Green Farm Cooling Pain Relief

Description

GREEN FARM COOLING PAIN RELIEF STICK is a topical formulation designed for pain relief. The product is presented in a stick dosage form, with a net weight of 1 ounce. The effective date for this formulation is December 19, 2022. The product is associated with the observation media ID 72937-101-01 and is represented visually by an image in JPEG format, titled "GREEN FARM - COOLING PAIN RELIEF STICK.jpg."

Uses and Indications

This drug is indicated for the temporary local relief of minor pain in muscles or joints.

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

Dosage and Administration

Adults and children over 12 years of age should apply a small amount of the product to the area intended for treatment. The application should be performed using a circular motion, allowing the product to set for a few seconds. This process may be repeated as necessary, but should not exceed 3 to 4 applications within a 24-hour period.

The product is intended for topical application only.

Contraindications

Use of this product is contraindicated in the following situations:

Tight bandaging or the application of a heating pad in conjunction with this product is not recommended, as it may exacerbate adverse effects. Contact with eyes and mucous membranes should be avoided to prevent irritation or injury. The product should not be applied to wounds or areas of damaged, broken, or irritated skin due to the risk of further complications. Additionally, exposure of the treated area to heat or direct sunlight is contraindicated, as it may lead to increased sensitivity or adverse reactions.

Warnings and Precautions

For external use only. Healthcare professionals should advise patients to adhere strictly to the recommended usage guidelines to ensure safety and efficacy.

Patients are instructed to discontinue use and consult a healthcare provider if any of the following occur: worsening of the condition, presence of redness, development of irritation, persistence of symptoms beyond 7 days, or recurrence of symptoms within a few days after initial improvement. Additionally, if patients experience signs of injury, such as pain, swelling, or blistering at the application site, they should seek medical advice promptly.

General precautions must be emphasized. The product should be used only as directed, and patients should avoid tightly bandaging the area or using it in conjunction with a heating pad. Contact with the eyes and mucous membranes should be strictly avoided. The product must not be applied to wounds or to skin that is damaged, broken, or irritated. In the event of an allergic reaction, patients should discontinue use immediately and consult a healthcare professional. Furthermore, treated areas should not be exposed to heat or direct sunlight to prevent adverse effects.

No specific emergency medical help instructions or laboratory tests are provided; however, healthcare professionals should remain vigilant for any signs of severe reactions or complications that may necessitate further intervention.

Side Effects

Patients using this product should be aware that it is intended for external use only. In the event that the condition being treated worsens, or if redness, irritation, or any other concerning symptoms develop, it is advised to stop use and consult a healthcare professional.

Additionally, if symptoms persist for more than 7 days, or if they clear up and then recur within a few days, patients should seek medical advice. Signs of injury, such as pain, swelling, or blistering at the site of application, also warrant immediate consultation with a doctor. These precautions are essential to ensure the safety and well-being of patients using this product.

Drug Interactions

No drug interactions have been identified for the product. Additionally, there are no reported interactions with laboratory tests. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary based on drug interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Green Farm Cooling Pain Relief (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients should be advised to keep this product out of reach of children. For adolescents aged 12 years and older, the recommended application involves using a small amount on the affected area, massaging it in a circular motion, and allowing it to set for a few seconds. This process may be repeated as necessary, but should not exceed 3 to 4 applications per day.

Geriatric Use

There is no specific information available regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. 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 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 in these populations. There is limited data available regarding the effects of this medication on fetal outcomes or during lactation, and therefore, healthcare providers should exercise caution and provide appropriate counseling to women of childbearing potential.

Lactation

Lactating mothers are advised to consult a health 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 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 clinical trials for this medication. Consequently, there is no available information regarding 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 warranted based on clinical judgment.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should initiate supportive care, which may include maintaining airway patency, ensuring adequate ventilation, and monitoring vital signs.

If available, the use of specific antidotes or treatments should be considered based on the substance involved and the clinical presentation. Consultation with a poison control center or a medical toxicologist may provide additional guidance on the management of overdose cases.

Documentation of the incident, including the amount and timing of the substance taken, is crucial for effective treatment and follow-up 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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep the product out of reach of children to prevent accidental ingestion or misuse. Patients should be instructed to stop using the product and consult a doctor if their condition worsens, if redness or irritation develops, if symptoms persist for more than seven days, or if symptoms clear up only to recur within a few days. Additionally, patients should seek medical advice if they experience signs of injury, such as pain, swelling, or blistering at the application site.

It is important for patients to use the product only as directed. They should be cautioned against bandaging the area tightly or using the product in conjunction with a heating pad, as this may lead to adverse effects. Patients should also be informed to avoid contact with eyes and mucous membranes, and not to apply the product to wounds or any damaged, broken, or irritated skin.

In the event of an allergic reaction, patients should discontinue use immediately and consult a healthcare professional. Furthermore, patients should be advised to avoid exposing the treated area to heat or direct sunlight to ensure optimal safety and effectiveness.

Storage and Handling

The product is classified as flammable and must be stored away from fire or flame to ensure safety. Proper handling procedures should be followed to minimize the risk of ignition.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Green Farm Cooling Pain Relief, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)