Careland Pain Relief Plus

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the temporary relief of pain.

There are no teratogenic effects associated with this drug. Additionally, no nonteratogenic effects have been reported.

Dosage and Administration

Adults and children 12 years of age and over should begin by cleaning and drying the affected area. The backing of the patch must be carefully removed, and the sticky side of the patch should be applied directly to the affected area. Each patch may be used for a maximum duration of 8 hours. After a single use, the patch should be discarded. It is recommended to apply only one patch at a time to the affected area, with a maximum frequency of 3 to 4 applications per day.

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

Contraindications

Use of this product is contraindicated in the following situations:

• Patients with a known allergy to any active or inactive ingredients in the formulation.

• Application of more than one patch on the body simultaneously.

• Application on cut, irritated, or swollen skin, as well as on puncture wounds.

• Use for more than one week without prior consultation with a healthcare professional.

• Use of a damaged or opened pouch.

Additionally, during the use of this product, the following precautions must be observed:

• Avoid contact with the eyes.

• Do not use concurrently with other topical anesthetics.

• Do not apply tight bandages or local heat (e.g., heating pads) to the application site.

• Do not microwave the product.

• Dispose of used patches safely to prevent access by children and pets, as they may still contain active drug that can cause serious adverse effects if ingested.

Warnings and Precautions

For external use only. The product is contraindicated in several scenarios to ensure patient safety. It should not be applied in the following circumstances:

• More than one patch should not be used on the body simultaneously.

• Application is prohibited on cut, irritated, or swollen skin, as well as on puncture wounds.

• The product should not be used for more than one week without prior consultation with a healthcare professional.

• Individuals with known allergies to any active or inactive ingredients should refrain from using the product.

• The product must not be used if the pouch is damaged or opened.

Healthcare professionals should advise patients to discontinue use and seek medical advice if any of the following occur:

• Worsening of the condition.

• Presence of redness or irritation at the application site.

• Symptoms persist beyond 7 days or resolve only to recur within a few days.

• Signs of skin injury, including pain, swelling, or blistering at the site of application.

In the event of accidental ingestion, immediate medical assistance should be sought, or the local poison control center should be contacted without delay.

Side Effects

Patients using this product may experience a range of adverse reactions, which should be monitored closely.

For external use only, the product is contraindicated in several scenarios. Patients should not use more than one patch on their body at a time, nor should they apply it to cut, irritated, or swollen skin, or on puncture wounds. Additionally, the product should not be used for more than one week without consulting a healthcare professional. Patients with known allergies to any active or inactive ingredients should avoid use, as should those with damaged or opened pouches.

While using this product, it is crucial for patients to adhere strictly to the provided directions and warnings. Contact with the eyes must be avoided, and concurrent use with other topical anesthetics is not recommended. Patients should refrain from tightly bandaging the area of application or applying local heat, such as heating pads, and should not microwave the product. Used patches should be disposed of carefully to prevent accidental ingestion by children or pets, as they still contain the drug product, which can lead to serious adverse effects if ingested.

Patients are advised to discontinue use and consult a healthcare provider if any of the following occur: worsening of conditions, presence of redness, development of irritation, persistence of symptoms beyond seven days, or recurrence of symptoms after resolution. Signs of skin injury, including pain, swelling, or blistering at the application site, also warrant immediate medical attention.

In the event of accidental ingestion, patients should seek medical help or contact a poison control center without delay.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Careland Pain Relief Plus (camphor, menthol, methyl salicylate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should consult a physician prior to use. It is important for healthcare professionals to evaluate the appropriateness of treatment in this age group, considering potential differences in efficacy and safety profiles compared to older populations.

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, 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 prescribing information 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 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 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 prescribing information.

Overdosage

In the event of an overdosage, immediate medical assistance is essential. If the product is swallowed, healthcare professionals should advise patients or caregivers to seek medical help or contact a Poison Control Center without delay.

It is important to note that used patches may still contain the drug product, which poses a significant risk. If a child or pet chews or ingests a used patch, it can lead to serious adverse effects. Therefore, proper disposal of used patches is crucial to prevent accidental exposure.

Healthcare providers should remain vigilant and ensure that patients are aware of the potential risks associated with overdosage, including the importance of safeguarding used patches from children and pets.

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 compound in these areas.

Postmarketing Experience

No postmarketing experience details are available in the insert.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a poison control center if the product is swallowed. Patients should be informed that they should not apply more than one patch to their body at a time and should avoid using the patch on cut, irritated, or swollen skin, as well as on puncture wounds.

It is important to counsel patients against using the patch for more than one week without consulting a healthcare professional. Patients should be made aware of the need to discontinue use and consult a doctor if they experience any allergic reactions to the active or inactive ingredients, if the pouch is damaged or opened, or if their condition worsens.

Patients should be instructed to monitor for signs of redness or irritation at the application site. If symptoms persist for more than seven days, or if they clear up and then recur within a few days, patients should seek medical advice. Additionally, they should be informed to watch for signs of skin injury, such as pain, swelling, or blistering where the product was applied.

Healthcare providers should emphasize the importance of using the product only as directed and to read and follow all directions and warnings provided. Patients should be cautioned against allowing the product to come into contact with their eyes and should not use it simultaneously with other topical anesthetics.

Patients should also be advised not to bandage the area tightly or apply local heat, such as heating pads, to the site of application. Microwaving the patch is not permitted. Finally, it is crucial to instruct patients on the proper disposal of used patches, ensuring they are kept out of reach of children and pets, as used patches still contain the drug product that can lead to serious adverse effects if ingested.

Storage and Handling

The product is supplied in a clean, dry package designed to protect it from direct sunlight and excessive heat. It is essential to store the product in a location that maintains these conditions to ensure its integrity and effectiveness.

Each patch is intended for single use only. After use, the patch should be discarded properly, ensuring that it is kept out of reach of children and pets to prevent accidental exposure or ingestion.

Additional Clinical Information

Patients should be informed that the medication is administered topically, with a recommendation to apply one patch at a time to the affected area, not exceeding three to four applications daily. Clinicians should advise patients who are pregnant or breastfeeding to consult a healthcare professional prior to use.

Additionally, it is crucial to instruct patients on the safe disposal of used patches, ensuring they are kept out of reach of children and pets, as these patches may still contain active drug that could lead to serious adverse effects if ingested.

Drug Information (PDF)

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

View product document (PDF)