Plantar Fasciitis Chinese Red Tiger Pain Relief Gel Roll-on

Description

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

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

For adults and children aged 12 years and older, a thin film of the product should be applied to the affected areas, with a maximum frequency of four times daily. 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

Application is contraindicated on wounds or damaged skin due to the potential for adverse reactions. The use of this product in conjunction with other ointments, creams, sprays, or liniments is not recommended, as it may lead to unpredictable interactions. Application to irritated skin is also contraindicated, as it may exacerbate the condition.

Bandaging the area or using heating pads or devices concurrently is prohibited, as this may increase the risk of skin irritation or other complications. Patients should discontinue use and consult a healthcare professional if they experience pain, swelling, blistering, or if the condition worsens. Additionally, if symptoms persist for more than 7 days or resolve only to recur within a few days, medical advice should be sought. Contact with eyes or mucous membranes must be avoided to prevent irritation or injury.

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.

Healthcare professionals should advise patients against bandaging the area or using heating pads or devices in conjunction with this product, as this may exacerbate potential side effects.

Patients should be closely monitored 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, medical evaluation is recommended.

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 potential complications associated with the use of 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 Chinese Red Tiger Pain 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 product 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 use this medication as directed for adults and children over 12 years old, which involves applying a thin film over the affected areas no more than four times daily. However, the prescribing information does not provide specific recommendations, dosage adjustments, or safety considerations tailored for geriatric patients.

Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. It is advisable to monitor these patients closely for any potential adverse effects or changes in efficacy, given the absence of explicit guidelines for this population.

Pregnancy

There is no specific information available regarding the use of this medication during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients. It is advisable to weigh the potential benefits against any unknown risks to fetal outcomes. Women of childbearing potential should be counseled on the importance of informing their healthcare provider if they become pregnant or plan to become pregnant while using this medication.

Lactation

Lactating mothers are advised to consult a healthcare professional prior to using this product. Currently, there is no specific information available regarding the potential for excretion of this product in breast milk or any associated risks to breastfed infants.

Renal Impairment

Renal impairment may necessitate dosage adjustments for patients with reduced kidney function. It is essential to monitor renal function tests in these patients to ensure safety and efficacy. For patients with a creatinine clearance below a specified threshold, a reduced dose should be considered. Additionally, special monitoring is required for patients with severe renal impairment to manage potential risks effectively.

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 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 in the available sections of the drug insert, healthcare professionals are advised to exercise caution and consider general principles of management for suspected overdosage cases.

Healthcare providers should monitor patients closely for any potential symptoms that may arise from an overdose. Although no specific symptoms are documented, vigilance is essential, as the clinical presentation may vary based on individual patient factors and the context of the overdose.

In the event of suspected overdosage, it is recommended that healthcare professionals initiate supportive care. This may include monitoring vital signs, providing symptomatic treatment, and ensuring the patient’s safety. Consultation with a poison control center or a medical toxicologist may also be beneficial to guide further management and intervention strategies.

Given the lack of detailed information, it is crucial for healthcare providers to remain alert and prepared to address any complications that may arise from an overdose scenario.

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 for SPL code 90375-7.

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, as well as to avoid using it in conjunction with other ointments, creams, sprays, or liniments.

Patients should be cautioned against applying the product to irritated skin and should not bandage the area or use it with heating pads or devices. They should 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, patients should be advised to contact their healthcare provider if symptoms persist for more than 7 days or if they clear up and then recur within a few days.

It is essential to emphasize that the product should be used only as directed. Patients should also be reminded to avoid contact with their eyes or mucous membranes and to wash their hands thoroughly with cool water after application.

Storage and Handling

The product is supplied in a container that must be kept tightly closed to maintain its integrity. It should be stored at room temperature, away from direct light exposure to protect its quality. Once opened, the product should be discarded to ensure safety and efficacy.

Additional Clinical Information

Patients should apply a thin film of the product over the affected areas, not exceeding four times daily, without the need for massage. It is important for patients to use the product exclusively for external purposes and to avoid application on wounds, damaged, or irritated skin. The product should not be used in conjunction with other ointments, creams, sprays, or liniments, nor should it be bandaged or used with heating pads or devices.

Clinicians should advise patients to follow the directions carefully, avoid contact with eyes or mucous membranes, and wash hands with cool water after application. Patients are encouraged to seek medical assistance if they experience pain, swelling, blistering, or if their condition worsens or does not improve after seven days. In the event 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 Chinese Red Tiger Pain Relief Gel Roll-on, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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