Sheng Chun Herbal

Description

The "SHENG CHUN" Herbal Patch is a pain-relieving patch designed for topical application. Each package contains three patches, each measuring 11 x 15 cm (4.3 x 5.9 inches). The product is identified by its distinctive green color. It is manufactured by Sheng Chun Tang Pharmaceutical Industrial Co., Ltd. in Taiwan and is distributed by Albert Max, located at 13859 Redwood Ave., Chino, CA 91710, USA. The patches are produced in Taiwan.

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, strains, bruises, sprains, and simple backaches. It is specifically indicated for the temporary relief of muscle and joint discomfort related to arthritis.

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

Dosage and Administration

Adults and children 12 years of age and older should first clean and dry the affected area before application. The patch must be removed from its protective layer and applied directly to the affected area. It is recommended to rub the area gently with the hand to ensure the patch adheres securely. Each patch will remain effective for a duration of 8 hours.

Healthcare professionals should advise patients to avoid using the same patch on the same area for more than 2 consecutive days. Additionally, the patch should not be applied to areas with excessive hair, as this may hinder adhesion and cause discomfort upon removal. To facilitate removal, it is advisable to wet the patch with warm water before detaching it from the skin.

For children under 12 years of age, the use of this patch is not recommended; consultation with a healthcare provider is necessary before considering its use.

Contraindications

Use of this product is contraindicated in the following situations:

• Application on wounds is prohibited due to the risk of exacerbating the injury.

• The product should not be applied to irritated or damaged skin, as this may lead to further irritation or adverse reactions.

• Use on sensitive skin is contraindicated to prevent potential adverse effects.

• Concurrent use with a heating pad is not recommended, as it may increase the risk of skin irritation or burns.

• The product is contraindicated in pregnant individuals due to potential risks to the fetus.

• Simultaneous use with other external analgesic products is not advised, as it may lead to increased systemic absorption and heightened risk of side effects.

• Individuals with a known allergy to aspirin or salicylates should not use this product to avoid allergic reactions.

• Use is contraindicated in patients with known allergies to any ingredients contained in this formulation.

Warnings and Precautions

For external use only; the product must not be used in any manner other than as directed.

To ensure safety, it is imperative to keep this product out of reach of children to prevent accidental poisoning. In the event of an overdose, immediate medical assistance should be sought, or a Poison Control Center should be contacted without delay.

The product is contraindicated in several situations. It should not be applied to wounds, irritated or damaged skin, or sensitive skin. Additionally, it must not be used in conjunction with a heating pad. Pregnant individuals should avoid using this product. It is also contraindicated for use with, or at the same time as, other external analgesic products. Individuals with known allergies to aspirin, salicylates, or any ingredients contained in this product should refrain from use.

Healthcare professionals should advise patients 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 rashes, itching, or redness appear. Should any side effects occur, patients may contact the provided helpline at 1-800-617-2021 for further assistance.

Side Effects

Patients should be aware that the product is intended for external use only and should not be used otherwise than as directed.

In clinical practice, it is advised that patients discontinue use and consult a healthcare professional 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 rashes, itching, or redness are observed. Additionally, if any side effects occur, patients are encouraged to contact the provided helpline at 1-800-617-2021 for further guidance.

These precautions are essential to ensure the safe and effective use of the product.

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 interactions with laboratory tests have been identified in the available data. Therefore, routine monitoring of laboratory tests is not necessary when using this product.

Packaging & NDC

Below are the non-prescription pack sizes of Sheng Chun Herbal (menthol, methyl salicylate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should not use this product without consulting a doctor. For patients aged 12 years and older, the affected area should be cleaned and dried prior to application. The patch should be removed from its protective layer and applied to the affected area, ensuring it is secured by rubbing with the hand. Each patch remains effective for 8 hours and should not be used on the same area for more than 2 consecutive days. Caution is advised when applying to areas with excessive hair, as the adhesive patch may cause skin irritation upon removal. It is recommended to wet the patch with warm water before removal to minimize discomfort.

Geriatric Use

There is no specific information 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 are advised to consult a healthcare professional prior to using this medication. The potential risks and benefits should be carefully considered, as the effects on fetal outcomes are not fully established. It is essential for women of childbearing potential to seek medical guidance to ensure the safety of both the mother and the developing fetus.

Lactation

There are no specific warnings or recommendations regarding the use of this medication in nursing mothers. Additionally, there are no specific warnings or recommendations concerning lactation. Healthcare professionals should consider the absence of data when advising lactating mothers about the use of this medication.

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 clinical trials for this medication. Consequently, there is no available information regarding dosage adjustments, special monitoring requirements, or precautions 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 warranted based on clinical judgment.

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 patients closely for any signs or symptoms that may arise following 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 standard 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 contribute to the ongoing evaluation of the safety profile of the medication.

Nonclinical Toxicology

If pregnant, it is advised to consult a health professional before use. The product should not be used by individuals with known allergies to aspirin, salicylates, or any other ingredients contained within the formulation.

No relevant information is available regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are provided in the insert.

Patient Counseling

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

Patients should be instructed not to use the product on wounds, irritated or damaged skin, or sensitive skin. Additionally, it is important to inform patients that the product should not be used in conjunction with a heating pad or with other external analgesic products. Pregnant patients should be cautioned against using this product.

Patients with known allergies to aspirin, salicylates, or any ingredients in this product should be advised not to use it. They should also be informed to stop use and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. Patients should be instructed to seek medical advice if they experience excessive skin irritation, rashes, itching, or redness.

While using this product, patients should avoid contact with the eyes and should not bandage tightly. They should also be informed not to apply more than three plasters a day and to refrain from using the product one hour before or after bathing. If any side effects occur, patients may call 1-800-617-2021 for assistance.

Storage and Handling

The unused patch should be stored in its original pouch to maintain its integrity. It is recommended to keep the product at room temperature, specifically within the range of 20 to 25° C (68 to 77° F). Proper storage conditions are essential to ensure the efficacy and safety of the patch.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)