Ez Massager 4

Description

The product is identified by the SPL code 34089-3 and is classified as a massager. It is designated as ezmassager04. The associated media type for the product image is image/jpeg.

Uses and Indications

This drug is indicated for the instant relief of pain associated with various musculoskeletal conditions, including arthritis, backache, bruises, cramps, sprains, and strains.

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

Dosage and Administration

Healthcare professionals are advised to massage the product into the painful area until it is thoroughly absorbed into the skin. This application may be repeated as necessary, but should not exceed 3 to 4 times per day. Care should be taken to ensure that the product is applied only to intact skin and not to open wounds or damaged areas.

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

For external use only. This product is contraindicated for application on wounds or damaged skin when using a heating pad.

Healthcare professionals should advise patients to seek medical consultation prior to use if any of the following conditions apply: redness is present over the affected area, if symptoms worsen or persist beyond 7 days, if symptoms resolve and then recur within a few days, if excessive skin irritation occurs, or if the patient is pregnant or breastfeeding.

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 with a Poison Control Center is recommended.

Side Effects

For external use only. Patients are advised not to use this product on wounds or damaged skin in conjunction with a heating pad.

Warnings include the necessity to consult a doctor before use if any of the following conditions apply: redness over the affected area, worsening of conditions or persistence of symptoms for more than 7 days, recurrence of symptoms after they have cleared up within a few days, excessive skin irritation, or if the patient is pregnant or breastfeeding.

Drug Interactions

There are currently no specific drug interactions identified for the medication. Additionally, no interactions with laboratory tests have been reported. Therefore, no dosage adjustments or monitoring recommendations are necessary at this time. It is advisable for healthcare professionals to remain vigilant and consult updated resources as new data may emerge.

Packaging & NDC

Below are the non-prescription pack sizes of Ez Massager 4 (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. In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

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 before using this medication. The potential risks associated with the use of this drug during pregnancy have not been fully established. Therefore, it is essential for women of childbearing potential to discuss their individual circumstances with their healthcare provider to ensure the safety of both the mother and the fetus.

Lactation

Lactating mothers are advised to consult a healthcare professional prior to using this medication if they are breastfeeding. There is no specific data available regarding the excretion of this medication in breast milk or its effects on breastfed infants. Therefore, caution is recommended when considering the use of this medication during lactation.

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 and individualized patient assessment.

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 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, 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 for guidance on the appropriate management strategies.

Overall, vigilance and prompt intervention are critical in managing cases of suspected overdose to mitigate potential complications and ensure patient safety.

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 question. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

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. It is important to emphasize that if the medication is swallowed, patients should seek medical help or contact a Poison Control Center immediately. This precaution is crucial to ensure the safety of children and to address any potential risks associated with accidental ingestion.

Storage and Handling

The product is supplied in configurations that ensure optimal handling and storage. It should be stored at room temperature, away from direct sunlight and moisture. To maintain safety, it is essential to keep the product out of reach of children.

Special handling precautions include avoiding contact with eyes or mucous membranes. Additionally, when applying the product, it is advised not to bandage tightly to prevent any adverse effects.

Additional Clinical Information

The product is administered topically, with the recommendation to massage it into the painful area until fully absorbed into the skin. This process may be repeated as necessary, but should not exceed 3 to 4 applications per day.

Clinicians should counsel patients to avoid contact with eyes or mucous membranes and to refrain from tightly bandaging the area after application. It is crucial to keep the product out of reach of children; if ingested, patients should seek medical assistance or contact a Poison Control Center immediately.

Drug Information (PDF)

This file contains official product information for Ez Massager 4, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)