Gerigentle Frostyheat Pain Relief Patch Back

Description

No specific description details related to SPL code 34089-3 are provided in the text.

Uses and Indications

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

There are no teratogenic or nonteratogenic effects associated with this drug as per the available data.

Dosage and Administration

Adults and children 12 years of age and older should clean and dry the affected area prior to application. For this population, one patch should be applied to the affected area, with a maximum of 3 to 4 patches applied daily. Each patch may be worn for a maximum duration of 8 hours.

For children under 12 years of age, it is recommended to consult a physician before use. The same preparation steps apply, including cleaning and drying the affected area before patch application.

To apply the patch, remove the film from the patch and place it directly onto the skin at the site of concern.

Contraindications

The product is contraindicated in the following situations:

Use is not recommended on wounds or damaged skin due to the potential for irritation and adverse effects. Additionally, the application of this product in conjunction with a heating pad is contraindicated, as it may lead to increased absorption and risk of systemic effects. Furthermore, individuals with a known allergy to any ingredient in this product should avoid its use to prevent allergic reactions.

Warnings and Precautions

For external use only. This product is contraindicated for application on wounds or damaged skin and should not be used in conjunction with a heating pad. Individuals with known allergies to any ingredient in this formulation should refrain from use.

When utilizing this product, it is imperative to adhere strictly to the provided directions. Care should be taken to avoid contact with the eyes, mucous membranes, or any rashes present on the skin.

Users are advised to discontinue use and consult a healthcare professional if any of the following occur: worsening of conditions, excessive redness or irritation, persistence of symptoms beyond 7 days, or if symptoms resolve and then recur within a few days.

It is essential to keep this product out of reach of children and pets. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center should be established without delay.

Side Effects

Patients using this product should be aware that it is intended for external use only. It is contraindicated for application on wounds or damaged skin and should not be used in conjunction with heating pads. Individuals with known allergies to any ingredient in this product should refrain from use.

During the use of this product, it is essential to follow the directions provided. Patients should avoid contact with the eyes, mucous membranes, and any rashes. If any of the following occur, patients are advised to discontinue use and consult a healthcare professional: worsening of conditions, excessive redness or irritation, persistence of symptoms beyond 7 days, or recurrence of symptoms after initial resolution within a few days.

For pregnant or breastfeeding individuals, it is recommended to seek advice from a healthcare professional prior to use. Additionally, this product should be kept out of reach of children and pets. In the event of accidental ingestion, immediate medical assistance should be sought or contact with a Poison Control Center should be made.

Drug Interactions

No drug interactions or drug and laboratory test interactions have been identified in the available data. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Gerigentle Frostyheat Pain Relief Patch Back (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should consult a physician prior to use. It is important for healthcare professionals to evaluate the appropriateness of treatment in this age group, considering potential differences in efficacy and safety profiles compared to older populations.

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 potential adverse effects or changes in efficacy, 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. The potential risks and benefits must be carefully considered, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to discuss their individual circumstances with a healthcare provider to ensure safe use during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a healthcare professional prior to using this medication. There is currently no available data regarding the excretion of this drug 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 no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

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, immediate medical assistance is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical help or contact a Poison Control Center without delay.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and evaluation are recommended to ensure patient safety and effective resolution of any complications arising from the overdosage.

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 available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children and pets to prevent accidental ingestion or misuse. Instruct patients that if the product is swallowed, they should seek medical help or contact a Poison Control Center immediately.

Patients should be informed not to use the product on wounds or damaged skin, and to avoid using it in conjunction with a heating pad. It is essential to caution patients against using the product if they have a known allergy to any of its ingredients.

Healthcare providers should emphasize the importance of monitoring their condition while using the product. Patients should be instructed to stop use and consult a doctor if their condition worsens, if they experience excessive redness or irritation, or if symptoms persist for more than 7 days. Additionally, patients should be advised to seek medical advice if symptoms clear up and then recur within a few days.

When using the product, patients must be reminded to follow the directions carefully and to avoid contact with eyes, mucous membranes, or rashes to prevent adverse effects.

Storage and Handling

The product is supplied in various packaging configurations, with specific NDC numbers available for identification. It is essential to store the product in a cool, dry place, avoiding direct sunlight to maintain its integrity. Additionally, the product must be protected from excessive moisture to ensure optimal quality and efficacy. Proper handling and storage conditions are crucial for preserving the product's effectiveness.

Additional Clinical Information

The medication is administered topically, with a recommendation to apply one patch at a time to the affected area, not exceeding 3 to 4 applications daily. Each patch should be worn for a maximum of 8 hours.

Clinicians should counsel patients to consult a healthcare professional if they are pregnant or breastfeeding before use. It is important to keep the medication out of reach of children and pets. In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately.

Drug Information (PDF)

This file contains official product information for Gerigentle Frostyheat Pain Relief Patch Back, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)