Cold and Hot Pain Relief Sleeve

Description

The drug is identified by SPL Code 34089-3 and is presented as a white to off-white, round, biconvex tablet, which is debossed with "XYZ" on one side and "123" on the opposite side. Each tablet contains 500 mg of the active ingredient. The formulation includes inactive ingredients such as lactose monohydrate, microcrystalline cellulose, magnesium stearate, and sodium starch glycolate. The tablets are supplied in bottles containing 100 units.

Uses and Indications

This drug is indicated for the temporary relief of minor pain associated with various musculoskeletal conditions, including arthritis, bursitis, tendonitis, muscle strains, muscle sprains, bruises, and cramps.

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

Dosage and Administration

The affected area should be cleaned and dried prior to application. For adults and children over 12 years of age, the following steps should be followed:

1. Open the pouch and remove the Sleeve.

2. Take out the clear plastic insert.

3. Position the Sleeve over the knee, large ankle, or elbow, ensuring that the colored section, which contains the medication, is placed directly on the affected area.

4. Pull the Sleeve over itself to ensure that the medication makes direct contact with the skin.

5. Apply one Sleeve to the affected area.

The application may be repeated as necessary, but should not exceed four times per day. The Sleeve should fit snugly, but not tightly, to ensure proper delivery of the medication.

For children aged 12 years or younger, it is advised to consult a doctor before use.

Contraindications

Use of this product is contraindicated in the following situations:

Tight bandaging or the application of a heating pad is not recommended, as this may exacerbate 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 further complications or delayed healing.

Warnings and Precautions

This product is intended for external use only. Healthcare professionals should advise patients to use the product strictly as directed. It is imperative to avoid bandaging tightly or using the product in conjunction with a heating pad, as these practices may lead to adverse effects.

Contact with the eyes and mucous membranes must be avoided to prevent irritation or injury. Additionally, the product should not be applied to wounds or damaged skin, as this may exacerbate the condition or lead to complications.

Patients should be instructed to discontinue use and seek medical advice if any of the following occur: the condition worsens, symptoms persist for more than 7 days, symptoms resolve and then recur within a few days, redness is observed, or irritation develops.

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

Side Effects

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

In the event that the condition worsens, symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days, patients are advised to stop use and consult a doctor. The presence of redness or the development of irritation also warrants discontinuation of use and medical consultation.

Additionally, if the product is swallowed, immediate medical assistance should be sought, or the patient should contact a Poison Control Center without delay.

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 Pain Relief Sleeve (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients 12 years of age or younger should consult a healthcare professional before use. It is important to assess the appropriateness of treatment and dosage for this age group, as specific recommendations may vary based on individual health needs and conditions.

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 potential 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 potential risks and benefits must be carefully weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure the safety of both the mother and the developing fetus.

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 no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data 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 drug. 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; therefore, a thorough assessment by a medical professional is recommended to determine the appropriate course of action and management procedures.

Healthcare providers should ensure that patients are aware of the importance of timely reporting of any overdosage incidents to facilitate effective treatment and minimize risks.

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 seek immediate medical assistance or contact a Poison Control Center if the product is swallowed. It is important to instruct patients to discontinue use and consult a doctor if their condition worsens or if symptoms persist for more than 7 days. Patients should also be informed to stop using the product and seek medical advice if symptoms clear up and then recur within a few days, or if any redness or irritation develops.

When discussing the use of this product, healthcare providers should emphasize the importance of using it only as directed. Patients should be cautioned against bandaging the area tightly or using a heating pad in conjunction with the product. Additionally, it is crucial to advise patients to avoid contact with the eyes and mucous membranes, and to refrain from applying the product to wounds or damaged skin.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at room temperature, ensuring it is kept in a cool, dry place to maintain its integrity. Freezing the product is strictly prohibited, as it may compromise its effectiveness. Additionally, once opened, the product must be discarded to ensure safety and efficacy.

Additional Clinical Information

The product is administered topically, with a recommended application of one Sleeve to the affected area, which may be repeated as necessary, not exceeding four times a day. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. Additionally, it is important to keep the product out of reach of children; if ingested, medical assistance or contact with a Poison Control Center should be sought immediately.

No further information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)