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Fruit of the Earth Cool Blue Aloe Mist Continuous

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Active ingredient
Lidocaine Hydrochloride 10 mg/1 g
Other brand names
Drug classes
Amide Local Anesthetic, Antiarrhythmic
Dosage form
Spray
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2014
Label revision date
October 18, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Lidocaine Hydrochloride 10 mg/1 g
Other brand names
Drug classes
Amide Local Anesthetic, Antiarrhythmic
Dosage form
Spray
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 2014
Label revision date
October 18, 2024
Manufacturer
Fruit Of The Earth, Inc.
Registration number
M017
NDC root
62217-095
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

This medication is designed to provide temporary relief from pain and itching caused by various skin issues, including sunburn, minor burns, minor cuts, scrapes, insect bites, and other minor skin irritations. It helps soothe discomfort and promotes a sense of relief when you experience these common skin problems.

If you find yourself dealing with any of these conditions, this product can be a helpful option to alleviate your symptoms and support your skin's healing process.

Uses

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, minor cuts, scrapes, insect bites, and other minor skin irritations.

This product is designed to help soothe discomfort and promote healing, making it a handy option for everyday skin mishaps.

Dosage and Administration

When using this medication, you can spray it onto the affected area of your skin up to 3 to 4 times a day. Make sure to hold the container about 4 to 6 inches away from your skin while applying. If you need to apply it to your face, it's best to spray it into your hand first and then gently apply it to your face.

If you are considering using this medication for a child under 2 years old, it's important to consult a doctor before proceeding. Always follow these guidelines to ensure safe and effective use of the product.

What to Avoid

It's important to use this product safely to avoid potential issues. You should not use it in large quantities, especially on raw or blistered skin, as this can lead to irritation. Additionally, never puncture or incinerate the container, as it is under pressure and could be dangerous. Make sure to store it in a cool place, keeping it away from temperatures above 120°F to ensure its effectiveness and safety.

Side Effects

This product is intended for external use only. You should stop using it and consult a doctor if your condition worsens, if your symptoms last longer than 7 days, or if your symptoms improve and then return within a few days. It's important to pay attention to these signs to ensure your safety and well-being.

Warnings and Precautions

This product is for external use only, so please avoid applying it to large areas of your skin, especially over raw or blistered surfaces. If you accidentally swallow the product, it’s important to seek medical help or contact a Poison Control Center right away.

You should stop using this product and call your doctor if your condition worsens, if your symptoms last longer than 7 days, or if your symptoms improve and then come back within a few days. Always prioritize your health and safety when using any medication.

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 this product during pregnancy, there is 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 product. They can help you understand any potential risks and make informed decisions that are best for you and your baby. Always prioritize open communication with your doctor regarding any medications or treatments during this important time.

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 it may pose to your infant.

As always, if you have any concerns or questions about using this product while breastfeeding, it's a good idea to consult with your healthcare provider for personalized advice.

Pediatric Use

If you have a child aged 2 years or older, you can use this medication by spraying it onto the affected area up to 3 to 4 times a day. However, if your child is under 2 years old, it’s important to consult with a doctor before using this product. Always ensure you follow these guidelines to keep your child safe and healthy.

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 is safe and effective for your specific condition. They can help you understand any necessary precautions or adjustments based on your kidney health.

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).

Before starting any new medication, including this one, you should discuss your liver health with your healthcare provider. They can help determine the best approach for your treatment and ensure your safety.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking. In this case, there are no specific drug interactions or laboratory test interactions noted, which means that this medication is generally considered safe to use alongside other treatments and tests. However, every individual is different, and your healthcare provider can help ensure that your overall treatment plan is safe and effective for you. Always feel free to ask questions or express any concerns you may have regarding your medications or tests.

Storage and Handling

To ensure the best use of your product, be mindful that it may stain some fabrics. It's important to handle it carefully to avoid any accidental spills or contact with clothing that could lead to staining. Always store the product in a safe place where it won't be knocked over or come into contact with materials that could absorb stains.

When disposing of any components, follow local guidelines to ensure safe and responsible disposal. Keeping these tips in mind will help you use the product effectively while minimizing any potential issues.

Additional Information

You can use this medication topically, which means you apply it directly to the skin. For adults and children aged 2 years and older, spray it onto the affected area no more than 3 to 4 times a day. Make sure to hold the container 4 to 6 inches away from your face when applying. If you need to apply it to your face, spray it into your hand first and then apply it. If the patient is under 2 years old, consult a doctor before use.

FAQ

What is this product used for?

This product is used for the temporary relief of pain and itching associated with sunburn, minor burns, minor cuts, scrapes, insect bites, and minor skin irritations.

How should I apply this product?

For adults and children 2 years of age and older, spray onto the affected area not more than 3 to 4 times daily. Hold the container 4 to 6 inches away from the face when applying.

What should I do if I have a child under 2 years of age?

If the patient is under 2 years of age, you should ask a doctor before use.

Are there any warnings I should be aware of?

This product is for external use only. Avoid spraying in the eyes and do not use in large quantities, especially over raw surfaces or blistered areas.

What should I do if the condition worsens or symptoms persist?

Stop use and ask a doctor if the condition worsens, symptoms persist for more than 7 days, or if symptoms clear up and occur again within a few days.

What should I do if I accidentally swallow this product?

If swallowed, seek medical help or contact a Poison Control Center immediately.

Can this product be used during pregnancy or while nursing?

The insert does not provide specific information regarding the use of this product during pregnancy or by nursing mothers.

Are there any specific storage instructions?

Do not store at temperatures above 120°F and do not puncture or incinerate the container, as it is under pressure.

Will this product stain fabrics?

Yes, this product may stain some fabrics.

Packaging Info

Below are the non-prescription pack sizes of Fruit of the Earth Cool Blue Aloe Mist Continuous (lidocaine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Fruit of the Earth Cool Blue Aloe Mist Continuous.
Details

Drug Information (PDF)

This file contains official product information for Fruit of the Earth Cool Blue Aloe Mist Continuous, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

The provided data does not specify the chemical name, physical characteristics, or inactive ingredients of the drug. Therefore, a detailed description cannot be formulated based on the available information. Further details are required to create a comprehensive description.

Uses and Indications

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

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

Dosage and Administration

Adults and children aged 2 years and older are instructed to spray the medication onto the affected area no more than 3 to 4 times daily. The container should be held 4 to 6 inches away from the face when applying to other areas.

For application to the face, it is recommended to spray the medication into the hand first, and then apply it to the affected area.

For children under 2 years of age, it is advised to consult a physician before use.

Contraindications

Use is contraindicated in the following situations:

Large quantities should not be applied, especially over raw surfaces or blistered areas, due to the potential for increased irritation or adverse effects. Puncturing or incinerating the product is contraindicated as the contents are under pressure, which may lead to hazardous situations. Additionally, storage at temperatures exceeding 120°F is contraindicated to prevent degradation of the product and ensure safety.

Warnings and Precautions

For external use only. It is imperative that this product is not applied in large quantities, especially on raw surfaces or blistered areas, to prevent potential adverse effects.

In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is advised.

Healthcare professionals should instruct patients to discontinue use and consult a physician if any of the following occur: the condition worsens, symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. These precautions are essential to ensure patient safety and effective management of their condition.

Side Effects

For external use only. Patients should discontinue use and consult a healthcare professional if the condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. These recommendations are crucial to ensure patient safety and to address any potential complications that may arise during treatment.

Drug Interactions

There are no specific drug interactions identified for this medication. Additionally, no laboratory test interactions have been reported. 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 Fruit of the Earth Cool Blue Aloe Mist Continuous (lidocaine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Fruit of the Earth Cool Blue Aloe Mist Continuous.
Details

Pediatric Use

Pediatric patients aged 2 years and older may use the product by spraying it onto the affected area no more than 3 to 4 times daily. For children under 2 years of age, it is advised to consult a doctor before use.

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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

The available prescribing information does not provide specific data regarding the use of this product during pregnancy. Consequently, healthcare professionals are advised to exercise caution when prescribing this product to pregnant patients. Due to the lack of safety concerns, dosage modifications, or special precautions outlined in the insert, the potential risks and benefits should be carefully considered on a case-by-case basis. Women of childbearing potential should be informed of the uncertainties surrounding the use of this product during pregnancy and encouraged to discuss any concerns with their healthcare provider.

Lactation

There are no specific warnings or recommendations regarding the use of this product by lactating 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 may not have specific dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. Therefore, healthcare professionals should exercise caution when prescribing to this population, as the absence of detailed guidance necessitates careful clinical judgment regarding the use of the medication in individuals with reduced kidney function. 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 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 from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

If the substance involved is known, specific antidotes or treatments may be indicated, and healthcare professionals should refer to established guidelines for the management of overdose related to that particular substance.

In all cases, contacting a poison control center or a medical toxicologist for guidance is recommended to ensure appropriate management and intervention.

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 question.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to seek medical help or contact a Poison Control Center immediately if the product is swallowed. It is important to instruct patients to avoid spraying the product in their eyes; if contact occurs, they should rinse their eyes with water to remove the substance.

Patients should be informed not to puncture or incinerate the container, as it is under pressure. Additionally, they should be cautioned against storing the product at temperatures exceeding 120°F to prevent potential hazards.

Healthcare providers should encourage patients to stop using the product and consult a doctor if their condition worsens or if symptoms persist for more than 7 days. Furthermore, patients should be advised to seek medical advice if their symptoms clear up and then reoccur within a few days.

Storage and Handling

The product is supplied in configurations that may include various packaging options. It is important to note that the product has the potential to stain certain fabrics, and appropriate precautions should be taken during handling to avoid contact with such materials.

For optimal storage, the product should be maintained at controlled room temperature. Specific temperature ranges and container requirements are not provided; however, it is advisable to store the product in a cool, dry place, away from direct sunlight and moisture. Special handling considerations should be observed to prevent any spillage or exposure to sensitive surfaces.

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. Patients should hold the container 4 to 6 inches away from the affected area during application. For children under 2 years of age, consultation with a physician is advised. When applying to the face, it is recommended to spray the product into the hand first before application.

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

Drug Information (PDF)

This file contains official product information for Fruit of the Earth Cool Blue Aloe Mist Continuous, 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 Fruit of the Earth Cool Blue Aloe Mist Continuous, 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.