Label: DEEP BLUE COPAIBA- menthol stick

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated July 15, 2021

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  • ACTIVE INGREDIENT

    Active Ingredient

    Menthol 10%

    Active Ingredient

  • PURPOSE

    Topical analgesic

    Dosage

  • INDICATIONS & USAGE

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

    Uses

  • WARNINGS

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

    Warnings

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

    Pregancy section

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

    KORC

    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 use

  • 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

    Directions

  • 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

    Other

  • 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

    Inactive ingredients

  • QUESTIONS

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

    Questions

  • DOSAGE & ADMINISTRATION

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

    Doses

  • PRINCIPAL DISPLAY PANEL

    doTERRA Deep Blue Stick +Copaiba

    Topical analgesic

    Net Wt. 1.69 oz/48g

    Front Panel

  • INGREDIENTS AND APPEARANCE
    DEEP BLUE  COPAIBA
    menthol stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71630-882
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL10 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    COCONUT OIL (UNII: Q9L0O73W7L)  
    STARCH, TAPIOCA (UNII: 24SC3U704I)  
    GAULTHERIA PROCUMBENS LEAF (UNII: 2125M16OWN)  
    HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)  
    HELICHRYSUM ITALICUM FLOWER OIL (UNII: O97ZV7726K)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    CAMPHOR OIL (UNII: 75IZZ8Y727)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    MATRICARIA CHAMOMILLA FLOWERING TOP OIL (UNII: SA8AR2W4ER)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CANANGA OIL (UNII: 8YOY78GNNX)  
    SAMBUCUS NIGRA SUBSP. CERULEA FRUIT (UNII: EPM36Z6E4L)  
    GLYCERYL LAURATE (UNII: Y98611C087)  
    GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
    TANACETUM ANNUUM FLOWERING TOP OIL (UNII: E2Q02N1ZC7)  
    GLYCERYL 1-UNDECYLENATE (UNII: B68LJT9544)  
    TABASCO PEPPER (UNII: J1M3NA843L)  
    LAURIC ACID (UNII: 1160N9NU9U)  
    WATER (UNII: 059QF0KO0R)  
    COPAIBA OIL (UNII: 64VX45Y68N)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71630-882-4848 g in 1 CYLINDER; Type 0: Not a Combination Product07/15/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34807/15/2021
    Labeler - dōTERRA International, LLC (832274935)
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