes back, stop using the product and consult a doctor. Keep it out of reach of children, and 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 returns, stop using the product and consult your doctor. 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 act quickly. You should seek medical help immediately or contact the Poison Control Center for guidance.

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 right away. Remember, it's always better to be safe and check with a healthcare professional if you suspect an overdose.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that there is currently no 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 established.

Given this lack of information, it is advisable to consult with your healthcare provider before using Lidocaine Hydrochloride if you are pregnant or may become pregnant. Your doctor can help you weigh the potential risks and benefits based on your specific situation.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to know that there is no specific information available regarding the use of this medication during nursing. This means that the effects on breast milk production and the nursing infant are not clearly defined.

As always, it's best to consult with your healthcare provider about any medications you are considering while breastfeeding to ensure the safety and well-being of both you and your baby.

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 are taking the safest approach for your little one’s health. Always follow these guidelines to help manage your child's burn care effectively.

Geriatric Use

When it comes to using Lidocaine Hydrochloride, there is no specific information available about how it should be adjusted or used differently for older adults. This means that, as an older adult or caregiver, you should be aware that there are no special dosage recommendations or safety precautions outlined for this age group.

It's always a good idea to discuss any concerns or questions with your healthcare provider, especially regarding how medications may affect you or your loved ones. They can provide personalized advice based on individual health needs and conditions.

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 plan is safe and effective for your specific situation. They can help monitor your kidney health and make any necessary adjustments to your medications.

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 the medication may affect you differently due to your liver health.

Always consult your healthcare provider for personalized advice and to ensure that any treatment you receive is safe and appropriate for your liver condition. They can help monitor your health and make any necessary adjustments to your care.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. In this case, there are no known interactions with other drugs or laboratory tests. However, always ensure that your healthcare team is aware of all the medications you are using, as this helps them provide the safest and most effective care tailored to your needs.

By discussing your full medical history and any treatments, you can help prevent potential issues and ensure that your healthcare provider can monitor your health effectively.

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 it after use to maintain safety and quality.

By following these simple storage and handling guidelines, you can help ensure that the product remains safe and effective for your needs.

Additional Information

For adults and children aged 2 years and older, you should spray an even layer of the burn spray over the cleaned affected area, applying it no more than 3 to 4 times a day. If the patient is under 2 years of age, it’s important to consult a physician before use.

FAQ

What is Safetec First Aid Burn Spray used for?

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

How should I use Safetec First Aid Burn Spray?

For adults and children 2 years of age and older, spray an even layer over the cleaned affected area no more than 3-4 times daily. For children under 2 years, consult a physician.

Are there any contraindications for using this burn spray?

No specific contraindications are mentioned for Safetec First Aid Burn Spray.

What should I avoid when using this burn spray?

Do not use in large quantities, particularly over raw or blistered areas, and avoid contact with eyes. If contact occurs, rinse thoroughly with water.

What should I do if my condition worsens?

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

How should I store Safetec First Aid Burn Spray?

Store at room temperature, protect from light, and do not freeze. Discard after opening.

Is there any information about using this spray during pregnancy or while nursing?

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

What should I do if the spray is swallowed?

Keep out of reach of children. 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

Safetec First Aid Burn Spray is indicated for the temporary relief of pain associated with minor burns. The product is packaged in a 3 fluid ounce (88.7 mL) container. The National Drug Code (NDC) for this formulation is 61010-5100-3, and the reorder number is 50104.

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

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 potential harm.

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, 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 or persists beyond 7 days, or if symptoms resolve and then recur.

Additionally, it is crucial to keep this product 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 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 without delay.

Drug Interactions

No drug interactions have been identified for the product, indicating that it does not have any known pharmacodynamic or pharmacokinetic interactions with other medications. Additionally, there are no reported interactions with 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 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 children under 2 years of age, it is recommended to consult a physician prior to use.

Geriatric Use

Elderly patients may not have specific dosage adjustments, safety concerns, or special precautions outlined in the drug insert for Lidocaine Hydrochloride. As there is no available information regarding geriatric use, healthcare providers should exercise caution when prescribing this medication to patients aged 65 and older.

It is advisable for clinicians to monitor elderly patients closely for any potential adverse effects or changes in therapeutic response, given the general considerations for this population. Individual patient factors, including comorbidities and concurrent medications, should also be taken into account when determining the appropriateness of Lidocaine Hydrochloride for geriatric patients.

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 this lack of data when prescribing Lidocaine Hydrochloride to pregnant patients and weigh the potential risks and benefits. Women of childbearing potential should be advised to discuss their pregnancy status and any plans for pregnancy with their healthcare provider prior to initiating treatment.

Lactation

There is no specific information available regarding the use of this medication in nursing mothers or any lactation considerations. Healthcare professionals should exercise caution and consider the potential risks and benefits when prescribing this medication to lactating mothers. Further research may be necessary to fully understand the implications for 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

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 management strategy.

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 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 the medication out of reach of children. Instruct patients that if the medication is swallowed, they should seek medical help or contact the Poison Control Center immediately.

Patients should be cautioned against using the medication in large quantities, especially on raw or blistered areas of the skin. It is important to inform patients not to apply the medication near the eyes. In the event of accidental contact with the eyes, patients should rinse thoroughly with water.

Additionally, healthcare providers should instruct patients to discontinue use and consult a doctor if their condition worsens, persists for more than 7 days, or if the condition clears up and then returns.

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 ensure safety and efficacy.

Additional Clinical Information

For adults and children aged 2 years and older, the recommended administration of the burn spray involves applying an even layer over the cleaned affected area, not exceeding 3-4 times daily. For children under 2 years of age, it is advised to consult a physician prior to use. No further information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

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

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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.