Kroger Hot and Cold Medicated Patch

Description

The product is identified by SPL code 34089-3 and is presented as a white to off-white, round, biconvex tablet, which is debossed with "A" on one side and "123" on the opposite side. Each tablet contains 500 mg of Acetaminophen as the active ingredient. The formulation includes several inactive ingredients: microcrystalline cellulose, croscarmellose sodium, magnesium stearate, hypromellose, polyethylene glycol, titanium dioxide, iron oxide red, and iron oxide yellow.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains of muscles and joints associated with various conditions, including arthritis, simple backache, bursitis, tendonitis, strains, sprains, bruises, and cramps.

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

Dosage and Administration

Adults and children aged 12 years and older 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 four patches should be applied in a 24-hour period. After opening, the pouch should be resealed to maintain the integrity of the remaining patches.

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

Contraindications

Use is contraindicated in the following situations:

• The product should not be used on infants.

• Application is contraindicated if the condition worsens, if redness is present, or if irritation develops.

• If symptoms persist for more than 7 days or resolve and then recur within a few days, use is contraindicated.

• Avoid tight bandaging or the use of heating pads in conjunction with this product.

• Contact with eyes and mucous membranes must be avoided.

• Do not apply to wounds or damaged skin.

Warnings and Precautions

For external use only. This product is not intended for use on infants. In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

Healthcare professionals should advise patients to discontinue use and consult a physician under the following circumstances: if the condition worsens, if redness occurs, if irritation develops, or if symptoms persist for more than seven days or resolve only to recur within a few days.

In cases of ingestion, it is imperative to obtain emergency medical help or contact a Poison Control Center immediately.

Side Effects

Patients should be aware that the product is for external use only. In clinical practice, it is advised that patients discontinue use and consult a healthcare professional under certain circumstances. Specifically, patients should seek medical advice if their condition worsens, if redness is present, if irritation develops, or if symptoms persist for more than 7 days or resolve only to recur within a few days. These recommendations are based on clinical observations and are intended to ensure patient safety and effective management of their condition.

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

Pediatric Use

Pediatric patients should be closely monitored, and the product must be kept out of reach of children. It is contraindicated for use in infants. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is advised. For children under 12 years of age, consultation with a physician is recommended prior to use.

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 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 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 toxicology experts for guidance on specific management protocols and interventions that may be appropriate based on the clinical scenario.

Documentation of the incident, including the amount and timing of the substance taken, is crucial for effective management and follow-up care.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to use the medication only as directed. It is important to inform patients not to bandage the area tightly or use a heating pad in conjunction with the medication, as this may lead to adverse effects.

Patients should be cautioned to avoid contact with the eyes and mucous membranes to prevent irritation or injury. Additionally, healthcare providers should instruct patients not to apply the medication to wounds or damaged skin, as this could compromise healing or exacerbate the condition.

Storage and Handling

The product is supplied in resealable pouches. After opening, it is essential to reseal the pouch to maintain product integrity. The product should be stored at room temperature to ensure optimal quality and effectiveness.

Additional Clinical Information

The product is administered topically, with specific instructions for different age groups. Adults and children aged 12 years and older should carefully remove the backing from the patch and apply the sticky side to the affected area, wearing it for up to 8 hours. This can be repeated as necessary, but no more than four times daily. For children under 12 years of age, consultation with a physician is advised.

Clinicians should counsel patients to use the product only as directed, avoiding tight bandaging or use with heating pads, and to prevent contact with eyes and mucous membranes. The product should not be applied to wounds or damaged skin. Patients are advised to discontinue use and consult a doctor if the condition worsens, if redness or irritation occurs, or if symptoms persist for more than 7 days or recur shortly after resolution. Pregnant or breastfeeding patients should seek advice from a health professional before use.

Drug Information (PDF)

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

View product document (PDF)