Dr. Blue

Description

Dr. Blue Bend Free All Day is a pain-relieving gel formulated to provide targeted relief from discomfort. The product is designed for topical application, allowing for localized treatment of pain. Its formulation is intended to deliver effective analgesic properties, making it suitable for individuals seeking relief from various types of pain. The gel's consistency and delivery method facilitate ease of use and absorption into the skin.

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, bruises, and sprains. It provides cooling pain relief to alleviate discomfort in these areas.

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, it is advised to consult a physician prior to use to determine the appropriate course of action and ensure safety.

Contraindications

Use of this product is contraindicated in the following situations:

Heating the product is prohibited, including methods such as microwaving or exposure to open flames, as these can lead to hazardous conditions. Additionally, the product should not be added to hot water or any container during the heating process due to the risk of splattering, which may result in burns.

Contact with eyes must be avoided to prevent irritation or injury. The product should not be applied to wounds or damaged skin to avoid exacerbating any existing conditions. Furthermore, tight bandaging of the area where the product is applied is contraindicated to ensure proper circulation and prevent complications.

Warnings and Precautions

For external use only. This product is not intended for ingestion. In the event of accidental swallowing, it is imperative to seek emergency medical assistance or contact a Poison Control Center immediately.

Healthcare professionals should advise patients to discontinue use and consult their physician if the condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. Monitoring for these signs is essential to ensure patient safety and effective management of their condition.

Side Effects

For external use only. Patients are advised to stop use and consult a doctor if the condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then occur again within a few days. No specific adverse reactions or side effects have been identified in clinical trials or postmarketing experiences.

Drug Interactions

There are no specific drug interactions or laboratory test interactions identified in the available data. Therefore, no recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

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

Pediatric Use

Pediatric patients aged 2 years and older may apply the medication to the affected area no more than 3 to 4 times daily. For children under 2 years of age, it is recommended to consult a physician prior to use.

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

The safety of this product during pregnancy has not been established. There are no adequate and well-controlled studies in pregnant women; therefore, this product should be used during pregnancy only if clearly needed. Pregnant patients or those planning to become pregnant are advised to consult a physician before use. Given the lack of data, healthcare professionals should weigh the potential benefits against any possible risks to fetal outcomes when considering this product for use in pregnant individuals.

Lactation

There are no specific warnings or recommendations regarding the use of this product by lactating mothers. Additionally, there are no statements concerning the potential for excretion in breast milk or any associated risks to breastfed infants during the use of this product in lactation.

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 event of an overdosage, there is currently no specific information available regarding the effects or management of such an occurrence. Healthcare professionals are advised to monitor the patient closely for any unusual symptoms and to provide supportive care as necessary.

Given the absence of detailed guidance, it is recommended that healthcare providers consult local poison control centers or relevant medical authorities for further assistance in managing potential overdosage situations. Continuous assessment of the patient's condition is essential to ensure appropriate interventions are implemented promptly.

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

Postmarketing experience has revealed reports of the following adverse reactions: skin irritation, allergic reactions, and contact dermatitis. These events have been reported voluntarily or identified through surveillance programs.

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 to discontinue use 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.

When discussing the proper use of this product, healthcare providers should emphasize the following precautions: Patients should not heat or microwave the product, nor should they use it near an open flame. Additionally, patients must be cautioned against adding the product to hot water or any container while heating water, as this may cause splattering and result in burns.

Providers should also remind patients to avoid contact with their eyes and to refrain from applying the product to wounds or damaged skin. It is essential to advise patients not to bandage the area tightly after application.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at a temperature range of 20°C to 25°C (68°F to 77°F) to maintain its integrity.

To ensure optimal preservation, the product must be protected from light exposure. It is crucial to use the product only if the seal is unbroken, and any remaining product should be discarded after opening to prevent contamination or degradation.

Additional Clinical Information

Patients aged 2 years and older are advised to apply the medication to the affected area no more than 3 to 4 times daily. For children under 2 years of age, it is recommended to consult a physician prior to use. No further information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)