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External Analgesic Cream with Menthol 5%

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Active ingredient
Menthol 5 g/100 g
Other brand names
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2025
Label revision date
October 2, 2025
Active ingredient
Menthol 5 g/100 g
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 2025
Label revision date
October 2, 2025
Manufacturer
BLOOMWELL GARDENS LLC
Registration number
M017
NDC root
85284-010

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Drug Overview

This medication is designed to provide temporary relief from minor aches and pains in your muscles and joints. It can be helpful for conditions such as simple backache, arthritis, strains, bruises, and sprains. If you're experiencing discomfort from these common issues, this drug may be a suitable option to help ease your pain.

Uses

If you're dealing with minor aches and pains in your muscles and joints, this medication can help provide temporary relief. It's effective for discomfort associated with simple backaches, arthritis, strains, bruises, and sprains.

You can rely on this treatment to ease your pain and get you back to your daily activities. Remember, it's designed for short-term use to help you feel more comfortable.

Dosage and Administration

To use this medication effectively, start by cleaning the affected area with mild soap and warm water. After cleaning, gently pat the area dry. You should then apply a thin, even layer of the medication to the affected area. This can be done up to 3 to 4 times each day.

If you are using this medication for a child under 12 years old, it’s important to consult a doctor before proceeding. They can provide guidance on the appropriate use and dosage for younger patients.

What to Avoid

It's important to be aware of certain situations where you should not use this product. First, if you are allergic to menthol or any other ingredient in this product, you should avoid using it entirely. Additionally, do not apply it to wounds or damaged skin, especially when using a heating pad, as this can lead to further irritation or complications.

By following these guidelines, you can help ensure your safety and the effectiveness of the product. If you have any concerns or questions about its use, please consult with a healthcare professional.

Side Effects

This product is intended for external use only. If you notice that your condition worsens, or if your symptoms last longer than 7 days, it's important to stop using the product and consult a doctor. Additionally, if your symptoms improve but then return within a few days, you should also seek medical advice.

Warnings and Precautions

This product is for external use only, so please avoid applying it to any wounds or damaged skin, especially if you are using a heating pad. Keep it out of reach of children, and if it is swallowed, seek medical help or contact a Poison Control Center immediately. Additionally, do not use this product if you are allergic to menthol or any of its ingredients.

You should stop using this product and consult your doctor if your condition worsens, if your symptoms last longer than 7 days, or if your symptoms improve and then return within a few days. Always prioritize your health and safety by following these guidelines.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, it's always important to be aware of the potential risks associated with taking more than the recommended dose. If you suspect an overdose, look out for any unusual symptoms or changes in your health.

In the event of an overdose, it is crucial to seek immediate medical attention. You can contact your healthcare provider or go to the nearest emergency room. If you experience severe symptoms, such as difficulty breathing, confusion, or loss of consciousness, call emergency services right away. Always remember to keep medications out of reach of children and follow the prescribed dosage to ensure your safety.

Pregnancy Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using this medication. They can provide guidance on whether it’s safe for you and your baby. Always prioritize your health and the health of your child by seeking expert advice.

Lactation Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using any medication. This ensures that you understand any potential risks and can make informed decisions about your health and the health of your baby. Always prioritize open communication with your doctor regarding your breastfeeding journey.

Pediatric Use

If you have a child under 12 years old, it's important to consult a doctor before using this medication. This ensures that the treatment is safe and appropriate for their age and health needs. Always prioritize your child's well-being by seeking professional guidance when it comes to their medication.

Geriatric Use

While there is no specific information available about the use of this medication in 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. They can monitor for any potential side effects and make recommendations based on individual health status. Always prioritize open communication with your healthcare team to ensure the best outcomes.

Renal Impairment

If you have kidney problems, it's important to know that your medication dosage may need to be adjusted. This is because renal impairment can affect how your body processes certain drugs. Your healthcare provider will likely monitor your renal function tests regularly to ensure your kidneys are working properly.

If you have decreased creatinine clearance (a measure of kidney function), your doctor may recommend a reduced dose of your medication to avoid potential side effects. Always communicate openly with your healthcare team about your kidney health to ensure safe and effective treatment.

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 discuss any concerns regarding your liver health and medication use. They can help ensure that you receive the safest and most effective treatment based on your individual needs.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you. Always share your complete list of medications and any recent lab tests to avoid any potential issues. Your health and safety should always come first.

Storage and Handling

To ensure the safety and effectiveness of your product, store it in a cool, dry place at a temperature between 15–30°C (59–86°F). It's important to protect it from excessive moisture and direct sunlight, as these can affect its quality. Always keep the original carton, as it contains important labeling information that you may need.

Additionally, please remember that the product is flammable, so keep it away from any fire or flame to prevent accidents. By following these simple storage and handling guidelines, you can help maintain the product's integrity and safety.

Additional Information

No further information is available.

FAQ

What is the drug used for?

The drug is used for the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains.

How should I apply the drug?

For adults and children 12 years and older, clean the affected area with mild soap and warm water, pat dry, and apply a thin, even layer not more than 3 to 4 times daily.

What should I do if I am under 12 years old?

If you are under 12 years old, consult a doctor before use.

Are there any contraindications for this drug?

Do not use this drug if you are allergic to menthol or any ingredient in the product.

Can I use this drug on wounds or damaged skin?

No, do not use this drug on wounds or damaged skin, especially with a heating pad.

What should I do if my condition worsens?

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

What precautions should I take?

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

Is it safe to use if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, ask a health professional before use.

How should I store the drug?

Store the drug at 15–30°C (59–86°F), protect it from excessive moisture and direct sunlight, and keep the carton for full labeling.

Is the drug flammable?

Yes, the drug is flammable; keep it away from fire or flame.

Packaging Info

Below are the non-prescription pack sizes of External Analgesic Cream with Menthol 5% (menthol 5%). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for External Analgesic Cream with Menthol 5%.
Details

Drug Information (PDF)

This file contains official product information for External Analgesic Cream with Menthol 5%, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

No description information is available for the specified drug.

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, strains, bruises, and sprains.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Adults and children 12 years and older should begin by cleaning the affected area with mild soap and warm water, followed by gentle patting to dry the skin. A thin, even layer of the medication should then be applied to the affected area, ensuring that it is not applied more than 3 to 4 times daily.

For children under 12 years of age, it is recommended to consult a doctor prior to use to determine appropriate treatment and dosage.

Contraindications

Use of this product is contraindicated in individuals with a known allergy to menthol or any other ingredient contained in the formulation.

Additionally, application on wounds or damaged skin in conjunction with a heating pad is contraindicated due to the potential for exacerbating injury or irritation.

Warnings and Precautions

For external use only. 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 a Poison Control Center without delay.

General precautions must be observed when using this product. It should not be applied to wounds or damaged skin, particularly in conjunction with a heating pad. Additionally, individuals with a known allergy to menthol or any other ingredient contained in this formulation should refrain from use.

Healthcare professionals should advise patients to discontinue use and consult a physician if any of the following occur: the condition worsens, symptoms persist beyond 7 days, or symptoms resolve only to reappear within a few days.

In cases of ingestion, it is crucial to seek emergency medical help or contact a Poison Control Center immediately.

Side Effects

For external use only. Patients should stop 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 currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

Below are the non-prescription pack sizes of External Analgesic Cream with Menthol 5% (menthol 5%). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for External Analgesic Cream with Menthol 5%.
Details

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional prior to use. It is important to assess the appropriateness of treatment and dosage for this age group, as specific recommendations may vary based on individual health needs and conditions.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to evaluate the potential risks and benefits associated with the use of this drug during pregnancy and lactation. Healthcare providers should consider the available data and individual patient circumstances when advising on the use of this medication in these populations.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding the excretion of this medication in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

Renal impairment may necessitate dosage adjustments for patients with reduced kidney function. It is important to monitor renal function tests in these patients to ensure safety and efficacy. Additionally, a reduced dose should be considered for patients with decreased creatinine clearance to mitigate the risk of adverse effects associated with impaired renal function.

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

There is currently no specific information available regarding overdosage for this medication. Healthcare professionals are advised to monitor patients closely for any unusual symptoms or adverse effects that may arise. In the event of suspected overdosage, it is recommended to initiate supportive care and symptomatic treatment as necessary.

Healthcare providers should consider contacting a poison control center or a medical toxicologist for guidance on management strategies tailored to the individual case. Continuous assessment of the patient's clinical status is essential to ensure appropriate interventions are implemented promptly.

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 use of the compound in these contexts.

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. Instruct patients that if the medication is swallowed, they should seek medical help or contact a Poison Control Center immediately.

Patients should be informed to avoid contact with the eyes and mucous membranes to prevent irritation or adverse reactions. Additionally, it is important to counsel patients not to bandage the area tightly, as this may lead to complications.

Storage and Handling

The product is supplied in a carton that should be retained for complete labeling information. It is essential to store the product at a temperature range of 15–30°C (59–86°F). Care should be taken to protect the product from excessive moisture and direct sunlight to maintain its integrity. Additionally, due to its flammable nature, it must be kept away from fire or flame to ensure safety during storage and handling.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for External Analgesic Cream with Menthol 5%, 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 External Analgesic Cream with Menthol 5%, 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.