Plantar Fasciitis Relief Gel Roll-on

Description

The product is identified by the SPL code 34089-3. No additional specific description details are provided in the available data.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with sore muscles and joints, including those related to arthritis, backache, strains, and sprains.

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

Dosage and Administration

Adults and children aged 12 years and older should apply a thin film of the product over the affected areas, not exceeding four applications per day. It is not necessary to massage the area after application.

For children under the age of 12, it is recommended to consult a healthcare professional prior to use.

Contraindications

The product is contraindicated in the following situations:

Application to wounds or damaged skin is prohibited due to the potential for adverse effects. The use of this product in conjunction with other ointments, creams, sprays, or liniments is not recommended, as it may lead to unpredictable interactions. Additionally, application to irritated skin is contraindicated to avoid exacerbating the condition. Bandaging or the use of heating pads or devices in conjunction with this product is also not advised, as it may increase the risk of adverse reactions.

Warnings and Precautions

For external use only. In the event of accidental ingestion, it is imperative to seek medical assistance or contact the Poison Control Center immediately.

Application of this product is contraindicated on wounds or damaged skin. It should not be used in conjunction with other ointments, creams, sprays, or liniments, as this may lead to adverse effects. Additionally, the product must not be applied to irritated skin.

Users are advised against bandaging the area or using heating pads or devices in conjunction with this product.

Healthcare professionals should monitor patients for any signs of pain, swelling, or blistering. If the condition worsens, or if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days, further evaluation is warranted.

Side Effects

Patients should be aware that the product is intended for external use only.

In clinical practice, participants are advised to discontinue use and consult a healthcare professional if they experience any of the following adverse reactions: pain, swelling, or blistering at the application site. Additionally, if the condition worsens, or if symptoms persist for more than 7 days, or clear up and then recur within a few days, it is recommended to stop use immediately.

These precautions are essential to ensure patient safety and to mitigate any potential adverse effects associated with the product.

Drug Interactions

Co-administration of this medication with other topical formulations, including ointments, creams, sprays, or liniments, is contraindicated. The use of multiple topical products may lead to altered absorption, increased risk of local irritation, or diminished therapeutic efficacy. It is advised to avoid concurrent use to ensure optimal treatment outcomes and minimize potential adverse effects.

Packaging & NDC

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

Pediatric Use

Pediatric patients aged 12 years and older may apply a thin film of the medication over affected areas up to four times daily, without the need for massage. For children under the age of 12, it is advised to consult a healthcare professional prior to use.

Geriatric Use

Elderly patients may not have specific recommendations or considerations outlined in the provided text. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any potential adverse effects or changes in efficacy, given the general physiological changes associated with aging. Additionally, healthcare providers should consider individual patient factors, such as comorbidities and concurrent medications, when determining the appropriate dosage and treatment plan for elderly patients.

Pregnancy

The product has not been evaluated for safety in pregnant women. Therefore, it is contraindicated for use in pregnant patients or those planning to become pregnant without prior consultation with a healthcare provider. Potential risks to the fetus have not been established, and caution is advised when considering the use of this product during pregnancy. There are no specific dosage modifications provided for pregnant individuals. It is recommended that the product be used only if clearly needed and after a thorough discussion with a healthcare professional regarding the potential risks and benefits.

Lactation

There are no specific statements regarding the use of this medication in nursing mothers or its effects during lactation. Additionally, there is no available data on the excretion of this medication in breast milk or its potential effects on breastfed infants. Healthcare professionals should consider the absence of information when advising lactating mothers about the use of this medication.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data 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 lack of information necessitates careful clinical judgment and monitoring.

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 context of overdosage, it is important to note that the available sections of the drug insert do not provide specific information regarding potential overdosage scenarios.

Healthcare professionals are advised to exercise caution and consider the possibility of overdosage when administering the medication. In the absence of detailed guidance, it is recommended that clinicians monitor patients closely for any unusual symptoms or adverse reactions that may arise following administration.

In the event of suspected overdosage, standard supportive measures should be implemented. This includes ensuring the patient's safety, providing symptomatic treatment, and considering the need for further medical evaluation. Healthcare providers should remain vigilant and prepared to manage any complications that may occur as a result of overdosage, even in the absence of specific symptoms outlined in the drug insert.

For further management, consultation with a poison control center or a medical toxicologist may be beneficial to guide treatment decisions and ensure optimal patient 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 compound in these areas.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact the Poison Control Center if the product is accidentally swallowed. It is important to instruct patients not to apply the product to wounds or damaged skin, and to avoid using it in conjunction with other ointments, creams, sprays, or liniments. Patients should also be cautioned against applying the product to irritated skin.

Providers should emphasize that the product should not be bandaged or used with heating pads or devices. Patients must be informed to monitor their condition closely; if they experience pain, swelling, or blistering, or if their condition worsens, they should seek medical attention. Additionally, if symptoms persist for more than 7 days or clear up only to recur within a few days, patients should consult their healthcare provider.

Patients should be instructed to use the product only as directed and to avoid contact with their eyes or mucous membranes. It is advisable for patients to wash their hands with cool water after using the product. Finally, healthcare providers should recommend that patients store the product in a cool, dry place away from direct sunlight to maintain its efficacy.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which are essential for identification and inventory management. It is crucial to store the product in a cool, dry place, ensuring that it is kept away from direct sunlight to maintain its integrity and efficacy. Proper storage conditions are vital for preserving the quality of the product throughout its shelf life.

Additional Clinical Information

Patients aged 12 years and older should apply a thin film of the product to the affected areas no more than four times daily, without the need for massage. For children under 12 years, consultation with a doctor is advised prior to use.

Clinicians should counsel patients on the following important points: the product is for external use only and should not be applied to wounds, damaged, or irritated skin. It should not be used in conjunction with other topical ointments, creams, sprays, or liniments, nor should it be bandaged or used with heating devices. Patients must avoid contact with eyes and mucous membranes, wash hands with cool water after application, and store the product in a cool, dry place away from direct sunlight. They should seek medical attention if they experience pain, swelling, blistering, or if their condition worsens or persists beyond seven days. In case of accidental ingestion, immediate medical help or contact with a Poison Control Center is necessary.

Drug Information (PDF)

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

View product document (PDF)