Winco Cold and Hot Medicated Patch Large

Description

The product is identified by the SPL code 34089-3. No additional specific description details are provided in the available data.

Uses and Indications

This drug is indicated for use in specific patient populations as determined by clinical guidelines. The precise indications and usage have not been explicitly stated in the provided information.

Healthcare professionals are advised to consider the absence of information regarding teratogenic and nonteratogenic effects when prescribing this medication. Further clinical evaluation and consultation of relevant guidelines are recommended to ensure appropriate use in targeted patient populations.

Dosage and Administration

No dosage and administration information is available for this product. Healthcare professionals are advised to consult the prescribing information or relevant clinical guidelines for specific dosing recommendations and administration techniques.

Contraindications

Use is contraindicated in the following situations:

• Application on wounds or damaged skin is prohibited due to the risk of exacerbating the condition or causing irritation.

• Concurrent use with a heating pad is contraindicated, as this may lead to excessive heat and potential skin damage.

• The product should not be used in children under 12 years of age with arthritis-like conditions, as safety and efficacy have not been established in this population.

• Tight bandaging is not recommended, as it may restrict circulation and lead to adverse effects.

• Application immediately after a bath or shower is contraindicated, as this may affect the product's absorption and efficacy.

Warnings and Precautions

For external use only. It is imperative to keep this product out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought by contacting a Poison Control Center at 1-800-222-1222.

General precautions must be observed to ensure safe use. This product should not be applied to wounds or damaged skin, nor should it be used in conjunction with a heating pad. Additionally, it is contraindicated for use in children under 12 years of age who present with arthritis-like conditions.

Healthcare professionals should advise patients to discontinue use and consult a physician if any of the following occur: the condition worsens or symptoms persist beyond 7 days; symptoms resolve only to recur within a few days; or if excessive skin irritation develops.

In all cases of ingestion, prompt medical help is essential.

Side Effects

For external use only. Patients should be advised to stop use and consult a doctor if the condition worsens or if symptoms persist for more than 7 days. Additionally, if symptoms clear up and then recur within a few days, or if excessive skin irritation occurs, medical advice should be sought.

Before using this product, patients are encouraged to ask a doctor if they have redness over the affected area, as this may indicate a more serious condition that requires professional evaluation.

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

Pediatric Use

Pediatric patients under 12 years of age with arthritis-like conditions should not use this medication. For children in this age group, it is advised to consult a healthcare professional prior to use.

For adolescents aged 12 years and older, the medication should not be applied for more than 8 hours at a time and should be used on the affected area no more than 3 times daily.

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.

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 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 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 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 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 text.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. In the event of swallowing the medication, patients should seek medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Patients should be instructed to use the medication only as directed and to avoid contact with eyes or mucous membranes to prevent irritation. It is important to inform patients not to bandage the area tightly, as this may lead to complications.

Patients should also be counseled to discontinue use of the medication at least one hour before taking a bath or shower and to avoid using it immediately after bathing. They should be made aware that if their condition worsens or if symptoms persist for more than seven days, they should stop use and consult a doctor. Additionally, if symptoms clear up and then recur within a few days, or if excessive skin irritation occurs, patients should also stop use and seek medical advice.

Finally, healthcare providers should remind patients to consult a doctor before using the medication if there is any redness over the affected area.

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, maintaining a range of 20-25ºC (68-77ºF). Proper storage conditions are crucial to ensure the integrity and efficacy of the product.

Additional Clinical Information

The medication is administered topically. For adults and children aged 12 years and older, the patch should not be worn for more than 8 hours and may be applied to the affected area no more than three times daily. For children under 12 years of age, it is advised to consult a doctor prior to use.

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

Drug Information (PDF)

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

View product document (PDF)