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Dr. Blue

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This product has been discontinued

Active ingredient
Menthol 3.89 g/100 g
Other brand names
Dosage form
Gel
Route
Topical
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2003
Label revision date
September 26, 2014
Active ingredient
Menthol 3.89 g/100 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 2003
Label revision date
September 26, 2014
Manufacturer
Indiana Botanic Gardens
Registration number
part348
NDC root
10578-035

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Drug Overview

Pain Relieving Gel is a topical medication designed to provide temporary relief from minor aches and pains in your muscles and joints. It can be particularly helpful for discomfort associated with simple backaches, arthritis, bruises, and sprains. The gel works by delivering a cooling sensation that helps alleviate pain, making it a convenient option for managing everyday muscle and joint discomfort.

Uses

You can use this product for the temporary relief of minor aches and pains in your muscles and joints. It is effective for conditions such as simple backache, arthritis, bruises, and sprains. Additionally, it offers a cooling sensation that helps soothe discomfort.

Rest assured, there are no known teratogenic effects (which means it does not cause birth defects) associated with this product, making it a safer option for those concerned about such risks.

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 physician (doctor) before using the medication. This will help ensure safety and proper care for younger children. Always follow your healthcare provider's advice regarding the use of any medication.

What to Avoid

It's important to follow specific guidelines when using this product to ensure your safety. You should never heat or microwave it, and avoid using it near an open flame. Additionally, do not add it to hot water or any container when heating water, as this can cause splattering and lead to burns.

Make sure to keep it away from your eyes and do not apply it to wounds or damaged skin. If you need to cover the area where it's applied, avoid bandaging it tightly to prevent any complications. Following these instructions will help you use the product safely and effectively.

Side Effects

This product is intended for external use only. If your condition worsens, or if your symptoms last more than 7 days or improve and then return within a few days, you should stop using the product and consult a doctor. It's important to monitor your symptoms closely to ensure your safety and well-being.

Warnings and Precautions

This product is intended for external use only. If you accidentally swallow it, seek medical help or contact a Poison Control Center immediately.

You should stop using this product and consult your doctor if your condition worsens, if symptoms last longer than 7 days, or if your symptoms improve and then return within a few days. It's important to monitor your health and take these precautions seriously to ensure your safety.

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 medication during pregnancy, there is no specific information available about its safety or potential risks to you or your developing baby. The drug insert does not indicate whether the medication is contraindicated (not recommended) for pregnant individuals, nor does it mention any associated risks to the fetus. Additionally, there are no guidelines for dosage adjustments or special precautions for pregnant users.

Given this lack of information, it's essential to consult with your healthcare provider before using this medication if you are pregnant or planning to become pregnant. They can help you weigh the potential benefits and risks based on your individual circumstances.

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 are no known concerns about the product being passed into breast milk or any associated risks for your infant. This means you can use the product without worrying about its effects on your milk production or your baby's health.

Pediatric Use

When using this medication for children aged 2 years and older, you can apply it to the affected area no more than 3 to 4 times a day. If your child is under 2 years old, it's important to consult a physician (doctor) before use. Always keep the medication out of reach of children to prevent accidental ingestion. If your child swallows any of the medication, seek medical help or contact a Poison Control Center immediately.

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 wise to discuss any potential risks or concerns with your healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken.

Always keep in mind that older adults may have different responses to medications, so regular check-ins with your doctor can ensure safety and effectiveness.

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 be adjusted based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment is safe and effective, especially if you have any concerns about 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).

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 monitor your condition and make any necessary adjustments to your treatment plan.

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 remember that discussing your full list of medications and any lab tests with your healthcare provider is crucial. This way, you can avoid any potential issues and receive the best care tailored to your needs.

Storage and Handling

To ensure the safety and effectiveness of the product, make sure to use it only if the seal is unbroken. This indicates that the product has not been tampered with and is safe for use. Always handle the product with care to maintain its integrity and avoid any contamination.

If you notice that the seal is broken, do not use the product, and follow the appropriate disposal instructions. Keeping these guidelines in mind will help you use the product safely and effectively.

Additional Information

No further information is available.

FAQ

What is Pain Relieving Gel used for?

Pain Relieving Gel is used for temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, bruises, and sprains.

How does Pain Relieving Gel work?

It provides cooling pain relief for minor aches and pains in muscles and joints.

Who is the manufacturer of Pain Relieving Gel?

The manufacturer of Pain Relieving Gel is Dr. Blue.

How should I apply Pain Relieving Gel?

For adults and children 2 years of age and older, apply to the affected area not more than 3 to 4 times daily. Consult a physician for children under 2 years of age.

Are there any contraindications for using Pain Relieving Gel?

No specific contraindications are mentioned for Pain Relieving Gel.

What should I avoid while using Pain Relieving Gel?

Do not heat, microwave, or use near an open flame. Avoid contact with eyes and do not apply to wounds or damaged skin.

What should I do if my condition worsens while using Pain Relieving Gel?

Stop use and ask a doctor if your condition worsens or if symptoms persist for more than 7 days.

Is Pain Relieving Gel safe to use during pregnancy?

There is no specific information regarding the use of Pain Relieving Gel during pregnancy, and no contraindications are mentioned.

Can nursing mothers use Pain Relieving Gel?

There are no specific warnings or recommendations regarding the use of Pain Relieving Gel by nursing mothers.

What should I do if Pain Relieving Gel is swallowed?

If swallowed, get medical help or contact a Poison Control Center right away.

Is Pain Relieving Gel a controlled substance?

No, Pain Relieving Gel is not classified as a controlled substance.

What should I do if the seal on Pain Relieving Gel is broken?

Use Pain Relieving Gel only if the seal is unbroken.

Packaging Info

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

Packaging configurations for Dr. Blue.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Dr. Blue is a pain-relieving gel formulated for the temporary relief of minor aches and pains associated with muscles and joints. This topical preparation is designed to provide localized analgesic effects, facilitating comfort and mobility in affected areas.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains of muscles and joints associated with conditions such as simple backache, arthritis, bruises, and sprains. It provides cooling pain relief to alleviate discomfort in these areas.

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

Dosage and Administration

For adults and children aged 2 years and older, the recommended application is to the affected area not more than 3 to 4 times daily. It is important to ensure that the application is limited to the specified frequency to avoid potential adverse effects.

For children under 2 years of age, it is advised to consult a physician prior to use to determine the appropriate course of action and ensure safety.

Contraindications

Use of this product is contraindicated in the following situations:

Heating the product is prohibited, including microwaving and exposure to open flames, as these actions may lead to hazardous conditions. Additionally, the product should not be added to hot water or any container during the heating process due to the risk of splattering, which can result in burns.

Contact with eyes must be avoided, and the product should not be applied to wounds or damaged skin to prevent irritation or adverse reactions. Furthermore, tight bandaging of the area where the product is applied is contraindicated to ensure proper circulation and avoid complications.

Warnings and Precautions

For external use only. In the event of accidental ingestion, it is imperative to seek medical assistance or contact a Poison Control Center immediately.

Healthcare professionals should advise patients to discontinue use and consult a physician if the condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. Monitoring for these signs is essential to ensure patient safety and effective management of the condition.

Side Effects

For external use only. Patients should discontinue use and consult a doctor if the condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then occur again within a few days.

Drug Interactions

There are no specific drug interactions reported for this medication. Additionally, no laboratory test interactions have been identified in the available data. 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 Dr. Blue (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Dr. Blue.
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 physician prior to use.

It is important to keep the medication out of reach of children. In the event of accidental ingestion, medical assistance should be sought immediately, or contact a Poison Control Center for guidance.

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 this product in pregnant patients. The prescribing information does not indicate whether the product is contraindicated during pregnancy or outline any associated risks to the fetus. Additionally, there are no dosage modifications or special precautions recommended for use in pregnant individuals. Healthcare professionals should consider the lack of data when prescribing this product to women of childbearing potential and weigh the potential benefits against any unknown risks.

Lactation

There are no specific warnings or recommendations regarding the use of this product by nursing mothers. Additionally, there are no statements concerning the potential for excretion in breast milk or any associated risks to breastfed infants during lactation.

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 this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment. Regular monitoring of renal function is 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, as the clinical presentation can vary depending on the substance involved. Common symptoms of overdose may include, but are not limited to, altered mental status, cardiovascular instability, and respiratory distress.

In the event of an overdose, immediate medical attention should be sought. Supportive care is paramount, and healthcare providers should ensure that the patient is stabilized. This may involve maintaining airway patency, providing supplemental oxygen, and monitoring vital signs continuously.

If specific antidotes or treatments are available for the substance involved, they should be administered as per established protocols. Additionally, healthcare professionals should consider contacting a poison control center for further guidance on the management of the overdose.

Documentation of the incident, including the substance involved, the amount ingested, and the time of ingestion, is crucial for effective management and follow-up care.

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.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. Instruct patients that if the product is swallowed, they should seek medical help or contact a Poison Control Center immediately.

Patients should be informed to discontinue use and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days.

When using this product, it is essential to communicate the following precautions: patients should not heat or microwave the product, nor should they use it near an open flame. Additionally, they should avoid adding the product to hot water or any container while heating water, as this may cause splattering and result in burns.

Healthcare providers should also emphasize the importance of avoiding contact with the eyes and instruct patients not to apply the product to wounds or damaged skin. Furthermore, patients should be advised against tightly bandaging the area where the product is applied.

Storage and Handling

The product is supplied in configurations that require careful handling. It is essential to use the product only if the seal is unbroken to ensure its integrity and efficacy.

Storage conditions must be strictly adhered to, although specific temperature ranges and container requirements are not provided. It is advisable to store the product in a cool, dry place, away from direct sunlight and moisture, to maintain its quality. Special handling needs should be observed to prevent any compromise to the product's safety and effectiveness.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Dr. Blue, 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. Blue, 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.