Pain Relief Cold Therapy Gel 3 Fl Oz

Description

Pain Relief Cold Therapy Gel is presented in a 3 fluid ounce (FL OZ) dosage form. This topical formulation is designed for the relief of pain through cold therapy. The gel is characterized by its specific consistency and appearance, suitable for application to affected areas.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with sore muscles and joints. Specifically, it is effective for conditions such as arthritis, backache, strains, 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 areas, not exceeding four applications per day. It is not necessary to massage the area after application.

For children under 2 years of age, it is recommended to consult a physician prior to use to ensure safety and appropriateness of treatment.

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, to prevent exacerbation of the condition. Bandaging the area after application is contraindicated, as it may alter the product's effectiveness and increase the risk of irritation. Additionally, the use of heating pads or devices in conjunction with this product is not advised, as it may enhance absorption and lead to increased side effects. Contact with the eyes or mucous membranes must be avoided to prevent irritation or injury.

Warnings and Precautions

For external use only. This product is flammable; it must be kept away from excessive heat or open flame to prevent fire hazards.

Healthcare professionals should advise patients to consult a physician prior to use if they have sensitive skin. During application, it is crucial to avoid contact with the eyes and mucous membranes. 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. Patients should refrain from applying the product to irritated skin or if excessive irritation develops. Additionally, bandaging the area after application is not recommended. It is important for users to wash their hands with cool water after use and to avoid using the product with heating pads or devices.

In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center (1-800-222-1222) should be contacted.

Patients should be instructed to discontinue use and consult their healthcare provider if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur.

Side Effects

Patients using this product should be aware of several important safety warnings and potential adverse reactions. This product is intended for external use only and is flammable; therefore, it should be kept away from excessive heat or open flames.

When using this product, patients are advised to avoid contact with the eyes or mucous membranes and not to apply it to wounds or damaged skin. It is also recommended that patients refrain from using this product in conjunction with other ointments, creams, sprays, or liniments, and to avoid application on irritated skin or if excessive irritation develops. Bandaging the area after application is not advised, and patients should wash their hands with cool water after use. Additionally, the use of heating pads or devices in conjunction with this product is not recommended.

Patients should discontinue use and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur. It is also advisable for patients with sensitive skin to seek medical advice before using this product.

This product should be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center (1-800-222-1222) is recommended.

Drug Interactions

Co-administration of this medication with other topical formulations, such as ointments, creams, sprays, or liniments, is contraindicated. The use of multiple topical agents may lead to increased risk of adverse effects or reduced efficacy of the treatment.

Additionally, the application of this medication in conjunction with heating pads or devices is not recommended. The combination may enhance local heat and increase the risk of skin irritation or other adverse reactions.

It is advised to monitor the treatment area closely for any signs of irritation or adverse effects when using this medication, particularly in the absence of other topical agents or heating devices.

Packaging & NDC

Below are the non-prescription pack sizes of Pain Relief Cold Therapy Gel 3 Fl Oz (menthol 4% gel). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 2 years and older may apply a thin film of the product over affected areas up to four times daily, without the need for massage. For children under 2 years of age, consultation with a physician is advised prior to use.

It is important to keep the product out of reach of children. In the event of accidental ingestion, medical assistance should be sought immediately, or contact a Poison Control Center at 1-800-222-1222.

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 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 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.

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 accidental ingestion, it is imperative to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222. Prompt action is crucial to ensure the safety and well-being of the individual affected by the overdosage.

Healthcare professionals should be aware that symptoms of overdosage may vary depending on the substance involved. Therefore, a thorough assessment of the patient's condition is essential. Monitoring vital signs and conducting a comprehensive evaluation will aid in determining the appropriate course of action.

Management of overdosage should be tailored to the specific circumstances and may include supportive care, symptomatic treatment, and, if indicated, the administration of antidotes. It is vital to follow established protocols and guidelines for the management of overdosage to mitigate potential complications and ensure optimal patient outcomes.

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 compound in these areas.

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 at 1-800-222-1222 if the product is accidentally ingested. It is important to instruct patients to avoid contact with the eyes and mucous membranes to prevent irritation.

Patients should be informed not to apply the product to wounds or damaged skin, and to refrain from using it in conjunction with other ointments, creams, sprays, or liniments. They should also be cautioned against applying the product to irritated skin or if excessive irritation develops. Additionally, patients should be advised not to bandage the area after application.

Healthcare providers should emphasize the importance of washing hands with cool water after using the product. Patients should be informed that the product should not be used with heating pads or devices, as this may lead to adverse effects.

Before using the product, patients with sensitive skin should be encouraged to consult with their healthcare provider. They should also be instructed to discontinue use and seek medical advice if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product in a cool, dry place to maintain its integrity and effectiveness. Proper storage conditions are crucial to ensure the product remains within its specified temperature range and is protected from moisture.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Pain Relief Cold Therapy Gel 3 Fl Oz, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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