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Quali Cold

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This product has been discontinued

Active ingredients
  • Camphor (synthetic) 0.5 g/100 g
  • Menthol 1 g/100 g
  • Methyl Salicylate 2 g/100 g
Other brand names
Dosage form
Patch
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2013
Label revision date
October 12, 2016
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Camphor (synthetic) 0.5 g/100 g
  • Menthol 1 g/100 g
  • Methyl Salicylate 2 g/100 g
Other brand names
Dosage form
Patch
Route
Topical
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 2013
Label revision date
October 12, 2016
Manufacturer
Teh Seng Pharmaceutical Mfg. Co. , Ltd
Registration number
part348
NDC root
67536-884
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 particularly helpful for conditions such as simple backache, arthritis, sprains, strains, and bruises. If you're experiencing discomfort from any of these issues, this drug may be a suitable option to help ease your pain.

Uses

You can use this medication for the temporary relief of minor aches and pains in your muscles and joints. It is effective for conditions such as simple backache, arthritis, sprains, strains, and bruises. This means if you're experiencing discomfort from any of these issues, this medication may help alleviate your pain and improve your comfort.

It's important to note that there are no reported teratogenic effects (which means it doesn't cause birth defects) associated with this medication, making it a safer option for those concerned about such risks.

Dosage and Administration

Before you apply the medication, make sure to clean and dry the affected areas thoroughly. This helps the treatment work effectively. When you're ready to apply the patch, remove the protective film and place it on the area you want to treat. You can use the patch 1 to 2 times a day, and if needed, you can apply up to 3 patches in a single day. If the patch is too large, feel free to cut it into smaller pieces to fit the area better.

It's important to use the medication exactly as directed. To ensure the patch stays in place, you may want to secure it with adhesive tape or an elastic bandage, especially if it's on a joint. This will help keep the patch firm and effective throughout the day.

What to Avoid

It's important to be aware of certain guidelines when using this medication. While there are no specific contraindications or risks of abuse, misuse, or dependence associated with it, you should discontinue use immediately if you experience any skin irritation. This precaution helps ensure your safety and well-being while using the medication. Always listen to your body and consult your healthcare provider if you have any concerns.

Side Effects

It's important to use this product only on the skin and to avoid contact with your eyes, mucous membranes, or any open wounds. If you are pregnant, nursing, or have a history of allergic reactions to drugs or cosmetics, please consult your doctor before using it. Children should use this product only under adult supervision.

If you experience any skin irritation while using the product, you should stop using it immediately.

Warnings and Precautions

This product is for external use only, so be sure to avoid applying it near your eyes, mucous membranes, or on open wounds. If you are pregnant, nursing, or have a history of allergic reactions to drugs or cosmetics, please consult your doctor before using this product. Children should use it only under adult supervision.

If you experience any skin irritation while using this product, stop using it immediately and contact your doctor for further advice. While there are no specific emergency instructions provided, it's always best to seek medical help if you have serious concerns about your health.

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 nursing, it’s important to talk to your doctor before using this medication. This is to ensure that it is safe for you and your baby. Additionally, if you have a history of allergic reactions to drugs or cosmetics, you should also consult your physician before use. Taking these precautions can help protect your health and the health of your child.

Lactation Use

If you are pregnant or breastfeeding, it's important to talk to your doctor before using any medications or cosmetics. This is especially crucial if you have a history of allergic reactions to these products. Your healthcare provider can help ensure that what you use is safe for you and your baby. Always prioritize your health and your child's well-being by seeking professional advice.

Pediatric Use

It's important for you to supervise your child when they are using this product. Always ensure that it is kept out of reach of children to prevent any accidental misuse or ingestion. Taking these precautions helps keep your child safe while using the product.

Geriatric Use

While there is no specific information about how this medication should be used by older adults, it’s important to approach any new treatment with caution. If you or a loved one is an older adult, it’s always a good idea to discuss any medications with a healthcare provider. They can help ensure that the treatment is safe and appropriate, considering any unique health needs or conditions that may be present.

Remember, even if there are no specific dosage adjustments or safety concerns mentioned, your healthcare provider may still recommend monitoring for any potential side effects or interactions with other medications you may be taking. Always prioritize open communication with your healthcare team to ensure the best care.

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 may affect you if you have hepatic impairment (issues with liver function).

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 monitor your condition and make any necessary adjustments to your treatment plan.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking. In this case, there are no specific drug interactions or laboratory test interactions noted, which means that this medication is generally considered safe to use alongside other treatments and tests. However, every individual is different, and your healthcare provider can help ensure that your overall treatment plan is safe and effective for you. Always feel free to ask questions or express any concerns you may have regarding your medications or tests.

Storage and Handling

To ensure the best quality and safety of your product, store it at room temperature, away from direct sunlight. This helps maintain its effectiveness. Make sure the product is properly sealed to keep it fresh and ready for use whenever you need it.

Handling the product with care is important. Always check that the seal is intact before use, and follow any additional safety instructions provided. By taking these simple steps, you can help ensure that the product remains safe and effective for your needs.

Additional Information

You should apply this medication topically to the affected areas 1 to 2 times a day, using up to 3 sheets per day if needed. It's important to use this product only on the skin and avoid contact with your eyes, mucous membranes, or open wounds. If you are pregnant, nursing, or have a history of allergic reactions to drugs or cosmetics, consult your doctor before using this product. Additionally, children should use it under adult supervision.

FAQ

What is the drug used for?

The drug is used for temporary relief of minor aches and pains of muscles and joints associated with conditions like simple backache, arthritis, sprains, strains, and bruises.

How should I apply the drug?

Clean and dry the affected areas before application. Remove the protective film and apply 1-2 times daily, using up to 3 sheets per day if necessary.

Are there any warnings I should be aware of?

Yes, the drug is for external use only. Avoid applying it around the eyes, mucous membranes, or open wounds. Pregnant women and nursing mothers should consult a physician before use.

What should I do if I experience skin irritation?

You should discontinue use if skin irritation develops.

Can children use this product?

Yes, but children should use this product under supervision.

Is there any information regarding use during pregnancy?

Pregnant women should consult a physician before using this product.

How should I store the drug?

Store the drug at room temperature away from direct sunlight and ensure it is properly sealed to remain fresh.

Packaging Info

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

Packaging configurations for Quali Cold.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The product is identified by the SPL code 34089-3. No additional specific description details are provided in the available text.

Uses and Indications

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

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

Dosage and Administration

The affected areas should be cleaned and dried prior to application. The product is to be applied to the skin 1 to 2 times daily. If necessary, up to 3 sheets may be used per day. The protective film should be removed during application, and the sheets can be cut into smaller sizes if desired to better fit the treatment area.

It is essential to use the product only as directed. To ensure proper adherence, the patches should be firmly affixed using adhesive tapes or elastic bandages, particularly around joint areas where additional security may be required.

Contraindications

There are no specific contraindications listed for this product. However, it is advised to discontinue use if skin irritation develops, as this may indicate an adverse reaction.

Warnings and Precautions

For external use only, this product should not be applied around the eyes, mucous membranes, or on open wounds. It is imperative that pregnant women, nursing mothers, and individuals with known allergies to drugs or cosmetics consult a physician prior to use. Additionally, children should utilize this product only under adult supervision to ensure safety.

Healthcare professionals should advise patients to discontinue use and contact their doctor if any skin irritation occurs. Monitoring for adverse reactions is essential to ensure patient safety and product efficacy.

No specific emergency medical instructions or general precautions have been provided; however, practitioners should remain vigilant for any unexpected reactions and provide appropriate guidance to patients.

Currently, there are no recommended laboratory tests associated with the use of this product. Regular assessment of the patient's condition and response to treatment is advised to ensure ongoing safety and effectiveness.

Side Effects

Patients should be aware that the product is for external use only and should avoid applying it around the eyes, mucous membranes, or on open wounds. Pregnant women, nursing mothers, and individuals with known allergies to drugs or cosmetics are advised to consult a physician prior to use. Additionally, it is recommended that children use this product under adult supervision.

In the event of skin irritation, patients should discontinue use immediately.

Drug Interactions

There are no specific drug interactions identified for this medication. Additionally, no laboratory test interactions have been reported. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

Packaging & NDC

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

Packaging configurations for Quali Cold.
Details

Pediatric Use

Pediatric patients should use this product under adult supervision to ensure safe and appropriate use. It is important to keep the product out of reach of children to prevent accidental ingestion or misuse.

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 women and nursing mothers should consult a physician prior to use of this medication. Additionally, individuals with a history of allergic reactions to drugs or cosmetics are advised to seek medical advice before initiating treatment. The potential risks and benefits must be carefully considered in these populations to ensure maternal and fetal safety.

Lactation

Lactating mothers are advised to consult a physician prior to using this medication, particularly if they have a history of allergic reactions to drugs or cosmetics. There is no specific data available regarding the excretion of this medication in breast milk or its effects on breastfed infants. Therefore, healthcare professionals should exercise caution and consider the potential risks and benefits when prescribing this medication to nursing mothers.

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 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 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.

Documentation of the incident, including the amount and timing of the substance taken, is crucial for guiding treatment decisions and ensuring optimal patient care.

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 in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion or misuse. It is important for patients to be aware of the potential for skin irritation. If any signs of skin irritation develop, patients should be instructed to discontinue use of the medication immediately and consult their healthcare provider for further guidance.

Storage and Handling

The product is supplied in a properly sealed container to ensure freshness. It should be stored at room temperature, away from direct sunlight, to maintain its integrity and effectiveness.

Additional Clinical Information

The product is administered topically, with application to affected areas recommended 1-2 times daily, allowing for up to 3 sheets per day if necessary. Clinicians should advise patients that the product is for external use only, cautioning against application near the eyes, mucous membranes, or open wounds. Pregnant women, nursing mothers, and individuals with known allergies to drugs or cosmetics are encouraged to consult a physician prior to use. Additionally, children should use the product under adult supervision.

No further information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Quali Cold, 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 Quali Cold, 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.

Learn more in our Editorial Policy

Last AI update:

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.