Deep Blue

Description

doTERRA Deep Blue Stick + Copaiba is a topical analgesic formulated for localized relief. The product has a net weight of 1.69 oz (48 g).

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

Menthol 10% is indicated for topical analgesic use. The recommended application involves applying a thin layer of the product to the affected area. The frequency of application may vary, but it is generally advised to use it up to four times daily, as needed for pain relief.

Prior to application, the skin should be clean and dry. The product should be gently massaged into the skin until fully absorbed. Care should be taken to avoid contact with eyes and mucous membranes. If symptoms persist or worsen, or if there is a rash or irritation, the healthcare professional should be consulted.

Contraindications

The product is contraindicated for application to wounds or damaged skin due to the potential for irritation or adverse effects. Additionally, it should not be used with tight bandaging or in conjunction with a heating pad, as this may increase the risk of skin irritation or other complications.

Warnings and Precautions

For external use only. Healthcare professionals should advise patients to avoid use in individuals with a known allergy to salicylates, including aspirin, unless consultation with a physician has occurred.

In the event of accidental ingestion, it is imperative to seek emergency medical assistance or contact a Poison Control Center immediately.

Patients should be instructed to discontinue use and consult a healthcare provider if any of the following occur: irritation or redness at the application site, gastrointestinal symptoms such as nausea, vomiting, abdominal discomfort, or diarrhea, the development of a skin rash, or if pain persists for more than 7 days. Additionally, special caution is warranted for use in children under 12 years of age, and healthcare professionals should be alerted if redness is present.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this product. Serious adverse reactions may occur, particularly in individuals with a known allergy to salicylates, including aspirin. It is advised that patients consult a physician before using this product if they have such allergies.

In clinical practice, patients are instructed to discontinue use and seek medical advice if they experience any of the following symptoms: irritation or redness, nausea, vomiting, abdominal discomfort, diarrhea, or skin rash. Additionally, if pain persists for more than 7 days, if redness is present, or if the product is being used in children under 12 years of age, patients should stop use and consult a healthcare professional.

These precautions are essential to ensure the safety and well-being of patients while using this product.

Drug Interactions

Patients with a known allergy to salicylates, including aspirin, should avoid the use of this medication unless they have consulted with a physician. This precaution is essential to prevent potential allergic reactions.

No specific drug or laboratory test interactions have been identified in the available data. Therefore, routine monitoring or dosage adjustments related to drug interactions are not necessary. However, healthcare providers should remain vigilant and consider individual patient circumstances when prescribing this medication.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 12 years of age should consult a doctor prior to use. It is advised to discontinue use and seek medical advice if any conditions affecting this age group arise.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients. Therefore, healthcare providers should exercise caution when prescribing this medication to elderly patients. It is advisable to closely monitor this population for any potential adverse effects or changes in drug efficacy, given the physiological changes associated with aging that may affect drug metabolism and response. Additionally, consideration should be given to the presence of comorbidities and polypharmacy, which are common in geriatric patients and may necessitate dosage adjustments or increased vigilance in monitoring.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing infant.

Lactation

Lactating mothers are advised to consult a healthcare professional prior to using this medication. There is currently no available data regarding 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 not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of 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 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 initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

Additionally, it is recommended to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols. Documentation of the incident, including the substance involved, estimated dose, and time of exposure, is crucial for effective treatment and follow-up care.

Overall, vigilance and prompt intervention are key components in managing any suspected overdose situation.

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 understanding of the potential toxicological profile in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

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 the product, patients should seek medical assistance or contact a Poison Control Center immediately.

Patients should be instructed to discontinue use and consult a doctor if they experience any of the following: irritation or redness, nausea, vomiting, abdominal discomfort, diarrhea, skin rash, persistent pain lasting more than 7 days, or if redness is present. Special caution should be taken for children under 12 years of age, and patients should be encouraged to seek medical advice in such cases.

When using this product, patients must be reminded to use it only as directed. They should avoid contact with the eyes and mucous membranes; if contact occurs, they should rinse thoroughly with water. Additionally, patients should not apply the product to wounds or damaged skin, and they should refrain from tightly bandaging the area or using it in conjunction with a heating pad.

Storage and Handling

The product is supplied in a configuration that includes specific packaging details, which are essential for maintaining its integrity. It is crucial to store the product at a temperature below 38°C (100°F) to ensure optimal stability and efficacy.

Healthcare professionals should be aware that the product must not be used if the seal is broken, as this may compromise its safety and effectiveness. After each use, it is important to close the cap tightly to prevent contamination and preserve the product's quality.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)