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She Xiang Zhuang Gu Gao Regular

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 25, 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 25, 2019
Manufacturer
Inner Mongolia Horqin Pharmaceutical Co. , Ltd
Registration number
part348
NDC root
72963-003
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 this treatment 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 you feel better when you need it most.

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 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 treatment without consulting a doctor first. Always follow these guidelines to ensure safe and effective use of the medication.

What to Avoid

You should avoid using this product in several important situations to ensure your safety. Do not apply it to wounds, irritated, or damaged skin, as this can lead to further complications. If the product's appearance has changed, or if you have a known hypersensitivity (allergic reaction) to it, do not use it. Additionally, make sure not to use the product for more than 12 hours at a time, and always follow the directions provided. Using it in any other way than directed can pose risks to your health.

Side Effects

This product is for external use only and 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 a 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 beyond 10 days, it's important to reach out to a healthcare professional. This product is not recommended for children under 12 years of age.

Warnings and Precautions

This product is for external use only and contains natural rubber latex, which may cause allergic reactions in some people. Be cautious if you have a history of allergies. Avoid getting the product in your eyes or on mucous membranes, and do not wrap the area tightly with a bandage. If children are using it, make sure to supervise them closely.

If you accidentally swallow the product, seek medical help or contact a Poison Control Center immediately. You should stop using the product and call your doctor if your condition worsens, if symptoms last more than 7 days, if symptoms improve and then return within a few days, if you experience excessive skin irritation, if you are using it for arthritis pain that lasts more than 10 days, if you notice redness, or if it’s being used on children under 12 years of age.

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 signs of overdose for this medication, general symptoms can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these signs, or if you are unsure, seek medical help right away.

In case of an overdose, contact your local emergency services or go to the nearest hospital. It's always better to be safe and get checked by a healthcare professional if you have any concerns about your health. Remember, timely intervention can make a significant difference.

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 open communication with your healthcare provider to ensure the best outcomes for your pregnancy.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of this product while nursing. This means that it is generally considered safe for you to use without concerns about it affecting your breast milk or posing risks to your infant. Always consult with your healthcare provider if you have any questions or concerns about your specific situation.

Pediatric Use

If your child is 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, particularly if they are under 12 years old, to ensure their safety.

Geriatric Use

When it comes to using this medication in older adults, there are no specific guidelines about adjusting the dosage or any unique safety concerns. This means that, while the medication can be used, it’s important for you or your caregiver to monitor for any side effects or changes in your health. Always consult with your healthcare provider to ensure that this medication is appropriate for your individual needs, especially if you have other health conditions or are taking other medications.

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 you understand any necessary precautions or adjustments based on your kidney health.

Hepatic Impairment

If you have liver problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard dosing and monitoring practices apply, but you should always consult your healthcare provider for personalized advice. They can help ensure that any medications you take are safe and effective for your liver health.

Make sure to keep your doctor informed about your liver condition, as they may want to monitor your liver function regularly to ensure everything is working well. Your health and safety are the top priority, so don't hesitate to ask questions or express any concerns you may have.

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.

While there are no specific laboratory test interactions noted, discussing any tests you may undergo with your healthcare provider is still a good practice. Always keep your healthcare team informed about all the medications and supplements you are taking to avoid any potential issues.

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 consult the product information or your healthcare provider for further guidance.

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.

Are there any contraindications for this drug?

Yes, do not use it on wounds, irritated or damaged skin, or if you have known hypersensitivity to the product. Also, do not use it in excess of 12 hours.

What should I do if my condition worsens?

If your condition worsens, symptoms persist for more than 7 days, or if excessive skin irritation develops, you should stop using the product and consult a doctor.

Is this drug safe to use during pregnancy?

You should ask a doctor or pharmacist before use if you are pregnant.

What precautions should I take while using this drug?

Avoid contact with eyes or mucous membranes, do not bandage tightly, and supervise use by children.

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?

Keep the container tightly closed and store it below 20ºC (68°F) in a dry area.

Does this drug have any teratogenic effects?

No teratogenic effects are mentioned for this drug.

Packaging Info

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

Packaging configurations for She Xiang Zhuang Gu Gao Regular.
Details

Drug Information (PDF)

This file contains official product information for She Xiang Zhuang Gu Gao Regular, 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 12 years of age and older are instructed 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 plasters 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 advised in such cases.

Contraindications

Use of this product is contraindicated in the following situations:

  • Application on wounds is prohibited due to the risk of infection and delayed healing.

  • The product should not be applied to irritated or damaged skin, as this may exacerbate the condition.

  • If there is any change in the appearance of the product, it should not be used to avoid potential adverse effects.

  • The product must not be used for periods exceeding 12 hours to prevent skin irritation or other complications.

  • Individuals with known hypersensitivity to this product should avoid its use to prevent allergic reactions.

  • The product should only be used as directed; any deviation from the instructions is contraindicated.

Warnings and Precautions

For external use only. This product contains natural rubber latex, which may cause allergic reactions in sensitive individuals. Healthcare professionals should be aware of the potential for allergic responses and advise patients accordingly.

It is essential to avoid contact with the eyes and mucous membranes to prevent irritation or injury. Additionally, bandaging should not be applied tightly, as this may lead to complications. Supervision is recommended when this product is used by children to ensure safety. Caution is advised for individuals with a history of allergic reactions.

In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

Patients should be instructed to discontinue use and consult a healthcare provider 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; pain associated with arthritis persists for more than 10 days; redness is observed; or if the product is being used in children under 12 years of age.

Side Effects

Patients should be aware that this product is for external use only. It contains natural rubber latex, which may cause allergic reactions in some individuals.

In clinical practice, patients are advised to stop using the product 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 the product is being used for arthritis pain and the pain persists for more than 10 days. Additionally, patients should seek medical advice if redness is present or if the product is being used in children under 12 years of age.

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 identified in the available data. However, it remains important for healthcare providers to consider the overall medication regimen of the patient when interpreting laboratory results. Regular monitoring may be warranted based on the patient's complete clinical picture and concurrent therapies.

Packaging & NDC

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

Packaging configurations for She Xiang Zhuang Gu Gao Regular.
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 the guidance of a healthcare professional.

For patients aged 12 years and older, the recommended dosage is to apply one or two plasters to the affected area once daily, with removal after 12 hours. It is important to supervise the use of this product in children, particularly in conditions affecting those under 12 years of age.

Geriatric Use

Elderly patients may not have specific dosage adjustments, safety concerns, or special precautions outlined in the prescribing information. Therefore, healthcare providers should exercise clinical judgment when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any potential adverse effects or changes in therapeutic response, given the variability in pharmacokinetics and pharmacodynamics that can occur with aging.

Pregnancy

Pregnant patients are advised to consult a healthcare professional, such as a doctor or pharmacist, before using this medication. The potential risks and benefits should be carefully considered, as the effects of the medication on fetal outcomes are not fully established. Women of childbearing potential should be aware of the importance of discussing their pregnancy status and any potential implications of treatment with their healthcare provider.

Lactation

There are no specific warnings or recommendations regarding the use of this product in lactating mothers. Additionally, there are no known concerns related to the potential for excretion in breast milk or associated risks for breastfed infants.

Renal Impairment

Patients with renal impairment may not have specific dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. Therefore, healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the lack of detailed guidance necessitates careful clinical judgment and individualized patient assessment. Regular monitoring of renal function is advisable to ensure patient safety and therapeutic efficacy.

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 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 and to consult poison control centers for additional guidance on management strategies.

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 for SPL code 90375-7.

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 using the product 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 excessive skin irritation develops, if they are using it 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. Supervision is advised when the product is used by children, and caution should be exercised in individuals prone to allergic reactions.

Patients should also 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 healthcare professional. 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 experiences.

Drug Information (PDF)

This file contains official product information for She Xiang Zhuang Gu Gao Regular, 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 Regular, 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.