Label: ON GUARD SANITIZING MIST- alcohol spray

  • 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 February 6, 2018

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  • ACTIVE INGREDIENT

    Ethyl Alcohol 64% (w/w)

    Drug Facts Panel

  • PURPOSE

    Antiseptic Antiseptic

  • INDICATIONS & USAGE

    Uses
    • Decreases bacteria on hands[skin]
    • Recommended for repeated use

  • WARNINGS

    Flammable. Keep away from flame, spark,
    or temperatures above 40°C (104°F)

    For external use only.

    Warning

  • WHEN USING

    When using this product avoid contact with
    eyes. If contact occurs, rinse thoroughly with
    water.

  • STOP USE

    Stop use and ask a doctor if irritation and
    redness develop

    Warnings p2

  • KEEP OUT OF REACH OF CHILDREN

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

  • OTHER SAFETY INFORMATION

    Other information
    • Store at a temperature below 38°C (100°F)
    • Do not use if quality seal is broken

  • INACTIVE INGREDIENT

    Inactive ingredients: Water (Aqua), Pyrus
    malus (Apple) Fruit Extract, Glycerin,
    Eucalyptus Globulus Leaf Oil, Citrus
    aurantium dulcis (Orange) Peel Oil, Eugenia
    caryophyllus (Clove) Bud Oil, Cinnamomum
    zeylanicum Leaf Oil, Cinnamomum
    zeylanicum Bark Oil, Rosmarinus officinalis
    (Rosemary) Leaf Oil, Citric Acid

    Inactive ingredients

  • QUESTIONS

    Questions? Call 1-800-411-8151

  • DOSAGE & ADMINISTRATION

    Active ingredient Purpose
    Alcohol 64% w/w.........................Antiseptic

    Directions
    • Wet hands thoroughly and allow to dry
    without wiping.
    • For children under 5, use adult supervision.

  • Principal Display Panel and Package Label

    doTERRA On Guard®

    Sanitizing Mist

    Antiseptic

    0.9 fl. oz/27 mL

    CPTG Certified Pure Therapeutic Grade®

    Sanitizer Label

  • INGREDIENTS AND APPEARANCE
    ON GUARD SANITIZING MIST 
    alcohol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71630-132
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ORANGE OIL (UNII: AKN3KSD11B)  
    APPLE (UNII: B423VGH5S9)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)  
    CINNAMON LEAF OIL (UNII: S92U8SQ71V)  
    CINNAMON BARK OIL (UNII: XE54U569EC)  
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    CLOVE OIL (UNII: 578389D6D0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71630-132-2727 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product11/17/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A11/17/2017
    Labeler - doTERRA International, LLC (832274935)
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