Equate Cold Therapy Pain Relieving Roll-on

Description

NDC 79903-022-01 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. The product features a hands-free roll-on applicator for ease of use. It is packaged in a 2.5 FL OZ (74 mL) container and is comparable to the active ingredient found in Biofreeze®. The soothing properties of menthol contribute to its effectiveness in pain relief.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains of muscles and joints associated with 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, 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.

For children under 2 years of age, it is advised to consult a healthcare professional before use to determine the appropriate course of action.

Contraindications

The product is contraindicated in the following situations:

Application to wounds or damaged skin is prohibited due to the potential for adverse effects. The use of this product in conjunction with other ointments, creams, sprays, or liniments is not recommended, as it may lead to unpredictable interactions. It should not be applied to irritated skin or if excessive irritation develops, as this may exacerbate the condition. Additionally, tight bandaging is contraindicated to prevent complications. The use of heating pads or heating devices in conjunction with this product is also not advised, as it may increase the risk of adverse reactions.

Warnings and Precautions

For external use only. Healthcare professionals should advise patients to consult a physician prior to use if they have sensitive skin.

When utilizing this product, it is imperative to avoid contact with the eyes. The product should not be applied to wounds or damaged skin, nor should it be used in conjunction with other ointments, creams, sprays, or liniments. Application to irritated skin is contraindicated, and if excessive irritation develops, the product should be discontinued. Additionally, patients should be instructed not to bandage the area tightly and to wash their hands thoroughly with cool water after application. The use of heating pads or other heating devices in conjunction with this product is also not recommended.

Patients must be advised to stop use and seek medical consultation if their condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days.

It is crucial 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 consult a doctor prior to use if the patient has sensitive skin. During the application of this product, patients must avoid contact with the eyes and should not apply it to wounds or damaged skin. Additionally, it is advised not to use this product in conjunction with other ointments, creams, sprays, or liniments, and to refrain from applying it to irritated skin or if excessive irritation develops. Bandaging should not be done tightly, and hands should be washed with cool water after use. The use of heating pads or heating devices in combination with this product is also not recommended.

Patients are instructed 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.

This product is flammable; therefore, it should be kept away from excessive heat or open flame. Pregnant or breastfeeding patients should seek advice from a health professional before using this product. It is crucial to keep this product out of reach of children. In the event of accidental ingestion, medical help should be sought immediately, or the Poison Control Center should be contacted at 1-800-222-1222.

Drug Interactions

Co-administration of this product with other topical formulations, such as ointments, creams, sprays, or liniments, is contraindicated. The combination may lead to altered absorption or increased risk of adverse effects due to overlapping ingredients or mechanisms of action.

Additionally, the use of heating pads or other heating devices in conjunction with this product is not recommended. The application of heat may enhance the absorption of the active ingredients, potentially leading to increased systemic exposure and heightened risk of side effects.

It is advised to monitor for any signs of irritation or adverse reactions when using this product, particularly in patients who may be using other topical therapies or heat sources.

Packaging & NDC

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

Pediatric Use

Pediatric patients aged 2 years and older may apply the medication to the affected area no more than 3-4 times daily. For children under 2 years of age, 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

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 on 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 lack of data 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 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 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

There is currently no available information regarding teratogenic effects. Additionally, no data has been provided concerning non-teratogenic effects. The nonclinical toxicology section does not contain any relevant information at this time. Furthermore, there is no information available related to animal pharmacology and toxicology.

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. 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 should be cautioned to avoid contact with the eyes and not to apply it to wounds or damaged skin. It is important to inform patients that they should not use the product in conjunction with other ointments, creams, sprays, or liniments, and to refrain from applying it to irritated skin or if excessive irritation develops. Additionally, patients should be advised against tightly bandaging the area after application and to wash their hands with cool water after use. They should also be warned not to use the product with heating pads or heating devices.

Lastly, healthcare providers should encourage patients to ask a doctor before use if they have sensitive skin.

Storage and Handling

The product is supplied in a configuration that ensures optimal preservation of its integrity. It is essential to store the product in a cool, dry place, ensuring that the lid is closed tightly to prevent contamination and maintain efficacy. Proper storage conditions are crucial for the longevity and effectiveness of the product.

Additional Clinical Information

Patients aged 2 years and older are advised to apply the medication to the affected area no more than 3-4 times daily. For children under 2 years of age, consultation with a doctor is recommended prior to use.

Clinicians should counsel patients on the following precautions: the product is for external use only; individuals with sensitive skin should consult a doctor before use; pregnant or breastfeeding patients should seek advice from a health professional. It is crucial to keep the product out of reach of children, and in case of ingestion, medical assistance or contact with a Poison Control Center (1-800-222-1222) is necessary. Patients should avoid contact with eyes, do not apply to wounds or damaged skin, and refrain from using it with other topical products. Additionally, the medication should not be applied to irritated skin or if excessive irritation occurs, and it should not be tightly bandaged. Hands should be washed with cool water after application, and the product should be kept away from excessive heat or open flames.

Drug Information (PDF)

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

View product document (PDF)