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Maximum Strength Burn Relief Aloe Gel

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This product has been discontinued

Active ingredient
Lidocaine Hydrochloride 4 g/100 mL
Other brand names
Dosage form
Gel
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2016
Label revision date
May 29, 2018
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Lidocaine Hydrochloride 4 g/100 mL
Other brand names
Dosage form
Gel
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 2016
Label revision date
May 29, 2018
Manufacturer
Product Quest Mfg.
Registration number
part348
NDC root
64048-5002
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

You can use this medication for the temporary relief of pain and itching caused by various skin issues. It is effective for conditions such as sunburn, minor burns, insect bites, minor cuts, scrapes, and minor skin irritation. This means that if you experience discomfort from any of these common skin problems, this medication can help soothe your symptoms and provide some comfort.

Uses

You can use this medication for the temporary relief of pain and itching caused by various skin issues. It is effective for soothing discomfort from sunburn, minor burns, insect bites, minor cuts, scrapes, and minor skin irritation.

This product is designed to help you feel more comfortable when dealing with these common skin problems, allowing you to get back to your daily activities with less discomfort.

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 of age, it’s important to consult a physician (doctor) before using the medication. This will help ensure safety and proper care for younger children.

What to Avoid

There are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with this medication. Additionally, there are no explicit instructions indicating that you should not take or use this medication. Always consult with your healthcare provider for personalized advice and to ensure this medication is appropriate for your situation.

Side Effects

When using this product, it's important to remember that it is for external use only. Avoid getting it in your eyes; if that happens, rinse your eyes with water immediately. If your symptoms last longer than 7 days, you should stop using the product and consult your doctor. Additionally, be cautious not to apply it in large amounts, especially on raw or blistered skin.

Warnings and Precautions

This product is for external use only, so please avoid applying it to your eyes. If it accidentally gets into your eyes, rinse them with water immediately. It's important to stop using the product and consult your doctor if your symptoms last longer than 7 days. Additionally, be cautious not to use large amounts, especially on raw or blistered skin.

If you experience any unusual reactions or if your symptoms do not improve, make sure to reach out to your healthcare provider for guidance. Your safety is important, so always follow these precautions when using the product.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While there is no specific information available about the signs of overdose for this medication, general symptoms can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these signs, or if you are unsure, seek medical help right away.

In case of an overdose, contact your local emergency services or go to the nearest hospital. It's always better to be safe and get checked by a healthcare professional if you have any concerns about your health. Remember, timely intervention can make a significant difference.

Pregnancy Use

When it comes to using MAXIMUM STRENGTH BURN RELIEF ALOE GEL during pregnancy, there is currently no information available about its safety, recommended dosage, 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 product. They can help you understand any potential risks and guide you on the best options for your situation. Always prioritize your health and the health of your baby when considering any medication or treatment.

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

When using this medication for children, it's important to follow specific guidelines. For children aged 2 years and older, you can apply the medication to the affected area up to 3-4 times a day. However, if your child is under 2 years old, you should consult a physician (doctor) before using it. This ensures that the treatment is safe and appropriate for their age. Always prioritize your child's health by following these recommendations.

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 healthcare providers may not have tailored guidelines for elderly patients, which can be important given the unique health considerations that often come with aging.

If you or a loved one is an older adult considering this medication, it’s essential to discuss any potential risks and benefits with your healthcare provider. They can help determine the best approach based on individual health needs and circumstances.

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 there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations apply, but you should always consult your healthcare provider for personalized advice. They can help determine the best approach for your treatment and monitor your liver function as needed.

Make sure to keep your doctor informed about your liver health, as they may want to conduct regular liver function tests (which check how well your liver is working) to ensure your safety while using any medication.

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 your complete list of medications and any tests you may undergo. Your healthcare provider can help you understand how different treatments may work together and monitor your health appropriately.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 20°C to 25°C (68°F to 77°F). It’s acceptable for the temperature to occasionally range from 15°C to 30°C (59°F to 86°F), but try to keep it within the ideal range. Make sure to protect the product from light and always keep the container tightly closed when not in use.

Once you open the container, remember to discard any remaining product after use to maintain safety and effectiveness. Following these guidelines will help you handle the product safely and ensure its proper storage.

Additional Information

You should apply this medication topically to the affected area, using it no more than 3 to 4 times a day if you are an adult or a child aged 2 years and older. If the patient is under 2 years old, it's important to consult a physician before use. There are no additional details available regarding laboratory tests, abuse potential, or postmarketing experiences related to this medication.

FAQ

What is this product used for?

This product is used for the temporary relief of pain and itching due to sunburn, minor burns, insect bites, minor cuts, scrapes, and minor skin irritation.

How should I apply this product?

Adults and children 2 years and older should apply it to the affected area not more than 3-4 times a day. For children under 2 years of age, consult a physician.

Are there any warnings I should be aware of?

Yes, this product is for external use only. Avoid contact with eyes, and rinse with water if contact occurs. Stop use and ask a doctor if symptoms persist for more than 7 days.

Is there any information about using this product during pregnancy?

There is no information provided regarding the use of this product during pregnancy.

What should I do if symptoms persist?

You should stop using the product and ask your doctor if symptoms persist for more than 7 days.

How should I store this product?

Store at 20°C to 25°C (68°F to 77°F), protect from light, and keep the container tightly closed. Discard after opening.

Packaging Info

Below are the non-prescription pack sizes of Maximum Strength Burn Relief Aloe Gel (lidocaine hydrochloride 4.00%). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Maximum Strength Burn Relief Aloe Gel.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The product is identified by the SPL code 34089-3. No specific description details are provided in the text.

Uses and Indications

This drug is indicated for the temporary relief of pain and itching associated with sunburn, minor burns, insect bites, minor cuts, scrapes, and minor skin irritation.

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 per day. It is important to ensure that the application is performed with clean hands and that the affected area is properly prepared prior to administration.

For children under 2 years of age, it is advised to consult a physician before use to determine the appropriate course of action.

Contraindications

There are no contraindications listed for the use of this product. It is important to evaluate each patient's individual circumstances and medical history when considering treatment options.

Warnings and Precautions

The product is intended for external use only. Healthcare professionals should advise patients to avoid contact with the eyes during application. In the event of accidental contact, it is recommended to rinse the eyes thoroughly with water.

Patients should be instructed to discontinue use and consult a healthcare provider if symptoms persist for more than 7 days. Additionally, caution should be exercised to avoid the application of this product in large quantities, especially on raw surfaces or blistered areas, as this may lead to adverse effects.

No specific general precautions or laboratory tests are indicated for the safe use of this product.

Side Effects

Patients should be aware that this product is intended for external use only. It is crucial to avoid contact with the eyes; in the event of contact, the affected area should be rinsed with water immediately.

In clinical practice, if symptoms persist for more than 7 days, patients are advised to discontinue use and consult a healthcare professional. Additionally, caution is warranted regarding the application of this product in large quantities, especially over raw surfaces or blistered areas, as this may lead to adverse effects.

These warnings are essential for ensuring the safe and effective use of the product, and adherence to these guidelines is strongly recommended to minimize the risk of complications.

Drug Interactions

No specific drug interactions have been identified for this medication. Additionally, there are no reported interactions with laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Maximum Strength Burn Relief Aloe Gel (lidocaine hydrochloride 4.00%). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Maximum Strength Burn Relief Aloe Gel.
Details

Pediatric Use

Pediatric patients aged 2 years and older may apply the medication to the affected area no more than 3-4 times a day. For children under 2 years of age, it is advised to consult a physician prior to use.

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 MAXIMUM STRENGTH BURN RELIEF ALOE GEL during pregnancy. Consequently, the safety of this product in pregnant patients has not been established, and there are no known dosage modifications or special precautions recommended for use in this population. Healthcare professionals should consider the lack of data when advising women of childbearing potential and weigh the potential risks and benefits before recommending this product during pregnancy.

Lactation

There are no specific warnings or recommendations regarding the use of this product in nursing mothers. Additionally, there is no information available about the potential for excretion in breast milk or any associated risks to breastfed infants.

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 individuals with reduced kidney function, as the lack of information necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and 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 absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise, as the clinical presentation can vary depending on the substance involved. Common symptoms of overdose may include, but are not limited to, respiratory depression, altered mental status, cardiovascular instability, and gastrointestinal disturbances.

In the event of an overdose, immediate medical attention should be sought. Recommended actions include:

  1. Assessment: Conduct a thorough evaluation of the patient's clinical status, including vital signs and level of consciousness.

  2. Supportive Care: Provide supportive measures as necessary, which may include airway management, oxygen supplementation, and intravenous fluids.

  3. Decontamination: If appropriate and within a reasonable timeframe, consider gastrointestinal decontamination methods such as activated charcoal, provided the patient is alert and able to protect their airway.

  4. Symptomatic Treatment: Administer treatment directed at alleviating specific symptoms as they arise.

Healthcare professionals should consult local poison control centers or toxicology experts for guidance tailored to the specific circumstances of the overdose. Continuous monitoring and supportive care remain paramount in managing any overdose situation effectively.

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 use of the compound in these contexts.

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 the reach of children to prevent accidental ingestion or misuse. It is important for patients to understand the potential risks associated with improper access to the medication by young individuals. Providers should encourage patients to store the medication in a secure location and to be vigilant about monitoring its use.

Storage and Handling

The product is supplied in a container that must be kept tightly closed to maintain integrity. It should be stored at a temperature range of 20°C to 25°C (68°F to 77°F), with permissible excursions between 15°C to 30°C (59°F to 86°F). It is essential to protect the product from light to prevent degradation. Additionally, the product should be discarded after opening to ensure safety and efficacy.

Additional Clinical Information

The medication is administered topically, with a recommended application frequency of 3 to 4 times daily for adults and children aged 2 years and older. For children under 2 years of age, it is advised to consult a physician prior to use. There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Maximum Strength Burn Relief Aloe 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 Maximum Strength Burn Relief Aloe 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.

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.