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Dragon Pain Numbing

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Active ingredient
Lidocaine Hydrochloride 40 mg/1 g
Other brand names
Drug classes
Amide Local Anesthetic, Antiarrhythmic
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2017
Label revision date
November 13, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Lidocaine Hydrochloride 40 mg/1 g
Other brand names
Drug classes
Amide Local Anesthetic, Antiarrhythmic
Dosage form
Cream
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 2017
Label revision date
November 13, 2024
Manufacturer
Genomma Lab USA Inc.
Registration number
M017
NDC root
50066-056
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

DRAGON® is a topical cream that contains lidocaine hydrochloride (HCl) at a maximum strength of 4%. It is designed to provide temporary relief from pain by blocking pain receptors in the affected area. This fast-acting cream numbs pain quickly and can offer hours of relief, making it a helpful option for those seeking comfort from various types of pain. Additionally, it is odor-free, ensuring a pleasant application experience.

Uses

You can use this medication for the temporary relief of pain. It is designed to help alleviate discomfort, making it easier for you to go about your daily activities.

Rest assured, this medication does not have any known teratogenic effects (which means it does not cause birth defects) or nonteratogenic effects. This makes it a safer option for those concerned about potential risks.

Dosage and Administration

If you are 12 years old or older, you can apply this medication to the affected area up to 3 to 4 times a day. Make sure to follow this guideline to ensure the best results. If you are caring for a child under 12, it’s important to consult a doctor before using this medication, as they can provide specific advice tailored to your child's needs. Always remember to apply it only to the areas that need treatment.

What to Avoid

It's important to use this medication safely. You should avoid applying it to large areas of your body or on raw, blistered, or damaged skin, including wounds. Following these guidelines will help ensure your safety and the effectiveness of the treatment. If you have any questions or concerns about how to use this medication, please consult your healthcare provider for guidance.

Side Effects

When using this product, it's important to apply it only as directed and avoid using it on large areas of the body, raw or blistered skin, or any wounds. Be cautious to keep it away from your eyes, and do not use tight bandages or heating pads on the treated area. If your condition worsens or symptoms persist for more than 7 days, or if symptoms improve and then return within a few days, stop using the product and consult a doctor.

If you are pregnant or breastfeeding, please consult a healthcare professional before using this product. Additionally, keep it out of reach of children to prevent accidental ingestion. If swallowed, seek medical help or contact a Poison Control Center immediately.

Warnings and Precautions

This product is for external use only, so please avoid applying it to large areas of your body, raw or blistered skin, or any wounds. When using this product, follow the instructions carefully. Use it in small amounts, keep it away from your eyes, and do not cover the treated area with tight bandages or heating pads.

If your condition worsens or symptoms last longer than 7 days, stop using the product and consult your doctor. Additionally, if your symptoms improve and then return within a few days, reach out to your healthcare provider. In case of accidental swallowing, seek emergency medical help or contact a Poison Control Center right away. If you are pregnant or breastfeeding, please consult a health professional before using this product. Lastly, keep it out of reach of children to prevent accidental ingestion.

Overdose

It's important to keep this medication out of reach of children to prevent accidental ingestion. If you or someone else accidentally swallows it, seek medical help right away or contact a Poison Control Center.

Signs of an overdose can vary, but if you notice unusual symptoms or feel unwell after taking the medication, don't hesitate to get help. Acting quickly can make a significant difference in ensuring safety and health.

Pregnancy Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional 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 child by seeking expert advice.

Lactation Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using any medication. This ensures that you understand any potential risks and can make informed decisions about your health and the health of your baby. Always prioritize open communication with your doctor regarding your breastfeeding journey.

Pediatric Use

If your child is under 12 years old, it's important to consult with a doctor before using this medication. For those aged 12 and older, you can apply it to the affected area, but be sure to limit the application to no more than 3 to 4 times a day. Always follow these guidelines to ensure safe and effective use for your child.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that healthcare providers may not have tailored guidelines for elderly patients.

If you or a loved one is an older adult considering this medication, it’s important to discuss any potential risks or concerns with your healthcare provider. They can help determine the best approach based on individual health needs and circumstances.

Renal Impairment

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

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your health situation. They can help you understand how to manage your treatment effectively while considering your kidney health.

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).

Before starting any new medication, including this one, you should discuss your liver health with your healthcare provider. They can help determine the best approach for your treatment and ensure your safety.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you. Always share your complete list of medications and any health conditions you have to receive the best care possible.

Storage and Handling

To ensure the best performance of your product, store it at room temperature. This helps maintain its effectiveness and safety. After each use, make sure to close the cap tightly to prevent contamination and preserve the integrity of the contents. Following these simple steps will help you use the product safely and effectively.

Additional Information

You should apply this medication topically to the affected area, using it no more than 3 to 4 times a day if you are an adult or a child aged 12 years and older. If the patient is under 12 years old, it's important to consult a doctor before use. Always follow the recommended application guidelines for safe and effective treatment.

FAQ

What is DRAGON®?

DRAGON® is a pain numbing cream containing 4% lidocaine hydrochloride, designed for the temporary relief of pain.

How does DRAGON® work?

It blocks pain receptors, numbs pain quickly, and provides hours of relief.

Who can use DRAGON®?

Adults and children 12 years of age and older can apply it to the affected area up to 3 to 4 times daily. Children under 12 should ask a doctor.

Are there any contraindications for using DRAGON®?

No specific contraindications are mentioned, but it should not be used on large areas of the body, raw or blistered skin, or wounds.

What should I do if I experience side effects?

Stop using the product and ask a doctor if conditions worsen or symptoms persist for more than 7 days.

Can I use DRAGON® if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, consult a health professional before use.

What precautions should I take when using DRAGON®?

Use only as directed, avoid contact with eyes, do not apply tight bandages or heating pads to treated skin, and keep it out of reach of children.

What should I do if DRAGON® is swallowed?

Get medical help or contact a Poison Control Center immediately if swallowed.

How should I store DRAGON®?

Store at room temperature and close the cap tightly after use.

Packaging Info

Below are the non-prescription pack sizes of Dragon Pain Numbing (lidocaine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Dragon Pain Numbing.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the temporary relief of pain.

There are no teratogenic effects associated with this drug. Additionally, no nonteratogenic effects have been reported.

Dosage and Administration

For adults and children aged 12 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 12 years of age, it is advised to consult a physician prior to use to determine the appropriate dosage and administration guidelines tailored to the child's specific needs.

Contraindications

The product is contraindicated for use on large areas of the body, as well as on raw or blistered skin. Additionally, it should not be applied to wounds or damaged skin to prevent potential adverse effects.

Warnings and Precautions

For external use only. This product is contraindicated for application on large areas of the body, raw or blistered skin, and any wounds or damaged skin.

When utilizing this product, it is imperative to adhere strictly to the directions provided. Users should refrain from applying large quantities and must avoid contact with the eyes. Additionally, tight bandages should not be used over the treated area, nor should heating pads be applied to the skin that has been treated.

If conditions worsen or if symptoms persist beyond 7 days, it is essential to discontinue use and consult a healthcare professional. Should symptoms resolve and then reoccur within a few days, medical advice should also be sought.

In the event of accidental ingestion, immediate medical assistance should be obtained, or contact with a Poison Control Center is advised.

For individuals who are pregnant or breastfeeding, it is recommended to consult a healthcare professional prior to use.

To prevent accidental ingestion, this product should be kept out of reach of children.

Side Effects

Patients should be aware that this product is for external use only. It is contraindicated for application on large areas of the body, raw or blistered skin, and wounds or damaged skin. When using this product, it is essential to adhere strictly to the directions provided. Patients should avoid using large quantities, and contact with the eyes should be avoided. Additionally, tight bandages should not be applied to treated areas, nor should heating pads be used on the skin that has been treated.

Patients are advised to discontinue use and consult a healthcare professional if conditions worsen or if symptoms persist for more than 7 days. If symptoms resolve and then recur within a few days, medical advice should also be sought.

For pregnant or breastfeeding individuals, it is recommended to consult a healthcare professional prior to use. Furthermore, to prevent accidental ingestion, this product should be kept out of reach of children. In the event of accidental swallowing, immediate medical assistance should be sought or contact with a Poison Control Center should be made.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Dragon Pain Numbing (lidocaine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Dragon Pain Numbing.
Details

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. For adolescents and children aged 12 years and older, the recommended application is to the affected area no more than 3 to 4 times daily.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. As such, healthcare providers should exercise caution 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 lack of targeted data for this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure the safety of both the mother and the developing fetus.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data on the excretion of this drug in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this medication. Consequently, there are no 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 event of an overdosage, it is crucial to keep the product out of reach of children to prevent accidental ingestion.

Should ingestion occur, immediate medical assistance is necessary. Healthcare professionals are advised to contact a Poison Control Center without delay to ensure appropriate management and intervention. Prompt action is essential to mitigate potential risks associated with overdosage.

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

Postmarketing experience has identified the following adverse reactions reported voluntarily or through surveillance programs. Allergic reactions have been noted, including manifestations such as rash, itching, and hives. Additionally, systemic reactions have been observed, which include symptoms such as dizziness, drowsiness, and confusion.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. In the event of accidental swallowing, patients should be instructed to seek medical help or contact a Poison Control Center immediately.

Patients must be informed to use the medication only as directed and to avoid using it in large quantities. It is important to emphasize the need to avoid contact with the eyes, as this could lead to irritation or injury.

Additionally, healthcare providers should counsel patients against applying tight bandages over the treated area, as this may affect the medication's efficacy or lead to adverse effects. Patients should also be cautioned not to apply a heating pad to the treated skin, as this could exacerbate irritation or cause other complications.

Storage and Handling

The product is supplied in a configuration that ensures optimal usability. It should be stored at room temperature to maintain its efficacy. After each use, it is essential to close the cap tightly to prevent contamination and preserve the integrity of the product.

Additional Clinical Information

The medication is administered topically, with a recommended application frequency of no more than 3 to 4 times daily for adults and children aged 12 years and older. For children under 12 years of age, it is advised to consult a doctor regarding the appropriate use.

There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Dragon Pain Numbing, 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 Dragon Pain Numbing, 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.