Cold and Hot Medicated Pain Relief Small

Description

Best Choice Cold and Hot Small Medicated Patch is a topical dosage form designed for localized relief. The patch is formulated to provide both cold and hot therapy, catering to various therapeutic needs. It is characterized by its small size, allowing for targeted application on affected areas. The patch is designed for ease of use and is intended for temporary relief of minor aches and pains.

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. The sticky side of the patch must be applied directly to the affected area of the skin. This application may be repeated as necessary, but should not exceed four times daily.

The route of administration is transdermal, and it is essential to ensure that the patch is securely adhered to the skin for optimal effectiveness.

Contraindications

Use of this product is contraindicated in infants.

Additionally, the following precautions must be observed: do not apply tightly bandaged or in conjunction with a heating pad, as this may lead to adverse effects. Contact with eyes and mucous membranes should be avoided to prevent irritation. Application to wounds or damaged skin is also contraindicated due to the risk of exacerbating the condition.

Warnings and Precautions

For external use only. This product should be utilized strictly as directed to ensure safety and efficacy. It is imperative to avoid bandaging tightly or using in conjunction with a heating pad, as these practices may lead to adverse effects. Care should be taken to prevent contact with the eyes and mucous membranes, and the product must not be applied to wounds or damaged skin.

Healthcare professionals should advise patients to discontinue use and seek medical advice if any of the following occur: the condition worsens, redness is observed, irritation develops, or symptoms persist for more than 7 days. Additionally, if symptoms resolve and then recur within a few days, medical consultation is recommended.

In the event of accidental ingestion, immediate medical assistance should be sought, or the local Poison Control Center should be contacted without delay.

For individuals who are pregnant or breastfeeding, it is essential to consult a healthcare professional prior to use to ensure safety for both the mother and child.

This product should be kept out of reach of children. For children aged 12 years or younger, consultation with a doctor is advised before use, and it should not be applied to infants.

Side Effects

Patients using this product should be aware that it is for external use only. It is essential to use the product only as directed and to avoid bandaging tightly or using it in conjunction with a heating pad. Contact with eyes and mucous membranes should be avoided, and the product should not be applied to wounds or damaged skin.

In clinical practice, patients are advised to discontinue use and consult a healthcare professional if any of the following occur: worsening of the condition, presence of redness, development of irritation, or if symptoms persist for more than 7 days or resolve and then recur within a few days.

For pregnant or breastfeeding individuals, it is recommended to seek advice from a health professional prior to use. Additionally, this product should be kept out of reach of children. For children aged 12 years or younger, consultation with a doctor is necessary before use, and it should not be applied to infants. In the event of accidental ingestion, immediate medical assistance should be sought or contact with a Poison Control Center is advised.

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 Cold and Hot Medicated Pain Relief Small (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients 12 years of age or younger should consult a doctor prior to use. The product is not indicated for infants. It is essential to keep the product out of reach of children. In the event of accidental ingestion, medical assistance should be sought immediately, or contact a Poison Control Center.

For patients over 12 years of age, the sticky side of the patch should be applied to the affected area, with the option to repeat application as necessary, not exceeding 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 adverse effects or changes in therapeutic response, 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 potential risks and benefits must be carefully considered in these populations to ensure the safety of both the mother and the fetus or infant.

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 drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this medication. Consequently, there are no 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 intervention is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical assistance or contact a Poison Control Center without delay.

Prompt action is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and evaluation are recommended to ensure patient safety and effective resolution of any complications arising from the overdosage.

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 elucidate these aspects of nonclinical toxicology.

Postmarketing Experience

No postmarketing experience details are provided in the insert.

Patient Counseling

Healthcare providers should advise patients to consult a doctor before using this product on children aged 12 years or younger, and to avoid its use on infants. In the event of accidental ingestion, patients should seek medical help or contact a Poison Control Center immediately.

Patients should be instructed to discontinue use and consult a doctor if their condition worsens, if redness appears, if irritation develops, or if symptoms persist for more than 7 days. Additionally, if symptoms clear up and then recur within a few days, patients should also seek medical advice.

It is important for patients to use this product only as directed. They should be cautioned against bandaging the area tightly or using a heating pad in conjunction with the product. Patients must also be reminded to avoid contact with the eyes and mucous membranes, and not to apply the product to wounds or damaged skin.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers. It should be stored at room temperature, ensuring that it is protected from light exposure. Freezing the product is not permitted, as it may compromise its integrity. Once opened, the product must be discarded to maintain safety and efficacy.

Additional Clinical Information

The product is administered topically, with instructions for adults and children over 12 years to carefully remove the backing from the patch and apply the sticky side to the affected area. This application may be repeated as necessary, but should not exceed four times daily.

Clinicians should counsel patients that the product is for external use only. Patients are advised to use the product as directed, avoiding tight bandaging or the use of heating pads, and to prevent contact with eyes and mucous membranes. It should not be applied to wounds or damaged skin. Patients should discontinue use and consult a doctor if the condition worsens, if redness or irritation occurs, if symptoms persist for more than seven days, or if symptoms clear up and recur within a few days. Pregnant or breastfeeding patients should seek advice from a healthcare professional before use. The product should be kept out of reach of children, and use in children 12 years or younger should be discussed with a doctor. It should not be used on infants, and in case of ingestion, medical help or contact with a Poison Control Center is recommended.

Drug Information (PDF)

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

View product document (PDF)