Mygrin Roll-on

Description

MYGRIN® Roll-On Gel is a topical formulation indicated for soothing menthol cooling pain relief associated with arthritis, back pain, and sore muscles and joints. The product is characterized by its non-greasy, dye-free, and non-staining properties, and it contains aloe as an additional ingredient. Each container holds a volume of 3 fluid ounces (90 mL).

The product is intended for external use only and should be shaken well before each application. It does not contain nonsteroidal anti-inflammatory drugs (NSAIDs), ibuprofen, aspirin, or salicylate. MYGRIN® Roll-On Gel is distributed by Sunascen Therapeutics LLC, located in Rockville, MD 20850-6252. The packaging features a tamper-evident safety seal, and consumers are advised not to use the product if the seal is broken or missing. Quality is guaranteed, and users are encouraged to recycle the packaging.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains of muscles and joints associated with conditions such as arthritis, backache, bruises, strains, and sprains.

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 areas not more than four times daily. It is essential to shake the product well before each use to ensure proper dispersion of the formulation.

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

Contraindications

The product is contraindicated in the following situations:

Use is not recommended in conjunction with other liniments, including ointments, creams, lotions, or sprays, as this may lead to adverse effects. Application to wounds, damaged skin, or irritated skin is contraindicated due to the potential for exacerbating irritation or causing further harm. Additionally, the product should not be bandaged or used in conjunction with heating pads or similar devices, as this may increase the risk of skin irritation or other complications.

Warnings and Precautions

For external use only. It is imperative to avoid contact with the eyes or other mucous membranes to prevent irritation or adverse reactions. This product should not be used in conjunction with other liniments, including ointments, creams, lotions, or sprays, as this may lead to unforeseen complications.

Application of this product is contraindicated on wounds, damaged skin, or irritated skin. If excessive irritation develops, discontinuation of use is advised. Additionally, the product should not be bandaged or used in conjunction with heating pads or similar devices, as this may exacerbate irritation or cause other adverse effects.

In the event of ingestion, immediate medical attention is required. Healthcare professionals should advise patients to contact a Poison Control Center at 1-800-222-1222 without delay. Prompt medical intervention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Patients should be instructed to discontinue use and consult a healthcare provider if their condition worsens, if symptoms persist for more than 7 days, or if the condition appears to resolve only to reoccur. These precautions are essential to ensure the safe and effective use of the product.

Side Effects

Patients using this product should be aware that it is for external use only. It is important to avoid contact with the eyes or other mucous membranes. The product should not be used in conjunction with other liniments, such as ointments, creams, lotions, or sprays. Additionally, it should not be applied to wounds, damaged skin, or irritated skin, and should be discontinued if excessive irritation develops. Bandaging or using the product with a heating pad or similar device is also not recommended.

Patients with sensitive skin are advised to consult a doctor before using this product. If any adverse reactions occur, such as worsening of the condition, persistence of symptoms beyond 7 days, or recurrence of the condition after it has cleared, patients should stop use and seek medical advice.

In the event of ingestion, it is critical to seek medical attention or contact a Poison Control Center immediately at 1-800-222-1222. Prompt medical attention is essential for both adults and children, even if no signs or symptoms are initially apparent.

Drug Interactions

Co-administration of this product with other topical liniments, including ointments, creams, lotions, or sprays, is contraindicated. The combination may lead to increased risk of adverse effects or diminished therapeutic efficacy. It is advised to avoid concurrent use to ensure optimal safety and effectiveness of the treatment.

Packaging & NDC

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

Pediatric Use

Pediatric patients aged 2 years and older may apply the medication to the affected areas up to four times daily. For children under 2 years of age, consultation with a physician is advised prior to use.

It is essential to keep the product out of the reach of children. In the event of ingestion, immediate medical attention should be sought, or contact with a Poison Control Center at 1-800-222-1222 is recommended. Prompt medical intervention is crucial for both adults and children, even if no signs or symptoms are apparent.

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 prior to using this medication. It is important to evaluate the potential risks and benefits associated with its use during pregnancy and lactation. The safety of this medication in pregnant women has not been established, and caution is advised to ensure the well-being of both the mother and the fetus.

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 drug insert text regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients, although specific recommendations are not provided.

Hepatic Impairment

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

Overdosage

In the event of an overdosage, it is imperative to seek immediate medical attention or contact a Poison Control Center at 1-800-222-1222. This action is crucial for both adults and children, as prompt intervention can significantly impact outcomes.

Healthcare professionals should be aware that even in the absence of noticeable signs or symptoms, the potential for serious complications exists. Therefore, it is essential to monitor the patient closely and provide appropriate medical care as needed. Early recognition and management of overdosage can mitigate risks and improve 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 these contexts.

Postmarketing Experience

No postmarketing experience details are provided in the insert for MYGRIN Roll-On menthol gel.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical attention or contact a Poison Control Center at 1-800-222-1222 if the product is ingested. It is important to emphasize that prompt medical attention is critical for both adults and children, even in the absence of noticeable signs or symptoms.

Patients should be instructed to discontinue use and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if the condition resolves and then recurs.

When using this product, patients must be cautioned to avoid contact with the eyes or other mucous membranes. Additionally, they should not use this product in conjunction with other liniments, such as ointments, creams, lotions, or sprays. It is also essential to inform patients not to apply the product to wounds, damaged skin, or irritated skin, and to discontinue use if excessive irritation develops.

Patients should be advised against bandaging the area or using a heating pad or similar device while using this product. Furthermore, healthcare providers should recommend that patients consult a doctor before use if they have sensitive skin.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product in a cool, dry place, away from excessive heat or open flame to maintain its integrity and efficacy. Proper handling should be observed to ensure the product remains within the recommended storage conditions.

Additional Clinical Information

The product is administered topically, with a recommended application frequency of up to four times daily for adults and children aged 2 years and older. For children under 2 years of age, consultation with a physician is advised prior to use.

Clinicians should counsel patients to seek advice from a health professional if they are pregnant or breastfeeding. It is important to keep the product out of the reach of children. In the event of ingestion, immediate medical attention should be sought, or contact with a Poison Control Center at 1-800-222-1222 is recommended, as prompt medical intervention is crucial for both adults and children, regardless of the presence of symptoms.

Drug Information (PDF)

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

View product document (PDF)