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Publix Burn Relief

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This product has been discontinued

Active ingredient
Lidocaine Hydrochloride 0.5 g/100 g
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 2013
Label revision date
July 12, 2013
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Lidocaine Hydrochloride 0.5 g/100 g
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 2013
Label revision date
July 12, 2013
Manufacturer
Publix Super Markets Inc
Registration number
part348
NDC root
56062-711
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

Aloe Vera Gel is a soothing topical product designed to provide temporary relief from pain and itching. It is particularly effective for alleviating discomfort caused by sunburn, minor burns, cuts, scrapes, skin irritations, and insect bites. The gel contains lidocaine, which helps cool and relieve sunburn pain, making it a helpful option for soothing irritated skin.

This product is often labeled as "burn relief" and comes in an 8 oz (226 g) container, making it easy to apply when you need quick comfort for your skin.

Uses

You can use this medication for temporary relief of pain and itching. It is particularly helpful for soothing discomfort caused by sunburn, minor burns, cuts, scrapes, skin irritations, and insect bites. Whether you're dealing with a pesky bug bite or a minor burn, this product can provide the relief you need to feel more comfortable.

Dosage and Administration

If you are an adult or a child aged 2 years and older, you can apply the medication to the affected areas of your skin. It’s important to do this no more than 3 to 4 times a day to ensure safety and effectiveness.

However, if your child is under 2 years old, you should not use this medication without first consulting a doctor. Always make sure to follow these guidelines to help manage your condition effectively.

What to Avoid

It's important to use this medication responsibly. You should avoid using it in large quantities, especially on raw surfaces or blistered areas, as this can lead to complications. While there are no specific contraindications or concerns about abuse, misuse, or dependence associated with this medication, always follow the recommended guidelines to ensure your safety and well-being. If you have any questions or concerns, consult your healthcare provider for personalized advice.

Side Effects

This product is intended for external use only, so please avoid applying it in large amounts, especially on raw or blistered skin. While using it, be careful to keep it away from your eyes.

If your condition worsens or does not improve after 7 days, or if your symptoms clear up and then return within a few days, stop using the product and consult a doctor. Additionally, keep this product out of reach of children. 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 surfaces. Be careful to keep it away from your eyes to prevent irritation.

If your condition worsens or does not improve after 7 days of use, or if your symptoms clear up and then 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 seek assistance if you suspect an overdose has occurred.

Pregnancy Use

It’s important to note that there is currently no information available about the use of Publix Burn Relief Aloe Vera (lidocaine hydrochloride gel) during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions for pregnant individuals have not been established.

If you are pregnant or planning to become pregnant, it’s best to consult with your healthcare provider before using this product to ensure it is safe for you and your baby. Always prioritize open communication with your doctor regarding any medications or treatments you are considering during pregnancy.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to be aware that there is no specific information available regarding the effects of this medication on nursing mothers or lactation (the process of producing breast milk). Since there are no guidelines or data provided, it’s advisable to consult your healthcare provider for personalized advice and to discuss any potential risks or concerns related to your situation. Your healthcare provider can help you make informed decisions that prioritize both your health and your baby's well-being.

Pediatric Use

If your child is under 2 years old, it's important not to use this medication without consulting a doctor first. For children aged 2 years and older, you can apply the medication to the affected areas, but make sure to do this no more than 3 to 4 times a 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, it’s important to consult with a healthcare provider before starting the medication. 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 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 should be used if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your liver health. They can help determine the best course of action based on your individual situation.

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 drug interactions or laboratory test interactions associated with the medication. However, always ensure that your healthcare provider is aware of all the medications you are using, as this helps them provide the best care tailored to your needs.

By discussing your full medical history and any other treatments, you can help prevent potential issues and ensure your safety.

Storage and Handling

To ensure the best quality and safety of your product, store it at room temperature, away from direct light. It's important to keep the container tightly closed when not in use to prevent contamination and maintain its effectiveness. Once you open the container, be sure to discard it after use to avoid any potential risks associated with prolonged exposure to air or light. Following these simple steps will help you use the product safely and effectively.

Additional Information

You should apply this medication topically to the affected areas, 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 your child is under 2 years old, do not use this medication without consulting a doctor first.

FAQ

What is ALOEVERA GEL used for?

ALOEVERA GEL is used for the temporary relief of pain and itching, helping to soothe pain from sunburn, minor burns, cuts, scrapes, skin irritations, and insect bites.

How does ALOEVERA GEL work?

It cools and relieves sunburn pain with lidocaine, providing a soothing effect on the skin.

Who can use ALOEVERA GEL?

Adults and children 2 years of age and older can apply it to affected areas up to 3 to 4 times daily. Children under 2 years should not use it without consulting a doctor.

Are there any warnings for using ALOEVERA GEL?

Yes, it is for external use only, and you should avoid contact with eyes. Do not use in large quantities, especially over raw surfaces or blistered areas.

What should I do if my condition worsens while using ALOEVERA GEL?

Stop use and ask a doctor if your condition worsens or if symptoms persist for more than 7 days.

How should I store ALOEVERA GEL?

Store it at room temperature, protect it from light, and keep the container tightly closed. Discard after opening.

What should I do if ALOEVERA GEL is swallowed?

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

Are there any contraindications for ALOEVERA GEL?

No specific contraindications are mentioned, but it should not be used in large quantities over raw surfaces or blistered areas.

Packaging Info

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

Packaging configurations for Publix Burn Relief.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Aloe Vera Gel is formulated to provide cooling and relief from sunburn pain, enhanced with the local anesthetic lidocaine. The product is presented in a net weight of 8 ounces (226 grams).

Uses and Indications

This drug is indicated for the temporary relief of pain and itching associated with various dermatological conditions. It helps relieve and soothe pain from sunburn, minor burns, cuts, scrapes, skin irritations, and insect bites.

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 areas 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, the product should not be used unless directed by a physician. Healthcare professionals are advised to consult with a doctor for appropriate guidance in such cases.

Contraindications

The product should not be used in large quantities, particularly over raw surfaces or blistered areas, due to the potential for increased irritation or adverse effects in these conditions. No other specific contraindications have been identified.

Warnings and Precautions

This product is intended for external use only. It is imperative that users refrain from applying it in large quantities, especially on raw surfaces or blistered areas, to prevent potential adverse effects.

Care should be taken to avoid contact with the eyes during application. In the event that the condition worsens or if symptoms persist beyond 7 days, it is advised to discontinue use and consult a healthcare professional. Additionally, if symptoms resolve and then recur within a few days, medical advice should be sought.

To ensure safety, this product must be kept out of reach of children. In the case of accidental ingestion, immediate medical assistance should be obtained, or contact with a Poison Control Center is recommended.

Side Effects

Patients should be aware that this product is for external use only. It is important to avoid using it in large quantities, particularly over raw surfaces or blistered areas. During use, contact with the eyes should be avoided to prevent irritation.

In the event that the condition worsens or if symptoms persist for more than 7 days, patients are advised to stop use and consult a doctor. Additionally, if symptoms clear up and then recur within a few days, medical advice should be sought.

This product should be kept out of reach of children. If swallowed, it is crucial to seek medical help or contact a Poison Control Center immediately.

Drug Interactions

There are no reported drug interactions associated with the use of this medication. Additionally, no interactions with laboratory tests have been identified. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug interactions.

Packaging & NDC

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

Packaging configurations for Publix Burn Relief.
Details

Pediatric Use

Pediatric patients under 2 years of age should not use this medication; consultation with a healthcare professional is advised. For children aged 2 years and older, the recommended application is to the affected areas no more than 3 to 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

There is currently no information available regarding the use of Publix Burn Relief Aloe Vera (lidocaine hydrochloride gel) during pregnancy. This includes any safety concerns, dosage modifications, or special precautions that may be necessary for pregnant patients. Healthcare professionals should exercise caution and consider the lack of data when prescribing this medication to women of childbearing potential. It is advisable to weigh the potential benefits against any unknown risks to fetal outcomes.

Lactation

There is no specific information available regarding the use of this medication in nursing mothers or 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

There is no specific information regarding renal impairment, dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function provided in the insert. Healthcare professionals should exercise caution when prescribing to patients with renal impairment, as the absence of detailed guidance necessitates careful clinical judgment and monitoring.

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 ingested, healthcare professionals should advise patients or caregivers to seek medical help or contact a Poison Control Center without delay.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and evaluation are recommended to ensure patient safety and effective resolution 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 seek immediate medical assistance or contact a Poison Control Center if the product is swallowed. It is important to inform patients not to use the product in large quantities, especially on raw surfaces or blistered areas, to prevent potential complications.

Patients should be instructed to discontinue use and consult a doctor if their condition worsens or if symptoms persist for more than 7 days. Additionally, they should be made aware that if symptoms improve and then recur within a few days, they should also stop using the product and seek medical advice.

Furthermore, healthcare providers should emphasize the importance of avoiding contact with the eyes while using this product to prevent irritation or injury.

Storage and Handling

The product is supplied in a container that must be kept tightly closed to maintain its integrity. It should be stored at room temperature, away from direct light exposure to protect its quality. Once opened, the product should be discarded 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 doctor before 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 Publix Burn Relief, 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 Publix Burn Relief, 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.