Numotizine

Description

Numotizine Ointment is available in two formulations: 3.5 oz (99 g) and 8 oz (228 g). The ointment is designed for topical application and is indicated for specific therapeutic uses. The product is identified by the National Drug Code (NDC) 10546-100-35 for the 3.5 oz formulation and 10546-100-08 for the 8 oz formulation.

The effective date of this labeling is September 13, 2019. Visual representations of the product include images of the ointment and its packaging, identified as Numotizine8, NumotizineCarton, and NumotizineCartonA, all in JPEG format.

Uses and Indications

This drug is indicated for use as a topical analgesic. It provides temporary relief of muscle pain, soreness, and stiffness. Additionally, it is effective for the temporary relief of pain associated with strains, sprains, and injuries to ligaments and tendons. This drug is also indicated for the management of pain related to arthritis.

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

Dosage and Administration

Healthcare professionals are advised to stir the contents of the jar in any liquid at the top before use, ensuring the jar remains sealed when not in use. The recommended application involves spreading a layer of ointment measuring between 1/8 inch to 1/4 inch onto the affected skin area. To protect clothing and maintain the integrity of the application, it is recommended to cover the ointment with a cloth or bandage.

The ointment should be removed with warm water before it becomes completely dry, which typically occurs within 8 to 12 hours. If necessary, the application may be repeated every 12 hours to achieve the desired therapeutic effect.

Contraindications

There are no specific contraindications listed for this product. However, it is advised to discontinue use and consult a healthcare professional if excessive skin irritation or persistent swelling occurs.

Warnings and Precautions

For external use only. It is imperative that the product is utilized strictly as directed. Healthcare professionals should advise patients to avoid contact with the eyes and mucous membranes to prevent adverse reactions. Additionally, the product should not be applied to irritated or broken skin, nor should it be used on large areas of the body, as this may increase the risk of systemic absorption and potential side effects.

Patients should be instructed to discontinue use and consult a healthcare provider if they experience excessive irritation of the skin or if persistent swellings occur. Monitoring for these adverse effects is essential to ensure patient safety and to facilitate timely medical intervention if necessary.

Side Effects

Patients should be aware that the product is intended for external use only and should be used strictly as directed. It is important to avoid contact with the eyes and mucous membranes. The product should not be applied to irritated or broken skin, nor should it be used on large areas of the body.

In clinical practice, patients are advised to discontinue use and consult a healthcare professional if they experience excessive irritation of the skin or persistent swellings. These reactions may indicate a need for further evaluation and management.

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 Numotizine (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients should be advised to keep this medication out of reach of children. It is essential to ensure that the medication is stored safely to prevent accidental ingestion or misuse.

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

There is no available information regarding the use of Numotizine menthol ointment during pregnancy, including safety concerns, dosage modifications, or any special precautions. Healthcare professionals should exercise caution when prescribing this medication to pregnant patients, as the lack of data precludes a comprehensive assessment of potential risks to fetal outcomes. Women of childbearing potential should be advised to discuss their pregnancy status and any potential risks with their healthcare provider before using this product.

Lactation

There are no specific warnings or recommendations regarding the use of Numotizine Ointment in lactating mothers. Additionally, there is no information available about the potential for excretion of the drug in breast milk or any associated risks to breastfed infants.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

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 absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and consider general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should initiate supportive care and symptomatic treatment as necessary. This may include monitoring vital signs, providing respiratory support, and administering intravenous fluids if indicated.

Additionally, healthcare professionals should consult local poison control centers or relevant toxicology resources for guidance on specific management protocols tailored to the substance involved.

Documentation of the incident, including the amount and timing of the substance taken, 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 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 the reach of children to prevent accidental ingestion or misuse.

Patients should be informed to discontinue use and consult a doctor if they experience excessive irritation of the skin. It is important for patients to recognize the signs of irritation and to seek medical advice promptly to avoid further complications.

Additionally, patients should be instructed to stop using the product and contact a healthcare professional if they notice any persistent swellings. This precaution is essential to ensure that any underlying issues are addressed appropriately.

Storage and Handling

The product is supplied in a sealed container to maintain integrity and prevent contamination. It is essential to keep the container sealed when not in use. The recommended storage condition is at room temperature, ensuring that the product remains stable and effective.

Additional Clinical Information

The product is administered topically, with applications that may be repeated every 12 hours as needed. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)