Dragon Pain Relief

Description

Dragon® Pain Relief Gel is a non-greasy topical formulation designed for the relief of muscle, back, and joint pain, as well as bruises, strains, and sprains. The gel contains 4% menthol as an active ingredient, providing a fast-acting cooling effect. It is infused with arnica, known for its therapeutic properties. The product is presented in a gel dosage form, with a net weight of 2.0 oz (56.7 g).

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 sprains, simple backache, arthritis, strains, and bruises.

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

Dosage and Administration

The medication should be used only as directed. For adults and children aged 12 years and older, it is recommended to apply the product to the affected area no more than 3 to 4 times daily. For children under 12 years of age, it is advised to consult a physician prior to use.

After application, it is important to wash hands thoroughly with cool water to prevent unintentional contact with other areas of the body or with other individuals.

Contraindications

Use of this product is contraindicated in the following situations:

• Application on wounds or damaged skin is prohibited due to the risk of exacerbating the condition and potential for adverse reactions.

• Concurrent use with a heating pad is contraindicated, as it may lead to increased absorption and potential toxicity.

• The product should not be used in children under 12 years of age with arthritis-like conditions, as safety and efficacy have not been established in this population.

• Co-administration with other ointments, creams, sprays, or liniments is contraindicated to avoid potential interactions and reduced effectiveness.

Warnings and Precautions

For external use only. This product is contraindicated for application on wounds or damaged skin and should not be used in conjunction with a heating pad. It is also not recommended for children under 12 years of age who present with arthritis-like conditions. The use of this product alongside other ointments, creams, sprays, or liniments is prohibited.

Healthcare professionals should advise patients to consult a physician prior to use if there is any redness present over the affected area. During application, it is crucial to avoid contact with the eyes or mucous membranes, and patients should refrain from tightly bandaging the treated area.

Patients must be instructed to discontinue use and seek medical advice if any of the following occur: the condition worsens or symptoms persist beyond 7 days; symptoms resolve only to reappear within a few days; or if excessive skin irritation develops.

This product should be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center (1-800-222-1222) is recommended.

Side Effects

Patients using this product should be aware that it is intended for external use only. It is contraindicated for application on wounds or damaged skin, and should not be used in conjunction with a heating pad. Additionally, it is not recommended for children under 12 years of age who have arthritis-like conditions, nor should it be applied alongside other ointments, creams, sprays, or liniments.

Participants are advised to consult a healthcare professional prior to use if there is redness over the affected area. During application, it is crucial to avoid contact with the eyes or mucous membranes, and to refrain from tightly bandaging the area.

Patients should discontinue use and seek medical advice if the condition worsens or if symptoms persist for more than 7 days. They should also stop use if symptoms resolve and then recur within a few days, or if excessive skin irritation occurs.

For those who are pregnant or breastfeeding, it is recommended to consult a healthcare professional before using this product. Furthermore, it is essential to keep this product out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought or contact with a Poison Control Center (1-800-222-1222) should be made.

Drug Interactions

Co-administration of this medication with other topical formulations, including ointments, creams, sprays, or liniments, is contraindicated. The use of multiple topical agents may lead to altered absorption or efficacy of the treatment, potentially resulting in adverse effects or diminished therapeutic outcomes.

There are no specific interactions identified with laboratory tests associated with this medication. Therefore, routine monitoring of laboratory parameters is not required in the context of drug interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Dragon Pain Relief (menthol, unspecified form). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age with arthritis-like conditions should not use this medication. For children in this age group, it is advised to consult a healthcare professional before use.

For adolescents aged 12 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

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 safe use during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is no specific data available regarding the excretion of this medication in 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. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this drug. 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, immediate medical assistance is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical help without delay. It is recommended to contact a Poison Control Center at 1-800-222-1222 for expert guidance on managing the situation.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Healthcare providers should be prepared to assess the patient's condition and implement appropriate management strategies based on the severity of symptoms and the specific substance involved.

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 provided data.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. In the event of swallowing, patients should seek medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Patients should be instructed not to use the product on wounds or damaged skin, and to avoid using it in conjunction with a heating pad. It is important to inform patients that this product should not be used on children under 12 years of age who have arthritis-like conditions, nor should it be combined with other ointments, creams, sprays, or liniments.

Patients should be counseled to discontinue use and consult a doctor if their condition worsens or if symptoms persist for more than 7 days. Additionally, they should seek medical advice if symptoms resolve and then recur within a few days, or if they experience excessive skin irritation.

While using this product, patients should be cautioned to avoid contact with eyes or mucous membranes and to refrain from tightly bandaging the affected area. Lastly, patients should be encouraged to consult a doctor before use if there is redness over the affected area.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at room temperature, maintaining a range of 20-25°C (68-77°F). Proper storage conditions are crucial to ensure the integrity and efficacy of the product.

Additional Clinical Information

The product is administered topically, with a recommended application frequency of 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 use.

Clinicians should counsel patients to seek advice from a health professional if they are pregnant or breastfeeding. Additionally, it is important to keep the product out of reach of children; in the event of ingestion, immediate medical assistance should be sought or contact with a Poison Control Center (1-800-222-1222) is recommended.

Drug Information (PDF)

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

View product document (PDF)