Denticalm

Description

The product is identified by the National Drug Code (NDC) 82765-0043-0.

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).

Limitations of Use: This medication is intended for short-term use and should not be used as a long-term solution for bruxism-related discomfort.

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 deemed safe for use in the absence of specific conditions or situations that would warrant avoidance.

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.

Care should be taken to avoid application on irritated skin or in cases where excessive skin irritation develops. If patients experience worsening conditions or if symptoms persist beyond 7 days, they should be advised to discontinue use and consult a healthcare provider. Furthermore, if symptoms resolve and then recur within a few days, it is recommended that the patient stop using the product and seek medical advice.

Side Effects

Patients using this product should be aware of several important warnings regarding its use. The product is intended for external use only and should not come into contact with the eyes or mucous membranes. It is contraindicated for application on wounds or broken skin, and users should refrain from bandaging the area after application. Additionally, the product should not be applied to 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 healthcare professional. If symptoms clear up and then recur within a few days, it is also recommended to stop using the product and seek medical advice. These precautions are essential to ensure the safety and well-being of patients while using this product.

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

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 application is over affected areas not to exceed four times daily, with massage as necessary to enhance absorption.

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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

There is no specific information available regarding the use of this medication during pregnancy, including safety concerns, dosage modifications, or special precautions that should be taken. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients and weigh the potential risks and benefits. Women of childbearing potential should be counseled on the absence of established safety data and the importance of discussing any potential pregnancy with their healthcare provider.

Lactation

There are no specific warnings or recommendations regarding the use of DentiCalm in lactating mothers. Additionally, there are no specific considerations or precautions related to lactation mentioned in the prescribing information. Therefore, healthcare professionals may consider the use of DentiCalm in nursing mothers without specific concerns related to breastfeeding.

Renal Impairment

There is no information available regarding renal impairment, dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function. Healthcare professionals should exercise caution and consider individual patient factors when prescribing to patients with renal impairment, as specific guidelines or recommendations are not provided in the available data.

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 signs or 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, respiratory distress, and gastrointestinal disturbances.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs. The use of activated charcoal may be considered if the patient presents within a suitable timeframe and if the ingestion was recent.

Furthermore, specific antidotes or treatments may be indicated based on the clinical scenario and the substance involved. Consultation with a poison control center or a medical toxicologist is recommended to guide management decisions and ensure optimal patient care.

Overall, vigilance and prompt intervention are critical in managing potential overdose situations effectively.

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 keep the medication out of reach of children to prevent accidental ingestion or misuse. It is important to emphasize the necessity of proper storage to ensure the safety of young children.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at room temperature, ensuring that it is protected from light exposure to maintain its integrity. Freezing the product is strictly prohibited, as it may compromise its effectiveness.

Prior to use, the product must be shaken thoroughly to ensure proper mixing. Once opened, it is important to discard any unused portion to prevent potential contamination or degradation.

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. 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 Denticalm, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)