Heel 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 over 12 years of age, a thin film of the product should be applied to 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 is prohibited on wounds or damaged skin due to the risk of exacerbating injury or infection. It should not be used in conjunction with other ointments, creams, sprays, or liniments, as this may lead to adverse interactions or reduced efficacy. Application to irritated skin is also contraindicated, as it may worsen irritation or cause further discomfort. Additionally, the product should not be bandaged or used with heating pads or devices, as this may increase the risk of skin reactions or other complications.

Warnings and Precautions

This product is intended 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, and it is recommended that hands be washed thoroughly with cool water after application to prevent unintended exposure.

Users should refrain from bandaging the treated area or using heating pads or devices in conjunction with this product. If the user experiences pain, swelling, or blistering, or if the condition worsens, it is essential to discontinue use. Furthermore, if symptoms persist for more than 7 days, or if they resolve and then recur within a few days, medical advice should be sought promptly.

Side Effects

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

In clinical use, participants have reported adverse reactions including pain, swelling, or blistering at the application site. It is important for patients to monitor their condition closely; if symptoms worsen, persist for more than 7 days, or if there is a recurrence of symptoms after they have cleared, they should seek medical advice. These observations highlight the necessity for patients to be vigilant regarding their response to treatment and to consult healthcare professionals as needed.

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 Heel 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 doctor prior to use.

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

There is no information available regarding the use of HEEL PAIN RELIEF GEL ROLL-ON during pregnancy. As such, the safety of this product in pregnant patients has not been established, and there are no known dosage modifications or special precautions recommended for use in this population. Healthcare professionals should consider the lack of data when advising women of childbearing potential and weigh the potential risks versus benefits before recommending this product during pregnancy.

Lactation

There are no specific warnings or recommendations regarding the use of this product in nursing 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 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 absence of specific details regarding overdosage for this medication (SPL code 34088-5), it is essential for healthcare professionals to remain vigilant and consider general principles of management in cases of suspected overdosage.

Recommended Actions In the event of an overdosage, immediate medical attention should be sought. Healthcare providers are advised to assess the patient's clinical status and initiate appropriate supportive measures.

Potential Symptoms While specific symptoms related to overdosage are not detailed, healthcare professionals should be aware that symptoms may vary based on the pharmacological profile of the medication. Monitoring for any unusual or severe reactions is crucial.

Management Procedures Management of overdosage typically involves symptomatic treatment and supportive care. Healthcare professionals should consider the patient's medical history, current medications, and any co-existing conditions when determining the appropriate course of action.

In summary, due to the lack of specific overdosage information, healthcare professionals are encouraged to apply general overdosage management principles and to consult relevant clinical guidelines or toxicology resources as needed.

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 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 be informed not to apply the product to irritated skin and to wash their hands with cool water after use. Additionally, they should be cautioned against bandaging the area or using heating pads or devices in conjunction with the product.

Healthcare providers should encourage patients to monitor their condition and report any pain, swelling, or blistering that occurs. Patients should also be advised to seek medical attention if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days.

It is essential to emphasize that patients should use the product only as directed and avoid contact with eyes or mucous membranes. Finally, patients should be instructed 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 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 should apply a thin film of the product over affected areas no more than four times daily, with no 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 precautions: 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, and hands should be washed with cool water after application. Patients should avoid bandaging the area or using heating pads/devices, and should use the product only as directed. Contact with eyes or mucous membranes should be avoided. The product should be stored in a cool, dry place away from direct sunlight. Patients are advised to seek medical help if they experience pain, swelling, blistering, or if symptoms persist beyond 7 days or recur shortly after resolution. In case of accidental ingestion, immediate medical assistance or contact with a Poison Control Center is necessary.

Drug Information (PDF)

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

View product document (PDF)