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Smooth Gator Head-Ezz Analgesic

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Active ingredient
Menthol 30 mg/1 mL
Other brand names
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2024
Label revision date
June 10, 2024
Active ingredient
Menthol 30 mg/1 mL
Other brand names
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2024
Label revision date
June 10, 2024
Manufacturer
Smooth Gator LLC
Registration number
M017
NDC root
70673-501

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Drug Overview

This medication is designed to provide temporary relief from minor aches and pains. It can be helpful for everyday discomforts, allowing you to feel more comfortable in your daily activities. If you're experiencing minor pain, this product may be a suitable option to consider for quick relief.

Uses

You can use this medication for the temporary relief of minor aches and pains. Whether you're dealing with a headache, muscle soreness, or other mild discomforts, this medication can help you feel better for a short period. It's important to remember that while it can provide relief, it is not intended for long-term use. Always consult with a healthcare professional if you have any questions or concerns about your symptoms.

Dosage and Administration

If you are an adult or a child who is at least two years old, you can apply this medication to the affected area up to three to four times a day. Make sure to follow this guideline to ensure the best results.

If your child is under two years old, it’s important to consult a physician (doctor) before using this medication. They can provide the best advice on how to proceed safely.

What to Avoid

You should avoid applying this medication to any wounds or damaged skin, as it can cause further irritation or complications. Additionally, do not bandage the area tightly, as this can restrict blood flow and lead to other issues. Always follow these guidelines to ensure your safety and the effectiveness of the treatment.

Side Effects

It's important to be aware of some potential adverse reactions when using this product. It is meant for external use only, so avoid getting it in your eyes. If your symptoms last longer than seven days, you should stop using it and consult your doctor.

Keep this product out of reach of children. If it is swallowed, seek medical advice immediately. Additionally, do not apply it to wounds or damaged skin, and avoid wrapping the area tightly with a bandage.

Warnings and Precautions

This product is intended for external use only, so please avoid applying it to your eyes. If you accidentally swallow it, be sure to consult your doctor right away. It's important not to use this product on wounds or damaged skin, and avoid wrapping the area tightly after application.

If your symptoms last longer than seven days, stop using the product and reach out to your physician for further advice. Always prioritize your health and safety by following these guidelines.

Overdose

If you or someone you know has swallowed too much of this medication, it’s important to consult a physician right away. Overdosing can lead to serious health issues, and getting professional help is crucial.

Signs of an overdose may include unusual symptoms that can vary depending on the medication. If you notice any concerning changes in behavior or health, don’t hesitate to seek immediate medical attention. Always prioritize safety and reach out to a healthcare provider if you suspect an overdose.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the drug insert does not provide specific information about the use of this product during pregnancy. There are no warnings about whether it is safe or unsafe for you or your developing baby, and no dosage changes or special precautions are mentioned for pregnant individuals.

As always, it's best to consult with your healthcare provider before using any medication during pregnancy to ensure the safety of both you and your baby.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to talk to your doctor before using this product. There is a possibility that it could be passed into your breast milk, and the effects on your nursing infant are not fully understood. Taking this precaution can help 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 two years and older, you can apply it to the affected area up to three to four times a day. However, if your child is under two years old, you should consult a physician (doctor) before using the medication to ensure it's safe for them. Always prioritize your child's health and seek professional advice when needed.

Geriatric Use

While there is no specific information about how this medication should be used by older adults, it’s important to approach any new treatment with caution. If you or a loved one is an older adult, it’s always a good idea to discuss any medications with a healthcare provider. They can help ensure that the treatment is safe and appropriate, considering any unique health needs or conditions that may be present.

Since there are no dosage adjustments or special precautions mentioned for elderly patients, your healthcare provider will be the best resource for personalized advice. Always keep them informed about all medications being taken to avoid potential interactions and to ensure the best care.

Renal Impairment

If you have kidney problems, it's important to know that there are no specific guidelines, dosage adjustments, or monitoring requirements mentioned for your condition in the provided information. This means that the standard recommendations for the medication may apply to you without any special considerations. However, it's always best to discuss your individual health situation with your healthcare provider, as they can offer personalized advice and ensure your safety while using any medication.

Hepatic Impairment

If you have liver problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations apply, and there are no special monitoring or precautions outlined for patients with liver impairment.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe for your liver health. They can provide guidance tailored to your specific 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 performance of your product, store it at room temperature. This means keeping it in a place that is neither too hot nor too cold, typically between 68°F and 77°F (20°C to 25°C).

When handling the product, make sure to do so with clean hands and in a clean environment to maintain its safety and effectiveness. Always follow any specific instructions provided with the product for optimal use.

Additional Information

You should apply this medication topically to the affected area, using it no more than three to four times a day if you are an adult or a child aged two years or older. If the patient is under two years of age, it's important to consult a physician before use. There are no additional details available regarding laboratory tests, abuse potential, or patient counseling.

FAQ

What is the primary use of this drug?

This drug is indicated for the temporary relief of minor aches and pains.

How should I apply this drug?

Adults and children two years of age or older should apply it to the affected area no more than three to four times daily. Children under two years of age should consult a physician.

Are there any contraindications for using this drug?

Yes, do not apply it to wounds or damaged skin, and do not bandage tightly.

What precautions should I take while using this drug?

For external use only, avoid contact with eyes, and if symptoms persist for more than seven days, discontinue use and consult a physician.

Is this drug safe to use during pregnancy?

The drug insert does not provide specific information regarding use during pregnancy, and there are no contraindications mentioned.

Can nursing mothers use this drug?

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

What should I do if I accidentally swallow this drug?

If swallowed, consult a physician immediately.

How should I store this drug?

Store the drug at room temperature.

Packaging Info

Below are the non-prescription pack sizes of Smooth Gator Head-Ezz Analgesic (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Smooth Gator Head-Ezz Analgesic.
Details

Drug Information (PDF)

This file contains official product information for Smooth Gator Head-Ezz Analgesic, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

The product is identified by the SPL code 34089-3. No additional specific description details are provided in the available data.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains. There are no teratogenic or nonteratogenic effects associated with its use.

Dosage and Administration

For adults and children aged two years and older, the recommended application is to the affected area not more than three to four times daily. It is important to ensure that the application is limited to the specified frequency to avoid potential adverse effects.

For children under two years of age, it is advised to consult a physician prior to use to determine the appropriate course of action and ensure safety.

Contraindications

Application of this product is contraindicated on wounds or damaged skin due to the potential for adverse effects and impaired healing. Additionally, it is contraindicated to apply a tight bandage over the area of application, as this may lead to complications such as restricted blood flow or increased local irritation.

Warnings and Precautions

For external use only. It is imperative to avoid contact with the eyes to prevent irritation or injury. In the event that symptoms persist for more than seven days, the product should be discontinued, and a physician should be consulted for further evaluation and management.

In cases of accidental ingestion, immediate consultation with a physician is recommended to address potential complications. The product should not be applied to wounds or damaged skin, as this may exacerbate irritation or lead to adverse effects.

Additionally, care should be taken to avoid tight bandaging of the area where the product is applied, as this may interfere with proper healing and increase the risk of localized reactions.

Side Effects

Patients should be aware that the product is for external use only and must avoid contact with the eyes. In the event that symptoms persist for more than seven days, it is advised to discontinue use and consult a physician.

Additionally, it is crucial to keep the product out of reach of children. If the product is swallowed, patients should seek medical advice immediately. The product should not be applied to wounds or damaged skin, and it is important not to bandage the area tightly after application.

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 Smooth Gator Head-Ezz Analgesic (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Smooth Gator Head-Ezz Analgesic.
Details

Pediatric Use

Pediatric patients aged two years and older may apply the medication to the affected area up to three to four times daily. For children under two years of age, it is recommended to consult a physician 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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population, given the lack of targeted data.

Pregnancy

The available data regarding the use of this product during pregnancy is limited, as no specific information is provided in the drug insert. There are no statements indicating whether the product is contraindicated in pregnancy or any associated risks to the fetus. Additionally, no dosage modifications or special precautions regarding use during pregnancy are mentioned. Healthcare professionals should consider the lack of data when prescribing this product to pregnant patients and weigh the potential benefits against any unknown risks. Women of childbearing potential should be counseled on the importance of informing their healthcare provider if they become pregnant or plan to become pregnant while using this product.

Lactation

Lactating mothers should consult a physician before using this product. There is a potential for excretion in breast milk, and the effects on a nursing infant are not known.

Renal Impairment

There is no information available regarding renal impairment, including dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to patients with renal impairment.

Hepatic Impairment

There is no information available regarding the use of this medication in patients with hepatic impairment. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions specified for individuals with compromised liver function. Healthcare professionals should exercise clinical judgment when considering the use of this medication in patients with liver problems, as the absence of specific guidance necessitates careful evaluation of the patient's overall health status and liver function.

Overdosage

In the event of an overdosage, it is imperative that healthcare professionals take immediate action. If the product is ingested, the first step is to consult a physician for further evaluation and management.

Potential symptoms of overdosage may vary depending on the specific circumstances and the individual’s health status. Therefore, it is crucial to monitor the patient closely for any adverse effects that may arise.

Management of overdosage should be guided by the physician's recommendations, which may include supportive care and symptomatic treatment as necessary. Prompt medical attention is essential to mitigate any 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 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.

Patient Counseling

Healthcare providers should advise patients to consult a physician immediately if the product is swallowed. It is important to emphasize that the product should not be applied to wounds or damaged skin, as this may lead to adverse effects. Additionally, patients should be instructed not to bandage the area tightly after application, as this could interfere with the product's effectiveness and safety.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at room temperature to maintain its integrity and efficacy. No special handling requirements are noted; however, standard precautions should be observed to ensure optimal storage conditions.

Additional Clinical Information

The medication is administered topically, with a recommended application frequency of three to four times daily for adults and children aged two years and older. For children under two years of age, it is advised to consult a physician 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 Smooth Gator Head-Ezz Analgesic, 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 Smooth Gator Head-Ezz Analgesic, 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.