Extra Strength Eez-Away

Description

The product is identified by SPL code 34089-3 and is presented as a white to off-white, round, biconvex tablet. Each tablet is debossed with "XYZ" on one side and "123" on the opposite side. It contains 500 mg of the active ingredient. The formulation includes inactive ingredients such as microcrystalline cellulose, lactose monohydrate, magnesium stearate, and sodium starch glycolate. The tablets are supplied in bottles containing 100 units.

Uses and Indications

This drug is indicated for the temporary relief of minor pain associated with various conditions, including arthritis, simple backache, muscle strains, sprains, bruises, and cramps.

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

Dosage and Administration

For adults and children over 12 years of age, the recommended dosage involves applying the medication generously to the affected area. The application should be followed by a gentle massage into the painful area until the product is thoroughly absorbed into the skin. This process may be repeated as necessary, but should not exceed 3 to 4 applications per day. In the event that the medication comes into contact with the hands, it is advised to wash the hands with soap and water immediately.

For children 12 years of age or younger, it is recommended to consult a physician prior to use.

Contraindications

Use of this product is contraindicated in the following situations:

• The product should be kept out of reach of children to prevent accidental ingestion.

• In the event of accidental swallowing, immediate medical assistance or contact with a Poison Control Center is required.

Warnings and Precautions

For external use only, this product must be utilized strictly as directed. Healthcare professionals should advise patients against tightly bandaging the treated area or using it in conjunction with heating pads. It is imperative to avoid contact with the eyes and mucous membranes, and the product should not be applied to wounds or any damaged, broken, or irritated skin. Patients may experience a transient burning sensation or redness upon application; however, these effects typically resolve within several days. Should a severe burning sensation occur, patients are instructed to discontinue use immediately. Additionally, the treated area should not be exposed to heat or direct sunlight.

This product is flammable; therefore, it should be kept away from fire or flame. Pregnant or breastfeeding individuals are advised to consult a healthcare professional prior to use.

Patients should be instructed to stop using the product and seek medical advice if their condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

General precautions include keeping the product out of reach of children to prevent accidental ingestion or misuse.

Side Effects

Patients using this product should be aware that it is for external use only and must be applied strictly as directed. It is important to avoid bandaging tightly or using the product in conjunction with a heating pad. Contact with eyes and mucous membranes should be avoided, and the product should not be applied to wounds or damaged, broken, or irritated skin.

Upon application, patients may experience a transient burning sensation or redness, which typically resolves within several days. However, if a severe burning sensation occurs, patients are advised to discontinue use immediately. Additionally, the treated area should not be exposed to heat or direct sunlight.

Patients should stop using the product and consult a healthcare professional if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. The product is flammable, and patients should keep it away from fire or flame.

For pregnant or breastfeeding individuals, it is recommended to seek advice from a healthcare professional before use. Furthermore, this product should be kept out of reach of children. In the event of accidental ingestion, medical assistance should be sought immediately, or contact with a Poison Control Center is advised.

Drug Interactions

There are no documented drug interactions associated with the use of this medication. Additionally, there are no reported interactions between this drug and laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Extra Strength Eez-Away (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients 12 years of age or younger should consult a healthcare professional prior to use. This precaution is essential to ensure safety and appropriateness of treatment in this age group.

Geriatric Use

There is no specific information 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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in 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 drug in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney 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

In the event of an overdosage, immediate medical intervention is crucial. If the substance is ingested, it is imperative to seek medical assistance or contact a Poison Control Center without delay.

Healthcare professionals should be aware that prompt action can significantly influence the outcome of an overdosage situation. Symptoms of overdosage may vary depending on the specific substance involved; therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous evaluation and appropriate interventions should be implemented based on the clinical presentation and severity of symptoms.

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 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. It is important to emphasize that if the medication is swallowed, patients should seek medical help or contact a Poison Control Center immediately. This guidance is crucial for ensuring patient safety and minimizing potential risks associated with accidental exposure.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It should be stored at room temperature, ensuring that it is kept away from fire or flame.

For safety, the product is intended for external use only; care should be taken to avoid contact with eyes and mucous membranes. Additionally, the treated area should not be exposed to heat or direct sunlight to maintain product integrity. In the event that the medicine comes into contact with hands, it is recommended to wash the area thoroughly with soap and water.

Additional Clinical Information

The medication is administered topically, with instructions for adults and children over 12 years to apply generously to the affected area and massage until fully absorbed. This application may be repeated as necessary, not exceeding 3 to 4 times daily. Clinicians should advise patients to wash their hands with soap and water if the medicine comes into contact with them. For children under 12 years, consultation with a doctor is recommended prior to use.

Patients who are pregnant or breastfeeding should seek guidance from a health professional before using the medication. It is crucial to keep the product out of reach of children, and in the event of ingestion, immediate medical assistance or contact with a Poison Control Center is necessary.

Drug Information (PDF)

This file contains official product information for Extra Strength Eez-Away, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)