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She Xiang Zhuang Gu Gao

Last content change checked dailysee data sync status

This product has been discontinued

Active ingredients
  • Camphor (synthetic) 1.91 g/100 g
  • Menthol 2.54 g/100 g
  • Methyl Salicylate 1.62 g/100 g
Other brand names
Dosage form
Plaster
Route
Transdermal
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2019
Label revision date
March 14, 2019
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Camphor (synthetic) 1.91 g/100 g
  • Menthol 2.54 g/100 g
  • Methyl Salicylate 1.62 g/100 g
Other brand names
Dosage form
Plaster
Route
Transdermal
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2019
Label revision date
March 14, 2019
Manufacturer
Inner Mongolia Horqin Pharmaceutical Co. , Ltd
Registration number
part348
NDC root
72963-001
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

If you are a consumer or patient please visit this version.

Drug Overview

This medication is designed to provide temporary relief from minor aches and pains in your muscles and joints. It can be helpful for various conditions, including simple backache, arthritis, strains, bruises, and sprains. If you're experiencing discomfort from any of these issues, this drug may be a suitable option to consider for alleviating your pain.

Uses

If you're dealing with minor aches and pains in your muscles and joints, this medication can help provide temporary relief. It's effective for various conditions, including simple backaches, arthritis, strains, bruises, and sprains.

You can rely on it to ease discomfort from these common issues, allowing you to get back to your daily activities with less pain. Remember, it's designed for short-term use to help manage these minor ailments.

Dosage and Administration

If you are 12 years old or older, you can apply one or two plasters to the affected area once a day. Make sure to remove the plasters after 12 hours. If you are a child between 2 and 12 years old, or if you are an adult with health issues, it’s important to use this treatment only under the guidance of a doctor.

For children under 2 years of age, do not use this medication without consulting a doctor first. Always prioritize safety and seek professional advice when it comes to treating younger children or those with health concerns.

What to Avoid

It's important to use this product safely to avoid potential issues. Do not apply it on wounds, irritated or damaged skin, or if the product's appearance has changed. You should also avoid using it for more than 12 hours, if you have a known hypersensitivity (allergic reaction) to it, or in any way other than as directed.

While using this product, be careful to keep it away from your eyes and mucous membranes, and do not wrap the area tightly. If children are using it, make sure they are supervised, and exercise caution if you have a history of allergic reactions.

Side Effects

This product contains natural rubber latex, which can cause allergic reactions in some individuals. If you experience any signs of an allergy, such as rash or difficulty breathing, seek medical attention immediately.

You should stop using this product and consult a doctor if your condition worsens, if symptoms last longer than 7 days, or if they improve and then return within a few days. Additionally, if you notice excessive skin irritation, persistent pain (especially if it lasts more than 10 days), or redness, it's important to reach out to a healthcare professional. This is particularly crucial for children under 12 years of age.

Warnings and Precautions

This product is for external use only, and it contains natural rubber latex, which may cause allergic reactions in some individuals. If you experience any signs of an allergy, such as rash or difficulty breathing, seek medical attention immediately.

You should stop using this product and consult your doctor if your condition worsens, if symptoms last longer than 7 days, or if they clear up and then return within a few days. Additionally, if you notice excessive skin irritation, redness, or if you are using it for arthritis pain that persists for more than 10 days, it's important to reach out to your healthcare provider. This product is not recommended for children under 12 years of age.

In case of accidental ingestion, seek emergency medical help or contact a Poison Control Center right away.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While there is no specific information available about the effects of an overdose for this medication, you should be aware of general signs that may indicate a problem. These can include unusual drowsiness, confusion, or difficulty breathing.

If you notice any of these symptoms or have concerns about a possible overdose, seek medical help right away. Contact your healthcare provider or go to the nearest emergency room. It's always better to be safe and get checked out if you think something might be wrong.

Pregnancy Use

If you are pregnant or planning to become pregnant, it’s important to consult with your doctor or pharmacist before using this medication. They can provide guidance on whether it’s safe for you and your baby. Always prioritize your health and the health of your developing child by seeking professional advice.

Lactation Use

If you are breastfeeding, it's important to know that the safety of this product during lactation (the period of breastfeeding) has not been established. This means that caution is advised when considering its use while nursing.

Additionally, there is a possibility that the product may be excreted in breast milk, but the effects on your nursing infant are currently unknown. It's always best to consult with your healthcare provider before using any new medication or product while breastfeeding to ensure the safety of both you and your baby.

Pediatric Use

If you have a child under 2 years old, it's important not to use this product without consulting a doctor first. For children aged 2 to 12 years, you should only use it under a doctor's guidance, especially if they have any health issues. For those 12 years and older, you can apply one or two plasters to the affected area once a day, but remember to remove them after 12 hours.

Always supervise children when using this product and keep it out of their reach. If your child under 12 experiences symptoms that last more than 7 days or if their skin becomes excessively irritated, stop using the product and consult a doctor.

Geriatric Use

When considering medication for older adults, it's important to be cautious, especially if you or your loved one has any health issues. If you are in this situation, it's best to consult with a doctor before starting any new medication. This is particularly true for children aged 2 to 12 and adults with compromised health, as they should only use the medication under a doctor's supervision.

Always prioritize safety and ensure that any treatment plan is tailored to meet the specific health needs of older adults. Regular check-ins with healthcare providers can help manage any potential risks effectively.

Renal Impairment

If you have kidney problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to change based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your specific situation. They can help monitor your kidney health and make any necessary adjustments to your medications.

Hepatic Impairment

If you have liver problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication should be used if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your liver health. They can help you understand any potential risks and monitor your condition effectively.

Drug Interactions

It's important to talk to your doctor or pharmacist before using this medication, especially if you are taking other medications. This helps ensure that everything works safely and effectively together.

Currently, there are no specific interactions noted with laboratory tests, but keeping your healthcare provider informed about all your medications is always a good practice. This way, they can monitor your health and adjust treatments as needed.

Storage and Handling

To ensure the safety and effectiveness of your product, always keep the container tightly closed when not in use. Store it in a dry area at a temperature below 20ºC (68°F). This helps maintain the quality of the product and prevents any potential degradation.

Handling the product with care is essential. Make sure to follow these storage guidelines closely to ensure optimal performance and safety. If you have any questions about disposal or specific components, please refer to the product instructions or consult a professional.

Additional Information

You will apply this medication through the skin using transdermal plasters. For adults and children aged 12 and older, you should apply one or two plasters to the affected area once a day and remove them after 12 hours. If you are using this medication for children aged 2 to 12 or for adults with health issues, it's important to do so only under a doctor's guidance. This medication is not recommended for children under 2 years old; consult a doctor if you have questions about its use in this age group.

FAQ

What is the drug indicated for?

The drug is indicated for the temporary relief of minor aches and pains of muscles and joints, including simple backache, arthritis, strains, bruises, and sprains.

Who can use this drug?

Adults and children 12 years of age and older can use it. Children 2 to 12 years and adults with compromised health should use it only under a doctor's guidance, while it is not recommended for children under 2 years.

How should the drug be applied?

You should apply one or two plasters to the affected area once a day and remove them after 12 hours.

What should I avoid while using this product?

Avoid using it on wounds or irritated skin, and do not bandage tightly. Also, supervise children during use and avoid contact with eyes or mucous membranes.

What should I do if my condition worsens?

Stop use and ask a doctor if your condition worsens, symptoms persist for more than 7 days, or if excessive skin irritation develops.

Is this drug safe during pregnancy?

You should ask a doctor or pharmacist before use if you are pregnant, as safety during pregnancy has not been established.

Can nursing mothers use this drug?

Caution should be exercised when using this product in nursing mothers, as the safety during lactation has not been established.

What should I do if I accidentally swallow the drug?

If swallowed, get medical help or contact a Poison Control Center right away.

What are the storage instructions for this drug?

Store the drug below 20ºC (68°F) in a dry area and keep the container tightly closed.

Packaging Info

Below are the non-prescription pack sizes of She Xiang Zhuang Gu Gao (camphor, menthol, methyl salicylate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for She Xiang Zhuang Gu Gao.
Details

Drug Information (PDF)

This file contains official product information for She Xiang Zhuang Gu Gao, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

No relevant information is available for SPL code 34089-3.

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

Adults and children aged 12 years and older are advised to apply one or two plasters to the affected area once daily. The plasters should be removed after 12 hours of application.

For children aged 2 to 12 years and adults with compromised health, the use of this product should only occur under the guidance of a healthcare professional.

The product is contraindicated for use in children under 2 years of age; consultation with a doctor is recommended in such cases.

Contraindications

The product is contraindicated in the following situations:

Use is not recommended on wounds or on irritated or damaged skin due to the potential for exacerbating the condition. Application is contraindicated if the product's appearance has changed, as this may indicate degradation or contamination. The product should not be used for periods exceeding 12 hours to prevent adverse effects. Individuals with known hypersensitivity to this product should avoid its use to prevent allergic reactions. Additionally, the product must be used strictly as directed; deviations from the instructions are contraindicated.

While using this product, it is essential to avoid contact with the eyes or mucous membranes to prevent irritation. Tight bandaging is not advised, and supervision is required when the product is used by children. Caution should be exercised in individuals prone to allergic reactions.

Warnings and Precautions

For external use only. This product contains natural rubber latex, which may cause allergic reactions in sensitive individuals.

Healthcare professionals should advise patients to discontinue use and seek medical attention 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; the product is used for arthritis pain and pain persists for more than 10 days; redness is present; or if the patient is a child under 12 years of age.

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

Side Effects

Patients using this product should be aware of the potential for allergic reactions due to the presence of natural rubber latex. Individuals with a known allergy to latex may experience serious allergic responses.

In clinical practice, patients are advised to discontinue use and consult a healthcare professional if any of the following occur: if the condition worsens, if symptoms persist for more than 7 days, if symptoms resolve and then recur within a few days, or if excessive skin irritation develops. Additionally, patients should seek medical advice when using the product for arthritis-related pain if the pain persists for more than 10 days, if redness is present, or if the product is being used in children under 12 years of age.

These precautions are essential to ensure patient safety and to mitigate the risk of adverse reactions associated with the use of this product.

Drug Interactions

Patients are advised to consult a healthcare professional, such as a doctor or pharmacist, prior to using this medication if they are currently taking other medications. This precaution is essential to avoid potential drug interactions that may affect the efficacy or safety of the treatment.

There are no specific laboratory test interactions associated with this medication. Therefore, routine laboratory monitoring is not indicated based on the available data.

Packaging & NDC

Below are the non-prescription pack sizes of She Xiang Zhuang Gu Gao (camphor, menthol, methyl salicylate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for She Xiang Zhuang Gu Gao.
Details

Pediatric Use

Pediatric patients under 2 years of age should not use this product; consultation with a doctor is advised. For children aged 2 to 12 years and adults with compromised health, use is recommended only under medical supervision.

In patients aged 12 years and older, the recommended application is one or two plasters to the affected area once daily, with removal after 12 hours. It is essential to supervise the use of this product by children and ensure it is kept out of their reach.

In cases where symptoms persist for more than 7 days or if excessive skin irritation occurs in children under 12 years of age, the product should be discontinued, and a doctor should be consulted.

Geriatric Use

Elderly patients, particularly those aged 65 and older, should be treated with caution, especially if they have compromised health. It is essential for healthcare providers to closely monitor these patients due to the potential for altered pharmacokinetics and increased sensitivity to medications.

In addition, the use of this medication in children aged 2 to 12 years and in adults with compromised health should only occur under the guidance of a physician. This recommendation underscores the importance of individualized treatment plans and careful consideration of the patient's overall health status when prescribing to geriatric patients.

Pregnancy

Pregnant patients are advised to consult a healthcare professional, such as a doctor or pharmacist, 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 guidance to ensure the safety of both the mother and the developing fetus.

Lactation

The safety of this product during lactation has not been established. Caution should be exercised when using this product in lactating mothers. There is a potential for excretion in breast milk, and the effects on breastfed infants are unknown.

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

There is currently no specific information available regarding overdosage in the provided sections of the Summary of Product Characteristics (SPL).

Healthcare professionals are advised to monitor patients closely for any signs or symptoms that may arise in the event of an overdose. In the absence of detailed guidance, standard supportive care measures should be implemented.

In cases of suspected overdosage, it is recommended that healthcare providers initiate appropriate management procedures, which may include symptomatic treatment and supportive care tailored to the patient's clinical presentation.

For further information or guidance, healthcare professionals should consult local poison control centers or relevant medical authorities.

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 safety profile in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center if the product is swallowed. It is important to instruct patients not to use the product on wounds, irritated, or damaged skin. Patients should be informed that the product should not be used if its appearance has changed and that it should not be applied for more than 12 hours.

Patients must be cautioned against using the product if they have a known hypersensitivity to it and should only use it as directed. They should be instructed 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. Additionally, patients should be advised to discontinue use and seek medical advice if they experience excessive skin irritation, if they are using the product for arthritis pain, if pain persists for more than 10 days, or if redness is present.

For children under 12 years of age, healthcare providers should recommend consulting a doctor before use. Patients should be reminded to avoid contact with the eyes or mucous membranes while using the product and to refrain from tightly bandaging the area of application. Supervision is advised when the product is used by children, and patients should exercise caution if they are prone to allergic reactions.

Furthermore, patients should be encouraged to consult a doctor or pharmacist before using the product if they are pregnant or taking other medications.

Storage and Handling

The product is supplied in a container that must be kept tightly closed to maintain its integrity. It should be stored in a dry area at temperatures below 20ºC (68°F) to ensure optimal stability and efficacy. Proper storage conditions are essential for preserving the quality of the product.

Additional Clinical Information

The transdermal route of administration is indicated for patients aged 12 years and older, who should apply one or two plasters to the affected area once daily, removing them after 12 hours. For children aged 2 to 12 years and adults with compromised health, use should only occur under the guidance of a physician. The product is contraindicated for children under 2 years of age, and consultation with a doctor is advised in such cases.

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 She Xiang Zhuang Gu Gao, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for She Xiang Zhuang Gu Gao, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

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Primary FDA sources:

Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.