Cold Zone Pain Relieving Gel- Rite Aid

Description

Cold Zone Pain Relieving Gel is a topical formulation developed by Rite Aid. The active ingredient in this gel is menthol, which is known for its analgesic properties. The product is designed to provide localized relief from pain through its cooling effect. The gel is intended for external use and is packaged in a convenient dosage form 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. Concurrent use with other ointments, creams, sprays, or liniments is not recommended, as this may lead to unpredictable interactions. The product should not be applied to irritated skin or in cases where excessive irritation develops, as this could exacerbate the condition. Bandaging the area after application is contraindicated to prevent occlusion. Additionally, the use of heating pads or devices in conjunction with the product is not advised, as this may increase the risk of irritation or other adverse reactions.

Warnings and Precautions

For external use only. It is imperative to avoid contact with the eyes or 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. Application to irritated skin is contraindicated, and if excessive irritation develops, use should be discontinued. Bandaging the area after application is not recommended. Following use, hands should be washed thoroughly with cool water. Additionally, the product should not be used in conjunction with heating pads or devices.

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

Healthcare professionals should instruct patients to discontinue use and consult a physician if the condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur.

Side Effects

For external use only. Patients should discontinue use and consult a healthcare professional if the condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur. Individuals with sensitive skin are advised to seek medical advice before using this product. No specific adverse reactions or side effects have been reported in clinical trials or postmarketing experiences.

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 other heating devices is not recommended. The combination may enhance local irritation or lead to unintended pharmacological effects.

It is advised to monitor the application site for any signs of irritation or adverse reactions 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 Cold Zone Pain Relieving Gel- Rite Aid (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 2 years of age should consult a physician prior to use. For children aged 2 years and older, the recommended dosage is to apply a thin film over the affected areas no more than four times daily. Massage of the application site is not necessary.

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. 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 considered, 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 not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

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 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 implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

Additionally, it is recommended to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols and antidotes, if applicable.

Documentation of the incident, including the substance involved, estimated dose, and time of exposure, is crucial for effective management 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 limits the assessment of potential risks associated with the use of the compound in these contexts.

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 accidentally ingested. Patients should be instructed to 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.

When using this product, it is important to inform patients to avoid contact with the eyes and mucous membranes. They should not apply the product to wounds or damaged skin, nor should they use it in conjunction with other ointments, creams, sprays, or liniments. Patients should be cautioned against applying the product to irritated skin or if excessive irritation develops, and they should refrain from bandaging the area after application. It is also essential to remind patients to wash their hands with cool water after use and to avoid using the product with a heating pad or any heating device.

Additionally, healthcare providers should encourage patients to consult a doctor before using the product if they have sensitive skin.

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, away from excessive heat or open flame to maintain its integrity and efficacy. Proper handling should be observed to ensure the product remains within the recommended storage conditions.

Additional Clinical Information

The product is administered topically, with a recommended application of a thin film over affected areas for adults and children aged 2 years and older, not exceeding four times daily. For children under 2 years of age, consultation with a physician is advised.

Clinicians should counsel patients on important safety information, including that the product is for external use only and is flammable, necessitating avoidance of excessive heat or open flames. Patients should be instructed to avoid contact with eyes and mucous membranes, and not to apply the product to wounds, damaged, or irritated skin. It is also advised not to use the product in conjunction with other topical treatments or to bandage the area. Patients should wash their hands with cool water after application and refrain from using heating pads or devices. They should discontinue use and consult a doctor if the condition worsens, persists beyond 7 days, or if symptoms clear and recur. Pregnant or breastfeeding individuals should seek professional advice before use, and the product should be kept out of reach of children, with immediate medical assistance sought in case of accidental ingestion.

Drug Information (PDF)

This file contains official product information for Cold Zone Pain Relieving Gel- Rite Aid, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)