Rite Aid Hot and Cold Back Patch

Description

Rite Aid Hot and Cold Back Patch is designed for therapeutic use, providing both hot and cold relief for back discomfort. The product is presented in a patch form, suitable for topical application. The effective time for this product is noted as March 1, 2023. The media type associated with the product is image/jpeg, which may be utilized for promotional or informational purposes. The reference value for the packaging is 92-64045 0223 PKG XL Cold Hot.jpg, indicating the specific design and labeling of the product.

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 arthritis, simple backache, bursitis, tendonitis, muscle strains, muscle sprains, bruises, and cramps.

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

Dosage and Administration

Adults and children 12 years of age and over should carefully remove the backing from the patch and apply the sticky side directly to the affected area. Each patch may be worn for a maximum of 8 hours. If necessary, the application may be repeated, but no more than three patches should be used in a 24-hour period. After each use, the patch must be discarded, and the pouch should be resealed to maintain product integrity.

For children under 12 years of age, it is recommended to consult a physician prior to use.

Contraindications

Use of this product is contraindicated in the following situations:

Infants should not be treated with this product due to the potential for adverse effects. Additionally, the product should not be applied to wounds or damaged skin, as this may exacerbate irritation or lead to complications. Contact with eyes and mucous membranes must be avoided to prevent serious irritation. Tight bandaging or the use of heating pads in conjunction with this product is contraindicated, as these practices may increase the risk of adverse reactions. Furthermore, concurrent use with other topical analgesics is not recommended, as this may lead to increased systemic absorption and potential toxicity.

Warnings and Precautions

For external use only. This product is contraindicated for use on infants. In the event of accidental ingestion, immediate medical assistance should be sought by contacting a Poison Control Center at 1-800-222-1222.

Healthcare professionals should advise patients to discontinue use and consult a physician if any of the following occur: worsening of the condition, the presence of redness, development of irritation, persistence of symptoms beyond 7 days, or recurrence of symptoms after a temporary resolution. Additionally, patients should seek medical attention if they experience signs of skin injury, including pain, swelling, or blistering at the site of application.

Side Effects

For external use only. Patients should discontinue use and consult a doctor if any of the following occur: the condition worsens, redness is present, irritation develops, symptoms persist for more than 7 days, or symptoms clear up and then recur within a few days. Additionally, patients should seek medical advice if they experience signs of skin injury, such as pain, swelling, or blistering at the site of application.

Drug Interactions

Concurrent use of this medication with other topical analgesics is contraindicated. The combination may increase the risk of adverse effects without providing additional therapeutic benefit. It is advised to avoid using multiple topical analgesics simultaneously to ensure patient safety and optimize treatment efficacy. Monitoring for any signs of increased local irritation or systemic effects is recommended if there is a concern about overlapping therapies.

Packaging & NDC

Below are the non-prescription pack sizes of Rite Aid Hot and Cold Back Patch (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients should not use this medication if they are infants. For children under 12 years of age, consultation with a physician is advised prior to use.

For adolescents and children aged 12 years and older, the application involves carefully removing the backing from the patch and applying the sticky side to the affected area. A single patch may be worn for up to 8 hours, with the option to repeat the application as necessary, not exceeding three times daily. After each use, the patch must be discarded, and the pouch should be resealed to maintain integrity.

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 safety of this drug during pregnancy has not been established, and potential risks to fetal outcomes are not fully understood. Therefore, it is essential for women of childbearing potential to seek medical advice to weigh the benefits and risks associated with the use of this medication 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 available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

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 initiate supportive care, which may include maintaining airway patency, ensuring adequate ventilation, and monitoring vital signs.

If available, the use of activated charcoal may be considered to limit further absorption of the substance, provided that the patient is alert and able to protect their airway.

In cases where specific antidotes are known, they should be administered as per established protocols. Continuous assessment and supportive measures are critical in managing the patient's condition effectively.

Healthcare professionals are encouraged to report any cases of overdose to the appropriate regulatory authorities and to consult local poison control centers for additional guidance tailored to the specific situation.

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

Rare cases of serious burns have been reported in postmarketing experience with products of this type. These events were identified through voluntary reporting and surveillance programs.

Patient Counseling

Healthcare providers should advise patients that this product is not intended for use on infants. In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately at 1-800-222-1222.

Patients should be instructed to discontinue use and consult a physician if any of the following occur: the condition worsens, redness develops, irritation occurs, symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. Additionally, patients should seek medical advice if they experience signs of skin injury, such as pain, swelling, or blistering at the site of application.

It is essential for patients to use the product only as directed. Providers should inform patients that there have been rare reports of serious burns associated with similar products. Patients should be cautioned against tightly bandaging the area where the product is applied or using it in conjunction with a heating pad.

Healthcare providers should emphasize the importance of avoiding contact with the eyes and mucous membranes, as well as instructing patients not to apply the product to wounds or damaged skin. Furthermore, patients should be advised not to use this product simultaneously with other topical analgesics to prevent potential adverse effects.

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 at room temperature, ensuring that the temperature does not exceed 86°F (30°C). Proper storage conditions are crucial to maintain the integrity and efficacy of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)