Free and Pure Cold Therapy Pain Relief

Description

Walgreens Free and Pure Cold Therapy Pain Relief Gel is a topical analgesic formulation containing 4% menthol. This product is designed for the temporary relief of minor aches and pains associated with muscles and joints, including conditions such as simple backache, arthritis, strains, bruises, and sprains. The gel features soothing menthol as its active ingredient, comparable to the active ingredient found in Biofreeze® Gel.

The formulation is characterized by its Free + Pure attributes, which include being fragrance-free, hypoallergenic, and paraben-free. The product is packaged in an 8 FL OZ (236.5 mL) pump for ease of application.

Uses and Indications

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

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

Dosage and Administration

For adults and children aged 2 years and older, a thin film of the medication should be applied to the affected area no more than 3 to 4 times daily. It is important to ensure that the application does not exceed this frequency to avoid potential adverse effects.

In children under 2 years of age, the use of this medication is not recommended. Healthcare professionals should advise caregivers to consult a physician for appropriate alternatives or guidance.

After application, it is essential to wash hands thoroughly with cool water to prevent unintentional contact with other areas of the body or with other individuals.

Contraindications

The product is contraindicated for use in the following situations:

Application to wounds or damaged skin is prohibited due to the potential for adverse effects. Additionally, the product should not be applied to irritated skin or in cases where excessive irritation develops, as this may exacerbate the condition. It is also contraindicated to bandage tightly or use in conjunction with a heating pad or device, as this may lead to increased risk of irritation or other complications.

Warnings and Precautions

For external use only. This product is flammable; therefore, it must be kept away from excessive heat or open flame.

General precautions should be observed when using this product. It is essential to use the product only as directed. Care should be taken to avoid contact with the eyes and mucous membranes. The product must not be applied to wounds or damaged skin, nor should it be used on irritated skin or if excessive irritation develops. Additionally, it is advised not to bandage tightly or use in conjunction with a heating pad or device.

Users should discontinue use and consult a healthcare professional if they experience pain, swelling, or blistering of the skin. If the condition worsens, or if symptoms persist for more than 7 days or resolve and then recur within a few days, medical advice should be sought. In cases where arthritic pain persists for more than 10 days, or if redness is present, or if the product is being used on children under 12 years of age, a healthcare provider should be consulted.

In the event of ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

Side Effects

Patients using this product should be aware of several important warnings and precautions. The product is intended for external use only and is flammable; therefore, it should be kept away from excessive heat or open flame.

When using this product, patients should avoid contact with the eyes and mucous membranes. It is contraindicated for application on wounds or damaged skin, as well as on irritated skin. If excessive irritation develops, patients are advised to discontinue use. Additionally, the product should not be tightly bandaged or used in conjunction with heating pads or devices.

Patients are instructed to stop use and consult a doctor if they experience any of the following adverse reactions: pain, swelling, or blistering of the skin; worsening of the condition; or if symptoms persist for more than 7 days or clear up and then recur within a few days. Furthermore, if arthritic pain persists for more than 10 days, if redness is present, or if the product is being used on children under 12 years of age, medical advice should be sought.

Drug Interactions

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

Packaging & NDC

Below are the non-prescription pack sizes of Free and Pure Cold Therapy Pain Relief (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 2 years of age should not use this medication; consultation with a physician is advised. For children aged 2 years and older, the recommended application is to rub a thin film over the affected area no more than 3 to 4 times daily.

Healthcare professionals should instruct caregivers to discontinue use and seek medical advice if the condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. Special caution is warranted in conditions affecting children under 12 years of age.

Geriatric Use

There is no specific information 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 they may have altered pharmacokinetics and pharmacodynamics. Close monitoring is recommended to ensure safety and efficacy in this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The safety of this drug during pregnancy has not been established, and potential risks to fetal outcomes are not fully understood. Therefore, it is essential for women of childbearing potential to seek medical advice to weigh the benefits and risks associated with the use of this medication during pregnancy and lactation.

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 medication 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 studied in relation to dosage adjustments, special monitoring, or safety considerations. Consequently, there is no available information regarding the use of this medication in individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing this medication to patients with renal impairment.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this medication. Consequently, there are no 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; therefore, a thorough assessment by a medical professional is recommended to determine the appropriate course of action.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. It is imperative that healthcare providers remain vigilant and prepared to address any complications that may arise from an overdosage 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 use of the compound in question. Further studies may be necessary to elucidate these aspects of nonclinical 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 a Poison Control Center if the product is swallowed. Patients should be instructed to discontinue use and consult a doctor if they experience any pain, swelling, or blistering of the skin. Additionally, they should be informed to stop using the product and seek medical advice if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up only to recur within a few days.

It is important for healthcare providers to communicate that patients should stop using the product and consult a doctor if arthritic pain persists for more than 10 days, if redness is present, or if the product is being used on children under 12 years of age. Patients must be reminded to use the product only as directed and to avoid contact with the eyes and mucous membranes.

Healthcare providers should also emphasize that the product should not be applied to wounds or damaged skin, nor should it be used on irritated skin or if excessive irritation develops. Furthermore, patients should be cautioned against tightly bandaging the area of application or using the product in conjunction with a heating pad or device.

Storage and Handling

The product is supplied in packaging that adheres to the National Drug Code (NDC) specifications. It is essential to store the product at a temperature range of 20-25°C (68-77°F). The storage location should be a cool, dry place, ensuring that the product is kept away from direct sunlight to maintain its integrity and efficacy. Proper handling and storage conditions are crucial for preserving the quality of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Free and Pure Cold Therapy Pain Relief, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)