Rite Aid Cold and Hot Medicated

Description

Rite Aid Cold & Hot Medicated Patch is a topical dosage form designed for the relief of muscle and joint pain. The patch features a dual-action formulation that provides both cooling and warming sensations to alleviate discomfort. It is intended for external use only and is applied directly to the affected area. The patch is characterized by its adhesive backing, which ensures secure placement on the skin. The specific composition and active ingredients are proprietary, contributing to its therapeutic efficacy. The product is packaged in a manner that maintains its integrity and effectiveness until use.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various musculoskeletal conditions. Specifically, it is effective for alleviating discomfort due to arthritis, bursitis, simple backache, tendonitis, strains, bruises, sprains, and cramps.

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

Dosage and Administration

Adults and children aged 12 years and older may apply the patch to the affected area as needed, with a maximum frequency of four applications per day. For children under 12 years of age, it is advised to consult a physician prior to use.

For optimal application, healthcare professionals should instruct patients to grasp both ends of the pad firmly and pull at both ends to stretch the pad until the backing separates. The protective film should be removed while applying the pad directly to the site of pain.

Contraindications

The product is contraindicated for application to wounds or damaged or very sensitive skin due to the potential for irritation or adverse reactions. Additionally, it should not be used with tight bandaging or in conjunction with heating pads, as these practices may exacerbate skin sensitivity or lead to complications.

Warnings and Precautions

This product is intended for external use only. Healthcare professionals should advise patients to use the product strictly as directed to ensure safety and efficacy. It is imperative to avoid contact with the eyes and mucous membranes, as this may lead to irritation or adverse effects. Additionally, the product should not be applied to wounds, damaged skin, or areas of very sensitive skin to prevent further complications.

When administering this product, it is crucial to avoid tight bandaging or the use of heating pads, as these practices may exacerbate irritation or lead to unwanted side effects.

Patients should be instructed to discontinue use and consult a healthcare provider if they experience excessive redness or irritation, if their condition worsens, if pain persists for more than 7 days, or if symptoms resolve only to recur within a few days.

Furthermore, 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 is recommended.

Side Effects

Patients using this product may experience adverse reactions, which can vary in severity. It is important to note that this product is for external use only and should be applied strictly as directed. Participants are advised to avoid contact with the eyes and mucous membranes, and the product should not be applied to wounds, damaged skin, or very sensitive areas. Additionally, patients should refrain from tightly bandaging the area or using a heating pad in conjunction with the product.

In the event of excessive redness or irritation, or if the condition worsens, patients should discontinue use and consult a healthcare professional. Furthermore, if pain persists for more than 7 days, or if symptoms resolve and then recur within a few days, it is recommended that patients seek medical advice. These precautions are essential to ensure the safe and effective use of the product.

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 Rite Aid Cold and Hot Medicated (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. For adolescents and children aged 12 years and older, the patch may be applied to the affected area as needed, with a maximum frequency of four times daily.

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 potential 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. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. Healthcare providers should consider individual circumstances and the specific health needs of the patient when making recommendations.

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 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 absence of guidance necessitates careful clinical judgment and monitoring.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this drug. 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 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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available in the insert.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. Instruct patients that if the product is swallowed, they should seek medical help or contact a Poison Control Center immediately.

Patients should be informed to stop using the product and consult a doctor if they experience excessive redness or irritation, if their condition worsens, if pain persists for more than 7 days, or if symptoms resolve and then recur within a few days.

When using this product, patients must be reminded to use it only as directed. They should avoid contact with the eyes and mucous membranes, and not apply the product to wounds or damaged or very sensitive skin. Additionally, patients should be cautioned against tightly bandaging the area or using a heating pad in conjunction with the product.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It should be stored at room temperature, ensuring that it is protected from excessive heat. Freezing the product is not recommended, as it may compromise its integrity. Once opened, the product must be discarded to ensure safety and efficacy.

Additional Clinical Information

The medication is administered topically. For adults and children aged 12 years and older, the patch should be applied to the affected area as needed, with a maximum frequency of four times daily. For children under 12 years, it is advised to consult a doctor before use.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Rite Aid Cold and Hot Medicated, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)