Deep Blue

Description

doTERRA Deep Blue Stick +Copaiba is a topical analgesic formulated for localized relief. The product is presented in a stick dosage form, with 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 simple backache, arthritis, sprains, strains, and bruises.

There are no teratogenic or nonteratogenic effects reported in the available data.

Dosage and Administration

The active ingredient in this formulation is menthol at a concentration of 10%, which serves as a topical analgesic.

Administration of the product is to be performed topically. Healthcare professionals should instruct patients to apply the product directly to the affected area of the skin. The frequency of application may vary based on individual patient needs, but it is generally recommended to apply as needed for pain relief. Care should be taken to avoid contact with eyes and mucous membranes.

Before application, the area should be clean and dry. A thin layer of the product should be gently massaged into the skin until fully absorbed. Patients should be advised to wash their hands after application to prevent unintentional contact with sensitive areas.

Contraindications

The product is contraindicated in the following situations:

Application to wounds or damaged skin is prohibited due to the potential for adverse effects. Additionally, tight bandaging or the use of heating pads in conjunction with the product is not recommended, as this may lead to complications or exacerbate the condition being treated.

Warnings and Precautions

This product is intended for external use only. Healthcare professionals should advise patients to consult a physician prior to use if they have a known allergy to salicylates, including aspirin.

When utilizing this product, it is imperative to adhere strictly to the directions provided. Patients should be cautioned against allowing the product to come into contact with the eyes or mucous membranes; in the event of such contact, thorough rinsing with water is recommended. Application to wounds or damaged skin is contraindicated. Additionally, patients should avoid tightly bandaging the area of application or using the product in conjunction with a heating pad.

To ensure safety, this product must be kept out of reach of children. In cases of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is advised.

Patients should discontinue use and consult a healthcare professional if any of the following occur: irritation or redness at the application site, gastrointestinal symptoms such as nausea, vomiting, abdominal discomfort, diarrhea, or the development of a skin rash. Furthermore, if pain persists for more than 7 days, if redness is observed, or if the product is being used on children under 12 years of age, medical advice should be sought promptly.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this medication. 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.

Common adverse reactions reported include irritation or redness at the site of application. Patients are advised to discontinue use and seek medical attention if they experience any of the following symptoms: nausea, vomiting, abdominal discomfort, diarrhea, or skin rash. Additionally, if pain persists for more than 7 days, if redness is present, or if the patient is a child under 12 years of age, it is recommended to stop use and consult a healthcare professional.

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

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 for drug interactions or laboratory test interference is not indicated.

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 pain persists for more than 7 days, if redness is present, or in any conditions affecting children in this age group.

Geriatric Use

There is no specific information available 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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, 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 considered in these populations to ensure the safety of both the mother and the fetus or 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 medication 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 drug insert text regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment and monitoring of these patients.

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 imperative to seek immediate medical assistance. Healthcare professionals should advise patients or caregivers to contact a Poison Control Center without delay if the medication is accidentally ingested.

Prompt intervention is crucial to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific medication involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and evaluation are essential to ensure patient safety and effective resolution of any complications arising from the overdosage.

Nonclinical Toxicology

No relevant information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no pertinent data concerning nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are provided in the insert.

Patient Counseling

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

Patients should be instructed to stop using the product 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 patients with conditions affecting children under 12 years of age.

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. 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 NDC numbers, which should be referenced for accurate identification. It is essential to store the product at a temperature below 38°C (100°F) to maintain its integrity and efficacy.

Healthcare professionals are advised to inspect the product prior to use; it should not be used if the seal is broken, as this may compromise the product's safety. After each use, the cap must be closed tightly to ensure proper storage conditions and prevent contamination.

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)