Pro Cold Hot Pain Relief Gel Roll-on (plantar fasciitis)

Description

No relevant information is available for SPL code 34089-3.

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 over 12 years of age, a thin film of the medication 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 to determine appropriate dosing and administration.

Contraindications

Use of this product is contraindicated in the following situations:

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

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 the event of adverse reactions, it is advised to discontinue use if any of the following occur: pain, swelling, or blistering at the application site; worsening of the condition; or if symptoms persist for more than 7 days. Additionally, if the condition appears to improve and then recurs within a few days, patients should also stop using the product. These precautions are essential to ensure the safety and well-being of individuals using the product.

Drug Interactions

Co-administration of this medication with other topical formulations, such as 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 Pro Cold Hot Pain Relief Gel Roll-on (plantar fasciitis) (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

Geriatric patients, defined as individuals aged 65 years and older, have not been specifically addressed in the provided prescribing information. There are no recommended age considerations, dosage adjustments, safety concerns, or special precautions outlined for this population.

Healthcare providers should exercise clinical judgment when prescribing this medication to elderly patients, considering the potential for altered pharmacokinetics and increased sensitivity to medications in this age group. Regular monitoring and assessment of therapeutic response and adverse effects are advisable to ensure safe and effective use in geriatric patients.

Pregnancy

The safety of this product during pregnancy has not been established. Pregnant patients or those planning to become pregnant should consult a healthcare provider before use. There may be potential risks to the fetus; therefore, use should be avoided unless directed by a healthcare professional. No specific dosage modifications for pregnant individuals are provided; healthcare professionals should be consulted for guidance regarding use in this population.

Lactation

There are no specific warnings or recommendations regarding the use of this product by lactating mothers. Additionally, there is no information available about the potential for excretion in breast milk or any associated risks to breastfed infants.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

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 overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt intervention is crucial to mitigate potential adverse effects associated with the overdose. Healthcare professionals should be prepared to provide comprehensive information regarding the substance involved and the circumstances of the overdose to facilitate appropriate management and treatment.

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 question.

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 if they clear up and then recur within a few days, patients should consult their healthcare provider.

It is crucial to remind patients to use the product only as directed and to avoid contact with their eyes or mucous membranes. After application, patients should wash their hands with cool water to prevent unintended exposure. Finally, healthcare providers should advise patients to 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 imperative 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 crucial 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 of age, 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 ointments, creams, sprays, or liniments, nor should it be bandaged or used with heating pads or devices. Patients must use the product as directed, avoiding contact with eyes and mucous membranes, and should wash their hands with cool water after application. The product should be stored in a cool, dry place away from direct sunlight. Patients are advised to seek medical attention if they experience pain, swelling, blistering, or if their condition worsens or persists beyond 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 Pro Cold Hot Pain Relief Gel Roll-on (plantar fasciitis), including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)