Sync Ice

Description

sync RELIEF ICE is a cold therapy pain relief gel formulated for the management of sore muscles, backaches, sore joints, and arthritis. This product is presented in a roll-on dosage form, providing ease of application. Each container holds 2.5 fluid ounces (74 ml) of the gel, which is paraben-free and does not contain nonsteroidal anti-inflammatory drugs (NSAIDs), ibuprofen, or salicylate. The product is identified by the National Drug Code (NDC) 82944-300-74. For additional information, visit www.syncrelief.com.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with sore muscles and joints, including those related to arthritis, backache, strains, and sprains.

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

Dosage and Administration

For adults and children aged 12 years and older, the recommended dosage is to apply a thin film of the medication to the affected area no more than four times daily. It is not necessary to massage the area after application.

For children under 12 years of age, it is advised to consult a physician prior to use to determine the appropriate dosage and administration.

Contraindications

The product is contraindicated in the following situations:

Application to wounds or damaged skin is prohibited due to the potential for adverse effects. The use of this product in conjunction with other ointments, creams, sprays, or liniments is not recommended, as it may lead to unpredictable interactions. Application to irritated skin or in cases where excessive irritation develops is contraindicated to prevent further skin damage. Bandaging the area after application is not advised, as it may alter the product's effectiveness. Additionally, the use of heating pads or devices in conjunction with this product is contraindicated due to the risk of increased irritation or adverse reactions.

Warnings and Precautions

For external use only. This product is flammable; therefore, it should be kept away from excessive heat or open flame. Healthcare professionals should advise patients to consult a physician prior to use if they have sensitive skin.

Patients are instructed to discontinue use and seek medical advice if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then reoccur.

In the event of accidental ingestion, it is imperative to obtain emergency medical assistance or contact a Poison Control Center immediately.

Side Effects

Patients should be aware that the product is for external use only and is flammable; it should be kept away from excessive heat or open flame.

In clinical practice, it is advised that patients consult a doctor prior to use if they have sensitive skin.

Patients are instructed to discontinue use and seek medical advice if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then reoccur.

Drug Interactions

Co-administration of this medication with other topical formulations, such as ointments, creams, sprays, or liniments, is contraindicated. The use of heating pads or devices in conjunction with this medication is also not recommended, as it may lead to adverse effects.

There are no specific interactions identified between this medication and laboratory tests. Therefore, no adjustments or special monitoring related to laboratory tests are necessary.

Packaging & NDC

Below are the non-prescription pack sizes of Sync Ice (sync relief ice). 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. For adolescents and children aged 12 years and older, the recommended dosage is to apply a thin film of the product over the affected area no more than four times daily. Massage of the application site is not necessary.

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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in 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 healthcare professional prior to using this medication. There is currently no available data regarding the excretion of this drug in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

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, as the clinical presentation can vary depending on the substance involved. Common symptoms of overdose may include, but are not limited to, respiratory depression, altered mental status, cardiovascular instability, and gastrointestinal disturbances.

In the event of an overdose, immediate medical intervention is recommended. Healthcare providers should initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs. The use of activated charcoal may be considered if the patient presents within a suitable timeframe and is deemed appropriate based on clinical judgment.

Furthermore, it is crucial to consult local poison control centers or toxicology experts for guidance on specific management protocols and antidotes, if applicable. Continuous assessment and supportive measures should be prioritized to ensure patient safety and mitigate potential complications associated with overdose.

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 provided data.

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 help or contact a Poison Control Center immediately.

Patients should be instructed to stop using the product and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then reoccur.

When using this product, it is important to avoid contact with the eyes or mucous membranes. Patients should not apply the product to wounds or damaged skin, and they should refrain from using it in conjunction with other ointments, creams, sprays, or liniments. Additionally, patients should not apply the product to irritated skin or if excessive irritation develops. Bandaging the area after application is not recommended.

Patients should wash their hands with cool water after using the product and should not use it in combination with a heating pad or any heating device. Finally, it is advisable to store the product in a cool, dry place.

Storage and Handling

The product is supplied in a configuration that ensures optimal handling and storage. It is essential to store the product in a cool, dry place to maintain its integrity and effectiveness.

Due to its flammable nature, it is critical to keep the product away from excessive heat sources and open flames to prevent any hazardous situations. Proper storage conditions are vital for ensuring safety and efficacy.

Additional Clinical Information

The medication is administered topically. For adults and children aged 12 years and older, a thin film should be applied no more than four times daily, with massage not being necessary. For children under 12 years of age, it is advised to consult a physician prior to use.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)