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Lidocaine hydrochloride

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This product has been discontinued

Active ingredient
Lidocaine Hydrochloride 20 mg/1 g
Other brand names
Dosage form
Gel
Route
Topical
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2022
Label revision date
November 11, 2013
Active ingredient
Lidocaine Hydrochloride 20 mg/1 g
Other brand names
Dosage form
Gel
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2022
Label revision date
November 11, 2013
Manufacturer
Provision Medical
Registration number
part348
NDC root
69103-5000

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Drug Overview

First Aid Burn Cream is a topical medication designed to provide temporary relief from pain associated with minor burns and cuts. It works by helping to protect the affected area from harmful bacteria, promoting a safer healing environment. This cream is part of the Provision First Aid Line™ and comes in a convenient 0.9 g packet, making it easy to use when you need it most.

Uses

You can use this product for the temporary relief of pain caused by minor burns. It also helps protect your skin from harmful bacteria, which can be important for preventing infections as your skin heals. This makes it a useful option for managing minor burn injuries effectively.

Dosage and Administration

To use this medication effectively, start by cleaning the area that needs treatment. Once the area is clean, apply a small amount of the medication. You can do this up to three times a day, but be sure not to exceed this limit.

If you are considering this medication for a child under the age of 2, it’s important to consult a doctor first to ensure it’s safe and appropriate for their use. Always follow these guidelines to help achieve the best results.

What to Avoid

It's important to use this medication safely to avoid potential issues. You should never apply it to your eyes or use it in large quantities. Additionally, avoid using it on raw or blistered skin, deep puncture wounds, animal bites, or serious burns. If you find that you need to use this medication for more than one week, please consult your doctor for guidance.

By following these instructions, you can help ensure that you use the medication effectively and safely. Always prioritize your health and well-being by adhering to these guidelines.

Side Effects

This product is intended for external use only. You should avoid using it in or around your eyes, in large amounts, or on raw or blistered skin, deep puncture wounds, animal bites, or serious burns. It’s also important not to use it for more than one week unless your doctor advises you to do so.

Keep this product out of reach of children. If a child accidentally ingests it, contact a Poison Control Center immediately for assistance.

Warnings and Precautions

This product is intended for external use only, so please avoid applying it to your eyes or using it in large amounts. It should not be used on raw or blistered skin, deep puncture wounds, animal bites, or serious burns. Additionally, do not use it for more than one week unless your doctor has specifically instructed you to do so.

Make sure to keep this product out of reach of children. If a child accidentally ingests it, contact a Poison Control Center immediately for assistance. Always prioritize your safety and consult your doctor if you have any concerns or experience unusual reactions while using this product.

Overdose

If you suspect an overdose has occurred, it’s important to act quickly. Contact a Poison Control Center immediately for guidance. They can provide you with the necessary steps to take based on the situation.

Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms, seek medical help right away. Your safety is the top priority, so don’t hesitate to reach out for assistance.

Pregnancy Use

When it comes to using Lidocaine Hydrochloride gel during pregnancy, there is currently no specific information available about its safety, dosage adjustments, or any special precautions you should take. This means that if you are pregnant or planning to become pregnant, it’s important to consult with your healthcare provider before using this medication. They can help you weigh the potential risks and benefits based on your individual situation. Always prioritize open communication with your doctor regarding any medications you may be considering during pregnancy.

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 is no information available about whether this product is excreted in breast milk or any potential risks to your infant. Always consult with your healthcare provider if you have any concerns or questions about medications while breastfeeding.

Pediatric Use

If you have a child under the age of 2, it's important to consult a doctor before using this medication. This ensures that any potential risks are properly assessed and managed. Always prioritize your child's safety by seeking professional guidance when it comes to their health.

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 determine the best approach for managing your health, especially if you have concerns about your kidneys.

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 (liver issues).

Always consult your healthcare provider for personalized advice and to discuss any concerns regarding your liver health and how it may relate to your treatment. They can help ensure that you receive the safest and most effective care.

Drug Interactions

It's great to know that there are no known interactions between this medication and other drugs or laboratory tests. 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.

Always keep your healthcare provider informed about any changes in your health or new medications you start. Open communication helps prevent any potential issues and supports your overall well-being.

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. Following these simple guidelines will help you use the product safely and effectively.

Additional Information

You should apply this medication topically, using a small amount no more than three times a day. It's important to follow this guideline to ensure safe and effective use. If you have any questions about how to use the medication or its effects, be sure to consult your healthcare provider for more information.

FAQ

What is First Aid Burn Cream used for?

First Aid Burn Cream is used for the temporary relief of pain associated with minor burns and helps protect against harmful bacteria.

How should I apply First Aid Burn Cream?

Clean the affected area and apply a small amount of the cream no more than 3 times daily.

Are there any contraindications for using First Aid Burn Cream?

There are no contraindications listed for First Aid Burn Cream.

What should I avoid when using First Aid Burn Cream?

Do not use it in the eyes, in large quantities, over raw or blistered areas, on deep puncture wounds, animal bites, or serious burns. Do not use for more than one week unless directed by a doctor.

Is First Aid Burn Cream safe for children?

For children under 2, you should consult a doctor before use.

What should I do if First Aid Burn Cream is ingested?

If ingested, contact a Poison Control Center right away.

How should I store First Aid Burn Cream?

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

Can I use First Aid Burn Cream during pregnancy or while nursing?

There is no specific information regarding the use of First Aid Burn Cream during pregnancy or while nursing.

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

First Aid Burn Cream, marketed under the brand name Provision First Aid Line™, is indicated for the treatment of burns and cuts. The product is supplied in a net weight of 0.9 g (1/32 oz.).

Uses and Indications

This drug is indicated for the temporary relief of pain associated with minor burns. Additionally, it helps protect against harmful bacteria, contributing to the overall management of minor burn injuries.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

The affected area should be cleaned prior to application. A small amount of the medication should be applied to the affected area, not exceeding three times daily. For pediatric patients under the age of 2, it is advised to consult a physician before use.

Contraindications

Use is contraindicated in the following situations:

  • Application in the eyes is prohibited due to potential irritation and damage to ocular tissues.

  • The product should not be applied in large quantities, as excessive use may lead to adverse effects.

  • Application over raw or blistered areas, deep puncture wounds, animal bites, or serious burns is contraindicated to prevent further tissue damage and complications.

  • Prolonged use beyond one week is not recommended unless directed by a healthcare professional, to mitigate the risk of potential side effects.

Warnings and Precautions

For external use only. This product is contraindicated for application in or around the eyes. It should not be used in large quantities or applied over raw or blistered areas, deep puncture wounds, animal bites, or serious burns. Prolonged use beyond one week is not recommended unless directed by a healthcare professional.

It is imperative to keep this product out of reach of children. In the event of ingestion, immediate contact with a Poison Control Center is advised to ensure appropriate management and care.

Side Effects

For external use only. Patients should be advised not to use this product in or around the eyes, in large quantities, over raw or blistered areas, on deep puncture wounds, animal bites, or serious burns. The product should not be used for more than one week unless directed by a healthcare professional.

It is essential to keep this product out of reach of children. In the event of ingestion, it is crucial to contact a Poison Control Center immediately.

Drug Interactions

No drug interactions or drug and laboratory test interactions have been identified for this product. Therefore, no specific 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 under 2 years of age should be evaluated by a healthcare professional before use. It is important to consider the specific needs and potential risks associated with this age group. Healthcare providers are advised to assess the appropriateness of treatment based on individual patient circumstances.

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 information available regarding the use of Lidocaine Hydrochloride gel 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. It is advisable to exercise caution and to discuss alternative treatment options with women of childbearing potential.

Lactation

There are no specific warnings or recommendations regarding the use of this product by nursing mothers. Additionally, there is no information provided regarding the potential for excretion in breast milk or any associated risk to 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 relation to the use of this medication. Consequently, there are no 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 action is crucial. Healthcare professionals are advised to contact a Poison Control Center without delay if an overdose is suspected.

Potential symptoms of overdosage may vary depending on the substance involved, and it is essential to monitor the patient closely for any signs of adverse reactions.

Management of an overdosage should be guided by the specific circumstances of the case, including the substance ingested and the patient's clinical status. Prompt assessment and intervention are critical to mitigate potential complications.

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 compound in these areas.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients that in the event of ingestion, it is crucial to contact a Poison Control Center immediately. This action is essential for ensuring the safety and well-being of the patient. Providers should emphasize the importance of prompt communication with poison control professionals to receive appropriate guidance and support.

Storage and Handling

The product is supplied in configurations that include 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. Once opened, the product must be discarded to ensure safety and efficacy.

Additional Clinical Information

The medication is administered topically, with a recommended application of a small amount not exceeding three times daily. There are no additional details available regarding laboratory tests, abuse information, 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.

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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.