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Denticalm

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Active ingredient
Menthol 2 g/1 mL
Other brand names
Dosage form
Emulsion
Route
Topical
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2024
Label revision date
October 16, 2025
Active ingredient
Menthol 2 g/1 mL
Other brand names
Dosage form
Emulsion
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2024
Label revision date
October 16, 2025
Manufacturer
NFUSE LLC
Registration number
M017
NDC root
82765-0002

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Drug Overview

This medication provides temporary relief from minor aches and pains in sore muscles and joints that may be associated with teeth grinding and clenching, a condition known as bruxism. It is designed to help ease discomfort, allowing you to feel more comfortable in your daily activities. If you're experiencing these types of muscle and joint pains, this medication may be a suitable option for you.

Uses

If you're experiencing minor aches and pains in your muscles and joints, especially due to teeth grinding and clenching (a condition known as bruxism), this medication can provide temporary relief. It's designed to help ease discomfort associated with these issues, allowing you to feel more comfortable in your daily activities.

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

Dosage and Administration

Before using this medication, make sure to shake the bottle well. If you are an adult or a child aged 12 years and older, you can apply the medication to the affected areas of your skin up to four times a day. Be sure to massage the area gently as needed to help the medication absorb.

If the patient is a child under 12 years old, it’s important to consult a physician (doctor) before use to ensure safety and proper guidance. Always follow these instructions carefully to get the best results from your treatment.

What to Avoid

You can feel reassured that there are no specific contraindications, controlled substance classifications, or risks of abuse or misuse associated with this medication. Additionally, there are no concerns regarding dependence (a condition where your body becomes reliant on a substance) or any explicit instructions advising against its use. Always consult with your healthcare provider if you have any questions or concerns about your treatment.

Side Effects

When using this product, it's important to be aware of certain warnings to ensure your safety. This product is for external use only, so avoid contact with your eyes and mucous membranes. Do not apply it to wounds, broken skin, or irritated areas. Additionally, do not bandage the area after application. If you notice that your condition worsens, or if symptoms persist for more than seven days, or if they clear up and then return within a few days, stop using the product and consult a doctor.

Warnings and Precautions

This product is for external use only. When using it, be careful to avoid contact with your eyes and mucous membranes (the moist tissues lining certain body parts). Do not apply it to wounds, broken skin, or irritated areas, and avoid bandaging the area after application. If you notice excessive skin irritation, stop using the product immediately.

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

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 signs of an overdose, which can include unusual drowsiness, confusion, or difficulty breathing. If you suspect an overdose, it’s crucial to seek immediate medical help.

In case of an emergency, contact your local poison control center or go to the nearest hospital. Always keep medications out of reach of children and follow the prescribed dosage to prevent any potential risks. If you have any concerns or questions about your medication, don’t hesitate to reach out to your healthcare provider for guidance.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the information provided does not specify any safety concerns related to the use of this medication during pregnancy. There are no dosage modifications recommended for pregnant individuals, and no special precautions have been outlined for its use in this context.

As always, it's best to consult with your healthcare provider about any medications you are considering or currently taking to ensure they are safe for you and your baby.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of DentiCalm while nursing. The information available does not indicate any particular considerations or precautions you need to take while breastfeeding. Always consult with your healthcare provider if you have any concerns or questions about medications and their effects on you or your baby.

Pediatric Use

If your child is under 12 years old, it's important to consult a physician (doctor) before using this medication. For those aged 12 and older, you can apply the medication to the affected areas up to four times a day, and you may gently massage it in as needed. Always follow your healthcare provider's advice to ensure safe and effective use.

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 for patients with renal impairment (kidney issues) are not provided.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment plan.

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 detailed guidelines available for how the medication may affect you or how your liver health might influence the treatment.

Given this lack of information, it's crucial to discuss your liver condition with your healthcare provider before starting any new medication. They can help determine the best approach for your treatment and ensure your safety. Always keep them informed about your liver health to receive the most appropriate care.

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 health concerns to receive the best care possible.

Storage and Handling

To ensure the best quality and safety of your product, store it at room temperature, away from direct light. It's important to keep the container tightly closed when not in use to prevent contamination. Once you open the container, please remember to discard it after use to maintain safety and effectiveness. Following these simple guidelines will help you use the product safely and effectively.

Additional Information

For adults and children aged 12 and older, you should apply the medication to the affected areas up to four times a day, massaging it in as needed. If the patient is under 12 years old, 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 provides temporary relief from minor aches and pains of sore muscles and joints associated with teeth grinding and clenching (bruxism).

How should I use this drug?

Shake before use. For adults and children 12 years and older, apply over affected areas no more than four times daily and massage as necessary. Consult a physician for children under 12.

Are there any warnings I should be aware of?

Yes, this product is for external use only. Avoid contact with eyes and mucous membranes, do not apply to wounds or broken skin, and stop use if conditions worsen or persist for more than 7 days.

Is this drug safe to use during pregnancy?

The insert does not provide specific information regarding safety concerns or dosage modifications for pregnant individuals.

Can nursing mothers use this drug?

There are no specific warnings or recommendations regarding the use of this drug in nursing mothers mentioned in the insert.

What should I do if I experience excessive skin irritation?

If excessive skin irritation develops, discontinue use of this product and consult a doctor.

How should I store this drug?

Store at room temperature, protect from light, and keep the container tightly closed. Discard after opening.

Packaging Info

Below are the non-prescription pack sizes of Denticalm (topical analgesic). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Denticalm.
Details

Drug Information (PDF)

This file contains official product information for Denticalm, 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 drug.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with sore muscles and joints resulting from teeth grinding and clenching (bruxism).

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

Dosage and Administration

The formulation should be shaken well before use. For adults and children aged 12 years and older, the recommended application is to apply the product over the affected areas up to four times daily, with gentle massage as necessary to ensure even distribution.

For children under 12 years of age, it is advised to consult a physician prior to use to determine appropriate dosing and administration.

Contraindications

There are no contraindications associated with the use of this product. It is not classified as a controlled substance, and there are no identified 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

This product is intended for external use only. Healthcare professionals should advise patients to avoid contact with the eyes and mucous membranes during application. It is imperative that the product is not applied to wounds or broken skin, as this may lead to adverse effects. Additionally, patients should be instructed not to bandage the area after application, as this could exacerbate potential irritation.

Caution is advised when applying the product to the skin. It should not be used on irritated skin or if excessive skin irritation develops. In the event that the patient's condition worsens, or if symptoms persist for more than 7 days, it is essential to discontinue use and consult a healthcare professional. If symptoms clear up and then recur within a few days, the patient should also stop using the product and seek medical advice.

Side Effects

Patients should be aware that the product is for external use only. It is crucial to avoid contact with the eyes and mucous membranes. The product should not be applied to wounds or broken skin, and it is advised not to bandage the area after application. Additionally, patients should refrain from using the product on irritated skin or if excessive skin irritation develops.

In the event that conditions worsen, or if symptoms persist for more than 7 days, patients are advised to discontinue use and consult a doctor. If symptoms clear up and then recur within a few days, it is also recommended to stop using the product and seek medical advice.

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 Denticalm (topical analgesic). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Denticalm.
Details

Pediatric Use

Pediatric patients under 12 years of age should consult a physician prior to use. For adolescents and children aged 12 years and older, the recommended dosage is to apply the medication over affected areas no more than four times daily, with massage as necessary to enhance absorption.

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 potential adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

The available data regarding the use of this medication during pregnancy do not indicate specific safety concerns. There are no documented dosage modifications required for pregnant individuals, nor are there any special precautions outlined for use during pregnancy. Healthcare professionals should consider the overall clinical context when prescribing this medication to pregnant patients, as individual circumstances may vary. It is advisable to weigh the potential benefits against any unknown risks when treating women of childbearing potential.

Lactation

There are no specific warnings or recommendations regarding the use of DentiCalm in lactating mothers. Additionally, the insert does not provide any specific considerations or precautions related to lactation. Therefore, healthcare professionals may consider the use of DentiCalm in nursing mothers without specific concerns related to breastfeeding.

Renal Impairment

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials for this medication. Consequently, there is no available information regarding dosage adjustments, special monitoring requirements, or precautions 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 warranted based on clinical judgment.

Overdosage

There is currently no specific information available regarding overdosage for this medication. In the absence of documented overdosage data, healthcare professionals are advised to monitor patients closely for any unusual symptoms or adverse effects that may arise following administration.

In the event of suspected overdosage, it is recommended that healthcare providers initiate supportive care and symptomatic treatment as necessary. Continuous assessment of the patient's clinical status is essential, and appropriate interventions should be implemented based on the severity of symptoms observed.

Healthcare professionals should also consider contacting a poison control center or a medical toxicologist for guidance on management strategies tailored to the individual case. Documentation of the incident and any interventions performed is crucial for ongoing patient care and future reference.

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 provided in the insert.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion or misuse. It is important for patients to understand the potential risks associated with improper access to the medication by young individuals. Providers should emphasize the necessity of storing the medication in a secure location, away from children's sight and reach, to ensure safety.

Storage and Handling

The product is supplied in a container that must be kept tightly closed to maintain its integrity. It should be stored at room temperature, away from direct light exposure to prevent degradation. Once opened, the product must be discarded to ensure safety and efficacy.

Additional Clinical Information

Patients aged 12 years and older are advised to apply the medication over affected areas no more than four times daily, with massage as necessary. For children under 12 years of age, consultation with a physician is recommended prior to use. No further information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Denticalm, 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 Denticalm, 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.