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Dr Bump Gel 16

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Active ingredient
Menthol 24 g/120 g
Other brand names
Dosage form
Gel
Route
Topical
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2020
Label revision date
July 5, 2025
Active ingredient
Menthol 24 g/120 g
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 2020
Label revision date
July 5, 2025
Manufacturer
CA-BOTANA INTERNATIONAL
Registration number
M017
NDC root
35192-053

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Drug Overview

You can use this gel to help relieve pain in specific areas of your body. It is designed to be applied directly to the affected area, where you should massage it into the skin until it is fully absorbed. This method allows the gel to work effectively at the site of discomfort, providing you with targeted relief.

Uses

You can use this gel to help relieve pain in specific areas of your body. Simply apply a generous amount directly to the affected area and massage it into your skin until it is fully absorbed. This method allows the gel to work effectively where you need it most.

It's important to note that there are no reported teratogenic effects (which means it doesn't cause birth defects) or nonteratogenic effects associated with this gel. This makes it a safe option for pain relief without concerns about these specific risks.

Dosage and Administration

When using this topical massage gel, you can apply it directly to the skin where you feel discomfort. It's important to use the gel no more than four times a day. This means you can spread it out throughout your day, but be sure not to exceed the recommended number of applications.

To use the gel effectively, simply massage a small amount into the affected area. This will help provide relief from pain or discomfort. Always remember to wash your hands after applying the gel to avoid getting it in your eyes or on other sensitive areas.

What to Avoid

It's important to be aware of certain guidelines when using this medication. You should stop using it and consult your doctor if you notice any redness, irritation, or if your condition worsens. Additionally, if your symptoms persist for more than 7 days or clear up only to return within a few days, it's crucial to seek medical advice.

Currently, there are no specific contraindications, controlled substance classifications, or noted risks of abuse, misuse, or dependence associated with this medication. However, always prioritize your health and safety by following these instructions closely.

Side Effects

If you notice any redness or irritation while using this product, it's important to stop using it and consult your doctor. Additionally, if your symptoms worsen or do not improve after seven days, or if your symptoms seem to clear up only to return within a few days, seek medical advice.

Always keep this product out of reach of children. If it is swallowed, get medical help or contact a Poison Control Center immediately.

Warnings and Precautions

It's 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.

You should stop using the product and consult your doctor if you notice any redness, irritation, or if your condition worsens. Additionally, if your symptoms last more than 7 days or clear up only to return within a few days, it's essential to reach out to your healthcare provider for further guidance.

Overdose

It's important to keep this medication out of reach of children. If a child accidentally swallows it, you should seek medical help or contact a Poison Control Center immediately.

In case of an overdose, you may notice symptoms such as unusual drowsiness, confusion, or difficulty breathing. If you or someone else experiences these signs, it's crucial to get medical assistance right away. Always prioritize safety and act quickly in these situations.

Pregnancy Use

When it comes to using this product during pregnancy, there is no specific information available regarding its safety or potential risks to you or your developing baby. The insert does not indicate whether the product is contraindicated (not recommended) for pregnant individuals, nor does it mention any necessary dosage adjustments or special precautions for use during pregnancy.

As always, it's important to consult with your healthcare provider before using any medication or product while pregnant to ensure the best care for you and your baby.

Lactation Use

If you are breastfeeding or planning to breastfeed, 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 baby. Since the effects on nursing infants have not been thoroughly studied, it's best to exercise caution. Always prioritize your health and your baby's well-being by discussing any concerns with your healthcare provider.

Pediatric Use

It's important to keep this product out of reach of children to prevent accidental ingestion. If your child swallows any of it, seek medical help immediately or contact a Poison Control Center for guidance. Taking these precautions can help ensure your child's safety.

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 there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

It's always best to discuss your individual situation with your healthcare provider, who can offer personalized advice and ensure that any medications you take are safe and effective for you.

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 differently due to your liver health.

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver function and how it relates to your treatment. They can help ensure that your medication is safe and effective for you.

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 the medication may not have known conflicts with other drugs or tests. However, every individual is different, and your healthcare provider can help ensure that your treatment is safe and effective based on your unique health situation.

Always feel free to ask questions and share all the medications and supplements you are using, as well as any lab tests you may be undergoing. This way, you can work together to manage your health effectively.

Storage and Handling

To ensure the best performance of your product, it's important to store it in a cool, dry place. Protect it from excessive heat and direct sunlight, as these conditions can damage the product.

When handling the product, always do so with care to maintain its integrity. Following these simple guidelines will help ensure that your product remains safe and effective for use.

Additional Information

No further information is available.

FAQ

How should I use this topical analgesic gel?

Apply a generous amount of gel directly to the affected area and massage it into the skin until thoroughly absorbed. You can use it no more than 4 times daily.

Are there any contraindications for this product?

No contraindications are listed for this topical analgesic gel.

What should I do if I experience redness or irritation?

Stop use and ask a doctor if redness is present, irritation develops, conditions worsen, or symptoms persist for more than 7 days.

Is this product safe to use during pregnancy?

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

Can nursing mothers use this product?

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

What should I do if the product is swallowed?

Keep this product out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Are there any known drug interactions?

No specific drug interactions are mentioned for this topical analgesic gel.

How should I store this product?

Protect this product from excessive heat and direct sunlight.

Packaging Info

Below are the non-prescription pack sizes of Dr Bump Gel 16 (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Dr Bump Gel 16.
Details

Drug Information (PDF)

This file contains official product information for Dr Bump Gel 16, 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 topical treatment of localized pain. It is recommended to apply a generous amount of gel directly to the affected area and to massage it into the skin until thoroughly absorbed.

Limitations of Use: There are no known teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

The external topical analgesic should be applied as a massage gel to the affected area. The recommended dosing frequency is no more than four times daily. It is important to ensure that the gel is applied gently and evenly over the skin to maximize its analgesic effect. Healthcare professionals should advise patients to wash their hands after application, unless the hands are the area being treated.

Contraindications

There are no specific contraindications listed for this product. However, it is advised to discontinue use and consult a healthcare professional if any of the following occur: redness, irritation, worsening of conditions, or if symptoms persist for more than 7 days. Additionally, if symptoms resolve and then recur within a few days, medical advice should be sought.

Warnings and Precautions

It is imperative to keep this product out of reach of children. 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 presence of redness, the development of irritation, worsening of conditions, or if symptoms persist for more than 7 days. Additionally, if symptoms resolve and then recur within a few days, medical advice should be sought.

Side Effects

In clinical use, patients should be advised to keep the product out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

Patients are also instructed to discontinue use and consult a healthcare professional if any of the following occur: the presence of redness, the development of irritation, worsening of conditions, or if symptoms persist for more than seven days. Additionally, if symptoms resolve and then recur within a few days, it is advised to seek medical advice.

Drug Interactions

There are no specific drug interactions identified for the product, nor are there any noted interactions with laboratory tests. As such, no dosage adjustments or monitoring recommendations are necessary based on the available data.

Packaging & NDC

Below are the non-prescription pack sizes of Dr Bump Gel 16 (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Dr Bump Gel 16.
Details

Pediatric Use

Pediatric patients should be advised to keep this product out of reach of children. In the event that the product is swallowed, it is crucial to seek medical assistance or contact a Poison Control Center immediately.

Geriatric Use

There is no specific information available 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

Pregnant patients should be aware that no specific information regarding the use of this product during pregnancy is provided in the prescribing information. 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 the use of this product during pregnancy are mentioned. Healthcare professionals should consider the lack of data when advising women of childbearing potential and weigh the potential benefits against any unknown risks.

Lactation

Nursing mothers should consult a doctor before using this product. There is a potential for excretion in breast milk, and the effects on nursing infants are not well studied; therefore, caution is advised.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring of these patients.

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, it is imperative to keep the product out of reach of children. Should ingestion occur, immediate medical assistance is required. Healthcare professionals are advised to contact a Poison Control Center without delay to ensure appropriate management and intervention.

Prompt action is crucial in mitigating potential adverse effects associated with overdosage. The symptoms may vary depending on the specific product involved, and healthcare providers should be prepared to assess and manage any clinical manifestations that arise.

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 discontinue use of the product and consult a physician if they experience any redness, irritation, or if their condition worsens. Patients should also be informed that if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days, they should seek medical advice. It is important for patients to understand these guidelines to ensure their safety and the effectiveness of their treatment.

Storage and Handling

This product is supplied in various package configurations, with specific NDC numbers available upon request. It is essential to protect the product from excessive heat and direct sunlight to maintain its integrity and efficacy. Proper storage conditions should be ensured to prevent any degradation of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Dr Bump Gel 16, 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 Dr Bump Gel 16, 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.