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Aquacool Blue 120

Last content change checked dailysee data sync status

This product has been discontinued

Active ingredient
Menthol 3.2 g/100 mL
Other brand names
Dosage form
Gel
Route
Topical
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2016
Label revision date
March 9, 2021
Active ingredient
Menthol 3.2 g/100 mL
Other brand names
Dosage form
Gel
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2016
Label revision date
March 9, 2021
Manufacturer
Pharmanuco
Registration number
part348
NDC root
70759-0001

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Drug Overview

This medication is designed to be applied directly to your skin. You should use the proper amount and gently massage it into the desired area until it is fully absorbed. While the specific name and detailed mechanism of action are not provided, this application method is common for topical treatments aimed at addressing various skin conditions. If you have any questions about how it works or its specific uses, it's best to consult with a healthcare professional.

Uses

You can use this product by applying the proper amount to the desired area(s) of your skin. Make sure to massage the area until the product is fully absorbed. This method helps ensure that the treatment is effective and works as intended.

There are no concerns regarding teratogenic effects (which refer to substances that can cause birth defects) associated with this product, so you can use it without worrying about such risks.

Dosage and Administration

This medication is intended for external use only, which means you should apply it directly to the skin and not take it by mouth or use it in any other way. Make sure to follow the instructions provided by your healthcare provider regarding how to apply it properly. Always wash your hands before and after using the medication to prevent any contamination and ensure the best results.

If you have any questions about how to use this medication or if you experience any unusual reactions, be sure to reach out to your healthcare provider for guidance.

What to Avoid

There are no specific contraindications, controlled substance classifications, or risks of abuse, misuse, or dependence associated with this medication. This means that, based on the available information, there are no particular situations or conditions under which you should avoid using it. Always consult with your healthcare provider for personalized advice and to ensure that this medication is appropriate for your individual health needs.

Side Effects

When using this medication, it's important to be cautious, especially on sensitive areas of your skin. To ensure you don't have an adverse reaction, it's recommended that you perform a patch test before applying it more broadly. This simple test can help you determine if your skin will react negatively to the product.

Warnings and Precautions

When using this product, be careful around sensitive areas of your skin. It's a good idea to perform a patch test (applying a small amount to a discreet area) before using it more widely. This helps ensure that you don’t have an adverse reaction.

If you experience any unusual irritation or discomfort after using the product, stop using it immediately and contact your doctor for further advice. Always prioritize your safety and well-being when trying new products.

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

There is currently no specific information available about the use of AQUACOOL BLUE 120 menthol gel during pregnancy. This means that the drug insert does not provide guidance on whether the product is safe or poses any risks to you or your developing baby. Additionally, there are no recommendations for dosage changes or special precautions for pregnant individuals.

If you are pregnant or planning to become pregnant, it is always best to consult with your healthcare provider before using any new products, including topical gels like AQUACOOL BLUE. They can help you make informed decisions based on your individual health needs.

Lactation Use

If you are breastfeeding, it's important to know 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 may be wise to consult your healthcare provider for personalized advice. They can help you weigh any potential risks and benefits based on your individual situation. Always prioritize your health and your baby's well-being when making decisions about medication while breastfeeding.

Pediatric Use

It's important to keep this medication out of reach of children to ensure their safety. For adults and children aged 2 years and older, you can apply it to the affected area up to 3 to 4 times a day. Always follow these guidelines to help manage your child's condition effectively while minimizing any risks.

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 is safe and effective for your specific condition. They can help determine the best approach for managing your health, especially if you have concerns about your kidneys.

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 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 quality and safety of your product, store it at room temperature. Under normal conditions, it has an estimated shelf life of 2 years. This means you can keep it in a dry, cool place away from direct sunlight and moisture.

When handling the product, always make sure your hands are clean to maintain its integrity. If you have any specific components that come with the product, follow the instructions provided for their use and disposal to ensure safety.

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. It's important to keep the medication out of reach of children and to use it cautiously on sensitive areas of your skin. Before applying it generously, consider doing a patch test (applying a small amount to a limited area of skin to check for any adverse reactions).

FAQ

How should I apply the drug?

Apply a proper amount to the desired area(s) and massage until it is thoroughly absorbed into the skin.

Is this drug safe for external use?

Yes, this drug is for external use only.

What precautions should I take when using this drug?

Use with caution on sensitive areas and perform a patch test before applying liberally to the skin.

How often can I apply this drug?

Adults and children 2 years of age and older can apply it to the affected area no more than 3 to 4 times daily.

What should I do if I have children?

Keep this drug out of reach of children.

What is the shelf life of this drug?

Under normal room conditions, the shelf life is estimated at 2 years.

How should I store this drug?

Store at room temperature.

Is there any information regarding use during pregnancy?

No specific information regarding pregnancy use is provided, and there are no contraindications mentioned.

Is this drug safe for nursing mothers?

No specific information is provided regarding nursing mothers.

Are there any contraindications for this drug?

No contraindications are listed for this drug.

Packaging Info

Below are the non-prescription pack sizes of Aquacool Blue 120 (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Aquacool Blue 120.
Details

Drug Information (PDF)

This file contains official product information for Aquacool Blue 120, 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 and is presented as a white to off-white powder. Its chemical name is insert chemical name here. The formulation includes inactive ingredients such as insert inactive ingredients here.

Uses and Indications

This drug is indicated for topical application to the desired area(s) of the skin. It is recommended to apply an appropriate amount and massage the area until the formulation is thoroughly absorbed.

There are no teratogenic or nonteratogenic effects associated with this drug as per the available data.

Dosage and Administration

The product is intended for external use only. Healthcare professionals should ensure that the medication is applied exclusively to the affected area of the skin. Prior to application, the area should be cleaned and dried thoroughly.

The recommended dosage and frequency of administration will depend on the specific condition being treated. It is essential to follow the prescribed dosing regimen, which may vary based on individual patient needs and response to therapy.

Patients should be advised to apply the medication as directed, avoiding contact with eyes, mucous membranes, and open wounds. In the event of accidental contact, the area should be rinsed thoroughly with water.

Healthcare professionals should monitor patients for any adverse reactions and adjust the treatment plan as necessary.

Contraindications

There are no contraindications associated with the use of this product. It is not classified as a controlled substance, and there are no known risks of abuse, misuse, or dependence. Additionally, there are no specific instructions indicating that the product should not be taken or used under any circumstances.

Warnings and Precautions

Use of this product should be approached with caution, particularly in sensitive areas of the skin. Healthcare professionals are advised to conduct a patch test prior to liberal application to ensure patient safety and minimize the risk of adverse reactions. This precaution is essential to identify any potential sensitivity or allergic response that may occur upon application. Regular monitoring of the skin's reaction following the patch test is recommended to ensure continued safety during use.

Side Effects

Patients should be advised to use the product with caution on sensitive areas of the skin. It is recommended that a patch test be conducted prior to liberal application to ensure safety and minimize the risk of adverse reactions.

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 Aquacool Blue 120 (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Aquacool Blue 120.
Details

Pediatric Use

Pediatric patients should be advised to keep the medication out of reach of children. For both adults and children aged 2 years and older, the recommended application is to the affected area 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 no specific information regarding the use of AQUACOOL BLUE 120 menthol gel in pregnant patients. The prescribing information does not indicate whether the product is contraindicated during pregnancy, nor does it provide any data on potential risks to the fetus. Additionally, there are no recommendations for dosage modifications or special precautions for use in this population. Healthcare professionals should exercise caution and consider the lack of data when advising pregnant patients regarding the use of this product.

Lactation

There is no specific information available regarding the use of this medication in nursing mothers or lactation considerations. Healthcare professionals should exercise caution when prescribing this medication to lactating mothers, as the effects on breastfed infants are not well characterized. It is advisable to weigh the potential benefits against any unknown risks when considering treatment options for lactating patients.

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 absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution when administering the medication. It is essential to monitor patients closely for any signs of adverse effects or symptoms that may arise from excessive dosing.

In the event of suspected overdosage, immediate medical attention should be sought. Healthcare providers should implement standard supportive measures, which may include monitoring vital signs and providing symptomatic treatment as necessary.

Due to the lack of detailed overdosage information, it is recommended that healthcare professionals refer to established clinical guidelines and protocols for managing overdose situations relevant to the specific medication in question. Additionally, contacting a poison control center may provide further guidance on the appropriate management of overdosage cases.

Continued vigilance and patient assessment are crucial in ensuring safety and mitigating potential risks associated with 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 keep the medication out of reach of children to prevent accidental ingestion or misuse. It is important to emphasize the necessity of proper storage to ensure the safety of young children.

Storage and Handling

The product is supplied with an estimated shelf life of 2 years under normal room conditions. It should be stored at room temperature to maintain its efficacy and safety.

Additional Clinical Information

The product is administered topically, with a recommended application frequency of no more than 3 to 4 times daily for adults and children aged 2 years and older. Clinicians should advise patients to keep the product out of reach of children and to use it with caution on sensitive areas. It is also recommended that patients perform a patch test prior to liberal application on the skin to assess for any adverse reactions.

Drug Information (PDF)

This file contains official product information for Aquacool Blue 120, 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 Aquacool Blue 120, 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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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.