Ching Wan Hung Soothing Herbal Balm

Description

CHING WAN HUNG is a soothing herbal balm formulated as an external analgesic. Each container contains 0.35 oz (10 g) of the product. The National Drug Code (NDC) for this formulation is 33217-001-01.

Uses and Indications

This drug is indicated for the temporary relief of pain and itching associated with minor burns and sunburn.

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

Dosage and Administration

For adults and children aged 2 years and older, the recommended application is to the affected area not more than 3 to 4 times daily. It is important to ensure that the application is limited to the specified frequency to avoid potential adverse effects.

For children under 2 years of age, the product should not be used without consulting a healthcare professional.

Contraindications

Use of this product is contraindicated in the following situations:

• The product should be kept out of reach of children to prevent accidental ingestion. If swallowed, immediate medical assistance or contact with a Poison Control Center is necessary.

• Contact with the eyes must be avoided to prevent irritation or injury.

• Discontinue use and consult a healthcare professional if the condition worsens, if symptoms persist for more than 7 days, if symptoms resolve and then recur within a few days, or if gastrointestinal symptoms such as nausea, vomiting, abdominal discomfort, diarrhea, or skin rash occur.

Warnings and Precautions

For external use only. It is imperative that this product is kept out of reach of children to prevent accidental ingestion. In the event of swallowing, immediate medical assistance should be sought, or contact a Poison Control Center without delay.

Healthcare professionals should advise patients to discontinue use and consult a physician 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, or if the patient experiences nausea, vomiting, abdominal discomfort, diarrhea, or a skin rash. These precautions are essential to ensure patient safety and effective management of any adverse reactions.

Side Effects

For external use only. Patients should discontinue use and consult a doctor if the condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. Additionally, patients should seek medical advice if they experience nausea, vomiting, abdominal discomfort, diarrhea, or a skin rash.

Drug Interactions

No drug interactions or drug and laboratory test interactions have been identified for this product. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Ching Wan Hung Soothing Herbal Balm (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 2 years of age should not use this medication; consultation with a healthcare professional is advised. For adults and children aged 2 years and older, the recommended application is to the affected area no more than 3 to 4 times daily.

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

There is no specific information regarding the use of this product during pregnancy provided in the drug insert. Additionally, there are no statements indicating whether the product is contraindicated in pregnancy or any associated risks to the fetus. As such, no dosage modifications or special precautions regarding use during pregnancy are mentioned. Healthcare professionals should consider the lack of data when prescribing this product to pregnant patients and weigh the potential benefits against any unknown risks.

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 may not have specific dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment and monitoring of these patients.

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 prescribing information.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and consider the potential risks associated with excessive administration of the medication.

It is essential to monitor patients closely for any signs or symptoms that may arise from an overdose. Symptoms of overdosage can vary widely depending on the medication involved and may include, but are not limited to, increased severity of known side effects, altered mental status, cardiovascular instability, or gastrointestinal disturbances.

In the event of suspected overdosage, immediate medical intervention is recommended. Healthcare providers should initiate supportive care and symptomatic treatment as necessary. It is advisable to contact a poison control center or seek specialized medical assistance for guidance on management strategies tailored to the specific circumstances of the overdose.

Documentation of the incident, including the amount ingested and the time of exposure, is crucial for effective management and follow-up care. Continuous monitoring of the patient’s vital signs and clinical status is imperative until they are stabilized.

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 use of the compound in these contexts.

Postmarketing Experience

No postmarketing experience details are available for SPL code 90375-7.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. In the event that the product is swallowed, patients should seek medical help or contact a Poison Control Center immediately.

Patients should be instructed to avoid contact with the eyes while using this product. It is important for healthcare providers to inform 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, or if they experience nausea, vomiting, abdominal discomfort, diarrhea, or a skin rash.

Storage and Handling

The product is supplied in a container that must be kept tightly closed to maintain its integrity. It should be stored at a temperature range of 15 to 30°C (59 to 86°F) to ensure optimal stability and efficacy. Proper handling and storage conditions are essential for preserving the quality of the product.

Additional Clinical Information

The medication is administered topically, with a recommended application frequency of 3 to 4 times daily for adults and children aged 2 years and older. For children under 2 years of age, it is advised to consult a doctor before use. There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Ching Wan Hung Soothing Herbal Balm, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)