Otc - Active Ingredient
Active Ingredient
Menthol 10%
Deep Blue
FDA Label NDC 71630-882
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Doterra International, Llc for the product Deep Blue (NDC 71630-882). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - when using, otc - pregnancy or breast feeding, otc - keep out of reach of children, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Topical analgesic
Indications & Usage
Uses for the temporary relief of minor aches
and pains of muscles and joints associated with:
• simple backache • arthritis • sprains
• strains • bruises
Warnings
For external use only
Allergy alert: Do not use if allergic to
salicylates (including aspirin) without
consulting a physician.
Otc - When Using
When using this product • use only as
directed • avoid getting into the eyes or
on mucous membranes. If contact occurs,
rinse thoroughly with water. • do not apply to
wounds or damaged skin • do not bandage
tightly or use with a heating pad
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health care
professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If accidentally
ingested, get medical help or contact a Poison
Control Center immediately.
Otc - Stop Use
Stop use and ask a doctor if • irritation or
redness occur • nausea, vomiting, abdominal
discomfort, diarrhea, or skin rash occurs
• pain persists for more than 7 days, or redness is
present, or in conditions affecting children under
12 years of age
Instructions For Use
Directions
adults and children over 12 years: apply
generously to affected area. Repeat as necessary,
but not more than 4 times daily.
children under 12 years of age: consult a doctor
Other Safety Information
Other information • Store at a temperature
below 38°C/100°F • Do not use if seal is broken
• Close cap tightly after use
Inactive Ingredient
Inactive ingredients Cocos nucifera
(Coconut) Oil, Tapioca Starch, Gaultheria
procumbens (Wintergreen) Leaf Oil, Helianthus
annuus (Sunflower) Seed Wax, Copaifera
coriacea/langsdorffii/officinalis/reticulata Resin
Oil, Water (Aqua), Sambucus nigra Fruit Extract,
Prunus amygdalus dulcis (Sweet Almond) Oil,
Glyceryl Laurate, Glyceryl Caprylate, Mentha
piperita (Peppermint) Oil, Cinnamomum
camphora (Camphor) Oil, Eucalyptus globulus
Leaf Oil, Tanacetum annuum Flower/Leaf/ Stem
Oil, Glyceryl Undecylenate, Cananga odorata
Flower Oil, Capsicum frutescens Fruit Extract,
Glycerin, Lauric Acid, Chamomilla recutita
(Matricaria) Oil, Helichrysum italicum
Flower/Leaf/Stem Oil, Citric Acid
Otc - Questions
Questions or comments? Call 1-800-411-8151
Dosage & Administration
Active Ingredient Purpose
Menthol 10%................... Topical analgesic
Package Label.Principal Display Panel
doTERRA Deep Blue Stick +Copaiba
Topical analgesic
Net Wt. 1.69 oz/48g
* Please review the disclaimer below.
