Solstice Pain Relieving

Description

No description information is available for the drug.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with muscles and joints. Specifically, it is effective for conditions such as simple backache, arthritis, strains, bruises, and sprains.

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

Dosage and Administration

For adults and children aged 3 years and older, the affected area should be cleaned and dried prior to application. The protective film from the patch must be removed, and the patch should be applied to the affected area. The patch may be applied no more than 3 to 4 times daily. It is important to remove the patch from the skin after a maximum application duration of 8 hours. To facilitate removal, the patch should be wetted with warm water before detaching it from the skin.

For children under 3 years of age, it is recommended to consult a physician for appropriate guidance.

Contraindications

Use is contraindicated in the following situations:

Application on irritated or damaged skin, including wounds, is prohibited due to the risk of exacerbating the condition. Contact with the eyes or mucous membranes should be avoided to prevent irritation or injury. Tight bandaging is contraindicated as it may compromise circulation. The application of heat, such as heating pads, hot water bottles, or lamps, is not recommended, as it significantly increases the risk of serious burns. Additionally, placement on extremely hairy areas of skin should be avoided to minimize irritation during patch removal.

Warnings and Precautions

For external use only. This product is intended solely for topical application and should not be ingested.

General precautions must be observed to ensure safe use. The product should be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is advised. It is imperative to avoid application on irritated or damaged skin, particularly over wounds.

Healthcare professionals should instruct patients to discontinue use and consult a physician 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; excessive skin irritation develops; gastrointestinal symptoms such as nausea, vomiting, abdominal discomfort, diarrhea, or skin rash manifest; or if the patient experiences actual pain, blistering, or burning following application. While a warming or cooling sensation may be expected, any severe discomfort should be addressed.

In cases where the product is used for arthritis-related pain, patients should be advised to seek medical advice if pain persists for more than 10 days, if redness is observed, or if the patient is under 12 years of age.

Emergency medical help should be sought immediately if the product is swallowed, and contacting a Poison Control Center is recommended in such instances.

Side Effects

Patients should be aware that the product is for external use only. In clinical practice, it is advised to discontinue use and consult a healthcare professional if any of the following occur: worsening of the condition, persistence of symptoms beyond 7 days, recurrence of symptoms after initial improvement within a few days, or development of excessive skin irritation.

Additionally, patients should seek medical advice if they experience nausea, vomiting, abdominal discomfort, diarrhea, or a skin rash. It is important to note that while a warming or cooling sensation may be expected after application, actual pain, blistering, or burning should prompt immediate cessation of use and consultation with a healthcare provider.

For patients using the product for arthritis-related pain, it is recommended to stop use and consult a doctor if pain persists for more than 10 days, if redness is observed, or if the product is being used in children under 12 years of age.

Drug Interactions

There are currently no documented drug interactions associated with the use of 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 Solstice Pain Relieving (camphor, menthol, methyl salicylate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 3 years of age should consult a physician prior to use. For children aged 3 years and older, the affected area should be cleaned and dried before applying the patch. The protective film must be removed, and the patch can be applied to the affected area no more than 3 to 4 times daily. It is important to remove the patch from the skin after a maximum application time of 8 hours.

In cases of arthritis-related pain, if symptoms persist for more than 10 days or if redness is present, particularly in children under 12 years of age, medical advice should be sought.

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 should be advised against using this product on irritated or damaged skin, including wounds. It is important for women of childbearing potential to consult a healthcare professional, such as a doctor or pharmacist, prior to use if they have any concerns regarding the safety of this product during pregnancy.

In the event that adverse reactions occur, such as nausea, vomiting, abdominal discomfort, diarrhea, or skin rash, pregnant patients should discontinue use and seek medical advice. Additionally, this product is not recommended for children under 3 years of age; consultation with a physician is advised for this population.

Lactation

There are no specific warnings or recommendations regarding the use of this product in nursing mothers. Additionally, there is no information available about the potential for excretion in breast milk or any associated risks to breastfed infants.

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 overdosage information, it is essential for healthcare professionals to remain vigilant and prepared for potential scenarios involving overdose.

Healthcare providers should be aware that the clinical presentation of an overdose may vary depending on the substance involved and the individual patient’s characteristics. Symptoms of overdose can range from mild to severe and may include altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

In the event of suspected overdosage, immediate medical evaluation is recommended. Healthcare professionals should assess the patient's vital signs and conduct a thorough clinical examination. Supportive care should be initiated as necessary, which may include airway management, intravenous fluids, and monitoring of vital parameters.

If specific antidotes or treatments are available for the substance involved, they should be administered according to established protocols. Consultation with a poison control center or a medical toxicologist may also be beneficial in managing the case effectively.

It is crucial to document all findings and interventions in the patient's medical record to ensure continuity of care and facilitate any necessary follow-up.

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

Reports of unexpected side effects associated with the use of this product have been received through voluntary submissions and surveillance programs. Healthcare professionals and consumers are encouraged to report any adverse events to the FDA MedWatch Program. Serious side effects can also be reported by contacting the designated phone number at 888-221-3496, available Monday through Friday from 9 am to 5 pm.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children. In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately.

Patients should be instructed not to use the product on irritated or damaged skin, particularly on wounds. They should be informed to discontinue use and consult a doctor 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, excessive skin irritation develops, or if they experience nausea, vomiting, abdominal discomfort, diarrhea, or a skin rash. Additionally, patients should seek medical advice if they feel actual pain or experience blistering or burning after application, noting that a warming or cooling sensation is expected.

For those using the product for arthritis pain, it is important to inform them to stop use and consult a doctor if pain persists for more than 10 days, if redness is present, or if the product is being used for conditions affecting children under 12 years of age.

While using this product, patients should be cautioned to avoid contact with the eyes or mucous membranes. They should not bandage the area tightly or apply heat in the form of heating pads, hot water bottles, or lamps, as this increases the risk of serious burns. Patients should also be advised to avoid applying the product to extremely hairy areas of skin to prevent irritation during patch removal.

Finally, patients should be encouraged to consult a doctor or pharmacist if they have any concerns regarding the use of this product.

Storage and Handling

Patches are supplied in a zip-lock pouch, which must be kept tightly closed to maintain product integrity. It is essential to store the patches in a cool, dry place, avoiding exposure to excessive heat to ensure optimal performance and longevity.

Additional Clinical Information

The product is administered topically, with patches applied to the affected area no more than 3 to 4 times daily. Each patch should be removed after a maximum application time of 8 hours. Clinicians should advise patients to report any unexpected side effects to the FDA MedWatch Program. Additionally, it is crucial to keep the product out of reach of children; if ingested, medical assistance or contact with a Poison Control Center should be sought immediately.

Drug Information (PDF)

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

View product document (PDF)