Equate Cold Therapy Pain Relieving

Description

Equate™ Cold Therapy Pain Relieving Gel is a topical analgesic formulated with 4% menthol, designed to provide relief from backache, muscle pain, and joint pain. This product is comparable to the active ingredient found in Biofreeze®. The gel is presented in a 3 fluid ounce (89 mL) container, featuring a soothing menthol formulation that delivers a cooling sensation upon application. The National Drug Code (NDC) for this product is 79903-021-01.

Uses and Indications

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

Limitations of Use: This drug is not indicated for any conditions beyond the specified minor aches and pains of muscles and joints. There are no reported teratogenic or nonteratogenic effects associated with this medication.

Dosage and Administration

For adults and children aged 6 years and older, the recommended application is to the affected area not more than 3 to 4 times daily. It is important to ensure that the application is performed with clean hands and that the affected area is properly prepared prior to administration.

Children under 6 years of age should not use this product.

Contraindications

The product is contraindicated in the following situations:

Application to wounds or damaged skin is prohibited due to the potential for irritation or adverse reactions. Additionally, tight bandaging is not recommended, as it may compromise circulation and lead to further complications. The use of heating pads or other heating devices in conjunction with this product is also contraindicated, as it may increase the risk of skin irritation or burns.

Warnings and Precautions

For external use only. Healthcare professionals should advise patients to avoid contact with the eyes when using this product. It is imperative that the product is not applied to wounds or damaged skin, and that it is not bandaged tightly. Additionally, the use of heating pads or other heating devices in conjunction with this product is contraindicated.

Patients should be instructed to discontinue use and seek medical advice if their condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days.

This product is flammable; therefore, it must be kept away from fire or flame. Pregnant or breastfeeding individuals should consult a healthcare professional prior to use to ensure safety.

It is essential to keep this product out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center (1-800-222-1222) should be contacted.

Side Effects

Patients should be aware that this product is for external use only. It is important to avoid contact with the eyes and to refrain from applying the product to wounds or damaged skin. Additionally, patients should not bandage the area tightly or use the product in conjunction with heating pads or other heating devices, as these practices may lead to adverse effects.

In the event that the condition worsens, or if symptoms persist for more than 7 days or resolve and then recur within a few days, patients are advised to stop use and consult a healthcare professional.

This product is flammable; therefore, it should be kept away from fire or flame. Pregnant or breastfeeding individuals should seek advice from a health professional prior to use.

To ensure safety, the product should be kept out of reach of children. In the case of accidental ingestion, immediate medical assistance should be sought, or contact should be made with a Poison Control Center at 1-800-222-1222.

Drug Interactions

There are no reported drug interactions associated with the use of this medication. Additionally, no interactions with laboratory tests have been identified. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Equate Cold Therapy Pain Relieving (menthol, unspecified form). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 6 years of age should not use this medication. For children aged 6 years and older, the recommended application is to the affected area not more than 3 to 4 times daily.

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 individual responses may vary. Monitoring for potential adverse effects and therapeutic efficacy is recommended in 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 weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use 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 addressed in the drug insert regarding dosage adjustments, special monitoring, or safety considerations. As such, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, given the absence of detailed guidance on its use in this population. Regular monitoring of renal function may be prudent in these patients, although specific recommendations are not provided.

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 without delay. It is recommended to contact a Poison Control Center at 1-800-222-1222 for expert guidance on managing the situation.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are provided in the insert.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children. Instruct patients that if the product is swallowed, they should seek medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Patients should be informed to stop using the product and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days.

When using this product, patients must be cautioned to avoid contact with their eyes. They should not apply the product to wounds or damaged skin, and they should refrain from bandaging the area tightly. Additionally, patients should be advised against using the product in conjunction with heating pads or other heating devices.

Storage and Handling

The product is supplied in a tube format, with specific handling and storage requirements to ensure its integrity and effectiveness. It should be stored at room temperature, away from direct light exposure. To maintain the quality of the product, it is essential to keep the tube tightly closed when not in use. Additionally, the product should be discarded after opening to prevent any potential degradation or contamination.

Additional Clinical Information

Patients aged 6 years and older are advised to apply the topical medication to the affected area no more than 3-4 times daily. For children under 6 years of age, the product should not be used.

Clinicians should counsel patients on the following important safety information: the product is for external use only; patients should discontinue use and consult a doctor if the condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and recur within a few days. The medication is flammable, and patients who are pregnant or breastfeeding should seek advice from a health professional before use. It is crucial to keep the product out of reach of children, and in the event of ingestion, medical assistance should be sought immediately. Patients should avoid contact with eyes, refrain from applying the product to wounds or damaged skin, and should not use tight bandages or heating devices in conjunction with the medication. Additionally, it should be kept away from fire or flame.

Drug Information (PDF)

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

View product document (PDF)