Assured

Description

ASSURED™ Extra Strength Pain Relieving Gel is a topical muscle rub formulated with 2.5% menthol. This product is designed to provide targeted relief for muscle discomfort. It is packaged in a net weight of 1.5 ounces (42.5 grams).

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains in muscles and joints associated with conditions such as simple backache, arthritis, strains, bruises, and sprains. It provides fast relief from arthritis pain, backache, muscle pain, and joint pain.

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

Dosage and Administration

For adults and children aged 2 years and older, the recommended application is to the affected area up to three to four times daily. It is important to ensure that the area is clean and dry prior to application.

For children under 2 years of age, it is advised to consult a healthcare professional before use to determine the appropriate course of action.

Contraindications

Use of this product is contraindicated in patients with wounds or damaged skin due to the potential for irritation and impaired healing. Additionally, the product should not be bandaged or wrapped tightly, as this may exacerbate adverse effects or compromise skin integrity.

Warnings and Precautions

For external use only, this product should not come into contact with the eyes or mucous membranes. It is contraindicated for application on wounds or damaged skin. In the event of excessive irritation, the use of this product should be discontinued immediately.

Healthcare professionals should advise patients to stop using the product and seek medical advice if any of the following occur: the condition worsens or symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days.

While using this product, it is important to avoid tightly bandaging or wrapping the treated area. Pregnant or breastfeeding individuals should consult a healthcare professional prior to use to ensure safety.

This product must be kept out of reach of children. In the case of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center should be made at 800-222-1222.

Side Effects

Patients using this product should be aware of several important warnings and precautions. The product is intended for external use only and should not be applied to wounds or damaged skin. Care should be taken to avoid contact with the eyes or mucous membranes.

In clinical practice, patients are advised to discontinue use if excessive irritation develops. Additionally, if the condition worsens or symptoms persist for more than 7 days, patients should stop using the product and consult a healthcare professional. It is also recommended that patients seek medical advice if symptoms clear up and then recur within a few days.

Drug Interactions

No drug interactions or drug and laboratory test interactions have been identified in the available data. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 2 years of age should consult a doctor prior to use. For children aged 2 years and older, the recommended application is to the affected area up to 3 to 4 times daily.

Geriatric Use

Elderly patients may not have specific dosage adjustments, safety concerns, or special precautions outlined in the drug insert for Assured Muscle Rub. As such, healthcare providers should exercise caution when prescribing this product to geriatric patients, given the general considerations for this population.

It is advisable for healthcare providers to monitor elderly patients closely for any potential adverse effects or changes in efficacy, as individual responses may vary. In the absence of specific data, clinical judgment should guide the use of this product in patients aged 65 and older.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully considered in these populations to ensure the safety of both the mother and the fetus or infant.

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 medication in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the prescribing information regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the absence of data limits the ability to make informed decisions regarding its use in this population. Regular monitoring of renal function may be warranted in these patients, although specific recommendations are not provided.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this drug. 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 prescribing information.

Overdosage

In the event of an overdose, immediate medical assistance is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical help without delay. It is recommended to contact a Poison Control Center at 800-222-1222 for expert guidance on managing the situation.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and evaluation are recommended to ensure patient safety and effective resolution of any complications arising from the overdose.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. It is crucial to inform patients that if the medication is swallowed, they should seek medical help immediately or contact a Poison Control Center at 800-222-1222 for assistance. This information is vital for ensuring patient safety and prompt action in case of an emergency.

Storage and Handling

The product is supplied in a tube format, with specific attention to the integrity of the packaging. It is essential to store the product at a temperature range of 15 to 30°C (59 to 86°F) to maintain its efficacy. Healthcare professionals are advised to inspect the tube prior to use; the product should not be utilized if the seal on the tube is punctured or missing, as this may compromise the product's safety and effectiveness.

Additional Clinical Information

The medication is administered topically, with a recommended application frequency of up to 3 to 4 times daily for adults and children aged 2 years and older. For children under 2 years of age, consultation with a healthcare provider is advised prior to use.

Clinicians should counsel patients to seek advice from a health professional if they are pregnant or breastfeeding. It is also important to keep the medication out of reach of children; in the event of ingestion, immediate medical assistance should be sought or contact with a Poison Control Center (800-222-1222) is recommended.

Drug Information (PDF)

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

View product document (PDF)