FDA.reportPublic FDA data

Deep Blue

Manufacturer
dōTERRA International, LLC
Effective date
2021-07-15
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:41:31

Label at a glance#

ProductDeep Blue Copaiba
Active ingredientMENTHOL
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

Menthol 10%

Active IngredientActive Ingredient

OTC - PURPOSE SECTION

Topical analgesic

DosageDosage

INDICATIONS & USAGE SECTION

Uses for the temporary relief of minor aches
and pains of muscles and joints associated with:
• simple backache • arthritis • sprains
• strains • bruises

UsesUses

WARNINGS SECTION

For external use only
Allergy alert: Do not use if allergic to
salicylates (including aspirin) without
consulting a physician. Warning sectionWarning section

OTC - WHEN USING SECTION

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

WarningsWarnings

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health care
professional before use.

Pregancy sectionPregancy section

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If accidentally
ingested, get medical help or contact a Poison
Control Center immediately.

KORCKORC

OTC - STOP USE SECTION

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

Stop useStop use

INSTRUCTIONS FOR USE SECTION

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

DirectionsDirections

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

OtherOther

INACTIVE INGREDIENT SECTION

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

Inactive ingredientsInactive ingredients

OTC - QUESTIONS SECTION

Questions or comments? Call 1-800-411-8151

QuestionsQuestions

DOSAGE & ADMINISTRATION SECTION

Active Ingredient Purpose
Menthol 10%................... Topical analgesic

DosesDoses

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

doTERRA Deep Blue Stick +Copaiba

Topical analgesic

Net Wt. 1.69 oz/48g

Front PanelFront Panel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2475356menthol 10 % Topical OintmentPSN3
2475356menthol 0.1 MG/MG Topical OintmentSCD3
2475356menthol 10 % Topical OintmentSY3
2475356menthol 10 % Topical StickSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71630-882-482023-01-30C16284748780-1f386c649-c492-0266-e053-dadaa90a7c1aDeep Blue Stick with Copaiba 300904-A

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71630-882-48Deep BlueCopaiba48 g in 1 CYLINDERSTICK483

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71630-882DEEP BLUE COPAIBA (MENTHOL) STICK [DŌTERRA INTERNATIONAL, LLC]3Legacy NDC, 1 package rows20210716_bdc48d22-c5f6-665e-e053-2995a90a9dbe.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71630-88271630-882-48

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
NameUNIIKind
COCONUT OILQ9L0O73W7LIACT
STARCH, TAPIOCA24SC3U704IIACT
GAULTHERIA PROCUMBENS LEAF2125M16OWNIACT
HELIANTHUS ANNUUS SEED WAX42DG15CHXVIACT
HELICHRYSUM ITALICUM FLOWER OILO97ZV7726KIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
ALMOND OIL66YXD4DKO9IACT
PEPPERMINT OILAV092KU4JHIACT
CAMPHOR OIL75IZZ8Y727IACT
EUCALYPTUS OIL2R04ONI662IACT
MATRICARIA CHAMOMILLA FLOWERING TOP OILSA8AR2W4ERIACT
GLYCERINPDC6A3C0OXIACT
MENTHOLL7T10EIP3AACTIB
CANANGA OIL8YOY78GNNXIACT
SAMBUCUS NIGRA SUBSP. CERULEA FRUITEPM36Z6E4LIACT
GLYCERYL LAURATEY98611C087IACT
GLYCERYL CAPRYLATETM2TZD4G4AIACT
TANACETUM ANNUUM FLOWERING TOP OILE2Q02N1ZC7IACT
GLYCERYL 1-UNDECYLENATEB68LJT9544IACT
TABASCO PEPPERJ1M3NA843LIACT
LAURIC ACID1160N9NU9UIACT
WATER059QF0KO0RIACT
COPAIBA OIL64VX45Y68NIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
c72e69ff-9db2-6bd7-e053-2a95a90a5085bdc48d22-c5f6-665e-e053-2995a90a9dbe2021-07-15WarningsExact identifier
spl id: c72e69ff-9db2-6bd7-e053-2a95a90a5085
spl set id: bdc48d22-c5f6-665e-e053-2995a90a9dbe

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.