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Lidocaine hydrochloride

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Active ingredient
Lidocaine Hydrochloride 20 mg/1 g
Other brand names
Drug classes
Amide Local Anesthetic, Antiarrhythmic
Dosage form
Gel
Route
Topical
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2019
Label revision date
March 5, 2025
Active ingredient
Lidocaine Hydrochloride 20 mg/1 g
Other brand names
Drug classes
Amide Local Anesthetic, Antiarrhythmic
Dosage form
Gel
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2019
Label revision date
March 5, 2025
Manufacturer
Redicare LLC
Registration number
M017
NDC root
71105-500

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Drug Overview

REDICARE is a burn gel designed to provide temporary pain relief for minor burns, scalds, and sunburn. This soothing gel contains aloe vera, which is known for its calming properties and can help enhance your comfort during recovery from these skin irritations.

Available in a convenient 3.5g (1/8 oz.) package, REDICARE is a supportive option to help you manage the discomfort associated with minor burns and similar skin issues.

Uses

If you’re dealing with minor burns, scalds, or sunburn, this medication can provide temporary relief from pain. It’s specifically designed to help soothe these types of skin injuries, making your recovery a bit more comfortable.

You can use it without worrying about any harmful effects on pregnancy, as there are no teratogenic (causing birth defects) or nonteratogenic effects mentioned. This means it’s considered safe for use in these situations.

Dosage and Administration

If you are an adult or a child aged 2 years and older, you can apply this medication to the affected area up to four times a day. Make sure to follow this guideline to ensure safe and effective use.

However, if your child is under 2 years old, it’s important not to use this medication without first consulting a doctor. Always prioritize safety and seek professional advice when it comes to younger children.

What to Avoid

It's important to use this medication safely to avoid potential harm. You should not apply it in large amounts, especially on raw or blistered skin, as this can lead to irritation or other complications. Additionally, be very careful to keep it away from your eyes; if it accidentally gets into your eyes, rinse them thoroughly with water to prevent any damage.

Always follow these guidelines to ensure your safety and the effectiveness of the treatment. If you have any questions or concerns about how to use this medication properly, don't hesitate to reach out to your healthcare provider for guidance.

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 your doctor if your condition worsens, persists for more than 7 days, or if it clears up and then returns within a few days. Always keep this product out of reach of children, and if it is swallowed, seek medical help or contact a 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 over raw or blistered spots. Be careful not to use it near your eyes; if it does come into contact with them, rinse thoroughly with water.

If your condition worsens, does not improve after 7 days, or clears up only to return within a few days, stop using the product and consult your doctor. Additionally, keep this product out of reach of children. If it is swallowed, seek medical help or contact a 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 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

When considering the use of Redicare Burn Gel during pregnancy, it's important to note that there is no available information about its safety, dosage adjustments, or any special precautions for pregnant individuals. This means that the effects of the gel on you or your developing baby are not well understood.

If you are pregnant or planning to become pregnant, it is always best to consult with your healthcare provider before using any medication, including topical treatments like Redicare Burn Gel. They can provide personalized advice and help you weigh the potential risks and benefits.

Lactation Use

If you are breastfeeding, it's important to know that the safety of this product during lactation (the period of breastfeeding) has not been established. There is a possibility that the product may be excreted in breast milk, which means it could potentially affect your baby. Therefore, you should exercise caution when considering its use while nursing. Always consult with your healthcare provider to discuss any concerns and to ensure the best choices for you and your infant.

Pediatric Use

When using this medication for children, it's important to follow specific guidelines. For children aged 2 years and older, you can apply it to the affected area up to four times a day. However, if your child is under 2 years old, you should not use this medication without first consulting a doctor. Always prioritize your child's safety and seek professional advice if you're unsure.

Geriatric Use

When it comes to using Redicare Burn Gel, there is no specific information available about its use in older adults. This means that if you or a caregiver are considering this product for someone elderly, it’s important to proceed with caution. Always consult with a healthcare professional to ensure it’s appropriate for your needs, especially since older adults may have different health considerations or sensitivities.

If you have any concerns or questions about using this gel, discussing them with a doctor or pharmacist can help 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 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 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 important to have open conversations with your healthcare provider about any medications you are taking, even if there are no known drug interactions or laboratory test interactions associated with them. This ensures that your treatment plan is safe and effective for your individual health needs. Always feel free to ask questions and share any concerns you may have regarding your medications or tests. Your health and safety are the top priority.

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 to the affected area, up to four times a day, if you are an adult or a child aged 2 years and older. If your child 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 REDICARE used for?

REDICARE is a burn gel indicated for temporary pain relief for minor burns, scalds, and sunburn.

What should I know about using REDICARE?

For adults and children 2 years and older, apply to the affected area no more than 4 times daily. Children under 2 should not use it without consulting a doctor.

Are there any warnings associated with REDICARE?

Yes, REDICARE is for external use only. Do not use in large quantities, particularly over raw or blistered areas, and avoid contact with eyes.

What should I do if my condition worsens while using REDICARE?

Stop use and ask a doctor if your condition worsens or persists for more than 7 days, or if it clears up and occurs again within a few days.

Is REDICARE safe for use during pregnancy?

There is no specific information regarding the use of REDICARE during pregnancy, so consult your doctor before use.

Can nursing mothers use REDICARE?

The safety of REDICARE during lactation has not been established, so caution should be exercised when administering it to nursing mothers.

How should I store REDICARE?

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

What should I do if REDICARE is swallowed?

Keep REDICARE out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Packaging Info

Below are the non-prescription pack sizes of Redicare Burn Gel. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Redicare Burn Gel.
Details

Drug Information (PDF)

This file contains official product information for Redicare Burn Gel, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

REDICARE BURN GEL is indicated for the treatment of minor burns, scalds, and sunburn. This formulation incorporates aloe vera to enhance relief. The product is available in a dosage form of 3.5 grams (1/8 oz) and is identified by the National Drug Code (NDC) 71105-500-01.

Uses and Indications

This drug is indicated for the temporary relief of pain associated with minor burns, scalds, and sunburn. It is specifically formulated to address discomfort resulting from these conditions.

There are no teratogenic or nonteratogenic effects associated with this drug, making it suitable for use in populations where such considerations are relevant.

Dosage and Administration

For adults and children aged 2 years and older, the recommended application is to the affected area, not exceeding four times daily. It is essential to ensure that the application is performed with clean hands and that the area is free from any contaminants prior to use.

For children under 2 years of age, the product should not be used without consulting a healthcare professional.

Contraindications

Use of this product 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 and adverse effects. Additionally, the product should not be applied near the eyes; in the event of contact, it is essential to rinse thoroughly with water to prevent ocular irritation.

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 for more than 7 days, or if the condition appears to improve and then recurs within a few days.

Additionally, it is crucial to keep this product out of reach of children. In the event of ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center should be made without delay.

Side Effects

For external use only. Patients are advised not to use the 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 healthcare professional if the condition worsens or persists for more than 7 days, or if the condition clears up and then recurs within a few days.

It is important to keep this product out of reach of children. In the case of ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is advised.

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions with 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 Redicare Burn Gel. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Redicare Burn Gel.
Details

Pediatric Use

Pediatric patients aged 2 years and older may apply the medication to the affected area up to four times daily. For children under 2 years of age, the use of this medication is not recommended without consulting a healthcare professional.

Geriatric Use

There is no specific information regarding the use of Redicare Burn Gel in geriatric patients. Therefore, healthcare providers should exercise caution when prescribing this medication to elderly patients. It is advisable to monitor this population closely for any potential adverse effects or complications, given the general considerations for increased sensitivity to medications in older adults. Additionally, healthcare providers may consider individual patient factors, including comorbidities and concurrent medications, when determining the appropriateness of Redicare Burn Gel for geriatric patients.

Pregnancy

There is currently no information available regarding the use of Redicare Burn Gel during pregnancy, including safety concerns, dosage modifications, or any special precautions that should be taken. Healthcare professionals should exercise caution when considering the use of this product in pregnant patients due to the lack of data on potential risks or fetal outcomes. Women of childbearing potential should be advised to consult their healthcare provider before using this product during pregnancy.

Lactation

The safety of this product during lactation has not been established. There is a potential for excretion in breast milk; therefore, caution should be exercised when administering this product to nursing mothers.

Renal Impairment

Patients with renal impairment may not have specific information regarding dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment and individualized patient assessment. Regular monitoring of renal function may be advisable to ensure patient safety and therapeutic efficacy.

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 swallowed, 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 reactions. Prompt recognition of symptoms can facilitate timely intervention and improve outcomes.

Management of overdosage should be conducted in a clinical setting, where healthcare providers can implement appropriate treatment protocols based on the severity of the symptoms and the specific substance involved. Continuous monitoring and supportive care may be necessary to ensure patient safety and recovery.

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 for SPL code 90375-7.

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 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, it is important to discard the product after opening to maintain safety and efficacy.

Additional Clinical Information

The medication is administered topically and is indicated for use in adults and children aged 2 years and older, with a recommended application frequency of no more than four times daily to the affected area. For children under 2 years of age, it is advised to consult a doctor before 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 Redicare Burn Gel, 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 Redicare Burn Gel, 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.