Sinsinpas Cold

Description

SINSINPAS COLD PATCH is a topical formulation designed for the relief of cold-related discomfort. The product is presented in a patch form, which allows for localized application. The effective date of this formulation is May 14, 2018. The labeling for SINSINPAS COLD PATCH is documented in an image/jpeg format, referenced as SINSIN COLD PATCH LABEL.jpg.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains of muscles and joints associated with various conditions, including arthritis, simple backache, strains, bruises, and sprains.

Limitations of Use: There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Adults and children aged 12 years and older should begin by cleaning and drying the affected area thoroughly. The patch should then be removed from its protective film and applied directly to the affected area. The patch may be applied no more than 3 to 4 times daily, with a maximum duration of 7 days. It is important to remove the patch from the skin after a maximum of 8 hours of application.

For children under 12 years of age, it is recommended to consult a healthcare professional before use.

Contraindications

Use is contraindicated in children due to the risk of accidental ingestion. In the event of swallowing, immediate medical assistance should be sought by contacting a Poison Control Center at 1-800-222-1222.

Warnings and Precautions

For external use only. This product is contraindicated in the following situations: it should not be applied to wounds or damaged skin, used by individuals with known allergies to any of its ingredients, utilized in conjunction with a heating pad, or applied simultaneously with other external analgesic products.

When using this product, it is imperative to adhere strictly to the directions provided. Users should avoid contact with the eyes, mucous membranes, or any rashes. Additionally, it is advised not to apply a tight bandage over the area of application.

Healthcare professionals should counsel patients to consult a doctor prior to use if they have a history of allergic reactions to aspirin or salicylates.

Patients must discontinue use and seek medical advice if any of the following occur: rash, itching, or excessive skin irritation; worsening of the condition; persistence of symptoms beyond 7 days; or if symptoms resolve and then recur within a few days.

For individuals who are pregnant or breastfeeding, it is essential to consult a health professional before using this product.

In the event of accidental ingestion, immediate medical assistance should be sought, or contact should be made with a Poison Control Center at 1-800-222-1222.

Side Effects

Patients using this product should be aware that it is for external use only and should not be applied to wounds or damaged skin. It is contraindicated in individuals with known allergies to any of the product's ingredients, and it should not be used in conjunction with heating pads or other external analgesic products.

During the use of this product, patients are advised to follow the directions carefully and avoid contact with the eyes, mucous membranes, or rashes. Additionally, tight bandaging of the area where the product is applied should be avoided.

Patients who are prone to allergic reactions from aspirin or salicylates should consult a healthcare professional before using this product.

Patients should discontinue use and seek medical advice if they experience any of the following: rash, itching, or excessive skin irritation; worsening of their condition; persistence of symptoms beyond 7 days; or if symptoms resolve and then recur within a few days.

Furthermore, it is recommended that pregnant or breastfeeding individuals consult a healthcare professional prior to use to ensure safety for both the mother and child.

Drug Interactions

The use of this product is contraindicated in conjunction with other external analgesic products. Co-administration may lead to an increased risk of adverse effects due to overlapping pharmacological actions.

No specific drug or laboratory test interactions have been identified in the available data. Therefore, routine monitoring for interactions with other medications or laboratory tests is not necessary.

Packaging & NDC

Below are the non-prescription pack sizes of Sinsinpas Cold (l-menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional prior to use. For adolescents aged 12 years and older, the recommended application is to the affected area no more than 3 to 4 times daily for a maximum of 7 days. The patch should be removed from the skin after a maximum application time of 8 hours.

It is essential to keep this product out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact a Poison Control Center at 1-800-222-1222.

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. It is essential to evaluate the potential risks and benefits associated with its use during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data on 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

Patients with renal impairment have not been specifically addressed in the available data 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 information necessitates careful clinical judgment and monitoring.

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 from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

If available, specific antidotes or treatments should be administered as indicated based on the clinical scenario and the substance involved. Continuous assessment and supportive care are critical in managing the patient's condition effectively.

Healthcare professionals are encouraged to report any cases of overdose to the appropriate regulatory authorities to enhance the understanding of the substance's safety profile and to contribute to the body of knowledge regarding its use.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. In the event that the medication is swallowed, patients should be instructed to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222 for assistance. It is important for patients to understand the potential risks associated with accidental ingestion and the necessary steps to take in such situations.

Storage and Handling

The product is supplied in a configuration that ensures optimal usability. It should be stored at room temperature to maintain its integrity and effectiveness. It is essential to keep the product out of reach of children to prevent accidental ingestion. Once opened, the product must be discarded to ensure safety and efficacy.

Additional Clinical Information

The medication is administered topically, with a recommended application to the affected area no more than 3 to 4 times daily for a duration of 7 days. It is important to remove the patch from the skin after a maximum of 8 hours of application.

Clinicians should counsel patients to keep the medication out of reach of children and to seek medical assistance or contact a Poison Control Center immediately if swallowed (1-800-222-1222). Additionally, patients who are pregnant or breastfeeding should consult a healthcare professional prior to use.

Drug Information (PDF)

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

View product document (PDF)