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Burn with Aloe

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This product has been discontinued

Active ingredient
Lidocaine Hydrochloride 200 g/1 L
Other brand names
Dosage form
Spray
Route
Topical
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2014
Label revision date
July 24, 2014
Active ingredient
Lidocaine Hydrochloride 200 g/1 L
Other brand names
Dosage form
Spray
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2014
Label revision date
July 24, 2014
Manufacturer
Provision Medical
Registration number
part348
NDC root
69103-3500

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Drug Overview

This product is a burn spray designed to provide temporary relief from pain associated with minor burns. It contains aloe vera, which is known for its soothing properties, making it a helpful option for easing discomfort. The spray is washable and comes in a 2 fl. oz. (59.15 ml) container, making it convenient for use at home or on the go.

Manufactured by Provision Medical Products, this burn spray is marketed specifically for its pain-relieving benefits, helping you manage the discomfort that can come from minor burns effectively.

Uses

If you’re dealing with minor burns, this medication can provide temporary relief from the pain associated with those injuries. It’s designed to help ease your discomfort while your skin heals.

Rest assured, there are no known teratogenic effects (which means it doesn’t cause birth defects) or nonteratogenic effects associated with this medication. This makes it a safe option for managing pain from minor burns without additional concerns.

Dosage and Administration

When using burn spray, you should apply an even layer over the cleaned area of the skin that has been affected by a burn. 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 burn spray. They can provide guidance on the safest and most effective treatment 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 could lead to irritation or other complications. 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

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 a doctor if your condition worsens, persists for more than 7 days, or if it clears up and then returns. 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 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 comes back, stop using the product and consult your doctor. Additionally, if you accidentally swallow any of the product, seek medical help immediately or contact your local Poison Control Center.

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 your local Poison Control Center or going to the nearest emergency room.

Signs of an overdose can vary, but they may include unusual symptoms that are not typical for the medication. Always err on the side of caution—if you suspect an overdose, don’t wait for symptoms to appear; get help right away. Your health and safety are the top priority.

Pregnancy Use

There is currently no specific information available about the use of BURN WITH ALOE, which contains lidocaine hydrochloride, during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions for pregnant individuals have not been addressed in the drug insert.

If you are pregnant or planning to become pregnant, it is important 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, you can feel reassured that there are no specific warnings or recommendations regarding nursing mothers or lactation in the information provided. This means that, based on the available data, there are no known risks associated with breastfeeding while using this medication. However, it's always a good idea to consult with your healthcare provider if you have any concerns or questions about your specific situation.

Pediatric Use

If your child is under 2 years old, it's important to consult a physician (doctor) before using this burn spray. For children aged 2 years and older, you can apply the spray by spraying an even layer over the cleaned affected area. This can be done up to 3 to 4 times a day, but be sure to follow the recommended guidelines for safe use. Always keep an eye on your child's response to the treatment and consult a healthcare professional if you have any concerns.

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 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 plan is safe and effective for your specific situation. They can help determine the best approach based on your liver function and overall health.

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 may start. Open communication helps prevent any potential issues and supports your overall well-being.

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. Once you open the container, please remember to discard it after use to maintain safety and effectiveness. Following these simple steps will help you use the product safely and effectively.

Additional Information

You should apply the burn spray topically by spraying an even layer over the cleaned affected area. For adults and children aged 2 years and older, you can use it up to 3-4 times a day. If the patient is under 2 years old, it's important to consult a physician before use.

FAQ

What is BURN SPRAY used for?

BURN SPRAY is used for temporary pain relief associated with minor burns.

How should I use BURN SPRAY?

For adults and children 2 years of age and older, spray an even layer over the cleaned affected area not more than 3-4 times daily. For children under 2 years, consult a physician.

Are there any contraindications for using BURN SPRAY?

No specific contraindications are mentioned for BURN SPRAY.

What should I do if I accidentally get BURN SPRAY in my eyes?

If BURN SPRAY gets in your eyes, rinse thoroughly with water.

What precautions should I take when using BURN SPRAY?

Do not use BURN SPRAY in large quantities, especially over raw or blistered areas, and keep it out of reach of children.

What should I do if my condition worsens or does not improve?

Stop using BURN SPRAY and ask a doctor if your condition worsens or persists for more than 7 days.

Is BURN SPRAY safe for pregnant or nursing mothers?

There are no specific warnings or recommendations regarding the use of BURN SPRAY during pregnancy or lactation.

How should I store BURN SPRAY?

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

Packaging Info

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

Packaging configurations for Burn with Aloe.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

This burn spray, formulated with aloe vera, is designed to relieve pain associated with minor burns. It is presented in a 2 fl. oz. (59.15 ml) dosage form and is washable. The packaging is not child-resistant. This product is manufactured for Provision Medical Products, located in Palm Desert, CA 92211.

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

Adults and children aged 2 years and older should apply an even layer of the burn spray to the cleaned affected area, not exceeding 3 to 4 applications per day. For children under 2 years of age, it is recommended to consult a physician prior to use.

Contraindications

The product should not be applied in large quantities, particularly over raw or blistered areas, due to the potential for exacerbating irritation or injury. Additionally, application near the eyes is contraindicated; in the event of contact, the area should be rinsed thoroughly with water to prevent adverse effects.

Warnings and Precautions

For external use only. It is imperative that the product is not applied in large quantities, especially over 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, persists for more than 7 days, or if symptoms resolve and then return. 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 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 doctor if the condition worsens or persists for more than 7 days, or if the condition clears up and then returns. It is important to keep this product 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

There are currently no documented drug interactions associated with this medication. Additionally, there are no known interactions with laboratory tests. As such, no specific dosage adjustments or monitoring recommendations are necessary at this time.

Packaging & NDC

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

Packaging configurations for Burn with Aloe.
Details

Pediatric Use

Pediatric patients under 2 years of age should consult a physician prior to use. For children aged 2 years and older, the recommended dosage is to spray an even layer of burn spray over the cleaned affected area, not exceeding 3-4 applications 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 no specific information regarding the use of BURN WITH ALOE - lidocaine hydrochloride spray in pregnant patients. The prescribing information does not provide safety concerns, dosage modifications, or special precautions for use during pregnancy. Therefore, healthcare professionals should exercise caution when considering this medication for women of childbearing potential and weigh the potential benefits against any unknown risks to fetal outcomes. It is advisable to consult relevant clinical guidelines and consider alternative treatments when necessary.

Lactation

There are no specific warnings or recommendations regarding the use of this medication in nursing mothers. Additionally, there are no specific warnings or recommendations related to lactation. Healthcare professionals should consider the absence of data when advising lactating mothers on the use of this medication.

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 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. Healthcare professionals are advised to instruct patients or caregivers to seek medical help or contact the Poison Control Center without delay if the substance has been ingested.

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 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 reach of children to prevent accidental ingestion. In the event that the medication is swallowed, patients should be instructed to seek medical help immediately or contact the Poison Control Center for assistance. It is important for patients to understand the urgency of the situation and the necessary steps to take if an accidental ingestion occurs.

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 prevent degradation. Once opened, the product should be discarded to ensure safety and efficacy.

Additional Clinical Information

The product is administered topically, with the recommended application for adults and children aged 2 years and older being an even layer of burn spray applied to the cleaned affected area up to 3-4 times daily. For children under 2 years of age, it is advised to consult a physician prior to use.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Burn with Aloe, 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 Burn with Aloe, 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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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.