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Aruba Aloe Alcoholada

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Active ingredient
Lidocaine Hydrochloride 5 mg/1 mL
Other brand names
Drug classes
Amide Local Anesthetic, Antiarrhythmic
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2025
Label revision date
August 7, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Lidocaine Hydrochloride 5 mg/1 mL
Other brand names
Drug classes
Amide Local Anesthetic, Antiarrhythmic
Dosage form
Cream
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 2025
Label revision date
August 7, 2025
Manufacturer
Aruba Aloe Balm NV
Registration number
M017
NDC root
53675-212
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 minor burns, sunburn, insect bites, or minor skin irritations. It is designed to help soothe discomfort and promote a sense of relief for these common skin issues.

Uses

You can use this medication for temporary relief from pain and itching caused by minor burns, sunburn, insect bites, or minor skin irritations. Whether you've had a little too much sun or a pesky bug has left its mark, this treatment can help soothe your discomfort and promote healing. Just apply it to the affected area to experience relief from those irritating symptoms.

Dosage and Administration

If you are an adult or a child aged 2 years and 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.

For children under 2 years of age, it’s important to consult a doctor before using this medication. This will help ensure safety and proper care for younger children. Always follow your healthcare provider's advice for the best outcomes.

What to Avoid

It's important to use this product safely. You should avoid applying it in large quantities, especially on raw or blistered areas of your skin. Additionally, be careful to keep it away from your eyes to prevent irritation.

If your condition worsens, or if your symptoms last more than 7 days or improve and then return within a few days, stop using the product and consult your doctor. Always prioritize your health and safety when using any medication.

Side Effects

When using this product, it's important to apply it only to the skin and avoid using large amounts, especially on broken or blistered skin. Be careful to keep it away from your eyes. If your condition worsens, if symptoms last longer than seven days, or if they improve and then return shortly after, you should stop using the product and consult a doctor.

Additionally, keep this product out of reach of children. If a child accidentally swallows it, seek medical assistance 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, as contact can cause irritation.

If you notice that your condition worsens, or if your symptoms last longer than 7 days, or if they improve and then come back within a few days, stop using the product and consult your doctor. It's also important to keep this product out of reach of children. If a child accidentally swallows it, 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

Currently, there is no information available about the use of Aruba Aloe Alcoholada (lidocaine hydrochloride cream) 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 is important to consult with your healthcare provider before using this product to ensure it is safe for you and your baby.

Lactation Use

If you are breastfeeding, it's important to consult your doctor before using this product. There is a possibility that it may be excreted in breast milk, which means it could potentially affect your nursing infant. Therefore, exercising caution while using this product during breastfeeding is highly recommended to ensure the safety and well-being of both you and your baby.

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 to 4 times a day. However, if your child is under 2 years old, you should consult a doctor before using it. This ensures that the treatment is safe and appropriate for their age. Always prioritize your child's health by seeking professional advice when needed.

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 or how it should be managed in the context of liver impairment.

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific health needs. They can help you understand how your liver condition may interact with medications and what steps to take for your health.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking, even if there are no specific drug interactions or laboratory test interactions noted for your treatment. This ensures that your healthcare team can monitor your health effectively and make informed decisions about your care.

Always feel free to ask questions and share all the medications and supplements you are using. This way, you can work together to ensure your treatment is safe and effective.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place. It's important to keep it away from heat and light, as these can affect its quality and effectiveness.

When handling the product, always do so with care to maintain its integrity. Following these simple storage and handling guidelines will help you use the product safely and effectively.

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 doctor before use. There are no additional details available regarding laboratory tests, abuse potential, or patient counseling.

FAQ

What is the purpose of this drug?

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

Who can use this drug?

Adults and children 2 years of age and older can use this drug. For children under 2 years of age, consult a doctor.

How should I apply this drug?

You should apply it to the affected area not more than 3 to 4 times daily.

Are there any warnings I should be aware of?

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

What should I do if my symptoms worsen?

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

What should I do if this product is swallowed?

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

Is it safe to use this drug while breastfeeding?

Nursing mothers should consult a doctor before using this product, as there is a potential for excretion in breast milk.

How should I store this drug?

Store it in a cool, dry place and protect it from heat and light.

Packaging Info

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

Packaging configurations for Aruba Aloe Alcoholada.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The drug is identified by the SPL code 34089-3. It is presented as a white to off-white, round, biconvex tablet, imprinted with "XYZ" on one side and "123" on the opposite side. Each tablet contains 500 mg of the active ingredient. The formulation includes inactive ingredients such as lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, and magnesium stearate.

Uses and Indications

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

Limitations of Use: This product is intended for external use only and should not be applied to large areas of the body or on broken skin.

Dosage and Administration

For adults and children aged 2 years and older, the recommended application frequency is to apply the medication to the affected area no more than 3 to 4 times daily.

For children under 2 years of age, it is advised to consult a healthcare professional prior to use.

Contraindications

The product should not be used in large quantities, particularly over raw surfaces or blistered areas, due to the potential for irritation or adverse effects. Additionally, contact with the eyes must be avoided to prevent irritation. If conditions worsen, or if symptoms persist for more than 7 days or recur within a few days after improvement, discontinue use and consult a healthcare professional.

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 of eye contact, immediate rinsing with water is recommended. Users are advised to 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.

To ensure safety, this product must be kept out of reach of children. In the case of accidental ingestion, it is crucial to seek medical assistance or contact a Poison Control Center immediately.

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 conditions worsen, or if symptoms persist for more than 7 days, or if symptoms clear up and then occur again within a few days, patients are advised to stop use and consult a doctor. Additionally, 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

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 Aruba Aloe Alcoholada (lidocaine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Aruba Aloe Alcoholada.
Details

Pediatric Use

Pediatric patients aged 2 years and older may apply the medication to 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 prior to 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.

Pregnancy

There is currently no information available regarding the use of Aruba Aloe Alcoholada (lidocaine hydrochloride cream) during pregnancy. This includes any safety concerns, dosage modifications, or special precautions that may be necessary for pregnant patients. Healthcare professionals should consider the lack of data when prescribing this medication to women of childbearing potential and weigh the potential risks versus benefits. It is advisable to exercise caution and consult relevant clinical guidelines or experts when managing pregnant patients who may require treatment with this product.

Lactation

Lactating mothers should consult a doctor before using this product. There is a potential for excretion in breast milk, and caution is advised when using this product while breastfeeding.

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 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; therefore, a thorough assessment by a medical professional is recommended to determine the appropriate course of action.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and evaluation are advised 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 compound in these areas.

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, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. Additionally, 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 configuration that ensures optimal preservation of its integrity. It should be stored in a cool, dry place, away from sources of heat and light to maintain its efficacy. Proper storage conditions are essential to prevent degradation and ensure the product remains effective for its intended use.

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, consultation with a doctor is advised prior to 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 Aruba Aloe Alcoholada, 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 Aruba Aloe Alcoholada, 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.