Dollar General Cold-Hot Medicated Patches

Description

Dollar General Cold-Hot Medicated Patches are designed for topical application to provide localized relief. The patches are formulated to deliver a combination of cold and heat therapy, aiding in the management of pain and discomfort. The effective time for these patches is noted as July 1, 2020.

Uses and Indications

This drug is indicated for the temporary relief of minor pain associated with various conditions, including 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 over 12 years of age 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 12 years of age or younger, it is recommended to consult a physician prior to use.

Contraindications

Use of this product is contraindicated in the following situations:

Tight bandaging or application with a heating pad is not recommended, as this may lead to adverse effects. Contact with eyes and mucous membranes should be avoided to prevent irritation or injury. Additionally, application to wounds or damaged skin is contraindicated due to the risk of exacerbating the condition or causing further harm.

Warnings and Precautions

For external use only. Healthcare professionals should advise patients to discontinue use and consult a physician if the condition worsens, if redness or irritation develops, or if symptoms persist for more than 7 days or resolve and then recur within a few days.

In cases of ingestion, immediate medical assistance should be sought, or contact with Poison Control is recommended.

General precautions must be observed to ensure safe use. Patients should be instructed to use the product only as directed. It is important to avoid tightly bandaging the area of application or using the product in conjunction with a heating pad. Additionally, contact with the eyes and mucous membranes should be strictly avoided, and the product should not be applied to wounds or damaged skin.

No specific laboratory tests are recommended for monitoring in relation to this product.

Side Effects

Patients should be aware that the product is intended for external use only. In the event of worsening conditions, the presence of redness, the development of irritation, or if symptoms persist for more than 7 days or resolve and then recur within a few days, it is advised to stop use and consult a healthcare professional. These precautions are essential to ensure the safety and well-being of individuals using the product.

Drug Interactions

There are no specific drug interactions reported for this medication. Additionally, no laboratory test interactions have been identified in the available data. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Dollar General Cold-Hot Medicated Patches (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients 12 years of age or younger should be evaluated by a physician prior to use. It is essential to consider the specific needs and conditions of this age group to ensure appropriate care and treatment.

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 before using this medication. The safety of this drug during pregnancy has not been established, and potential risks to fetal outcomes are not fully known. Therefore, it is essential for women of childbearing potential to seek medical advice prior to use to ensure appropriate management and consideration of any potential risks.

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 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 question. Further studies may be necessary to fully evaluate the nonclinical toxicology profile.

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 a resealable pouch, which should be resealed after each use to maintain product integrity. It is essential to keep the product out of reach of children to ensure safety. Specific temperature ranges and container requirements are not provided; however, general best practices for storage should be followed to preserve the quality of the product. Special handling needs are not indicated, but care should be taken to avoid exposure to conditions that may compromise the product.

Additional Clinical Information

The route of administration for the medication is topical. For adults and children over 12 years, the patch should be applied by carefully removing the backing and placing the sticky side on the affected area. Each patch can be worn for up to 8 hours, with a maximum of 4 applications per day. For children aged 12 years or younger, consultation with a physician is advised prior to use.

Clinicians should counsel patients to use the medication only as directed. Patients are advised not to bandage the area tightly or use a heating pad in conjunction with the patch. It is important to avoid contact with eyes and mucous membranes, and the patch should not be applied to wounds or damaged skin. Pregnant or breastfeeding patients should seek advice from a health professional before using the product.

Drug Information (PDF)

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

View product document (PDF)